Author: Adaptive Research

Virtual visits (e.g., emails, phone calls, and videoconferencing) allow participants to interact with their trial team without the need for face-to-face meetings. They can be used in various settings but are frequently implemented to minimize travel requirements—for example, patients living in remote areas far from clinical centers. Or locations where frequent travel may present logistical challenges, such as international studies involving multi-country sites. Virtual contact is also increasingly being used in place of physical site visits to support the process of receiving informed consent and determining patient eligibility. Virtual contact is often combined with real-time technologies such as Web cameras and electronic patient diary apps to collect data. Virtual visits are becoming increasingly common in clinical research, but can they be implemented effectively? The Clinical Trials Transformation Initiative (CTTI)  The CTTI launched a multi-stakeholder, decentralized clinical trial addressing the best ways to implement remote patient data collection and monitoring — and provided researchers and regulators with the tools they need to support this new approach. At any rate, because of these combined factors, everyone involved in clinical research must understand how virtual visits work, their benefits and drawbacks, and what steps need to be taken to ensure that trials involving virtual visits adhere to ethical guidelines […] Virtual contact can take place either synchronously (e.g., using real-time technologies, such as web cams), or asynchronously (e.g., through electronic diaries). Benefits of Virtual Visits Virtual contact can bridge geographical or organizational gaps in clinical trials and has been used in a wide range of therapeutic areas [5, 6]. Examples include psychiatric [7], oncology [8], and cardiovascular studies [9], as well as infectious disease research with tuberculosis and HIV cohorts. Virtual visits may also be efficient when patients are experiencing severe symptoms that prevent travel to the clinic, such as most recently with…

Clinical trials face various issues that affect their scope and execution, with compliance being chief among them. Getting the cooperation of patients has long been one of the biggest issues with clinical trial planning and execution, with patients expressing how their visits were long and stressful while also pointing out travel issues and outdated processes as factors leading them to opt-out of trials. Add to that the regulatory complexities that clinical trials face, medical adherence, and following privacy requirements, and you have a lot of boxes that must be checked before trials can evolve.  Thanks to the increased advent of virtual clinical trials and connected medical devices, some of the burdens surrounding compliance have been reduced. But, to truly understand how to address compliance challenges, it must first be understood what drives these challenges and the modern solutions to firmly address them.  Keeping Patients on Protocols A major aspect of clinical trial retention is ensuring patients stay on protocols. Patient retention is key to driving trials through each phase seamlessly, keeping studies on track and saving clinical trial sites money, time, and resources. A failure to keep patients in protocols and stay in the trial until its conclusion invalidates data collected throughout the trial process. Most trials fail because they cannot retain enough patients. Statistics show that 40% of patients don’t adhere to protocols within 150 days of a clinical trial.  Much of the issues surrounding keeping patients on protocols deal with engagement, particularly a failure to meet unique patient demands. Patients feel especially empowered now during the pandemic era, so a failure to meet evolving patient demands puts trials at severe risk. A lack of appreciation, financial constraints, and inconvenient locations are among the main reasons why patients don’t comply with clinical trials.  A Lack of Medical Adherence Another…

Clinical trial budgets are hard to tabulate precisely. Contingencies often occur with trials, ranging from unforeseen expenses to patient-related delays to mounting site management costs. Even when expectations and objectives for a trial are clearly defined, the possibility of scope creep causes potential budget headaches, dissuading participation and putting trial execution in jeopardy.  Clinical trial budgets require more robustness and inventiveness than ever, considering the increasing average costs of new drugs and extensive setup times thanks to the increased emergence of multinational trials. Especially in 2022, when trials are harder to execute than ever because of all-time high costs, budget optimization should be a greater priority for researchers. All involved in trials should expect delays and prepare for the financial impact those delays will have. Here are five useful ways to maximize your clinical trial budget. Make the Budget Realistic Too often, scientists undervalue clinical trial costs and don’t prepare enough for the unforeseen circumstances that arise during planning and execution. A decrease in global averages regarding the year-over-year enrolment of patients in recent years means that more flexibility is needed to accommodate unexpected expenses.  Putting large contingencies in place to accommodate issues and variables negatively impacting trials will ensure greater planning and execution. Among these issues and variables are:  Protocol amendments Recruitment problems Issues with outsourced vendor management  Inflation Paying for Clinical Research Associates (CRAs) Clinical research associate shortages are profound worldwide, triggering increased demands and wages. Advertisements for CRA roles are in earnest. But, those in charge of clinical trials must be prepared to invest significant resources, with a long-term approach to attract the right staff and strong retention strategies to keep them.  Though trials are paying higher wages for CRAs, those costs are offset by reduced delays and costs cut with more efficient processes. The relationship between…

Clinical trials are very layered, and with those layers come various costs to weigh. Because of all the elements involved, mapping out exact budgets for trials can be challenging. Planning for unexpected costs is just as vital for clinical trials, especially when you account for factors such as: Slow enrolment  Amendments to various protocols  Various contingencies For all parties involved in a clinical trial to achieve a successful clinical trial, creating a budget that considers both the planned and unplanned costs is important, requiring diligent financial planning and structure. Clinical research organization (CRO) service costs and pass-through costs, as well as the regulatory authority and licensing costs, are among the various cost drivers you must consider that determine the success and failure of a clinical trial.  Costs Involved In Creating a Clinical Trial Budget The average clinical trial budget ranges from $4 million at phase one to $20 million for phase three. Typically, a clinical trial budget is broken up into two main parts: the CRO service costs and pass-through costs.  Pass-Through Costs The pass-through costs are expenses passed directly to sponsors at the actual cost. These costs include site and grant fees, fees that are paid to principal investigators, and sites for patient recruitment, with these costs usually comprising the largest aspect of the clinical trial budget. The site costs also include administrative costs, any fees for adding or removing trial sites, as well as site overhead, and storage fees to house trial records.  Another key cost driver among pass-through costs is travel costs. Travel costs could make up a substantial part of the clinical trial budget depending on study design and requirements, such as on-site monitoring frequency and where the site is located. If trials are planning to conduct multinational studies, there may also be currency fluctuations affecting…

Convenience, digitization, and greater application are three key benefits that decentralization provides clinical trials and the health industry as a whole. The pandemic demands more modern, digital healthcare solutions and, considering the financial and travel restrictions brought about by COVID, it’s crucial for sites to refine their setups and more seamless ways made available to encourage trial participation.  Decentralized trials are expected to increase by nearly 30% in 2022, with web-based questionnaires and eConsent among the elements to grow considerably, as well as enhanced clinical trial protocols. Additionally, decentralized trials provide more seamless ways for researchers and doctors to do their jobs while enhancing patient experiences. Why are these digital clinical trial alternatives on the rise, and what do they provide that their traditional counterparts do not?  Decentralized Clinical Trials Facilitate More Innovation Decentralized clinical studies are becoming more commonplace as clinical research organizations (CROs) find new ways to connect with patients from various backgrounds, made harder by the fact that turnover rates high within these organizations are high. Patient dropout continues to be a pertinent area of concern that hampers clinical trials, with travel and a reliance on outdated technologies cited as reasons for low participation rates.  Because of the limitations created by the pandemic, more innovative digital platforms are vital to optimize the collection and distribution of clinical data. Decentralized clinical trials are patient-centered alternatives to traditional clinical trials, becoming strategic priorities for providers as they conduct trials remotely or through local healthcare providers to boost patient experiences. Initially looked on as luxury pilot projects, decentralized virtual clinical trials have become more commonplace since Pfizer first introduced them in 2011.  Decentralized clinical trials utilize advanced technology, with more horizontal and vertical integrations initiated by technology providers, creating more end-to-end measures to deliver these trials.  What are the Benefits…

Clinical trials are moving more and more towards being fully digitized, with more digital health products being utilized to enhance data collection and remotely monitor patients, regardless of location. Considering that 58% of clinical trials were disrupted by the pandemic last summer, a greater need exists for the technological enhancement of all aspects of the clinical trial process.  Additionally, there is increased demand for personalized medicine to aid patient convenience and help physicians directly address patient needs. And, there is a wide range of macroeconomic trends like the increase of deal activity and job availability. The objective of every clinical trial going forward should be to minimize costs while creating the most engaging patient experience possible. These are some of the notable clinical trial trends you need to pay attention to throughout 2022.  Addressing Trust Issues  Trust is a crucial aspect of conducting clinical trials. The biggest challenge in the clinical trial industry for 2022 is gaining the trust of patients and doctors alike. Disconnects between the drug development industry and the public health sector have led to declining patient recruitment and increased scrutiny surrounding clinical research.  It’s clear that the traditional approaches to clinical trials are outdated and, with the widespread effects of the pandemic to be felt for the foreseeable future, the clinical trial industry. Not only should there be an increased focus on digitization, but more transparency is needed to ensure the clinical trial process achieves the kind of data optimization and exchange it craves.  Regaining trust requires the breaking down of silos and showing all of the processes that benefit patients. The drug development industry aims to step up in more proactive ways to gain public trust, responding to increased empowerment from the public as they question things more. Because of this increased empowerment, expect to…

Virtual clinical trials are crucial because they drive significant changes to how clinical research is conducted. While a plus for the industry, these decentralized trials also create more convenience for patients hoping to eliminate travel and improve accessibility for better, more efficient care.  Clinical trials are typically time-consuming and multi-layered processes that can take several years to complete. The average time ranges between six and seven years, sometimes taking up to 15 years. Plus, the costs involved with traditional clinical trials vary from marketing approval to research and development. Additionally, a large proportion of therapies falter during the early stages of clinical development. Virtual clinical trials, by contrast, as patient-centric because they take full advantage of advanced technologies like electronic monitoring devices and apps to improve patient care with less cost. What are the possibilities and opportunities that virtual trials offer patients?  Recruiting Patients with Traditional Clinical Trials is Very Costly One of the biggest causes of clinical trial delays is a lack of patient engagement. Typically, patient recruitment takes up a considerable chunk of the overall budget, which rose in 2021. Many trials fail to meet initial timelines and enrollment targets, with delays resulting in millions of dollars lost for companies. While reaching out to patients who have previously expressed interest in participating in clinical trials and improved targeting strategies help with patient engagement, the costs are still so hefty that they compromise any good-faith attempts to optimize patient recruitment.  Virtual clinical trials change the approach for patient engagement, reducing time and costs along the way. Traditional clinical trials exhaust time and expenses due to having a limited reach of fitting trial participants. These traditional trials recruit participants through clinics, hospital visits, and traditional media outlets like TV advertising, radio, and newspapers. Patient geography, however, limits the reach of…

The possibility of clinical research is unlikely to be achieved without the greater participation of physicians in the study. Physicians face a variety of barriers concerning involvement in clinical research. These limitations are system-or organization-related as well as research-and physician-related. To motivate physician participation, appropriate organizational and operational infrastructures are required in health care institutes to aid research planning and direction. All physicians should obtain education and training in the fundamentals of research. What factors limit doctors from conducting clinical trials and the way forward? Infrastructure limitations: Operating clinical trials within a practice also necessitates a particular type of infrastructure. For instance, staff members must attain training on informed consent, working with Institutional Review Boards, and research ethics. Additionally, clinicians and staff should be knowledgeable of achievable bioethical issues. Staff members must not put undue force on patients to participate in trials and should also ensure that patients who decline or pull back are not handled differently.Way forward: Most practices solve this by having distinct staff members who maintain an eye on enrollment, informed consent, and other research-related processes. Most practices must also launch another entity to store the finances and other operations of the clinical trials independently. Doctors have no room for making profits from clinical trials: Sponsors typically pay clinicians a particular amount per study participant recruited at the practice, contingent on the essentials of the trial. The compensation is typically enough to allow a practice to participate without losing income.Way forward: Sandoval identifies that profit should not be a solid ground to get involved in clinical trials. He also says that physicians should quit engaging in trials for the money. A much superior objective to participate is "for the patients.” Sandoval states. Participating in clinical trials can provide patients access to brand-new treatment choices or off-label uses…

Finding clinical trial sponsors can sometimes seem challenging because of many factors, including the lengthy risk aversion procedures imposed by the same clinical trial sponsors. In attempting to formulate a purely scientific experiment (to uphold the likelihood of drug approval), sponsors may constrain enrollment using extensive eligibility criteria that may exclude, for example, people on other medications or with comorbidities. These constraints on registration make it even more challenging to find a sufficient number of participants and protract the recruiting process. 2 main reasons why it is challenging to attract clinical trial sponsors? 1. Due to Clinical Trial Sponsor Induced Barriers Clinical Trial sponsors face various barriers before, during, and after conducting clinical research outside their control. However, there are also several barriers that clinical trial sponsors voluntarily impose upon themselves, unnecessarily adding further cost and delay to the clinical trial process. While some of these avoidable expenses and delays are incurred due to deficient early planning or inefficiencies in company operations, the majority of them arise from a desire to avoid failure at all costs (Kramer & Schulman, 2011). Failure for clinical trial sponsors to Integrate Study Design with Clinical Practice Flow.  Industry sponsors typically do not involve site investigators in the protocol design procedure. As a result, the necessary procedures outlined in the protocol might not be easy to easily combine into clinical practice at the sites (Kramer, Smith, & Califf, 2012).  A CRO representative interviewed provided these examples: for instance, a protocol could necessitate that magnetic resonance imaging (MRI) and a collection of neurocognitive tests be executed within three days of each other at a location that does not have adequate access to an MRI machine; or, a protocol might necessitate a series of labs that are remarkably specialized and can’t be executed by the site in-house.  Improved…

Clinical trials help researchers to discover new and superior treatments for illnesses and their side effects. One of the biggest barriers to patient participation is widespread myths about being in a clinical trial. Those involved with research can play an essential role in clearing up these myths by addressing them directly in recruitment materials and during initial conversations with potential participants. What are myths? They are widely held but false beliefs or ideas. Myths surrounding clinical trial participant recruitment Myth: I may be handled like a guinea pig.  Suggested message: This is not true. Instead, most clinical trial participants report that they were fully informed of all the outcomes of the clinical trials and were handled with dignity and respect. Most clinical trial participants feel that they were given extra attention and had more well-trained people observing them. Typically, strict guidelines are crafted to ensure that all clinical trial participants are treated honestly and ethically. Before any investigational drug can be administered to humans, researchers must complete rigorous testing and screening. Myth: After enrolling in a clinical trial, I won’t have the opportunity to change my mind. Suggested message: Understand that you are forever in complete control of your treatment plan as a patient. If you choose to get out of the clinical trial participation, you can withdraw. Myth: Clinical trials are dangerous as they use new medications and practices Suggested message: Since clinical trials are conducted to get new solutions to health problems, research may involve some level of risk. However, clinical trial participants get investigational medicine only after such treatment has undergone extensive testing. The extensive testing indicates that the medication is likely to be safe and effective in human beings. The utmost safety of all clinical trial participants is a priority for all researchers. Amidst the research,…

Adequate patient enrollment and retention are critical to the successful execution of a clinical trial. But, they are among the most demanding variables to control, with the average dropout rate across all clinical trials hitting around 30%. Even though patients are free to drop out from any clinical trial, this hinders new medical inventions. On average, it costs $6,533 to recruit a patient to a clinical study, and the average cost of recruiting a new patient if one is lost due to noncompliance is $19,533. In this blog, we explain why it's challenging to find people to participate in clinical trials and why they leave before accomplishing their intended purpose. What are the 9 major reasons for low patient recruitment and retention in clinical trials? 1. Covid 19 has worsened the difficulties of trial participant recruitment and retention. The challenges of trial participant recruitment and reservation have been intensified by COVID-19. Researchers point to patients’ heightened unwillingness to enroll in new trials, patient dropout, and noncompliance linked to travel restrictions and quarantined locations.  Based on a study organized by Continuum Clinical, 39% of sites surveyed in the USA stated they believe trial participants will be much less or a bit less likely to join the newest clinical research trials. Other considerations include elevated patient anxiety, hesitancy to visit healthcare facilities, and contamination risk between patients, sites, and the community. 2. Failure to see and appreciate the value of clinical trials due to personal reasons Suppose a patient feels like a number rather than an individual making a meaningful contribution to the clinical trial. In that case, they are most likely to drop out or hesitate to participate in future clinical trials. Most people are reluctant to participate in clinical trials because of the complex and highly demanding protocols they entail.…

In clinical research, budgeting is a key element of effective planning. To provide the best possible care to study participants, clinicians must have a budget that allows them to cover all their expenses. In other words, a clinical research budget should be balanced, enabling the clinician to have enough money to fund the necessary clinical activities while ensuring that the research center has enough to cover other expenses. To provide a framework for clinicians, clinical research professionals should estimate the average cost for certain procedures or general expenses required by a trial. You can begin to estimate this average cost by looking at other trials within your center and understanding what previous trials have done. A close review of a few previous studies should give you a sense of what companies typically budget for specific types of activities. In addition, some groups have conducted studies about budgets in clinical research organizations (CROs). With collaborative efforts from these different sources, you stand a good chance of creating reasonable budgets that allow your organization to handle study demands and meet its other responsibilities effectively. Consider Regulatory Costs Costs that are not directly related to the conduct of a trial but which can have an impact on a trial's success must be considered. Regulatory costs include licensure fees, product tracking and storage, informed consent forms, labeling changes, and equipment modifications. Recruitment and Retention Costs The cost of successfully recruiting human participants for clinical trials has been found to be increasing. It has also been shown that it is much more expensive to recruit people with certain characteristics. For example, older people are harder to reach, have higher refusal rates, take longer to screen, spend less time in study centers, are less compliant with treatment protocols, and have a lower retention rate than younger…

In the world of clinical research, certain practices will lead to effective collaborations between the sponsor and the site. It is important to plan, organize, and execute clinical trials in a way that minimizes inconsistencies due to differences in study design, participant characteristics, and clinical trial specifications. Many of the pitfalls encountered by trial sponsors that lead to inconsistent results are preventable. The following best practices can help you reduce these common errors and ensure that your trial is conducted in a consistent manner. Minimize Subject and Site Variation Reduce the amount of variability between your sites as much as possible. For example, if you're conducting a cardiovascular clinical trial with multiple sites, create one set of inclusion/exclusion criteria that applies to all sites within the study. This will help reduce inconsistencies and increase productivity by eliminating redundant explanations during training and certification. You should also minimize your site clientele. If you have an extensive participant population or numerous treatment arms for single-site studies, it is best to divide these types of trials into two separate studies. It is important to note that any changes made before the first screening visit requires a new protocol submission and approval process from the FDA. Additionally, deviations from your clinical trial agreement (CTA) will need to be addressed and approved by the sponsor and FDA before implementation. During study set-up, you must provide a detailed site profile that includes: Site Name, Company Name, Address, Contact Person(s), Phone Number(s), and FAX Number(s). You should also include the following: contact email address, website address, descriptions of your clinical trial-related tasks such as randomization/treatment allocation, data entry/quality control coordination, patient follow-up, and names of key personnel responsible for each task. Share Enrollment Updates Regularly Enrollment is a dynamic process, and the information you provide to your…

The patients who volunteer to participate in clinical trials are the backbone of medical research. They provide key information about their particular disease and what will help people with that disease in the future worldwide.  However, participating in a clinical trial is always associated with some degree of risk. The experimental treatment might be less effective than standard therapy, and there may be unpredictable adverse effects that can't be detected until after participants have taken part. This is where informed consent becomes critical to protect both participants and researchers. The goal is to balance potential benefits vs. risks while gathering high-quality data for everyone involved: patients, care teams, and study coordinators alike. Surprisingly, though, one important element in the informed consent process is often ignored: safety. While prospective participants have a right to know all potential risks involved with participating in a study, one side of this equation isn't always addressed—how much risk arises from not participating. In other words, patients who don't participate may miss out on important treatments or could be at higher risk for illness or death because they didn't receive the "new" treatment being tested. This, in turn, can negatively impact health care costs and overall patient care. To address this issue and offer a solution, here are three suggestions: Develop options for treatment outside of clinical trials. Ensure that research coordinators provide unbiased information regarding available treatments during the informed consent process. Monitor the health of patients who decline to participate in clinical trials or are unable to participate. The Importance of Participant Safety  Clinical research is essential to ensuring that the benefits of new drugs and devices outweigh their risks. The Food and Drug Administration (FDA) routinely approves new drug therapies for distribution to the public after clinical trials indicate that the benefits of…

Virtual visits (e.g., emails, phone calls, and videoconferencing) allow participants to interact with their trial team without the need for face-to-face meetings. They can be used in various settings but are frequently implemented to minimize travel requirements—for example, patients living in remote areas far from clinical centers. Or locations where frequent travel may present logistical challenges, such as international studies involving multi-country sites. Virtual contact is also increasingly being used in place of physical site visits to support the process of receiving informed consent and determining patient eligibility. Virtual contact is often combined with real-time technologies such as Web cameras and electronic patient diary apps to collect data. Virtual visits are becoming increasingly common in clinical research, but can they be implemented effectively? The Clinical Trials Transformation Initiative (CTTI)  The CTTI launched a multi-stakeholder, decentralized clinical trial addressing the best ways to implement remote patient data collection and monitoring — and provided researchers and regulators with the tools they need to support this new approach. At any rate, because of these combined factors, everyone involved in clinical research must understand how virtual visits work, their benefits and drawbacks, and what steps need to be taken to ensure that trials involving virtual visits adhere to ethical guidelines […] Virtual contact can take place either synchronously (e.g., using real-time technologies, such as web cams), or asynchronously (e.g., through electronic diaries).  Benefits of Virtual Visits Virtual contact can bridge geographical or organizational gaps in clinical trials and has been used in a wide range of therapeutic areas [5, 6]. Examples include psychiatric [7], oncology [8], and cardiovascular studies [9], as well as infectious disease research with tuberculosis and HIV cohorts. Virtual visits may also be efficient when patients are experiencing severe symptoms that prevent travel to the clinic, such as most recently with the pandemic.…

Clinical trials by their very nature are very complex. They are lengthy, costly, and often difficult to access. That makes the field ripe for real-world application, and by most accounts, decentralized clinical trials are the most promising way to implement them.  But challenges remain, especially when considering how to best implement them in the medical industry.  The potential of decentralization is significant, but it can be difficult to implement. Organizations must decide on the best way to use this approach and how to implement the technology without overextending budgets.The bottom line is that the current research model is flawed, but decentralized clinical trials are not necessarily the perfect solution. Let's explore these challenges and some solutions a little further. Challenge #1: Collecting Patient Data One of the major benefits of decentralized clinical trials is that they allow for a wider range of participation, as long as patients have appropriate access to the internet. In fact, this new model will likely be able to reach more people than traditional models due to its ease of use. However, it must be considered that not everyone has access to the internet. A decentralized clinical trial that cannot reach these populations will not be very effective at all. This is especially important in developing regions of the world where internet access might be more limited. It will also be important to consider how patient data are handled. Each person's medical history can provide valuable insight into the efficacy of a new drug or treatment. If this data is stored on a centralized server or database, it could be exploited by hackers or governments. New technology must be developed to prevent the loss of this important data and keep it secure. Challenge #2: Refinement of Data Decentralized trials present unique challenges related to patient safety…

Clinical trials are experiments that test new treatments and therapies. They can help researchers learn whether a drug is effective in treating a disease, or if it has harmful side effects with few benefits. These studies may impact the lives of thousands, even millions of people by providing more information on diseases and improving standards of care. Unfortunately, there are a number of misconceptions surrounding clinical trials.  Here we provide information from our own experiences to address some common concerns with clinical trial participation: 1) "I Don't Have Time" One of the most frequent reasons patients give for not participating is that they don't have time or cannot miss work. In fact, many clinical trials do not require participants to spend additional time beyond their normal activities outside of work or school. Some studies will even allow participants to continue taking their medications as prescribed, without interrupting their normal activities, during the clinical trial. 2) "I Don't Want To Risk Harm" In most cases of participation in a clinical study, a patient would not be exposed to new drugs or treatments if they did not have a disease or condition being studied. In rare instances where a placebo is being used – meaning there are no active ingredients – it is nearly always for cancer trials and under strict guidelines with oversight by an independent board responsible for protecting patients from harm (IRB).  3) "I Won't Get The Medication" This myth can often keep patients from participating in trials even when they may actually qualify and could benefit. Even though drugs tested in clinical trials are not readily available because they have not been approved by the FDA, many patients report getting access to new medications once they enroll in a trial. In fact, some companies make experimental drugs available…

Social media is a great resource for clinical trial recruitment, but it takes more than just posting information to drive recruitment. To maximize recruitment through social media, the social media manager needs to use certain best practices. These tips for effective social media recruitment will help you reach more potential participants and drive clinical trial enrollment. 1) Be Relevant Your posts should be targeted at the people you want to see them. For instance, if your research is on children's diabetes, post about things that affect this community, such as local news and events related to diabetes. If your research is on adults' fertility, share stories about infertility and family planning.  You should also make an effort to learn what types of posts are most popular with your targeted followers—you can usually see at least a rough estimate of how many people have liked or commented on each one. If something isn't getting much interest, consider changing things up before trying it again.  2) Use Images Posting information without including an image makes your message less memorable and reduces sharing. Social media audiences rely heavily on visuals such as photos and videos rather than text so it's important not to underestimate their power. One study found that 80% of people remember what they both see (as images) and read (as text), compared to only 20% of people remembering text. There's no magic formula that works on every social media platform, so you'll want to do some experimenting and see what kinds of posts get the highest rates. Photos with faces generally perform better than those without as they show there are real people behind a study—if you can't include actual photos, stick to graphics like infographics or logos for companies involved in your trial. 3) Be Consistent Recruitment is time-intensive…

On social media, patients can connect with healthcare professionals (HCPs) and ask questions about day-to-day life, offer feedback, and respond to health news and research. Social media can also be a great way to recruit individuals to clinical trials. But, there are many factors to consider, such as recruitment strategies, privacy issues, and social media rules.So, how can clinical trialists effectively recruit using social media?First, you must ask yourself if using social media is the best way to reach your audience. There are many different recruitment techniques that can be used on social media. For example, some HCPs might choose blogging as a way to recruit patients because it provides specific information about the clinical trial. But others may choose Facebook Ads! In fact, Facebook Ads are a great way to reach people who are interested in a clinical trial. You can reach just about anyone with an interest in your study. This diversification is important for clinical trial designers, as patient recruitment can often be age-dependent. However, not every Facebook user has the time to read your status update or research on your page. For this reason, it is important that you post high-quality content and ensure that your posts are highly relevant to both end-users and search engines. Then you should think about how social media fits into your overall recruitment strategy. Social Media Recruitment StrategiesThere are a number of ways that social media can be used as part of a wider recruitment strategy. These include:Using ads to target those with an interest in your condition. In addition, you could use the same adverts to point those interested towards other resources such as clinicaltrials.gov or your own study website.Linking up with groups that are relevant to your study—for example, patients' support networks or patient organizations that have a high online presence.…

Clinical trials are important to business and society and play a significant role in the industry. From medical benefits to product development, trials allow for the development of new products and therapies. When companies leverage these trials to drive income, they are able to achieve their business goals while improving the quality of life for patients around the world.If you’re planning a clinical trial to gather data on a new drug, service, or technology, several clinical trial factors can help to drive income and achieve business goals.Collaborate With Other Academic InstitutionsMany universities and research facilities have the capacity and resources to conduct clinical studies. You can collaborate with these institutions and combine your company’s resources to conduct a study with more patients. This will be beneficial for you and help you gather significant data quickly without any additional cost.For example, a pediatric patient population can find it difficult to enroll in a clinical trial. By joining forces with a research facility that already has patients enrolled, you will increase your chances of enrolling a larger pool of study participants who fit the inclusion/exclusion criteria for your trial.Collaborate with Industry PartnersCollaborating with experts in the industry can be a great way to overcome barriers such as funding, patient recruitment and retention, regulatory guidance, and statistical analysis. A pharma company may have specific insight into clinical research challenges that you can use when hiring an outsourced clinical research organization (CRO). For example, some CROs are specifically equipped to deal with clinical trial management for large products where the endpoints are different.You can also consider partnering with CROs that possess regional knowledge and the ability to recruit the right patient population for your study. This will allow you to focus on monitoring patient compliance, ensuring proper documentation of side effects, and safety concerns,…

Clinical trial performance metrics are among the most powerful tools for assessing progress, decision making, and measuring the strength of evidence used in clinical trials. These metrics are vital for both sponsors and regulatory authorities to make informed decisions about continuing a clinical trial, modifying the trial protocol, selecting the sample size for statistical power, or terminating a study early. These metrics clarify a trial’s performance expectations regarding patient recruitment and retention, which drives both cost-effectiveness and efficiency.  This is called the "critical path" in the drug development industry (i.e., when a clinical trial starts and ends, how long it takes). As the number of clinical trials increase year after year, planning and monitoring is more important than ever. What Are Clinical Trial Metrics?Clinical trial performance metrics are the numbers used to measure the performance of a clinical research team. This includes site patient accrual, site staff compliance with study procedures, site accuracy in data entry, and site retention rates. Sites are measured based on these metrics so that researchers can determine whether they are being effective.The Importance of Measuring Site PerformanceClinical research organizations (CROs) rely on clinical trial data to make decisions about effective sites. Sites that do not meet acceptable performance levels may be dropped from studies or added to the list of sites that are excluded from ongoing study selection processes. Before being considered for future work, a site must prove itself to be effective at managing the clinical trial.How to Measure Site PerformanceSite performance is generally measured by researchers on three core metrics: 1) patient enrollment rate, 2) data accuracy, and 3) retention/attrition rate. All three are critical for developing an accurate picture of whether your clinic is meeting its recruitment goals.1. Patient Enrollment RateIn the fast-paced world of clinical trials, speed is essential. The faster a site…

One of the most important aspects of clinical trials is obtaining informed consent from all patients. The word “informed” is critical here because it underlines that researchers must explain the purpose, procedures, and potential benefits of research in order for study participants to honestly give informed consent before enrolling in a trial.Informed consent is also a legal requirement of a clinical trial that requires a clinical trial sponsor to provide prospective participants with adequate information about the trial. The U.S. Food and Drug Administration (FDA) regulates the safety and efficacy of drugs and medical devices. Patients must understand the trial’s objectives, risks, and benefits to make an informed decision about participating in a clinical trial.The Importance of Informed ConsentAuthorization is given or withheld by the patient after being informed of all pertinent facts regarding the study. A researcher cannot ethically enroll human participants into a clinical trial unless they have gained informed consent from them.When patients are informed of the risks and benefits associated with a clinical trial, they can then determine whether or not to participate. This process ensures that research is performed ethically. This process protects both patients and researchers, ensuring that all parties involved are protected in the event that issues arise later about whether consent was adequately obtained or if the study was adequately explained.Informed consent is obtained through written documents, verbal explanation, audio presentation, visual aids, or some combination thereof.Why is Informed Consent Obtained?Informed consent is obtained for the following purposes: To protect the rights and welfare of human research participants. The Federal policy on human research participants is intended to ensure that adequate information about potential benefits and risks are described in a clear, understandable way. This allows people to make free, voluntary, and informed decisions about whether or not they wish to participate in a…

There's plenty of work that goes into facilitating clinical trials. From patient consent to oversight of data collection, clinical trials take a diverse set of skills and disciplines. In addition to understanding these areas, an important aspect of a clinical trial's organization is knowing how it is organized and how it impacts the services they offer. Teamwork is a crucial part of creating high-quality data in a clinical trial. This requires effective communication between different teams within the company. But do you know the differences between DMCs and IRBs? The following article provides an overview of these groups, their role in clinical trials, and how they work together to ensure quality data. There's plenty of work that goes into facilitating clinical trials. From patient consent to oversight of data collection, clinical trials take a diverse set of skills and disciplines. In addition to understanding these areas, an important aspect of a clinical trial's organization is knowing how it is organized and how it impacts the services they offer. Teamwork is a crucial part of creating high-quality data in a clinical trial. This requires effective communication between different teams within the company. But do you know the differences between DMCs and IRBs?  The following article provides an overview of these groups, their role in clinical trials, and how they work together to ensure quality data. What Are Data Monitoring Committees (DMCs)? A DMC is a group that has been officially approved by either the FDA or its local equivalent to monitoring data produced by a clinical trial. DMCs are cross-institute groups that are composed of patient representatives, statisticians or methodologies, clinical experts, and sponsors to ensure all data was collected correctly.  Typically comprised of 5-6 members, DMCs work independently from the study team by verifying the scientific validity of the data…