Monthly Archives: July 2022

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,…