Monthly Archives: August 2022

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execution, with patients expressing how their visits were long and stressful while also pointing out travel issues and outdated processes as factors leading them to opt-out of trials.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…