Monthly Archives: June 2022

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…