The site selection process often gives insight into factors that may determine the clinical trial’s success, notably subject enrollment. Unfortunately, the site selection process is primarily manual and prone to errors, creating many challenges that prolong the trial, inflate its costs, and compromise the quality of its results. Here is a brief overview of the common challenges hampering research site selection and three possible solutions to help optimize subject enrollment.
Challenges Hampering Research Site Selection & Subject Enrollment
The most common challenges facing research site selection and subject enrollment include:
- Poor site selection resulting in under-enrollment of subjects
- Failure to meet enrollment targets
- Enrolled subject lost of follow up
- Budgetary and cost pressures
Subject enrollment is the greatest challenge facing research sites. Notably, about 37% of research sites don’t enroll enough subjects, while 11% fail to enroll even one subject, effectively crippling the trial. 89% of research sites eventually enroll enough subjects, but they often require more time, resulting in delays.
Budgeting and costs are also significant challenges for many clinical trials. Pharmaceutical companies spend about $2 billion to bring a new drug to the market, and about 30% of the budget is allocated to subject enrollment. Unfortunately, delays experienced in subject enrollment usually increase the trial’s cost, forcing sponsors to increase their budgets. Notably, delayed market entry costs sponsors between $1 and $8 million daily.
Practical & Reliable Solutions
Improving the research selection process to optimize subject enrollment requires a holistic approach. The following tips can help improve your research selection process and overcome some of the challenges discussed above:
- Reviewing the Site’s Past Performance
Experience is crucial in the clinical trial niche, and a research site’s past performance usually reflects its competence. Has the site met its previous subject enrollment targets and what cycle time can it provide for your trial?
Ideally, the site should also implement strategies that facilitate continual innovation to improve its clinical trial processes. For example, does the site conduct post-mortem on subjects to identify factors that may have contributed to the test’s failure?
- Considering the Site’s Access to Potential Subjects
The research site’s location can affect its ability to find potential subjects for your clinical trial. Ideally, the site should be located close to an area with enough people diagnosed with the target disease.
Site must be able to not only identify and recruit potential subjects, but must also be able to retain any subjects enrolled in the study.
- Site Processes & Infrastructure
Proper adherence to protocol design is of critical importance. In some instances protocol deviations may not be the result of site action or inaction and thus may be very difficult to avoid completely. However, sites that have proper policies and procedures in place will ultimately be able to collect the best data for Sponsor
Is the research site equipped to handle your clinical trial? Ideally, the site should have the entire infrastructure listed in the protocol. Notably, the site’s staff should be appropriately skilled and experienced to conduct the trial while ensuring compliance.
It is also advisable to consider a research site specializing in the target disease. It also helps if the site has a principal investigator with publications on the target disease.
- People Make All The Difference
All other things being equal, the experience of a site with regards to successfully enrolling subjects into a clinical trial may be the most important factors in predicting future success. Sites with a history of successful enrollment are likely to maintain this level of performance. During the site selection process, Sponsors should spend considerable time and effort to understand past performance, as well as the factors behind past success.
Conclusions & Takeaways
Our site has considerable experience in Phase I, as well as Phase II to IV clinical trials. We have a long history of successful enrollment with a number of different specific patient populations. However, the biggest factor is the quality of our people. A site’s Investigators and the quality of its clinical research staff is really the x-factor in terms of producing a successful outcome. A high quality staff will not only help to ensure the factors noted above are in place, but will help to overcome unforeseen challenges that may arise during the course of a clinical trial.