Do CROs Over-Complicate Clinical Trials? An Opinion by a PI Presents Challenges
[Thursday, May 2, 2019]
Clinical trials are complicated long-term and high-risk projects. But is it because of the inherent nature of the project, the regulations, the investigators, or the contractors hired to help with doing clinical trials? A recent opinion piece by two prolific clinical investigators blames the CROs with adding many unnecessary and overtly cumbersome processes that make clinical trial projects hard to conduct both for physicians and patients. The two clinical investigators, one from the United Kingdom and another from France, contend that while the clinical trial rules have not changed for the last 20 years, during the same time, clinical operations have become highly bureaucratic creating enormous burden for the patients and investigators and hurting the trials in the process. While most clinical trial industry professionals may be inclined to simply reject these complaints as individual cases, many of the comments made by the authors are reasonable grievances from clinical investigators. It is true that many clinical trial operations are designed to increase the documentation by adding tasks that can be either pooled with other tasks or reduced in their scope. Clinical sites are expected to do a lot with a justification that it is needed by regulations while the rules may be more flexible than presented. For example, the authors are right to point that informed consent forms longer than 8-10 pages are less likely to be read by the patients or investigators carefully, and reconsenting process needs to be appropriately justified based on risk to the patients and not due to a bureaucratic requirement. The authors are also right that simplifying many steps in the clinical operations and reasonable risk-based reduction in the burden on patients for participation are direly needed. It is important that the clinical operations be true to the regulatory requirements and every task be justified based on practical and clinical requirements. The authors are also right to point out that clinical operations have become more legalistic aiming to protect the sponsors and contractors involved in the clinical trials. There is need to revisit and simplify the clinical trial process to assure patient safety and data integrity. There is no question that clinical trials have become very sophisticated over the last 2 decades but in the process the simplicity of testing a drug to find its utility have somehow been forgotten. But to blame just the CROs would be an over-simplification of the problem. Sponsors, consultants, planners, and strategists need to share the responsibility. By not asking important questions during planning and not forcing everyone involved to justify every task, we aggravate the problem. Bureaucratic justifications should be shunned and focused efforts to reduce the number of steps involved implemented. It is important to listen to criticism so better, productive, and easier trials can be conducted.