The pharmaceutical industry has long grappled with the problem of poorly written clinical study protocols. The study protocol describes the conduct of a study, its objectives, methodology, design, and statistical considerations and ensures the safety of participants and integrity of data collected. The teams generally responsible for protocol writing are the medical writing and regulatory and clinical and operations groups. The medical writing and regulatory groups usually know what content belongs in protocols while the clinical and operations groups select the optimal design for studies.
Unfortunately, the clinical and operations groups generally lack adequate time to coordinate well-written protocol documents. Therefore, cutting corners often occurs during protocol writing. This leads to unnecessary amendments and problems when reporting clinical trial results. More serious implications include a study that generates inconclusive data, extensions of study timelines to collect additional measurements, inconsistencies that require explanations to health authorities, and more involved quality assurance activities. The ultimate ramifications comprise increased costs and a potentially jeopardized program.
In recent years, Synchrogenix has supported organizations transforming their approach to developing protocols. The approach has evolved from clinical and operations protocol ownership and resistance to medical writing participation, to embracing of the role of a medical writer in the process to finally creating their own writing team focused on protocol creation and lifecycle. In addition, medical writers working on protocols often review the informed consent form and case report form and participate in cross-functional reviews with transparency and disclosure representatives. This bridges the strengths of medical writers (clarity, consistency, adherence to process, coordination of reviews, balance of objectives of speed and completeness, and creation of the building blocks for downstream documentation) while allowing the clinical and operations teams to be critical reviewers, owning the design and feasibility, bringing in the patient perspective and understanding of the disease, and focusing on the training and site set up. This approach also supports coordination across studies if amendments are needed after study initiation.
Regardless of your organization’s size, you must define who is responsible for each element of developing a protocol. Realize that these fundamental elements will carry through the program for its duration. Focusing on the goals for your protocol, defining responsibilities, and identifying owners will ensure generating quality protocols that lessen the need for future amendments. This wise approach solves problems now and avoids them in the future.
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