Clinical Data Interchange Standards Consortium (CDISC)
August 22, 2024
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The clinical trial protocol is an essential document for the successful conduct of a clinical trial. As per the US FDA, “Clinical Protocol should be submitted for each planned clinical study or trial. An original IND application submission lacking a clinical protocol is considered incomplete.” Therefore, a clinical trial protocol must be prepared to conduct any trial under the US FDA. Though it is mandatory, however, what is more important is what this clinical trial protocol contains. Other than the sponsor, only an experienced medical writer could assess the real value of a well-written clinical trial protocol that could generate quality data. This blog will discuss the importance of a clinical trial protocol in drug development, the challenges related to clinical trial protocol development, and the importance of hiring an experienced medical writer.
As the clinical trial protocol lays down the plan for a clinical study, it provides detailed information about multiple downstream activities during the conduct of a clinical trial. Therefore, it should be enriched with valuable information, which can lead to as few amendments as possible. The major components of a clinical trial protocol include:
The clinical trial protocol is the basis for trial registration,3 and it guides those responsible for conducting the study. Its importance is reflected in the below points collected from the regulatory guidelines:
A protocol should be specific, uncomplicated, sensible, and understandable in terms of the study design and its implementation in the real world.
Clinical trial protocol writing begins while considering the sponsor’s viewpoints of their study. The primary error in writing an effective protocol can begin here only. Understanding the sponsor’s viewpoints and implementing these (considering the practicality of the protocol) is essential. Firstly, a sponsor should consider achieving a few precise objectives during the study instead of doing it all. Secondly, these objectives must be technically sound and clear to the writer. This way, the study design in a protocol will focus on answering these precise objectives only. This will make the protocol writing and implementation effective in the real world.
A lot of protocols lead to amendments because the documented activities in these seem impractical when the clinical trial is being conducted. Therefore, a sensible protocol is crucial for the timely completion of a clinical trial.
In many scenarios, the documented procedures in the protocol turn out to be unclear to the clinical study site personnel, and they misunderstand what they are intended to do and when. This further leads to protocol violations and errors in collecting data from enrolled patients. Therefore, a protocol should be written in simple and clear language that can be understandable by the personnel involved in its implementation.
The most common challenge in developing a clinical trial protocol is deciding what to include in it and what not. Many protocols fail to provide clear information about important study elements (as described in the section above), which affects understanding and implementation of the protocol. The importance of protocol is often not truly recognized by the sponsors and writers, which delays the study and increases the cost to the sponsor.9
As per 21 CFR 312.42(b)(2)4, the FDA may place a proposed or ongoing Phase 2 or 3 investigation on clinical hold if it finds that the plan or protocol for the investigation is deficient in design to meet its stated objectives. Therefore, this challenge can be overcome by the medical writer in consultation with the sponsor team to include all required study elements in the protocol in a complete, clear, and easy manner.
An experienced medical writer will know these challenges and the importance of an effective clinical trial protocol. Writing protocols for multiple indications can be useful in providing suggestions about the study designs. Specifically, medical writers who are involved in writing all downstream documents related to a clinical study protocol (for example, an informed consent form or a clinical study report and its publishing activities) will know how the data collected with their written protocol can impact the clinical study report and its publishing.
The clinical trial protocol is a significant document in the journey of clinical drug development from the beginning to its marketing approval. Developing too complex a protocol can affect all the downstream activities involved with its implementation in the real world. Effectively written protocols can increase the value of a clinical trial by only collecting quality data. This can further make the work of the regulatory reviewers effortless, ultimately benefiting the sponsor. Therefore, choosing an experienced medical writer to develop an effective protocol is the key to this whole process, which should not be compromised at any level.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.
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