Drafting a clinical study protocol

In the last few years, the importance of clinical trials has become increasingly apparent. Unfortunately, in our modern, global community, COVID-19 may not be our last pandemic. Moving forward, it is vital we pinpoint new ways of ensuring their accuracy, legitimacy, and efficacy. Clinical trials are a vital function of Life Sciences, and new requirements to increase diversity as well as perform them remotely need a great deal of expertise, focus, and planning. In this first of a two-part series, we will outline the foundational needs related to clinical protocol. In the second installment, we will then discuss and highlight the implication of the evolving environment including diversity and decentralized clinical trials.

Fundamentally, trial investigators need to describe the objectives, design, methodology, statistical considerations, and organization of a trial while ensuring adherence to stringent regulatory guidelines. This is essentially a clinical study protocol.

A clinical study protocol is an essential parameter for trial investigators, enabling them to tick all the necessary boxes for a successful clinical trial. It is the first document that is drafted when designing and planning a clinical trial. All related and involved documents, templates and forms, digital interventions, etc. are in alignment with the protocol. Moreover, a clinical study protocol also enables everyone working on a trial to adhere to stringent regulatory guidelines. This is critical to the success of the trial, which is why multiple parties help to draft a protocol. The spotlight shines bright on clinical trials right now. As such, it is paramount that the investigators get everything right.

High-level overview of how to draft a clinical study protocol

There are several steps involved in the design and development of a protocol. A high-level, simplified representation is illustrated in the diagram below:

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