Learn what is A clinical trial protocol, why it’s important, what the protocol should include, and how to conduct a clinical trial with a CRO
This article will address the following topics:
- What is a clinical trial protocol?
- Why is a clinical trial protocol important?
- What should a protocol for clinical trials include?
- Conducting a clinical trial with a CRO
- Clinical trials with Gsap
Clinical trials must strictly adhere to detailed protocols, which dictate every aspect of a trial. The clinical trial protocol documents the objectives, study design, methodology, statistical analyses, and general organization of a planned trial. It’s a critical document that helps to ensure that all data collected is robust, and also that the safety of trial participants is guaranteed.
What is a clinical trial protocol?
A clinical trial protocol is a written document that forms the backbone of the clinical trial. The protocol is finalized before any clinical trial activities commence, and must be observed and adhered to throughout the trial. A clinical trial protocol provides answers to many of the critical questions that come with a clinical trial, including:
● Why is the clinical trial being conducted?
● What are the questions that will be examined?
● How will the clinical questions be measured?
● Who can participate in the trial?
● What are the procedures that will be done during the trial?
The clinical trial provides details for physicians, study coordinators, and other staff regarding how to execute the trial. It also describes timelines for the trial, as well as ensuring data integrity and patient safety.
Before the trial commences, the protocol must be submitted for review by an ethics committee and be granted formal approval.
Why is a clinical trial protocol important?
A clinical trial simply can’t be completed without a clinical trial protocol. The protocol essentially acts as a set of quality control guidelines, put in place to protect both the participants in the trial and the integrity of data collected throughout the trial, and to ensure uniformity in the execution across all participating sites.
Specifically, a clinical trial protocol is important because:
● It ensures the safety and health of all participants in the clinical trial
● It details a strict and accurate study plan that all physicians, study investigators, coordinators, and trial staff must follow accordingly
● It ensures consistency in data collection and integrity, meaning that data from multiple different study sites can be compared or compiled
● Approval from ethics committees for the conduct of clinical trial cannot be granted without a robust clinical trial protocol
As you can see, the clinical trial protocol is crucial to the success of the trial itself.
What should a protocol for clinical trials include?
A clinical trial protocol needs to include all the information required to carry out the trial. More specifically, the protocol follows good clinical practice (GCP) guidelines or the closely related ISO 14155 guidelines for clinical trials of medical devices. GCP is an international ethical and scientific quality standard, which dictates how clinical trials should be conducted, and the roles of investigators, review boards, sponsors, monitors, and other stakeholders.
So, now that we know what a clinical trial protocol is, here is an overview of what needs to be included in a clinical trial protocol:
Purpose of the clinical trial
The clinical trial protocol must provide enough background information and rationale to outline the purpose of the trial, and justify why the trial is being conducted. The purpose of the trial will likely depend on the phase of the trial; earlier phase trials are usually to collect safety data, while later phase trials are to examine efficacy.
Trial outcomes and measures
The clinical trial protocol also needs to outline the measures that will define whether or not the trial is deemed successful. The protocol must detail measures that assess the safety and, if relevant, efficacy. Typically, a trial has one or two primary objectives and a few secondary or exploratory objectives.
Study participant criteria
Any given clinical trial has a strict set of guidelines relating to who can and cannot participate in the trial. These inclusion and exclusion criteria depend (among other things) on the disease being studied and the treatment being evaluated. For example, participants in a trial drug efficacy trial will likely need to have the condition or disease that the drug is being evaluated for. Exclusion criteria that could prevent a patient from participating in a trial may include age, medical history, or other medications that the patient is currently taking.
Study design and details
Other elements that need to be included in a protocol for a clinical trial include:
● The length of the trial and the number of participants needed
● The schedule relating to the frequency and duration of clinical visits for participants
● Suitable control measures, and whether or not some participants will be issued a placebo
To summarize, a clinical trial protocol must satisfy GCP guidelines, therefore ensuring both the integrity of the trial and the safety and well-being of trial participants.
Conducting a clinical trial with a CRO
As shown above, a clinical trial protocol needs to be extremely thorough and provide all necessary information to satisfy GCP guidelines and ethical considerations. If a clinical trial protocol is incomplete or insufficient, the trial will likely not receive ethics approval, and therefore cannot proceed. In addition, the trial objective must be carefully considered for the trial to meet the target and succeed.
Given that the clinical trial protocol is such a critical component of the trial itself, and essentially dictates how the trial will proceed, it is often necessary to enlist the services of a professional clinical research organization (CRO). A CRO works closely with the study sponsor to ensure that the clinical trial protocol contains all the necessary details for the trial to be approved.
CROs offer medical writers, clinical experts, and regulatory specialists that can assist in the clinical design and protocol development of your trial.
Clinical trials with Gsap
Gsap is a full-service CRO with years of experience in the design and execution of clinical trials. Gsap offers a team of professionals that can work with you to develop the clinical trial protocol, along with providing any other support your trial needs.
A boutique CRO providing personalized support
As a boutique CRO, Gsap ensures that you have more than an organization to develop your clinical trial protocol and manage your trial - you have a partner to assist you every step of the way.
Gsap has helped many clients create clinical trial protocols and manage the transition from pre-clinical development to clinical studies. The Gsap holistic approach to CRO services helps to ensure the success of your own clinical trial.
Contact Gsap today to discuss your upcoming clinical trial.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager
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