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Eight Steps To Writing an Immaculate Clinical Trial Protocol

The role of a clinical trial protocol is essential in research and CRO services, hence the importance of its correctness and validity. In this article we share some key tips on how to write a successful clinical trial protocol. 

A clinical trial protocol describes a precise study plan and guarantees the safety of study subjects and the integrity of the collected data. The aim of a study protocol is to formulate hypotheses and objectives, describe visits and study procedures, as well as methods and statistical considerations for analyzing data in detail, clarify ethical considerations, and suggest the methodology necessary to solve the issue and reach the objectives for a clinical study. 

1. Check your clinical trial protocol team  

While developing a protocol there should be effective coordination with a multidisciplinary team in place. Make sure to involve as many of the major stakeholders of clinical trials in the process as possible, which frequently includes a clinical scientist, statistician, data manager, project manager, medical writer, medical monitor, regulatory manager, quality assurance manager, safety manager and investigators. 

2. Double-check the requirements  

All clinical trials must be compliant with the ICH’s (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) GCP (Good Clinical Practice) guidelines, and have subject protection based on the Declaration of Helsinki. Additionally, the laws and regulations of the country where the study is going to be conducted may imply more requirements. For example, if you are going to conduct a study in a European Union country, you will have to ensure compliance with local General Data Protection Regulation (GDPR). 

3. Take your time with protocol contents  

The ICH’s GCP guidelines report the list of contents that should be included in the protocol. It consists of the following: title page (general information), background information, objectives/purpose, study design, selection and withdrawal of subjects, treatment of subjects, assessment of efficacy, assessment of safety, statistics, direct access to source data/documents, quality control and assurance, ethics, data handling and recordkeeping, financing and insurance, publication policy and supplements/appendices. Don’t hesitate to use ready-made templates for protocol development such as protocol templates recommended by TransCelerate. 

4. Be clear, precise and thorough with your wording 

It is vital that all research team members have the same understanding of all aspects and procedures to be followed. Allow no ambivalence, double interpretations or overgeneralized phrases in the text, especially in terms of critical points such as assessment of the primary endpoints, main aspects of statistical analysis, and measures to prevent bias in the study. Simplicity and consistency of the text are other integral components of a successful protocol for a clinical trial. 

5. Justify study conduct and study design 

The introductory part of a research protocol should outline a detailed plan of the study, its goal, objectives and rationale, justification of the target population, therapy, and design of the study, so that regulatory authorities and investigators understand why this study is carried out and so they can evaluate its compliance with the requirements of regulatory guidelines and clinical practice standards. 

6. Anticipate risks  

Recruitment failure is the most frequent reason for premature discontinuation of clinical trials. In order to avoid this, evaluate and discuss the practical implementation of the requirements set out in the protocol with colleagues. Special attention should be paid to the list of eligibility criteria and description of all study procedures. Review by investigators engaged in the trial is crucial at this stage. Identifying all weak points in advance, you will minimize risks of poor recruitment and ensure the successful initiation of a research program in accordance with planned milestones and timelines. 

7. Make up a list of activities for subjects  

Describe in detail all study activities that participants will be undergoing. Lack of detail in this area makes it difficult for an IRB (Institutional Review Board) to understand and approve a research plan and complicates further understanding of research procedures by research and project teams. 

8. Proof-read, proof-read again and verify the pre-final version   

Developing a protocol is a time-consuming process. The number of draft versions can reach several dozens. Thorough review of a protocol by the whole multidisciplinary team engaged in a project is crucial so that all final decisions are taken into account and no intermediate comments remain in the document. Final verification of a protocol should be done by a quality assurance department. 

The OCT Clinical team has more than 15 years’ experience of managing clinical trials and delivering CRO services in Europe. Due to our vast experience, we can anticipate most risks and pitfalls at the study design development stage. Contact us to learn more about our protocol preparation services and to find out how we can help you with your studies. 

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