Clinical Study Protocols: A Comprehensive Guide to Best Practices From A Senior Medical Writer

Clinical study protocols serve as the foundation for conducting medical research and are critical for drug development and approval.

To ensure compliance with subject protection standards and statutory requirements, clinical study protocols are submitted to global health authorities, such as U.S. Food & Drug Administration (FDA) for rigorous review prior to a Sponsor being allowed to conduct a study.

In this article, the basic steps to write clear, concise clinical study protocols that meet regulatory guidelines are explained and examined in-depth.

Tips for writing great clinical study protocols

When drafting a clinical study protocol, medical writers should know the following key points:

  • Understand all relevant regulatory requirements (refer to content guidelines such as ICH E6 [R2]1 and FDA guidance2) before writing.
  • Use the Protocol Concept Sheet as a starting tool. This is a draft clinical study protocol of the Sponsor Clinical Trial to explain what a proposed study is about, why it is being undertaken, and how it will be carried out.
  • Develop the Synopsis and Schedule of Events early in the process. A concise synopsis provides an overview of all study aspects and mirrors the outline of the clinical study protocol
  • Templates may be available online such as joint NIH/FDA clinical study protocol
    • The National Institutes of Health (NIH) and Food and Drug Administration (FDA) developed a clinical trial protocol template3 with instructional and example text for NIH-funded investigators to use when writing protocols for phase 2 and 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications.
    • Recommend use of a Smart template that provides automation and reduces the time needed to draft the protocol.
  • Instead of copying text, consider cross-referencing to one appropriate location.
  • Always take the necessary time to check that you are not missing critical details or even entire sections.
  • Check for consistency between the clinical study protocol body and the synopsis.
  • Submit the clinical study protocol for review by Quality Control (QC)/Quality Assurance (QA) before final approval to ensure quality and compliance.

Bearing the above in mind, clinical study protocols should also include the following features:

Clear and Specific Objectives

Begin by outlining the study’s objectives in a clear and specific manner.

  • Define the primary research question, secondary objectives, and endpoints.
  • Clearly state the hypothesis or research hypothesis tested during the study.

Comprehensive Background and Rationale

  • Provide a concise yet comprehensive overview of the background and rationale for the study.
  • Explain the necessity of the research and its contribution to the current body of knowledge.
  • Describe how the study fulfils an unmet need.
  • Cite relevant literature to support the rationale for the study.

Precise Study Design

Choose a study design that aligns with the stated research objectives.

Inclusion and Exclusion Criteria

Set forth the criteria that will be used to select participants for the study. These standards ensure that the study population is relevant to the research objectives. Inclusion and exclusion criteria should be well defined and based on medical and scientific justifications.

Ethical Considerations

Describe the ethical principles that will guide the study, including patient confidentiality, informed consent procedures, and participant safety. Adhere to the ethical guidelines and regulations set by relevant authorities.

Interventions and Procedures

Detail the interventions or treatments that participants will receive during the study. Outline the procedures, study visits, dosages, and frequency. This section should be comprehensive and provide a clear understanding of how the study will be conducted.

Data Collection and Analysis

Explain how data will be collected, including the types of data, measurement methods, and tools to be used. Describe the statistical methods that will be employed for data analysis, including sample size calculation and statistical tests.

Study Timeline

Create a detailed timeline that outlines key milestones of the study, from participant recruitment to data analysis and publication. A well-structured timeline helps manage expectations and ensures the study progresses smoothly.

Adverse Event Monitoring

Detail the procedures for monitoring and reporting adverse events during the study. This is crucial for participant safety and maintaining the integrity of the research.

Collaborator Roles and Responsibilities

Drafting a clinical study protocol is a team effort. A medical expert, a biostatistician, a pharmacokinetic expert, the clinical research coordinator, and the project manager all provide input to the medical writer to produce the final document. Clearly defined roles and responsibilities for each member of the research team, including study investigators, statisticians, and data managers ensures effective collaboration and accountability.

Conclusions

Writing an efficient clinical study protocol requires meticulous planning, a deep understanding of the research objectives, and adherence to ethical guidelines. A well-crafted clinical study protocol not only ensures the success of the study but also contributes to the advancement of medical knowledge. By following the strategies described above, researchers can create clinical study protocols that are clear, concise, and capable of yielding meaningful and impactful results.

References

  1. ICH guideline for good clinical practice E6(R2).
  2. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials.
  3. Clinical Research – Office of Science Policy (nih.gov): Clinical trial E-protocol tool and template documents.

For questions related to this article, please click here and we will connect you with a expert.

Authored by: Anju Bhakri, Senior Medical Writer, Regulatory and Medical Writing at MMS Holdings

Suggested For You

perspectives

September 30th, 2024

Meet the Leaders Driving MMS’s European Growth

perspectives

September 30th, 2024

The Future of Data Management and Biostatistics: Trends and Technologies Shaping the Industry

perspectives

September 24th, 2024

Embracing Quality Management Maturity (QMM) at the Cornerstone of the Pharmaceutical Industry

perspectives

September 11th, 2024

From Historical Precedent to Modern Approvals: Lessons Learned on OTC Drug Products for FDA OMORs

perspectives

September 4th, 2024

Email Security – Navigating Through the Process of Validation and Compliance with Healthcare Business Stakeholders

perspectives

August 27th, 2024

Optimizing Oncology Drug Development: FDA Expedited Pathways, Real-Time Review, and Global Programs

perspectives

August 13th, 2024

How To Navigate The Nonclinical Evaluation Landscape Of Biopharmaceuticals

perspectives

August 5th, 2024

Ensuring Robust Data Privacy and Protection: An Overview of the MMS Framework

perspectives

July 30th, 2024

The Critical Role of Quality Control (QC) – Medical Writing and Beyond

perspectives

July 23rd, 2024

PSI 2024 Ignited Conversations on External Data Sources, Requirements for Estimands, and Bayesian Methodology for Statisticians in Pharma

perspectives

July 16th, 2024

Key Steps to Successful CMC Authoring of IND and IMPD Submissions

perspectives

July 9th, 2024

Managing RTOR Submissions: How to Run a Successful Race from the Top Line Starting Line