5 Proven Ways to Improve Your Clinical Trial Protocol Synopsis

by Dr. Dean Meyer

The synopsis is an essential summary of the protocol for your clinical trial. You may be tempted to think of it as similar to the abstract in a manuscript of original research; it allows readers to understand the main points—what, why, who, where, and how—without reading the entire protocol. But the synopsis of a clinical trial is so much more than an abstract. 

On the surface, it appears that you are writing the synopsis of your clinical trial protocol for others: researchers in the field, funders assessing the merits of sponsoring your work, or regulators and policy-makers reviewing the ethics or feasibility of the work involved. However, the primary beneficiary of writing the synopsis is you.

Follow the five tips below to write a great clinical trial synopsis.

Tip #1: Write the synopsis before you write the protocol.

Instead of writing it after you’ve written the entire protocol, write the synopsis first. Use the synopsis as your tool for developing the protocol. If you write the protocol first and then summarize it in the synopsis, you lose a valuable opportunity to write a good, strong protocol in a systematic and thoughtful manner while minimizing stress. Save yourself time and aggravation by writing the synopsis first. This tactic enables you to do the hard thinking work up front, and writing the protocol will then become simply a matter of adding details to the statements you’ve made in the synopsis.

Tip #2: Include all the important (high-level) elements.

Use the synopsis to address each and every basic, major factor relating to the proposed clinical trial. What is the research question? When you know what your research question is, you will know which study design to use in the trial. What are your objectives in the trial? Have only one or two objectives, and define them in very specific words. When you know what your objectives are, you will know which measurement endpoints to use in the trial. Will these endpoints complicate the conduct of the trial in terms of time, expense, or inconvenience to participants? What is your hypothesis? Formulate your hypothesis after you conduct a search of the literature. The published literature will tell you what has been done in the field and what we know. The literature will also tell you whether your proposed research question has been answered already. If it has, save yourself time and revise your research question, objectives, and hypothesis.

Tip #3: Include only the high-level elements.

A good synopsis is short. Do not stuff it with small details! The synopsis is not a repetition of the protocol. Leave the small details to the protocol and keep the synopsis succinct. Answer the major questions and then stop. Cramming too many details into the synopsis is a mistake. In a manuscript of an original research study, a 200-word abstract is good and a 400-word abstract is terrible. Similarly, the synopsis of a clinical trial protocol is not intended to include every detail. Stick to the high-level facts and statements.  

Tip #4: Get someone outside your team to review and critique the synopsis.

Time for fresh eyes! You’ve been working intensively on formulating the basics of the clinical trial proposal, and it’s difficult to step back and see what is missing, unnecessary, or illogical in the document you wrote. Grab someone who has the scientific education to understand the synopsis but is not involved in the project, and let this person review the synopsis and ask you questions about it. In addition, remember that ambiguity and lack of clarity can arise from language barriers rather than from the scientific premise of the research question. If the language in which you wrote the synopsis is not your first language, get a professional editor to ensure that the synopsis is clear and easy to read. This will facilitate review board approval of your protocol and the scientific community’s interest in your objectives.

Tip #5: After you write the full protocol of the clinical trial, go back and check your synopsis again.

Should any sections of the synopsis be revised at this time? Look at the title: does it convey the objectives, design, and study population accurately? Is the participant timeline feasible, or will recruitment and the conduct of the trial take more time than you had originally estimated? Do you need to revise the calculated size of the sample required? Are the methods suitable to answering the research question in full, or should other endpoints be added or substituted?

Your synopsis is a tool for writing your protocol. Your protocol is the recipe for a successful trial. The synopsis is your tool, your map to writing an excellent protocol, and the protocol is the “recipe” for a successful clinical trial that will produce good insights and increase the knowledge base in the field. It all starts with the synopsis, step by step, answering one question at a time. Writing a good synopsis is the key to streamlining the process and creating the protocol for a clinical trial that would benefit everyone involved. Make that difference!

Dr Dean Meyer has a background in environmental science with a specialist interest in toxicology and public health. Her doctoral research work focused on molecular mechanisms of metal detoxification in an invertebrate model. Her other research interests include the mechanisms of toxicity and disease causation, and the occupational sources of xenobiotics and their physiological effects.

Dr Meyer spent 8 years working at the Centers for Disease Control and Prevention in Atlanta, and has an extensive background in the areas of laboratory safety and environmental health.

Dr Meyer is a certified Editor in the Life Sciences (ELS) and joined Edanz Group as an editor in 2015.

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