Creating a protocol for a new clinical study is no easy task. High stakes make this process more difficult. Therefore, the protocol not only details the purpose of the study, the questions it aims to answer, and the methods used to do so, but it also tackles ethical concerns. The protocol synopsis is used to write the full clinical trial protocol. It is usually written by the sponsor or the sponsor along with the clinical development consulting CROs like Veristat.
Here are four things you should think about when making a protocol to help you meet the challenge:
Hold a protocol strategy meeting
Before you start your at home clinical trials, have a meeting with everybody who will be involved in developing the protocol. To avoid unnecessary revisions and delays in the development process, it is important to get consensus early on important details such as the protocol’s end goal and the regulatory clinical endpoints that will serve as a benchmark for later stages. Don’t forget to include as many of the main players as possible. Involving everyone early can prevent serious concerns from being missed and costly protocol revisions later.
Consider the development stage when drafting your objectives
When a protocol is in its early stages, there are different things to think about than when it is in its later stages. Don’t lose sight of the big-picture goals that apply to your current developmental stage. Always remember that in phase I studies, safety is the most important thing to look out for, and pharmacodynamics and efficacy should be secondary concerns. When conducting phase 2 trials, effectiveness is of paramount importance, followed by safety. Validation of efficacy should be your primary goal in phase 3, with safety as your secondary priority.
Create a synopsis and timeline of events early on
The protocol synopsis provides an overview/summary of your protocol. In a table called the “calendar of events,” events like subject screening and recruitment, safety analysis, efficacy evaluations, pharmacokinetics testing, etc. are all described in detail. These subsections provide an ideal setting for consensus building among all parties involved in the study’s design, including sampling and evaluation points, before the creation of the full protocol. Protocol amendments can be avoided, as well as discrepancies within the text, by completing a synopsis and schedule of evaluations before writing the whole body of the protocol.
Include clear objectives and related endpoints
All clinical studies must have clear objectives to answer critical questions because all medications include risk. Every objective should also have a clear, unambiguous endpoint. Writing clear, precise research objectives allows Sponsors, regulatory authorities, and even the IRB to objectively examine if the intended study design will produce the necessary information. It can also assist the Sponsor to consider probable outcomes and the way the study design would support not only this study’s conclusions but the development programs as a whole. Scientific and medical professionals should examine the study design’s validity, including objectives, outcomes, and other features. A good protocol avoids ambiguity.
Well-written protocols protect patients, acquire quality data, and minimize trial development delays. Understanding regulatory obligations, clearly defining relevant study outcomes and objectives, including enough material within the protocols, and ensuring that the protocol document is user- and reviewer-friendly will all contribute to the study’s success.