It all Starts with the Protocol
A well-designed study protocol is paramount to ensuring the success of a clinical trial, and therefore should be approached with utmost consideration. Here, we will show you what a strong study protocol is comprised of and will give you the necessary framework for writing efficacious protocols in the future.
More than just instruction manuals, protocols are multifunctional and detailed roadmaps that are the core mechanism behind translating an idea into an effective clinical trial. When writing a protocol, it is important to carefully consider its various objectives, from scientific methodology to patient safety parameters.
It is likewise important to critically assess the study’s clinical importance, and to robustly examine its feasibility. We have found that there is a direct correlation between the simplicity, clarity and practicality of a protocol, and its successful implementation.
7-tips for successful clinical trail protocol:
Dr. Michael Kamkha, MD, MRQA, Cromos Pharma’s Head of QA, outlines his tips for a well-written protocol:
1. Understand the requirements before writing
This means being fully aware of ICH requirements, as well as local laws and regulations in the country where the trial will be conducted, (e.g., if you are conducting a trial in an EU country, you will have to ensure compliance with local GDPR).
2. Content guidelines and templates
Avoid leaving out important details by compiling a content list in advance, referring to all relevant ICH requirements and guidelines of local regulatory authorities (e.g., FDA or EMA). Check your list carefully against current requirements. If you are using a template, make sure to check that it is up to date with current regulations (e.g., new EU regulations on single country submission).
3. Develop the synopsis and schedule of events as early in the process as possible.
Developing the synopsis and finalizing the schedule of events early on can help avoid inconsistencies in the text and the need for amendments later. It also allows for various stakeholders to opine on the design, the inclusion/exclusion criteria that may require adjustments.
4. Clear objectives and endpoints
Ambiguity is to be avoided at all costs when writing a protocol. Create clear and definitive objectives, associated endpoints, and avoid the use of vague language. Selecting improper endpoints can be catastrophic for a clinical trial. If possible, avoid selecting multiple primary endpoints.
5. Provide detailed descriptions of assessments and operational feasibility
Provide clear and detailed information, on the who, what, when, where and how of study conduct, so clinical researcher can follow procedures effectively and consistently. It’s a good exercise to have your clinical operations staff check for inconsistencies or potential for misunderstandings in the protocol as soon as it is conceptualized.
6. Arrange the protocol to promote ease of reference
It may seem obvious, but it is important to organize the layout of your protocol in a way which allows readers to efficiently locate specific sections. This will increase productivity and eliminate any unnecessary confusion. Using headers and sub headers effectively, as well as adding page numbers and section headings, will help readers more easily navigate the protocol. Regardless of who is reading it, regulatory authorities or clinical site staff, a proper layout will make following the protocol a more straightforward process .
7. Rigorous risk-assessment
Finally, any study protocol should be subjected to rigorous risk-assessment before submission, to highlight any inconsistencies and to mitigate any risks. Whenever possible, it is strongly recommended to involve KOLs, clinicians with experience in a given therapeutic area, and CRO medical partners that can provide an objective analysis of potential problems.
Cromos Pharma has extensive experience in developing protocols, aiding in scientific and operational input, and adjusting protocols to country-specific requirements. Our medical writing team is comprised of MD’s and Ph.D.’s in biomedical sciences. Over the past 18 years, they have crafted a vast number of submission dossiers for all phases of global clinical trials, in a wide range of therapeutic indications. They are ready to assist you in the design and writing of a protocol, and all other trial-related documentation, to ensure timely and effective progression of you clinical development plan.
About Cromos Pharma
Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management.
Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Türkiye to offer exceptional patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials.
We provide accelerated study start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data.
Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is located in Portland, Oregon, USA and its European HQ is in Dublin, Ireland.
If you have any questions or want to find out more about how Cromos Pharma can support your next clinical program please get in touch with us by emailing firstname.lastname@example.org.