Discover the top 5 mistakes in clinical study protocols that threaten research integrity and participant safety. Learn effective strategies to avoid these pitfalls for successful clinical trials.
Clinical study protocols are the bread and butter of any productive clinical research project. Following these protocols protect us and make sure that the research being done is safe, ethical and efficacious. Nevertheless, a large proportion of protocols are plagued with errors that can threaten the validity of study and participants safety. This article lists down the top 5 scary mistakes encountered by clinical study protocols accompanied with ways for avoiding such pitfalls.
Insufficient Informed Consent Process
The informed consent process is one of the most important parts in any clinical study protocol. However, only 20% of protocols properly define this process which can potentially give rise to ethical and legal concerns.
How to Avoid:
Generalize your Language: Write in layman’s terms and see if the average person can understand.
Exhaustive: Conduct Informed Consent clearly stating the purpose of the study, Risk and benefits from a Study.
Explanatory diagram: it is important that the new policy include every step of how consent will be informed and recorded.
Insufficient Risk Management
A good protocol will recognize associated risks, and how to handle them. While this is a good start, many protocols come short when it comes to both aspects and leave important parts out of place which is not only an issue with safety but also regulatory.
How to Avoid:
Comprehensive Risk Assessment: Perform deep risk assessment at the planning phase itself.
Robust Mitigation Plans: Create more granular mitigation strategies and solutions for addressing risks.
Strengthen Monitoring: Develop strong monitoring systems for adverse events detection, and reporting.
Unclear Objectives and Endpoints
A clinical study that has no clear objectives or endpoints, is doomed to fail. If your objectives are not well-defined, this leads to confusion and a tendency to interpret results incorrectly.
How to Avoid:
SMART: Make sure your goals are specific, measurable, achievable and relevant to time.
Unlike Fit-for-purpose, Clear Definitions defines the primary and secondary endpoints clearly.
Abstract of targets and endpoints that are consistent with the general study objectives.
Lack of Detailed Methodology
The methods section of a protocol describes how the study will be done. A poorly articulated or incomplete methodology can make your results hard to reproduce.
How to Avoid:
Detailed Procedures: Describe in detail all procedures of the study.
Consistency: Make sure that each site is following the same standard operating procedures
Consistency whereever possible: use same method wherever used in the study and provide a valid scientific reason for any deviation.
There are no data management plans.
Proper data handling is a must for the maintenance of both integrity and confidentiality in research. Most of the protocols are failing to have strong data management plans which is why we often see a security breach and the loss of data integrity.
How to Avoid:
More security: Apply strong data and confidentiality protections.
Concise Procedures: Clearly define the procedures of collecting, entering and managing data.
Provide Detailed Analysis Plans: Plan in-detail how you will analyze the data, including which statistical methods and software to be used.
These are some very common mistakes when doing a clinical study and avoiding them is essential for its success. A specialized consulting firm understands the language of medical research and enables a precise visualization that will translate positively.
Clinical Study Protocols
A unique opportunity for success through enhanced quality. Documenting excellence in the protocols by telling accurately and clearly what must be done and provide all necessary information.
Conclusion
Biotech consulting firms and pharma consulting firms in Boston can provide you with excellent support when it comes to clinical study design, implementation etc.
Reach out to BioBoston Consulting or go to the website and we will find a way that works best for you.
