Clinical research is integral for the progress and advancement of treatments for a variety of diseases, cancers, viruses and so much more. Participating in clinical research at the site level by way of managing and executing a clinical trial is a noble task and with it comes great responsibility. That responsibility is typically shared across a team of highly trained, and caring individuals. Everyone has a role, and a responsibility delegated by the primary investigator. No matter what your role is in the clinical trial process, it often comes with a heavy focus on clear, accurate and reliable documentation. Another way of looking at how reliable the documentation is how it relates to trust. Clinical trial data should be trusted data, and transparency related to data builds trust.
Clinical Trial Participants – Demand for Safety Driven by Trust
Not only is it a noble task to agree to assist in managing a clinical trial, but it is also considered noble to participate in one. Because patients that agree to participate in a clinical trial are in a vulnerable position, they need to know they can trust that their safety and their rights are always respected. Unfortunately, the climate of trust has not always been preserved within clinical trials. From the Nuremberg war trials to the PHS Study of Untreated Syphilis (commonly known as the “Tuskegee Syphilis Study), transparency was not even remotely considered. As we know, some of those unfortunate events have created the need for various regulatory and ethical considerations such as the Belmont Report, the FDA modernization act of 1997, and the WHO resolution of 2005. All these efforts and others have laid the groundwork for modern day clinical trials which demand transparency to drive trust, and engagement.
We know that trust is a key driver for clinical trial participation. Does the participant trust that their safety is a consideration? Do they trust that they will be presented will all of the information before agreeing to participate and throughout the trial?
Data Sharing – Sharing is Caring
In addition to standard regulations, other organizations have published commitments to responsible data sharing practices such as the Pharmaceutical Research and Manufacturers of America (PhRMA) or policies requiring registration of clinical trials as a condition of publication as in the International Committee of Medical Journal Editors. These regulatory and policy considerations drive the need for increased transparency towards the public, the clinical trial participants, and other researchers. Further, a recent FDA News Release from June 26, 2024, details drafted guidance on diversity action plans for certain clinical studies. Underrepresented population’s engagement is historically lacking in many different types of clinical studies. The increased effort for clinical trials to be more inclusive aims to help those in need, and better the existing and future data related to those studies making transparency ever more important thus improving trust.
Data Integrity
One of the tenants of transparency is data that can be trusted. Data integrity is key in clinical trials. All data that is complete, consistent, and accurate should have the following characteristics: attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). As most of the clinical trial data is generated electronically, transmission of data has become more convenient, yet is also prone to be altered.
To prevent alteration and to align with the ALCOA principles, the US Code of Federal Regulations (21 CFR Part 11) outlines the criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. An example of this are automated audit logs. They record each action taken, when it occurred, and the user who made the action. These records are automatically and independently captured by a computer system or software (like Vestigo, Vestigo Verify and Vestigo Verify Central), timestamped, and cannot be edited. Users can only enter and update information. This ensures an unalterable record.
Data Policies – Transparency is the Best Policy
When considering best practices for maintaining transparency, it’s important to think about implementing policies that promote transparency. Some notable topics to perhaps include are:
- Data system access guidelines and processes if using an electronic accountability system
- Information about what technology is being used
- Technical specifications for technology being used
- Data sharing:
- How will data be stored?
- How will data be shared?
- Who will have access to the data?
- How will access to the data be limited?
- Communication guidelines:
- What will you be communicating internally and externally?
- How and what will be communicated?
Don’t leave the person reading your policy unassured of anything about the clinical trial data, and how it is controlled and maintained.
Treat Transparency as a Tool
When considering the tools you will need to have a successful clinical trial, transparency should be amongst the tools in your box. Because there is an anticipated role transparency will play in clinical trials, driven by more and more technology platforms becoming available to assist and maintain documentation, it is important to vet such platforms to make sure transparency and privacy is being preserved. As increasingly complex data is needed in clinical research trials, security measures should be established in research methodologies. One of the many drivers for a successful trial is its data, how it is stored, shared, and maintained. Make sure your data is backed by reliability and transparency – the patients consenting to participate deserve it.
About the Author
Andrea Lane, CPhT, CSPT, ACRP-CP
Customer Success Manager, McCreadie Group
Andrea brings over 20 years of experience as a certified pharmacy technician, with 13 of those years dedicated to clinical research. Currently serving as a Customer Success Specialist at McCreadie Group, Andrea is a subject matter expert for Vestigo, McCreadie Group’s flagship solution for investigational drug services. In her role, she provides training and support to new and existing clients, ensuring seamless adoption and utilization of Vestigo across research pharmacy sites.
Andrea is passionate about engaging with the clinical trials she supports, drawing on her extensive background to provide exceptional service and insights to clients.
She holds certifications as a CPhT, CSPT, and ACRP-CP, underscoring her commitment to advancing excellence in clinical research pharmacy operations.