Enhancing Adherence in Clinical Trials: A Strategic Imperative
When a high-profile authority in the medical world, such as the World Health Organization (WHO), publishes guidelines on best practices in clinical trials, the industry takes note.
Aiming for Reform and Improvement
WHO’s latest guidelines aim to “reform, improve, and streamline” oversight and approval processes, strengthening clinical research systems. While the true impact will depend on the adoption of these measures, the broader recognition of the need for change is a positive step forward for the industry.
Defining a “Good” Clinical Trial
The WHO guidelines outline five key scientific and ethical considerations essential for a “good” clinical trial—one that is reliably informative, ethical, and efficient. The first of these key points emphasizes that trials must be “designed to produce scientifically sound answers to relevant questions.” Within this, adherence to the allocated trial intervention is highlighted as a critical area of focus.
The Role of Adherence in Trial Integrity
WHO unequivocally states that adherence—faithfully complying with the allocated intervention—is critical to the success of randomized clinical trials. Adherence ensures that regulators can confidently determine the efficacy and safety of the therapy under trial. Furthermore, the integrity of the trial’s output depends on robust methodologies and rigorous data-capture techniques to evidence this adherence.
The Challenge of Ensuring Adherence
Despite this logic, adherence within the clinical trial ecosystem remains a challenge. Many participants do not consistently adhere to dosing regimens or accurately report their dosing activity, leading to:
- An incomplete picture of exposure
- Obscured efficacy and safety conclusions
- An increased risk of misleading results or trial failure
In short, adherence may be valued, but it is not always adequately monitored, promoted, or protected.
Addressing the Adherence Challenge
A crucial part of the solution lies in WHO’s fifth key point: “Good clinical trials manage quality effectively and efficiently.” Given the risk adherence poses to trial integrity, monitoring and measuring adherence should be considered a key priority. This aligns with the Risk-Based Quality Management (RBQM) framework and Quality by Design (QbD) principles, long championed by both the FDA and EMA.
Optimizing Trial Design for Adherence Monitoring
To optimize dosing-history data capture, trials must move beyond human-centric adherence monitoring methods, such as:
- Pill counts
- Self-reported data
Instead, there is a clear need to adopt automated digital techniques that:
- Reliably, efficiently, and accurately track dosing activity
- Empower regulators with better information
- Provide a clearer picture of true exposure levels
A Strategic Imperative for the Future
Implementing automated digital adherence monitoring should not just be a best practice—it should be a strategic imperative driving better outcomes and stronger results. A clinical trial’s core purpose is to evaluate treatment effectiveness, not just according to protocol but in relation to actual exposure levels.
Turning Best Practices into Reality
The clinical trial sector has a unique opportunity to not only embrace WHO’s adherence strategy but also implement practical solutions and technologies that enhance study strength. By doing so, the industry can transition from theoretical best practices to a practical reality of improved clinical trials.
