The Top Compliance Issues Affecting Clinical Trials

The Top Compliance Issues Affecting Clinical Trials

Clinical trials face various issues that affect their scope and execution, with compliance being chief among them. Getting the cooperation of patients has long been one of the biggest issues with clinical trial planning and execution, with patients expressing how their visits were long and stressful while also pointing out travel issues and outdated processes as factors leading them to opt-out of trials. Add to that the regulatory complexities that clinical trials face, medical adherence, and following privacy requirements, and you have a lot of boxes that must be checked before trials can evolve. 

Thanks to the increased advent of virtual clinical trials and connected medical devices, some of the burdens surrounding compliance have been reduced. But, to truly understand how to address compliance challenges, it must first be understood what drives these challenges and the modern solutions to firmly address them. 

Keeping Patients on Protocols

A major aspect of clinical trial retention is ensuring patients stay on protocols. Patient retention is key to driving trials through each phase seamlessly, keeping studies on track and saving clinical trial sites money, time, and resources. A failure to keep patients in protocols and stay in the trial until its conclusion invalidates data collected throughout the trial process. Most trials fail because they cannot retain enough patients. Statistics show that 40% of patients don’t adhere to protocols within 150 days of a clinical trial. 

Much of the issues surrounding keeping patients on protocols deal with engagement, particularly a failure to meet unique patient demands. Patients feel especially empowered now during the pandemic era, so a failure to meet evolving patient demands puts trials at severe risk. A lack of appreciation, financial constraints, and inconvenient locations are among the main reasons why patients don’t comply with clinical trials. 

A Lack of Medical Adherence

Another key compliance issue affecting clinical trials is a lack of medical adherence, leading to necessary increases regarding patient sample sizes to maintain sufficient statistical power. Additionally, declining medical adherence leads to clinical trial delays and compromises medical product approval. Plus, many clinical trial participants throw out investigational products before study visits and also aren’t being upfront about their medication compliance when connecting with clinicians. This lack of transparency negatively impacts regulatory dosing recommendations once medical products are approved. 

Without patient compliance, clinical trials lose accuracy and are forced to contend with compromised budgets. 

Confusing Forms and Communication Issues Don’t Help 

Many patients fail to comply during clinical trials because of consent forms that are hard to understand and filled with a mish-mash of information. Some of these consent forms are too difficult for patients to read, and some exceed 20 pages, making it hard to retain the information they contain.

Furthermore, there are constant communication issues between patients and doctors/physicians as patients, driven by a fear of disappointing the doctor/physician they interact with, will not be completely truthful about their experience and concerns. Also, some patients live busy lives, believing they will be dropped from clinical trials if they don’t perfectly adhere to trial protocols. 

How Can Compliance Issues Be Addressed Properly?

First and foremost, there should be complete clarity and definition regarding the expectations of the clinical trial and their participation requirements. People who understand these expectations are more likely to comply with the trial and will be more open about their experience as long as they know from the beginning what is expected of them. Such patients will be more eager to complete a trial and participate in future trials. 

Establishing greater transparency also encourages greater compliance as many patients are hesitant about blindly sharing data with entities conducting health-related research. Greater data transparency builds trust between patients and medical personnel as many patients want to feel like they are partnering with the people when conducting trials. Patients want to know what the trial steps are and have a clear idea of how they can participate. 

With virtual trials on the rise in today’s marketplace, clinical trial sponsors can provide more simulations to illustrate how trials work while designing patient-friendly protocols. Additionally, sponsors can create networks allowing participants to maintain contact after trials have been completed or to provide information to future trial participants. 

Facilitating Constant, Real-Time Feedback

Another measure to simplify compliance issues is to facilitate data collection methods from remote locations, providing added convenience to patients and doctors/physicians alike. Gamification improves feedback with the information provided in real-time. Additionally, with artificial intelligence paving the way for a more digitized future for clinical research, AI tools can analyze to what extent patients follow trial protocols and alert patients whether they’re taking their medication incorrectly. 

Using Remote Data Collection to Improve Communication and Information Quality 

Using digital data collection means improving communication and ease of use for patients who feel uncomfortable sharing their sensitive information with medical professionals. Collecting data through connected medical devices and wearables allows more results to be collected rather than just collecting one result during an in-person visit. With more longitudinal data at their disposal, investigators have a more comprehensive overview of patient data within a real-world setting. 

Telemedicine can also be used to improve communication between investigators and patients, enabling them to review test results while working on ways to improve care. More tests can be completed in remote locations, with data transmission done from a patient’s home via connected medical devices. As a result, patients won’t be required to travel as frequently, improving a patient’s willingness to stay in a trial. 

With remote data collection comes more security diligence, identifying potential cyber threats. Particularly virtual clinical trial leaders must understand the presence of cyber risks and apply strong control measures to identify risks throughout the entire trial ecosystem. By addressing cyber issues, the reliability of clinical research increases, with compliance improving as a result. 

At Adaptive Partners, we team up with community physicians to integrate clinical trials into their practices to provide new opportunities for the patients they recruit. Learn how we do this through our various solutions.

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