Decentralized Clinical Trials

Jenna Brager, PhD, RN, MS
Senior Executive Director of Regulatory Affairs for MyMD Pharmaceuticals^®, Inc. April 27, 2022

Differing from traditional clinical research, Decentralized Clinical Trials (DCTs) employ a more patient-centric approach by minimizing common barriers to participation (e.g. time and travel demands) by utilizing different technologies.1 Depending on the study design (patient population, length of the study, objective(s), and intervention(s), etc.) various technology platforms, digital health apps or wearables can be employed to impact the number of in-person visits required on behalf of the patients. At times, mobile healthcare providers, or even patients' personal physicians may be able to interact with study participants to reduce study-specific visits.2,3 DCTs use of technology to monitor patients and collect real-time data allow visits to occur virtually anywhere. Since patient assessments are not restricted to visits held solely on site, more frequent data collection is possible as well. As a result, study costs are reduced which help support medications reaching the market at an increased pace. Additional benefits include:

Adaptability

Patients typically travel to a site to complete visits throughout the course of study. Depending on the length of the study, this may lead to day-to-day disruptions leading to an increase in attrition. DCTs, however, could implement a patient-centered approach by leveraging virtual tools such as telemedicine and wearable devices to carry out remote visits and monitor data at the convenience of the patients. The more adaptable the study design, the easier it is for patients to seamlessly complete all the requirements outlined in a specific protocol. This not only helps the sponsor and research teams but enhances patient satisfaction.²

Data Variability

As mentioned above, DCTs allows visits to happen outside of the site. As a result, geographic barriers are decreased which may result in greater diversity in participants enrolled in the trial. Common challenges impacting the elderly, those living in remote areas, or minority groups who are currently underrepresented in traditional onsite designs can increase overall representation in clinical trials.¹

Removing these common barriers plaguing clinical trials results in a more diverse set of data reflective of a real-world setting which can enhance the external validity of the clinical trial. ¹

Communication

Effective communication between the patient and the study site personnel is essential in any clinical trial as it helps keep the participants motivated and enhances retention. DCTs can employ ePRO (electronic patient reporting outcome) tools to maintain real-time communication with the patients. These tools give participants the ability to report symptoms and other data in real-time, thus eliminating reporting error, missed data points, or safety issues. Additionally, the utilization of telemedicine makes it easier for patients to interact with study personnel at their own convenience. Also, e-Reminders can be employed to help participants remember to submit important data consistently and in real-time.

Even though there are benefits to DCTs, it is important to consider the following challenges:

Data Protection

DCTs need to ensure safeguards are in place to monitor the safe transmission of patient data across digital platforms. Sponsors and CROs need to ensure cybersecurity measures and risk assessments are completed to ensure compliance with data protection regulations.

Fortunately, most deployed tools are HIPAA compliant and have already passed various safety checks to ensure storing and transfer processes are validated.

IP Distribution and Management

Drug management and distribution is an essential part of a clinical trial. Traditional clinical trials have an easier time with managing this task in comparison to DCTs as traditional trials ensure drug is stored at a central location or research site where storage and stability requirements can be monitored regularly.¹

DCTs, on the other hand, afford patients the ability to have drug shipped directly to the home. However, this approach can be costly and limits the ability to track storage, stability requirements, identifying potential drug tampering, and untimely drug refills due to shipping issues. Additionally, complications can occur as drug dispensing regulations can vary across locations. ¹

Implementation Technology

DCTs take advantage of numerous technology platforms to complete all tasks and assessments outlined in a protocol. With that said, many devices such as wearables are continuing to be tested and developed. Many biometric devices still require validation and thoughtful consideration before being approved for use.1 Aside from validity, an additional point for consideration depends on the availability of technical support for troubleshooting issues, various transmission methods, physical parts such as batteries, and intranet infrastructure that the patient may need to access. All these things can increase the challenges with DCTs.¹

There and benefits and challenges to traditional clinical trials and DCTs. As mentioned earlier, DCTs reduce the time and potential burden on patients and can accelerate patient recruitment and reduce drop-out rates. However, the sponsor needs to consider trial design, the population of interest, and assessments included in each potential visit before deciding which decentralized tools to implement.

References
1. Atlantic Research Group. Benefits and Challenges of Decentralized Clinical Trials. https://atlanticresearchgroup.com/benefits-and-challenges-of-decentralized-clinical-trials
2. Veradigm.(2021). Decentralized clinical trials: Are they here to stay? https://www.healthcaredive.com/spons/decentralized-clinical-trials-are-they-here-to-stay/602613/
3.PPD. (2022). Optimizing research with decentralized strategies. https://www.ppd.com/how-we-help/decentralized-clinical-trials/decentralized-strategies/?gclid=CjwKCAjwx46TBhBhEiwArA_DjE2ztihL8kYUFIKhTbdg56susIer7mWXgxELRI29UJSnXzppX9AHbRoCiF8QAvD_BwE

Jenna Brager, PhD, RN, MS, is the senior executive director of regulatory affairs at MyMD Pharmaceuticals^®. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.

Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email [email protected].

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