Support Effective, Efficient Research with Decentralized Clinical Trials
Clinical trials are well understood to be complex, time-consuming, expensive endeavors. Worse yet, when a trial fails, all that time, effort, and money are largely wasted. Given the complexity of the undertaking, there are certainly many ways that change could be affected to some degree or another. But moving from traditional to decentralized or hybrid studies can make a positive impact in several areas at once. Let’s touch on four of them:
Boosting Patient Recruitment
DCTs allow healthcare professionals involved in clinical research to work with patients where they live, in the comfort of their homes. In taking trials to people, wherever they might be, sponsors have the opportunity to engage with far more potential participants, including those in communities that research does not typically touch.
Improving Patient Engagement
It's often assumed that DCTs rely heavily on new technologies, but actually, the critical element is people. In trials run at central study sites, a busy study team will be dealing with multiple patients attending clinic visits on the same day. In such situations, interactions can end up being transactional. Taking clinical research to participants' homes means connections with patients can be strengthened and personalized. Also, patients have more opportunity to ask questions, while healthcare professionals get to observe patients in their day-to-day environment, providing an essential perspective on how they're coping with the study.
Moving trials from the clinic to patients' homes can also minimize patient drop-out, as patients are not burdened with having to travel to clinics.
Supporting Compliance and Data Quality
Compliance for participants on a clinical trial extends beyond taking a treatment at the right time. In addition, participants must take treatments correctly and faithfully provide information about symptoms and side effects. Thanks to today’s DCT resources and technologies, this can be accomplished more readily than ever. A system such as the Reveles DCT System provides all the integration and automation necessary to support patient compliance and safeguard the quality of data. Everything from the dispensing of clinical supplies through to patients’ reporting of data is covered. It’s even possible to detect if participants are not replenishing treatment supplies when they should be or have stopped taking their treatments. Timely reminders via mobile technology can prompt patients to take a measurement or report how they're feeling, guaranteeing that important actions are not forgotten.
Managing Investigational Products
Another benefit of DCTs is that providers can offer end-to-end supply chain management for investigational products by using networks of established hubs of Specialty Pharmacies. These can manage all study-specific supply and reconciliation processes, including supply destruction, and provide a complete audit trail. Such services can also offer equipment for in-home sample collection or tests, including centrifuges, portable ECGs, and kits for patients to self-administer medicines, supported by training from in-home health professionals.
With these services available, patients no longer need to visit a site to get their treatment. Investigational drug products of all formulations and temperature ranges can be shipped directly to the patient's home or another preferred destination, such as a workplace.
Learn More About the Benefits of DCTs
This post is an excerpt from our eBook “Decentralized Clinical Trials: The Solution to Biopharma’s Problems?” Click here to read the complete eBook and learn more about the reasons to consider DCTs.