Decentralized Clinical Trials (DCT) bring the opportunity to change how we have carried out clinical trial research for over 50 years, but these changes are not without their challenges. As the Chief Technology Officer at KCR, a mid-sized boutique CRO, I would like to share some of the opportunities and operational challenges that we face in this area.
Challenging Standard of Care
Clinical trials have typically leveraged standard of care methods. The only significant adjustment to methods used are that a patient might receive is the frequency of patient visits and the consent/screening process. With Decentralized Clinical Trial (DCT) methods applied, the trial might involve the patient using a sponsor-provided app on their own smartphone, using wearable sensors, and being consulted remotely using video conferencing by the investigator. Pre-pandemic, this sponsor-controlled switch in methods was difficult for many countries and regulators to actively support. As we emerge from a global pandemic experience, we are seeing an increasing realization that remote standard of care methods are not only possible, but in many cases preferable.
In 2018, I spoke at the Cystic Fibrosis Trust annual meeting in Manchester, England. At this meeting, I had an opportunity to listen to two parents of teenage Cystic Fibrosis patients. They were asked by an audience what the number one thing they would change in how clinical trials are run. They both agreed that allowing their kids to avoid the inconvenience and stigma of frequent time off school to attend hospital visits would increase their willingness to participate. Teenagers with long-term chronic conditions wish to continue a normal life, and frequent clinical trial patient visits to satisfy a traditional trial protocol can go against this.
Hybrid Multi-Modality Methods
Patient convenience is one of the primary reasons for applying decentralized methods in a clinical trial, but what might be convenient for one, might be inconvenient for another. For instance, a particular DCT might arrange for a home study nurse to visit a patient to take blood. It is not uncommon for a patient to wish to hide the fact they are in a clinical trial from family members. A nurse appearing at the door to take blood can make this wish difficult to maintain. In addition, some patients may experience anxiety from having a person they do not know visit their house and ask to draw blood from them.
The obvious solution is choice. This provides the patient, where choice is welcome, the opportunity to choose whether de-centralized methods are used or not.
The difficulty this creates for a clinical trial protocol and their interpretation by regulators is how to deal with the potential for statistical variance based on methods applied. I believe the answer to this challenge is to tackle it with a risk-based approach. An ill-considered approach to mixed methods of carrying out a clinical trial that combine central and decentralized methods may define a bias, but, by considering the alternative approaches and ensuring the alternatives achieve a clear rationale for equivalence, such risks can be mitigated. As an example, providing the patient the opportunity to participate in a remote video consultation versus a physical site visit. This gives the investigator the means to see and speak with the patient, gauging a treatment and the patients disposition in very similar ways.
Patient Engagement Platforms
One of the enablers for DCTs is technology, and in particular mobile app technology, but it needs to be the right technology for it to be an effective replacement to standard of care methods.
What has become clear with DCTs since the first published trial in 2011, and with patient engagement in particular, is that it is not a case of ‘one size fits all’. Each clinical trial has their own demands whether it be patient mobility, drug delivery, or other protocol requirement. To satisfy these demands, it is not viable to ask that a patient operates a suite of ‘apps’ – one for travel organizing, one for remote video consultations, one for drug compliance monitoring, etc. This will simply be too confusing and too error-prone to be reliably usable by patients.
The solution is to ensure that all the DCT patient supporting functions operate within a single ‘app’ or common ‘platform’. This provides a single place where all tasks can be seen and addressed. It ensures the safe and effective coordination of activities that inter-relate with each other. It simplifies the user experience.
The site/patient interactions that occur during traditional hospital visits must be replaced when using decentralized methods. To some degree, the app must become the friendly face of a study nurse that greets an apprehensive patient that steps into a reception area. When we see effective DCT patient engagement platforms that succeed at this, then we will see widespread application of these methods.
About the Author:
Douglas Bain, CTO at KCR, an international clinical development solutions provider,, is responsible for company technology strategy and implementation. Doug has over 30 years of experience in the development and implementation of clinical trial technology solutions.