Any decentralized clinical trial can be a highly complex project; when such a study reaches across national borders into multiple countries, the equation becomes even more complicated. Taking in all the variables presented by dealing with people speaking different languages, observing different customs, and facing different resources calls for a thoughtful, forward-thinking approach.
Keeping the patients themselves in mind can help increase the chances of success. Outsourcing-Pharma recently spoke with two representatives from decentralized trial solutions provider Medable about the ins and outs of running international clinical research:
- Alison Holland, head of decentralized clinical trials
- Jena Daniels, vice president of patient success
OSP: Could you please share some of the differences in conducting international trials, versus trials run in a more limited geographic area?
AH: When conducting international trials, it’s critical to accommodate different national, regional, and local standards, regulations, and practices – at first instance. For example, understanding the local data privacy governing requirements is key to ensure we can deploy a global solution that meets the highest rigor of all the geographics included.
OSP: How can trial teams ensure their DCTs consider key cultural, economic, language, and other differences?
AH: In addition to the above, it is important to understand the local standards of care available to patients and designing pathways into the study and activities within the study that offer choices, all while focusing on central data integrity and quality. For instance, consideration of local technology standards and connectivity can influence which web and/or mobile application to be deployed. Further, understanding connectivity support and local infrastructure may require more provisioning of devices, or ensuring effective off-line or backup features.
It is vital to also consider the patient and site burden of the solutions being implemented and assess the ease of their usage within the local environment, particularly if patients reside in remote locations from any site or core infrastructure. Of course, all patient-facing applications need to be deployed in local languages. Often, we need to support five or more languages within a single country so planning effectively for this is critical.
OSP: Could you please share an example of how failure to anticipate such differences can lead to problems in trial execution?
AH: When deploying decentralized study solutions, Medable always considers the local socio-economic environments of the patients themselves – especially if provisioning devices and sensors – and remaining mindful of local standards. Smartphone devices that may be ubiquitous in some countries, may be seen as irresistibly attractive and an unreasonable inducement for study entry if a different device that can complete the same functions would be more aligned to what is common in that geography.
Understanding all these factors, and the logistics, and provisioning workflows are key to ensuring we are supporting all patients consistently around the world and collecting evaluable and compliant data.
OSP: Is it ever possible to design a one-size-fits-all DCT—or to even come close?
AH: At Medable, we believe it’s important to design and deploy DCT solutions that offer consistent choices to sites and patients about how they can engage within the study, offering flexibility where a protocol can safely accommodate, for some or all activities, to be conducted in non-traditional bricks and mortar settings. With this in mind, we all have different views on what would be an attractive choice and therefore, a one-size-fits-all model is not fit for purpose.
Being able to accommodate different workflows within a single study is key, for example, and being able to utilize different consenting execution workflows according to age, local legal standards, etc. means that several workflows need to be available within a single study to maintain compliance and quality.
OSP: Are there ways DCT teams can partner with local researchers, healthcare providers or other resources to help improve the access and inclusivity of their trials, to ensure maximum patient engagement/retention, and minimal snags?
AH: Absolutely! DCTs enable us to make studies much more visible to a far broader audience, bringing the study into the community and into the home and providing more convenience and consumer-style choice to collect high-quality, robust, and quantifiable data from participants from a location of their choice.
For example, collecting real-time patient diaries, together with wearable sensor data for vital signs measurement allows many patients to remain out of the traditional site but under the care of their clinical study team for symptoms and health monitoring. In addition, trials augmented by local pharmacies and community clinics can further improve trial access, enrollment, and retention.
By enabling local pharmacies to become access points or supplemental investigator sites, for DCTs, 90% of Americans suddenly become within a five-minute drive of a clinical trial. Not only does this provide greater convenience for patients, but it also helps nurture greater trust because patients are getting care from the people they know and see around town.
JD: To define a more human-centered approach to research and better embed the patient and caregiver voices across the clinical development landscape, Medable established its Patient Success team. Our network of diverse patients, advocates, and caregivers provides their candid perspectives on every feature and functionality of the Medable platform.
We incorporate their valuable feedback; their unique backgrounds, experiences, and direct understanding of patient preferences make them an invaluable resource to those intent on removing patient-facing barriers to participation in clinical research. When properly implemented, the power of the patients’ and caregivers’ lived experiences can reduce protocol deviations, minimize trial dropout, and improve patient engagement.
Through these kinds of engagements, we may be able to truly disrupt the clinical trial model and redefine what it means to be human-centered…rather, human-invested.
OSP: Does a CRO need to have its own international presence for international trials to succeed?
AH: Medable partners with CROs and sponsors to enable clinical trials all around the world. In fact, Medable’s software-as-a-service (SaaS) platform has been deployed in more than 60 countries via more than 150 decentralized and hybrid clinical trials to achieve unprecedented results – including 3X faster enrollment, 90% retention rates, and 50% cost reductions.
Regardless of location, it’s very important to have a clear and informed perspective of standards and practices locally and the regulatory and data localization requirements for compliance. As such, we appreciate working with CROs that have a local presence and, for some studies, this is critical for compliance and other GCP-required processes but not mandatory for all studies. We approach each study individually, on a trial-by-trial basis.
OSP: What other words of wisdom do you have?
AH: The world is rapidly changing and evolving as we adapt to our ongoing pandemic ‘new normal’ making it more important than ever to enhance the quality of clinical trials, the speed to drug decision-making, and the accessibility and inclusivity of clinical research to patients around the world.
Designing and deploying DCT solutions focused on patient needs and preferences, optimizing and amplifying their connectivity with clinical care, and collecting real-time data will transform clinical trials in ways we’ve never seen before. Specifically, we will begin to generate richer insights from machine learning and advanced data analytics that will inform optimal disease and therapeutic management and help the industry create effective, breakthrough treatments of the future.