Clinical trial sponsors are constantly trying to balance different goals and demands. Ensuring data quality is key, yet clients also seek to recruit diverse patient populations and improve patient experience for increased retention. On top of this, the site burden of new approaches needs to be kept to a minimum. Balancing all of these demands can seem impossible, but with the growing shift to hybrid trials, connections and data quality can be maintained to provide support and enhance transparency. The key is to deliver a better, hybrid, trial experience.
Traditional trials deliver high-quality data and benefit from direct communication with patients. However, there is a significant participant burden and such an approach can lead to issues including prolonged recruitment, lack of patient diversity and lower participant retention, increasing overall trial time and sponsor costs.
In recent years, the fully decentralized clinical trial (DCT) has become a buzz word in clinical circles. In the rare disease space, decentralized components of clinical trials have been successfully boosting recruitment, accessibility and retention for some time. Since 2020 and the onset of COVID-19, other therapeutic areas are increasingly following suit. This has led to a growing evidence base on decentralised approaches. While there are benefits from a patient-burden perspective, there are also implications for data quality and participant communication, and site challenges. The majority of studies are unsuited to a purely DCT approach as most protocols require at least some face-to-face participant, site interaction and evaluation. There is also the crucial factor of patient choice. The European Medicines Agency (EMA) recommendation paper on decentralized elements in clinical trials published in December, 2022, said sponsors should give all participants the opportunity to visit the investigator if needed/preferred.
A shift to hybrid trials, combining the best of both traditional and DCT models, could be the holy grail for site sponsors. This approach sees in-clinic visits complemented by remote data collection and mobile health, where it is safe and effective to do so. This leads to that seemingly ‘impossible’ outcome – increased participant diversity, high quality data and participant communication, higher patient satisfaction and retention, and positive site experiences.
However, the transition from a traditional to hybrid model needs to be carefully managed. Despite the buzz, uptake of decentralized solutions, even in a hybrid format, is still relatively low. If we are to squeeze every drop of potential from hybrid trials, we need to identify and address key challenges.
Preparation remains one of the most important considerations. Part of the reason for low uptake of decentralized solutions is patient management strategies are not always built into study protocols from the outset. This can lead to conflicts between patient, site and sponsor understanding and trial expectations. Every decentralized element of a study needs to be embedded into the protocol from day one to avoid frustrating and expensive amendments and delays – and this was another aspect covered in the EU recommendation paper. Effective communication between sites, sponsors, patient groups and providers is crucial.
Sites are key stakeholders in the shift away from traditional trial models, yet they are often forgotten. Investigators, who are ultimately responsible for patient safety and oversight, can be confused about regulatory and contractual commitments, concerned about the quality and integrity of study data, and frustrated by the volume of different technologies they are being asked to engage with.
We need to support sites and give clear guidance on what their responsibilities are when data is collected outside of clinic. Investigators should be given the opportunity to build relationships with healthcare professionals conducting remote study visits and have the option to gain better insight into remote data collection by joining home health visits virtually.
Choice is also crucial to patient centricity. Decentralized elements can help trials meet the logistical needs of patients. However, only by sitting with patients as true allies and advocating for their care can we create a trial experience that speaks to all their needs. It may be necessary for patients to attend clinics for some assessments to be performed and some patients may prefer to travel to site for their appointments. Others may have a home environment which is not safe or effective for study procedures. In cases like this, other solutions, such as travel concierge services and expense reimbursement, should be utilized to prevent them being excluded from a study and to ensure that wherever the visit takes place, the participant is supported every step of the way. In the world of hybrid trials, patient management strategies need to focus on how to make the experience as positive as possible for participants, regardless of the location of the visit.
Processes should be streamlined by introducing integrated solutions which offer mobile health, travel and reimbursement on the same platform. All of these measures can boost confidence in data, lower site burden and enable better support for participants.
Patient centricity is key to a successful hybrid trial approach. Combining technology with white-glove, personalized patient care can empower patients. Yet much of the industry is still operating in silos and seeing patients as research subjects rather than active and involved partners. A potential pitfall of remote data collection is a loss, or worsening, of the link between investigators and participants. If people feel they are not appreciated, or ‘kept in the loop’ it can lead to drop-outs and missed data points. Hybrid trial approaches must enable two-way conversation between the site and participants. Mobile health teams should be able to share information, not just about the logistical aspects of the trial but also information about the progress of the study in general and their own data. If we really want engaged and motivated patients, we need to open up their own data and work with them to understand it.
Now is the time to stop having conversations and start taking genuinely revolutionary action to focus on the patient and improve trial data. Patients, the clinical trial industry, and sponsors are all invested in establishing global health equity. If implemented correctly, hybrid clinical trials can offer the ‘impossible’ – improved patient experience and retention, engaged sites and fast, high-quality data for sponsors. But to achieve this, we need to work together, sharing knowledge freely and leading with empathy to enable efficient delivery of medicines to those who need them most.
About the Author: Caroline Jackson, Executive Vice President, Patient Services, mdgroup
With over 27 years in the industry, Caroline Jackson brings a wealth of knowledge and understanding of the clinical development process to her role as Executive Vice President, Patient Services at mdgroup. Caroline is passionate about the future of clinical research, and the use of new technologies and other decentralised solutions to facilitate better participant experience in trials.
mdgroup are on a mission to deliver remarkable technologies and experiences for patients taking part in site-based and decentralized/hybrid clinical trials. They support all sizes of pharma and biotech to attract, engage, maintain, and support patient participation in healthcare research around the world, all underpinned by our latest innovations in healthcare technologies. Let’s make your next study remarkable. Contact us now to discuss how. Find out more at mdgroup.com
Amanda Leweson – Discovery PR, on behalf of mdgroup
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