Report: Hybrid Clinical Trials Are Here To Stay
By Ed Miseta, Chief Editor, Clinical Leader
ISR Reports has released a new report titled Hybrid/Virtual/Decentralized Clinical Trials Market Outlook. The report looks at the adoption of these trials and the components that are gaining the most traction.
To gather the insights, ISR surveyed 109 respondents at sponsors and CROs regarding their experiences with hybrid trials and providers of these services. Though not all reported a smooth, pain-free experience, nearly two-thirds of respondents came away with a positive overall impression of hybrid trials. Furthermore, respondents do not seem to consider the hybrid trial model as a temporary solution to be discarded after the pandemic has subsided. A whopping 83% of respondents expect the hybrid trial model will be used more frequently than the traditional trial model three years from now. These data are saying loud and clear that hybrid trials are here to stay.
Ed Miseta: Survey respondents noted which remote components are currently being used and which ones they expect to be using in two years. A couple of the findings surprised me. For example, even though decentralized trials allow patients to participate in studies from their homes, only
16% of companies report direct-to-patient shipment of IMP. Only 18% are using wearable sensors/connected health devices. Any thoughts on why those numbers are so low?
Rebecca McAvoy: There certainly was a rush to convert traditional trials to decentralized trials at the start of the pandemic. Although these remote components can facilitate the ability to participate in some parts of clinical trials from home, implementation of these remote components isn’t easy and doesn’t come without risk. Directly shipping IMP to patients comes with concerns about patient safety, patient compliance, cold chain/distribution issues, etc. Using wearable sensors or connected health devices introduces challenges of training patients/sites on use of the devices, device/technology malfunctions, patient compliance, and analyzing massive datasets, to name a few. I expect there to be an uptick in usage of these remote components, but it does take time for companies to get these functionalities up and running and to feel comfortable with these new approaches.
Miseta: Respondents were asked what components of a trial are easier to manage in a hybrid approach and which were easier to manage in a traditional trial. Only patient recruitment and ePRO were cited as easier to manage in a hybrid trial. Seven components were cited as easier to manage in a traditional trial, and six components were noted as not differing between the models. Are some respondents feeling that certain functions are not easier to manage in a hybrid model simply because they have not had sufficient time to evaluate them?
McAvoy: One thing to remember about hybrid trials is that only some of the activities take place at home while other activities still take place in a clinical setting, meaning that those responsible for running the trial need to account for both home-based activities and clinic-based activities, further complicating the already complex process of trial operations. The components that were considered harder to manage in a hybrid setting will likely become easier over time as the folks in charge of the trials become more well-versed in the hybrid trial design and execution.
Miseta: I think the best statistic in the report was the satisfaction level noted by companies using a hybrid approach. Sixty-three percent of respondents noted a somewhat or extremely positive experience using a hybrid approach. Another 24% noted a neutral experience, while only 13% reported a negative experience. Companies are not using most of the capabilities available in a hybrid approach, and there are only a few capabilities that they note are easier to manage in a hybrid trial. That being the case, to what do you attribute that high satisfaction rating?
McAvoy: Based on responses in other areas of the survey, I have a few thoughts. The top ‘lesson learned’ is that the hybrid approach can work. I think people are pleased that their trials didn’t have to completely shut down amid the pandemic. There had been dabbling in these types of trials prior to the pandemic but the pandemic forced companies to jump in with both feet, regardless of apprehension. Some aspects of hybrid trials that have gone well are higher quality/faster data, easier patient recruitment, improved patient compliance, and easier/more flexible for patients. I suspect those qualities of hybrid trials played a role in the positive satisfaction rating.
Miseta: The most important lesson learned by respondents is that the hybrid approach can work, followed by that approach requiring significant planning and project management and patients being open to them. Were you able to determine from respondents what some of the additional planning and management requirements were that do not exist in traditional trials?
McAvoy: As we all know, hybrid trials were new for many in the industry prior to the pandemic so this was not a space in which people had a lot of prior experience to draw from. Also, as I mentioned before, hybrid trials are designed to have both in-clinic and remote components, creating additional challenges related to set-up, coordination, and communication. The following quote about ‘lessons learned’ sheds light on several of these ideas: “Extreme planning for each visit required, advance patient reminders, provide opportunity for direct person to person communication with patient together with their physician before and after each visit…”
Miseta: I feel like one of the primary concerns about hybrid trials that I hear from sponsor companies is the quality of the data that will be gathered from patients. Yet the report asked respondents what aspects of their hybrid trials have gone well, and the number one answer was higher quality and faster data. Are the concerns over data quality a bit overblown?
McAvoy: Interestingly, perspectives on the quality of data in hybrid trials can vary. We asked respondents to share, in their own words, what has worked well with hybrid trials and what has been frustrating. “Higher quality/faster data” was the most mentioned response for aspects that have gone well; however, “data concerns” was tied for the second most mentioned response for aspects that have been frustrating. It all comes down to individual experience. If data collection and management has gone smoothly, the person responsible for that trial might say that higher quality/faster data is a great benefit of hybrid trials. On the other hand, if someone has had data-related challenges in their hybrid trials, they might not have as rosy of a perspective.
Miseta: When asked what aspects of their hybrid trials have been the most frustrating, the number one answer was technology-related issues. Number two was setting up the model. These issues may fade as the model gains increased usage, but it does make me wonder if many companies are attempting to set up these trials themselves rather than engaging with vendors who have the required expertise.
McAvoy: Just as this trial design is new for sponsors, it is also new for service providers. CROs don’t necessarily have all the answers either and may have a steep learning curve when it comes to hybrid trial design and execution. We didn’t ask specifically about whether sponsors are attempting to set up trials on their own, but we do know that hybrid trials often involve additional vendors compared to traditional trials which adds complexity to the overall trial management for the sponsor.
Miseta: When asked about the potential benefit to sponsors and CROs, respondents noted better patient recruitment, retention, compliance, and diversity. All of these are issues that have plagued clinical trials for years. As the adoption of these trials increases, can we expect to finally make a dent in these industry challenges?
McAvoy: Yes, I think hybrid trials will be a great tool for improving some of the age-old challenges related to recruitment, retention, compliance, and diversity. Because of the ability to participate from home, patients in the more difficult-to-reach demographics will have increased participation opportunities. Improved patient compliance and recruitment come up frequently as benefits of these trials. Being able to complete at least some trial activities remotely facilitates easier participation and lower likelihood of dropping out, particularly for patients for whom travel is difficult.
Please visit ISR Reports for more information on the Hybrid/Virtual/Decentralized Clinical Trials Market Outlook.