As noted in our last blog, Mednet surveyed its customers in 2020 to understand how clinical trial teams viewed COVID-19 and how it impacted their work and the design and conduct of clinical trials. We recently conducted a second survey, asking many of the same questions, but also expanding the questions to assess the trend towards virtual, hybrid, and decentralized trials. This blog will explore the responses related to hybrid, virtual, and decentralized trials.
Nearly all (96%) of the survey respondents believe COVID either significantly or somewhat accelerated the growing trend toward decentralized trials. Almost half (48%) believed it significantly accelerated the trend. This aligns with what we have been seeing in the industry and hearing from our customers. As we discussed last year in our webinar with CRO partner MedTrials, months of unplanned disruption accelerated change and innovation in the industry.
Approximately 40 percent (39%) of respondents reported their organizations are currently conducting or planning a hybrid, virtual or decentralized trial.
When asked why they have chosen hybrid, virtual, or decentralized trial designs, more than half (56%) indicated doing so to help increase their ability to recruit study participants. Forty-four percent said they wanted to reduce patient dropout rates, and an equal amount (44%) wanted to enable clinical research teams to work remotely. Surprisingly, only 22% noted a potential increase in the diversity of study participants as one of the reasons for their choice and only 22% listed reduced costs as a driver. However, these lower than expected rates might simply be a sign of the current and recent environment. In the past year, a key priority for clinical research teams has been how to get their studies up and running – and keep them running – despite a rapidly changing environment.
There is seemingly no consistent definition for virtual or decentralized trials, and the terms are often used interchangeably. Most trials lie somewhere on a continuum between traditional site-based and entirely virtual, decentralized models. For the purposes of this survey, we defined the different types as follows:
- Virtual – All visits are e-visits, data collected remotely from sites.
- Hybrid – A combination of in-person and virtual visits / check-ins.
- Decentralized Trial – Decentralization of clinical trial operations where technology is used to communicate with study participants and collect data; may incorporate Real World Evidence (RWE).
Of those respondents planning or currently conducting these types of trials, 78% indicated they were involved in hybrid trials, 33% were doing virtual trials and 11% reported working on a decentralized trial. The breakdown is not surprising, as for most research teams, there continues to be significant work to be done to enable completely decentralized trials. At the same time, given the COVID restrictions and limitations in the past year, many research teams have been forced to enable at least some element of virtual participation.
For the 17% of respondents who were not conducting or planning hybrid, virtual, or decentralized trials, 25% suggested that the format would not work for their current or near-term study protocols. Exactly half (50%) said they currently don’t have a need. Some of this may be due in part to the type of study being conducted. For example, for medical device trials where procedures and / or in office visits are required, it may be more difficult, if not impossible, to move to a completely virtual or even hybrid format.
These responses are not surprising since the continuum of types of hybrid trials is very broad. Many clinical research teams dip their toes in the virtual trial waters by starting with small, hybrid trials. And the pandemic forced many to do so. However, some disease states and therapeutic areas that require surgical or other complex medical or diagnostic procedures are not well-suited for these types of trial designs. Research in these areas will continue to utilize traditional site models.
This discussion and related design decisions are reflected in the survey responses about technology evaluations. We asked if support for decentralized trials will be important when evaluating technology vendors. While 39% said yes, approximately half (48%) said it would depend on the requirements of the specific study.
The range of requirements for hybrid, virtual, and decentralized trials is broad. Any supporting technologies must be flexible enough to accommodate trials at any point within this range. When asked about what features and capabilities would be important when selecting a new technology vendor, 83% of respondents chose a flexible platform. Approximately two-thirds (65%) thought the ability to integrate various data sources would be important. Forty-three percent felt a mobile app for research team members would be important, and more than half (52%) said a mobile app for study participants would be important in the decision-making process.
A sign of these transitional times, only 22% of respondents thought the ability to integrate EHR data would be a key factor in choosing a technology vendor. In comparison, 39% thought creating more direct access to the patient would be important. The current focus on the patient experience and the patient voice suggests this number may increase. Over time, as more clinical trials are conducted virtually, the need to integrate EHR data can also be expected to increase.
The wide variety of approaches illustrates an industry in motion. As teams have adapted to the COVID-19 pandemic rules with minimal disruption, the realm of possibilities has begun to widen. Though requirements are still fluctuating, the path toward decentralized trials is becoming clearer. As the industry gains experience, advanced standards of practice and new requirements will emerge.
Mednet partners with our clients to ensure that our technology solutions provide the flexibility and functionality needed to handle hybrid, virtual, or decentralized trials. We use tools like this survey to inform our product strategy and initiate dialogs about evolving requirements. Contact us to learn more about the iMednet platform and how it can help your team prepare for hybrid, virtual and decentralized trials.