By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
It’s no secret that decentralized clinical trials, also known as virtual trials, are one of the hottest technology trends in the clinical space. Although this trial model has been touted by vendors for many years, it took the emergence of the COVID-19 pandemic in 2020 to get many companies scrambling to implement the new approach.
Virtual trials use digital technologies and processes to take trials to patient homes and places of work. The reduction in site visits reduces the burden placed on patients and eases the challenges of trial participation. The technologies used in virtual trials can include eConsent, eCOA, telemedicine, wearables, mHealth, remote patient monitoring, and more. While a fully virtual trial would involve the trial being conducted remotely, some companies have adopted a hybrid approach, which involves both at home visits and visits to a site.
The traditional clinical trial model is outdated for several reasons. First, it is incapable of solving the patient issues that have plagued clinical trials. Patient recruitment has been a challenge for drug developers and would continue to be under the traditional model. Studies will under enroll patients, and many are even cancelled due to the lack of patients. When patients are forced to give up time at work and with their families to make burdensome trips to a clinic, they will be more hesitant to enroll in a trial. Once a patient is enrolled, the next challenge faced is retention. Those burdensome visits will also result in some patients dropping out of a trial. These recruitment and retention issues will result in trial delays and higher costs.
Diversity is a third patient issue facing drug sponsors. Trial patients have traditionally been young, white, and male. The lack of minority, elderly, and low-income patients in clinical trials can produce results that may not be similar to the results seen when the drug is available to the entire population.
Virtual Trials Bring Benefits And Challenges
A virtual or decentralized approach to trials will bring many benefits. The most important is likely the improved patient experience. If the patient burden is decreased, patients are comfortable with the conduct of the trial, are more likely to enroll in it, and are less likely to drop out. That will help eliminate trial delays and the associated costs. Other benefits are an improved adherence to the protocol and dosing requirements, improved data quality, a lessened burden on sites, accelerated timelines, and reduced costs.
But taking a virtual approach also brings additional challenges. The first is concerns over patient safety which arise from those patients making fewer visits to the clinic. Data privacy and integrity is also a concern, as is the interoperability and data flow between software and devices. There is also concern over regulatory frameworks and differences in regulations between countries.
Despite the challenges that exist, the adoption of virtual trials is moving forward at a rapid pace. Groups like the Decentralized Trials & Resource Alliance (DTRA) and Digital Medicine Society (DiMe) are working to help companies overcome the challenges, while the #NoGoingBack movement continues to stress the importance of not allowing trials to go back to the traditional model once the pandemic has passed.
Trends In Virtual Trials
A recent report on virtual trials produced by GlobalData highlights the trends that currently exist around the adoption of virtual trials and what that means for sponsor companies.
There is no question that the COVID-19 pandemic had a significant impact on the adoption rate of virtual trials. More than 1,200 trials were disrupted by COVID in June 2020 alone. Companies adopted a virtual model for trials to mitigate the impact of the disruptions. The report notes only one-third of companies were using virtual trials prior to the pandemic. Seventy percent of companies who had never used virtual trials suddenly had plans to implement them.
The past seven years has also seen the emergence of companies specialized in offering drug developers a range of services needed to implement a virtual trial. Science 37 and Medable are considered the two leaders in that field, with increased competition coming from THREAD, ObvioHealth, and Lightship. Partnerships with these firms is also on the rise, increasing from three partnerships in 2019 to 19 in 2020. Sponsor company interest in virtual trials also has more CROs entering the arena, and those may be the companies most drug sponsors go to when seeking a partner. A market outlook report on decentralized trials published by ISR Reports asked survey respondents what organizations could provide hybrid trial services, seven of the top nine companies mentioned were global CROs. Medable and Science 37 placed 11th and 12th on the list.
The entrance of bigger players into the space is also noteworthy. Verily Life Sciences, with former FDA principal deputy commissioner Amy Abernethy leading its clinical research business, has big plans. A partnership with four Big Pharma companies will develop patient-centered research that makes use of digital tools. Amazon has not yet entered the clinical research space, but GlobalData notes it has the capabilities to do so. Last year the company announced Amazon Care will be expanded to all 50 states and include a telehealth element for patients to connect with nurses and physicians.
Trends in Patient Centricity And RWE
The major areas where virtual trials are likely to make a significant impact are in real-world evidence (RWE) and patient centricity.
GlobalData notes recruitment rates are improving, but retention remains an issue. Patient satisfaction with trials is also a problem, with one report showing only 46% of trial participants willing to recommend a trial to others, and 34% saying they would advise others to not participate.
Making trials more patient centric is one way to improve those figures. Virtual trials can play a key role in patient-centric studies by using available technology to improve the patient experience and make studies more convenient to participants. Patient reimbursement and reducing the number of procedures required to be conducted will also help improve the experience.
With the importance of RWE growing in the clinical space, it’s important to note that RWE generated from digital devices used in virtual trials can be used to improve the drug development process. RWE is a top priority of the FDA, and the 21st Century Cures Act also supports the use of real-world data (RWD). The RWE generated from virtual trials can be used to create synthetic control arms, which can then eliminate the use of control patients.
A Satisfactory Experience
Despite the rush to launch virtual technologies in 2020, most companies working with a decentralized approach seem to be happy with the results. The market outlook report from ISR Reports found 63% of respondents were feeling somewhat or extremely positive about the experience. Only 13% reported a negative experience.
The experience also created learnings for the companies involved. Most cited learning that a hybrid model could work, that virtual trials required significant planning and project management, and that patients were open to a decentralized approach. The main benefits seem to be faster and higher quality data, easier patient recruitment, improved patient compliance, and a more flexible trial experience.
Challenges do remain, and respondents most frequently cited technology-related issues, difficulties setting up the model, concerns over data, regulatory uncertainty, and direct to patient shipments. Some respondents also noted the inability or unwillingness of patients to use new technologies.
There is no question that the use of virtual and hybrid trials will continue to grow. Respondents to the ISR Reports market outlook noted the use of these models will increase significantly (39%) or slightly (44%) in the future. The primary areas of investment will include establishing partnerships with technology providers, wearable sensors and connected devices, and building in-house data management capabilities.
Visit GlobalData to learn more about trends in virtual trials or to view the entire report.
The complete Hybrid/Virtual/Decentralized Clinical Trials Market Outlook report from ISR Reports can be purchased here.