Virtual trials offer an innovative solution to these problems by improving patient experiences using digital technologies and other remote services.
Listed below are the key healthcare trends impacting the virtual clinical trials theme, as identified by GlobalData.
Impact of Covid-19 on clinical trials
A significant number of companies announced disruptions to planned and ongoing clinical trials because of COVID-19 lockdowns and social distancing measures. There was a peak of 1,265 disrupted trials in June 2020, impacting nearly 1,000 companies. Disruptions included delayed initiation or complete withdrawal of planned trials, as well as suspended enrolment or termination of ongoing trials. The number of disrupted trials has been falling slowly since June 2020, with most current disruptions due to slow enrolment.
Impact of Covid-19 on pharma digital transformation
The Covid-19 pandemic has led to an acceleration of digital health innovation. The pharma industry has traditionally been risk-averse and taken a “wait and see” approach when it comes to adopting new innovations. The past year has forced pharmaceutical research and development (R&D), manufacturing, supply chain, and sales and marketing teams to rapidly respond and adapt to the challenges presented by the Covid-19 pandemic.
Rise of specialist virtual trial providers
Several specialist start-ups have emerged in the virtual trials space since 2014. These companies offer a full range of services needed to implement a virtual trial, including patient recruitment, eConsent, in-home health visits, telemedicine, eCOA collection, remote monitoring device integration, data collection and analysis and DtP drug supply. Leaders in this field include Science 37 and Medable, which were founded in 2014 and 2015, respectively. Interest in these companies has surged since the start of the pandemic. As of mid-June 2021, 18 collaborations have already been formed this year.
Evolution of contract research organisations (CROs) into virtual trial providers
Few CROs offered a full range of virtual clinical trial services to clients prior to the Covid-19 pandemic, while the move towards these trials was well underway. CROs have shown significant activity in this space since the pandemic began, particularly through partnerships and acquisitions of home healthcare services, eClinical software, and remote patient monitoring (RPM) providers, in order to bolster their virtual trial capabilities.
Other companies vying for a share of the virtual trials market
Several unexpected players have emerged in the virtual trials space in recent months. In May 2021, for example, CVS Health announced that it was launching its Clinical Trial Services business to solve some of the challenges often seen with clinical trials, such as low recruitment and retention rates due to low patient diversity or inconvenient trial site locations. CVS is building this business using its experience in care delivery and clinical research garnered through its subsidiary Coram, a home infusion provider, which has been involved in more than 200 home-based clinical trials.
Impact of virtual trials on low patient accrual rates
A high proportion of clinical trials (80% on average) do not meet patient recruitment targets, while 20%-30% of participants drop out of trials. A 2020 study by the Tufts Center for the Study of Drug Development (CSDD), however, found that recruitment rates actually improved between 2012 (47%) and 2019 (77%), which was attributed to increased use of mobile data collection devices, virtual trials, and more involvement of patients in protocol development (CenterWatch, 2020).
Increased focus on patient centricity in clinical trials
Trial recruitment rates appear to be improving, but retention rates are still an issue, with a high proportion of patients dropping out of studies before their completion. Making trials more patient-centric is key to improving the overall trial experience and increasing retention rates. A patient-centric study should be designed and executed with participants’ needs at its centre, ensuring that the patient voice is incorporated. Engaging patients in study protocol design has been shown to improve research quality, patient outcomes, and relevance to participants, all of which can lead to improved enrolment, adherence, and retention.
Use of real-world data from virtual trials
The vast majority of real-world data (RWD) generated from digital devices used in virtual trials can be used to improve the drug development process. It can be used to enhance trial design, improve eligibility criteria and access to trials, and provide deeper patient insights. Data from virtual trials can also be used for the development of synthetic control arms. Synthetic control arms use RWD to simulate control or standard-of-care study arms and can include historical data from previous trials, electronic health records (EHRs), registries, claims data, wearable devices, and remote monitoring devices. This approach removes the need to recruit control participants, thus increasing trial efficiency while reducing delays and costs.
Increased use of digital biomarkers in clinical research
One important discovery from the increased collection of RWD from connected devices and mobile health (mHealth) has been digital biomarkers or endpoints. These are defined as objective, quantifiable, physiological, and behavioural measures that are collected by sensors embedded in portable, wearable, implantable, or digestible devices. The term refers to data collected about health or disease management that explains, influences or predicts health-related results (Karger Publishers, 2020). They include smartwatches that can track heart rate or epileptic seizures, portable electrocardiogram (ECG) monitors, smart inhalers and smart pills for medication adherence and continuous glucose monitoring (CGM) devices in diabetes.
Activating community physicians in clinical research
One area that is being explored to improve patient diversity and recruitment into trials is engaging community physicians in front-line clinical research. This represents an opportunity to bring research to underrepresented or rural populations, allowing patients to participate in trials under the continued care of their own doctor rather than travelling to central trial sites. There are several examples of companies operating in this area. Elligo Health Research’s Goes Direct platform, for example, identifies potential patients for trials using data from EHRs and provides their physicians with the support and infrastructure needed to conduct trials in their offices.
This is an edited extract from the Virtual Clinical Trials – Thematic Research report produced by GlobalData Thematic Research.