In a world where connectivity is transforming every business, it was only a matter of time until one of the most critical functions in the biopharmaceutical industry – the clinical trial – began to evolve. Virtual clinical trials are now here, using technology as an enabler to drive new levels of patient access and engagement, reduce patient burden, accelerate speed to market, improve data quality, heighten efficiencies and reduce costs. Highly flexible in approach, decentralized clinical trials take the trial directly to the patient, enabling all steps to be conducted in the patient’s home.
Yet, in the fast-moving, complex arena of clinical trials and real-world studies, biopharma companies should keep in mind that virtual trials involve more than just technology. Like traditional trials, they demand clinical, therapeutic and regulatory to protect patient safety, optimize data quality, and maximize the chance of success.
Dramatic changes in stakeholder roles
In virtual trials, the roles of study stakeholders – including the patient, clinical research associate (CRA) and investigator – are dramatically different from those in traditional clinical trials. Investigators and patients can be located anywhere. A technology-enabled centralized site and study team – including centralized research coordinators, digital recruitment specialists and clinical operations leads – supports trials and patients. Traditional roles such as on-site study coordinator or CRA are changing, and new roles such as ‘patient guide’ and ‘connected device expert,’ will evolve.
For a virtual trial to run smoothly, a network of diverse technologies and platforms must connect seamlessly. Stakeholders must be able to communicate and transmit data via smart, connected devices. The investigator network and support team must be able to interact with patients securely and remotely via videoconference, voice, text and email. Remote-monitoring systems are a key element. And finally, a secure, robust SaaS platform is essential to facilitate and integrate all study activity.
There are no hard-and-fast rules governing which trial types or indications are appropriate for a virtual approach. Multiple factors drive decision-making. First, patient safety must be assured. Thus, approved therapies with well-understood safety signals can be promising candidates for virtual trials – for example in a new indication or late-phase study. Second, trial endpoints must lend themselves to accurate, high quality, remote assessment – for example, lung capacity in asthma patients might be measured via wireless spirometry.
For conditions where complex physical assessments are required to support the evaluation of the endpoint, such as lupus or multiple sclerosis, virtual trials could be more challenging. Or, the best solution might be a combination or hybrid approach including remote assessments and face-to-face encounters.
A decentralized clinical should be selected only if it adds value compared with a traditional one – for example, by enabling access new patient populations, accelerating recruitment speed or decreasing cost.
Alzheimer’s disease: A virtual trial case study
One area where virtual trials have particular promise is in Alzheimer’s disease (AD), where the time and cost of trials could be reduced, and disruption to the lives of patients and their families minimized. As part of IQVIA’s validation of the virtual approach, an AD proof-of-concept study was carried out with a strategic partner.
The case study focused on recruiting patients with early AD, when the illness is often unrecognized and patients are frequently cared for by primary care physicians (PCPs). In an innovative approach, IQVIA used a telemedicine platform to create a hub-and-spoke referral structure, focusing recruitment efforts on PCPs. Twelve PCPs served as the sub-investigators, with links to a central hub site with AD neurology experts to support diagnosis and to conduct cognitive assessments. This contrasted with the traditional clinical trial approach, where neurology investigative sites are typically used to recruit early AD patients.
This hub-and-spoke model resulted in rapid recruitment rates. Although it is challenging to compare traditional early AD trials to this virtual trial given that this was a non-interventional study, the virtual trial enrolled rapidly.
To ensure that the remote assessments of symptom severity by the central hub site generated high quality data, an endpoint validation study was carried out. This confirmed a very high correlation between the quality of cognitive endpoint data collected remotely and those from a standard, in-person neurological assessment – an essential step in validating the promise of virtual trials in this indication. Overall, the case study yielded high data integrity, and successfully demonstrated the economic, scientific, and social benefits of a virtual trial.
Clinical, therapeutic and regulatory expertise required
In this fast-moving and complex arena, biopharma companies should keep in mind that virtual trials involve more than just technology, also requiring extensive clinical development and therapeutic expertise to optimize the chances of success.
Virtual trials offer potential for expanded reach beyond traditional site catchment areas, reduced patient burden, accelerated development, and lower costs. When considering this approach for a particular trial, factors to take into account include the safety and formulation of the investigational compound, the characteristics of the patient population and type of indication, the phase and design of the trial, and the measurement of the endpoints. This is a promising approach for many circumstances – and experience at IQVIA indicates that patients and caregivers alike report high levels of satisfaction in the virtual trials experience.
IQVIA Virtual Trials is uniquely qualified to orchestrate the unique complexity of patient-centered virtual trials to accelerate the path to approval. Click here to learn more.