The lack of overall regulatory frameworks addressing these challenges is hindering the widespread adoption of virtual clinical trials.
Listed below are the key regulatory trends impacting the virtual clinical trials theme, as identified by GlobalData.
Specific regulatory frameworks for virtual trials expected in the near future
Regulatory bodies are committed to improving access to clinical trials, enhancing patient diversity, and improving patient experience, retention rates, and outcomes. One commonly cited barrier to the widespread implementation of virtual trials, however, is the lack of clear regulatory guidance. Much of the delay in developing such frameworks is caused by issues with measuring digital endpoints, data integrity, and ensuring patient safety.
Furthermore, there are local differences in regulations concerning the use of remote principal investigators, telemedicine, home nursing, delivery of a study drug to a patient’s home, and local imaging centres. There has been some recent activity in the regulatory space moving toward the development of specific frameworks for virtual trials in the future. Regulatory agencies around the world released guidance on how to mitigate disruptions and ensure trial continuity, including the use of remote monitoring, in response to the impact of the Covid-19 pandemic on clinical trials.
Regulatory guidance on maintaining clinical trial continuity during Covid-19
Many regulatory bodies around the world, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), and Singapore’s Health Science Authority issued guidance documents containing information on how trials could continue during the pandemic.
The documents provided support on remote trial visits, site monitoring, informed consent, maintaining data integrity, and remaining compliant to good clinical practice (GCP). In March 2020, for example, the FDA issued guidance on conducting clinical trials during the pandemic to help sponsors mitigate disruption while maintaining patient safety, trial integrity, and compliance.
Role of non-profit working groups in supporting virtual trials
Regulatory bodies are not the only ones increasing their support of the use of remote technologies in clinical research. Several non-profit working groups were active in this space for many years before the pandemic, developing guidelines and recommendations for sponsors and clinical research organisations (CROs) looking to implement virtual components into trial design.
The US Clinical Trial Transformation Initiative (CTTI) published several recommendations on virtual trials, including Use of Mobile Technologies in Clinical Research (July 2018) and CTTI Recommendations: Decentralised Clinical Trials (September 2018). The recommendations on the use of mobile technologies provide best practices on the use of mobile devices and apps for capturing objective data.
The Decentralised Trials and Research Alliance (DTRA) was formed in December 2020 when more than 100 life science and healthcare companies partnered to promote collaboration and accelerate the global adoption of virtual trials. DTRA aims to make participation in clinical trials widely accessible by advancing policies, research practices, and new technologies in decentralised clinical research. Members include pharma and biotech companies, regulatory bodies, patient advocacy associations, CROs, health technology companies, investigator site networks, and others.
Lack of acceptance of eConsent
eConsent has been available to use for many years and offers many benefits to patients, trial sites, and sponsors. The adoption of this technology, however, has been slow in many countries mainly due to regulatory hurdles, resistance to change, and cultural barriers. The FDA was one of the first regulatory bodies to publish guidance on the use of eConsent in clinical trials in 2016, which provides sponsors and investigators with a framework on how to provide participants with information about trials and capture informed consent electronically.
The guidance refers to the existing Code of Federal Regulations (CFR) including 21 CFR Part 11, which provides details on criteria for electronic records and electronic signatures in order to be considered by the FDA (FDA, 2016). However, there is no central guidance on the use of eConsent in Europe, and laws governing the acceptability of electronic signatures are set at a national level.
Ensuring data security and participant privacy in virtual trials
Data privacy issues are a central concern associated with digital transformation initiatives in pharma. In GlobalData’s Digital Transformation and Emerging Technology in the Healthcare Industry surveys from 2019 and 2020, for example, the highest proportion of respondents indicated that digital privacy and data security issues were the main concerns related to digital transformation. Data security and privacy cannot be overlooked as the use of virtual trials grow and compliance with regulations is imperative.
Frameworks are required to ensure that remote data-collecting technologies, such as wearables and smartphone applications, are safe, ethical, and effective, and that consent and data ownership are considered. It not only applies to sponsors and CROs, but also to any technology vendors that companies partner with. GCP guidelines provide requirements to ensure data integrity and protection of clinical trial participant data, such as validation of computer systems, data access control, and audit trails.
This is an edited extract from the Virtual Clinical Trials – Thematic Research report produced by GlobalData Thematic Research.