Regulatory Insights: Virtual Trials Gaining Traction in the EU
In this blog post, Patricia Dresel, director of regulatory affairs, and Annsofie Holmborn, regulatory affairs manager, discuss the evolution towards a virtual clinical trials model in the EU, including initiatives being taken by industry associations and regulators to drive this paradigm shift.
A step closer to virtual clinical trials in the EU
It is widely recognized that virtual trial solutions have accelerated in the new reality of COVID-19. However, the concept of virtual trials had been maturing for some time in the EU prior to the pandemic and has been propelled further by the need for social distancing.
For example, in September 2019, the [email protected] project was launched by the public-private partnership Innovative Medicines Initiative (IMI) to explore the use of digital technologies in clinical trials. This is a large scale, collaborative project involving 31 members representing the European Federation of Pharmaceutical Industries and Associations (EFPIA), academia, small- and mid-sized life science companies as well as patient organizations.
This project will involve a pan-EU pilot study where one group of patients will participate entirely via virtual trial solutions (e.g., telemedicine, study drug delivery and administration in patients’ homes, use of home care staff for study procedures); another group will participate via partial virtual solutions; and a third group will follow the traditional clinical research model, attending the trial site for procedures and study drug. The project will assess all aspects of the trial lifecycle from concept and startup to close-out, as well as other parameters, such as impact on the patient-healthcare provider relationship. Diabetes has been selected as the therapeutic area for the pilot study.
The [email protected] project is scheduled to continue to August 2024. In contrast to how protocols have been adapted by necessity during the COVID-19 pandemic, the [email protected] study will incorporate virtual trial elements from its start and thus has the potential to contribute necessary evidence to demonstrate that data integrity and patient safety are, at minimum, not jeopardized by the virtual aspects of trials. Beyond this, the results will explore and may support the real possibility that virtual trial solutions could improve data integrity and patient safety.
In collaboration with the [email protected] project and also planned before the pandemic struck, the Electronic Components and Systems for European Leadership (ECSEL) launched a call for proposals on virtual clinical trial solutions in May. This invites potential candidate partners to share their vision for digital solutions that could simplify and accelerate clinical research.
In Sweden, PPD and other local stakeholders recently participated in panel discussions with the Swedish regulatory authority, the Medical Products Agency (MPA), as part of its project to assess opportunities and limitations associated with use of virtual trial solutions. The MPA is now concluding the initial information-gathering phase of this project. The next stage, planned for the second half of 2020, will pilot three to five clinical trials, designed to be either fully virtual or with partial virtual design. At its Virtual Trials Workshop on 25 May the MPA advised it hopes the outcome of this project will form a basis for the planned future Heads of Medicines Clinical Trial Facilitation Group (HMA-CTFG) guidance for virtual trials in the EU.
Regulatory and operational considerations
The message these initiatives send is that virtual trials are rapidly becoming a reality. CROs, such as PPD, accustomed to identifying and implementing solutions for sponsors have utilized various levels of digital concepts in trials over the past decade. With more industry associations and regulators coming on-board, the shift toward digital solutions appears to be gaining traction and progressing more quickly with increased acceptance of new technology and novel solutions.
There are concerns and expectations across the life science industry that guidance and regulations must be adapted to fit this new reality, and this is an assumption of the IMI [email protected] project and the MPA project. However, many regulators currently do take a pragmatic view on virtual trial elements in the light of current guidance and encourage its use. A key concern raised is how to ensure adequate investigator oversight of the trial, one of the cornerstones of good clinical practice, when part of, or the entire, trial occurs remotely from the investigator site. Another significant challenge lies in ensuring patient privacy when implementing new technology (telemedicine) to transfer data from the patient. The lessons being learned during the pandemic are providing significant useful insights for overcoming these challenges and helping us understand early on which studies are most suitable to virtual solutions.
Looking to the Future
As outlined here, steps have been and continue to be taken to move to virtual clinical trials, independent of the COVID-19 pandemic. Industry associations, regulatory authorities, sponsors and CROs alike had to turn to these solutions during the pandemic and are gaining further valuable insight quickly. We are confident that use of decentralized clinical trial solutions can improve the clinical trial experience for patients while maintaining regulatory compliance and delivering reliable data. Our regulatory intelligence, policy and advocacy team continues to monitor efforts and developments in this area to enable us to support stakeholders exploring the potential of digital solutions to become part of the “new norm” post COVID-19.