Regulatory Insights: Pandemic Speeds Adoption of Telemedicine in Clinical Trials
In this post, Ilse-Maria Nolan, senior director of regulatory affairs and leader of PPD’s regulatory intelligence policy and advocacy team, discusses the regulatory aspects of telemedicine, a digital solution that is seeing increased utility in providing continuity of clinical trials during the COVID-19 pandemic.
COVID-19 Pandemic Speeds Adoption of Telemedicine in Clinical Trials
In February 2020 the realities of the detrimental impact COVID-19 was having on clinical trials in China became apparent. With government-imposed travel restrictions and fears of contracting the virus growing, patients participating in trials and monitoring teams could no longer access hospital trial sites. Within weeks, as the virus spread, governments took unprecedented steps to limit the contagion, while its impact on clinical trials began to multiply and play out across the globe.
The scale of the challenges those of us responsible for clinical development faced and continue to deal with has been unprecedented and complex. Clinical research associates and site inspectors have been unable to access hospital trial sites to perform oversight; delivery of investigational medicinal product to sites has been disrupted; regulatory authorities and ethics committees have been forced to operate at reduced capacity or suspend work altogether; sites have been closed; and some clinical trials have been put on hold or cancelled.
Across our industry, everyone responsible for the conduct of clinical trials has been forced to make critical decisions that support patient safety and trial integrity, fast. As a result, telemedicine has been given a fresh look to maintain clinical trial continuity.
So, what is telemedicine? Telemedicine encompasses activities, such as telephone or video appointments in place of onsite visits, that enable the provision of health care services through the use of technology and are employed in situations in which the health care professional and the patient are in different locations. Traditionally, there has been slow uptake for telemedicine in clinical trials, primarily due to a lack of legal, including patient and data privacy, and regulatory frameworks. However, stakeholders have recognized its suitability for supporting clinical trial continuity during the pandemic. In the U.S., the Federal Communications Commission adopted a $200 million program supporting telemedicine and, as of 5 May 2020, 49 states are allowing waivers to standard telemedicine procedures during the pandemic.1 In recent guidance documents, many regulatory authorities have acknowledged or advocated the use of telemedicine when necessary to support clinical trials during the COVID-19 outbreak.
Guidance from regulatory authorities varies across countries and jurisdictions, and is continuously being updated, with some authorities providing more direction than others. Our regulatory intelligence policy and advocacy team has identified common themes and important considerations, which we recommend sponsors consider when planning to introduce telemedicine to clinical trials. These include:
- Patient centricity: Any measures implemented should safeguard patient safety, maintain compliance with good clinical practice and minimize risks to trial integrity. Many clinical trials and/or patients are not adaptable to telemedicine, therefore its appropriate use in relation to the complexity of the study’s clinical assessments should be considered and a patient-centric approach adopted.
- Proper planning: Decisions to incorporate telemedicine should be based on a risk assessment by the sponsor, in conjunction with investigators where appropriate.
- Data monitoring committee: Sponsors should consider involving the data monitoring committee when assessing the impact of telemedicine on patient safety.
- Regulatory authority contact: Some regulatory authorities recommend early consultation if feasible regarding protocol modifications for the collection of efficacy endpoints.
- Protocol modifications: The potential limitations and risks of introducing telemedicine with a focus on trial robustness should be assessed in conjunction with the study statistician when planning protocol modifications. Some authorities require critical scheduled site visits, which must be planned when feasible.
- Data protection and patient consent: Sponsors should take into consideration and adhere to local requirements.
- Security and validity of IT systems: Contingency plans may need to be updated to include additional systems. Common consumer applications may be proposed. The solution should adhere to national requirements, such as hosting health data regulations and information system security requirements.
- Communication: Patients should be informed early about changes in the conduct of the clinical trial relevant to them. Regulatory authorities should be notified per national guidance.
- Data integrity: Adequate documentation of deviations is important. Decisions and deviations should be thoroughly documented in line with national guidance where appropriate. Documentation, at the site level and in electronic data capture, should be clear to allow the statistician to use this information in future analysis summaries.
Shaping the Present and Future of Clinical Trials
Through the implementation of regulatory considerations, leveraging partnerships with existing telemedicine service providers and collaborating with regulatory authorities and sponsors, PPD is using telemedicine to support trial continuity during COVID-19. For example, we have implemented new mobile applications to enable patients to connect visually with their clinical study sites and allow investigators to complete safety assessments more efficiently. We are confident telemedicine can improve the trial experience for patients, maintain regulatory compliance, increase efficiency and speed delivery of reliable data.
Industry reports and actions echo agreement. These reports describe successful telemedicine and digital strategies supporting trial continuity during COVID-19, noting how such innovations benefit patients, who may be receiving lifesaving or life-altering treatments through clinical trial participation. In addition, and importantly through the pandemic, the use of telemedicine also lessens the burden on the health care system and conserves the use of personal protective equipment (PPE) for those who need it most. We also are encouraged by proactive actions such as the recent announcement by the Swedish Regulatory Authority (MPA) of its plan to undertake a one-year feasibility study to investigate how to support virtual clinical trials. Despite the ambiguity the pandemic has posed for our industry, our vision to improve health remains clear as we work to overcome the obstacles the pandemic has presented and embrace the opportunities in this period of change.