Challenges with traditional clinical trials
The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. They are centred around the trial site(s). The trial protocols tend to be increasingly complex, and regulatory and safety requirements mandate frequent site visits at all stages of the trial, namely screening, counselling, consenting, administration of interventions, outcome assessment, and follow-up. As a result, patients are often required to visit the site to complete trial-related processes, while the infrastructure and staffing demands of these sites consume significant resources. Consequently, such research sites are typically established within larger medical institutions, which may be located far from the participants’ residence.
Traditional clinical trials encounter various challenges that can impede efficient conduct of research, such as operational inefficiencies in participant identification, recruitment, data acquisition, and follow-up. These challenges can inflate costs, increase participant burden, and prolong an already lengthy trial timeline, all of which contribute to low clinical trial participation. In addition, individuals living at a distance from research sites or those facing mobility or scheduling constraints may find participation financially burdensome or logistically unfeasible, thereby expanding disparities in research access and limiting participant diversity. For instance, a 2019 systematic review revealed that only around 8% of cancer patients in the United States enroll in cancer trials.
Decentralised clinical trials
Decentralised clinical trials, also known as remote, digital, virtual, or siteless trials, were introduced several years ago to decentralise the conduct of a clinical trial, bringing certain procedures closer to the participants’ homes for enhanced convenience (participant-centric approach).
These trials leverage digital technologies like computer and mobile apps, web-based tools, and remote monitoring devices to facilitate participant recruitment, counselling, informed consent, endpoint measurement, and adverse event monitoring. This approach reduces or eliminates the need for participants to visit traditional trial sites.
The COVID-19 pandemic accelerated the adoption of virtual trials due to challenges such as physical distancing requirements, staff shortages, and research limitations. In 2022, Thomas EE et al. published a study on telehealth adoption in cancer clinical trials in Australia. The pandemic disrupted cancer clinical trial operations globally, prompting the adoption of alternative delivery models to safeguard vulnerable and immunocompromised patients. Consequently, telehealth usage surged as a means of maintaining trial continuity, patient safety, and access. Telehealth services in clinical trials include virtual study procedure explanations and patient support, remote consent acquisition (eConsent), and video/telephone appointments between trial staff and participants.
Advantages of decentralised clinical trials
Virtual clinical trials offer several advantages. They reduce the reliance on site infrastructure and staffing, leading to lower trial costs. Additionally, they enhance efficiency by enabling targeted and more timely recruitment. These trials expand the pool of potential participants by offering care closer to their homes, thereby reducing the need for travel and associated expenses. This is especially beneficial for individuals with serious illnesses. By including a more diverse range of participants, such as those with rare cancers, adolescents, pediatric groups, rural residents, indigenous populations, and culturally and linguistically diverse (CALD) individuals, decentralised trials improve generalisability of trial results.
Eliminating the need for frequent site visits enhances participant compliance and retention rates, while also potentially improving the timeliness of data measurements. Innovative methods of data collection provide continuous real-time data rather than data collected at specific intervals, allowing for earlier identification of adverse events. Decentralised trial operations also generate real‑world data on the efficacy of interventions.
Challenges in conducting virtual clinical trials
Decentralised trials rely heavily on technology, particularly internet access and proficiency with web-based applications. Paradoxically, this dependence may inadvertently exclude certain participant demographics. Virtual trials may not be suitable for all types of clinical trials; for instance, early phase trials or those investigating complex or potentially hazardous interventions may necessitate specialised care and are better suited as site-centric studies. Clinical conditions and tasks such as administering intravenous treatments or radiotherapy, conducting physical examinations, or engaging in difficult or sensitive conversations are not conducive to digital tools.
Reliance on digital methods for processes like consenting, data transfer, and storage (e.g. cloud storage) raises concerns regarding participant confidentiality and data privacy. Additionally, the remote delivery of study interventions relies on supply chain logistics, potentially impacting drug efficacy due to storage and handling conditions. Similarly, ensuring quality becomes crucial when relying on local laboratories or imaging centers for study assessments.
Conclusion
While the healthcare and clinical trials sectors have traditionally been hesitant to embrace digital alternatives, there has been a notable shift in recent times. A plethora of digital tools capable of reshaping healthcare and clinical research have emerged and are experiencing rapid growth.
These advancements present an opportunity for clinical trial research to utilise electronic technology in lieu of the conventional face-to-face methods for recruitment, intervention delivery, data collection, and participant retention. Nonetheless, numerous challenges persist, and valuable lessons are being gleaned from past and ongoing decentralised clinical trials.
Véronique Ropion, MD
Strategic Projects Director, Pharmalys Ltd
April 2024
From references:
Abiodun T.N. et al. 2022. Remote Health Monitoring in Clinical Trial using Machine Learning Techniques: A Conceptual Framework
Inan O.T. et al. 2020. Digitizing clinical trials.
Ranganathan P. et al. 2023. Virtual clinical trials.
Thomas E.E. et al. 2022. Telehealth adoption in cancer clinical trials: An Australian perspective.
Unger J.M. et al. 2019. Systematic Review and Meta-Analysis of the Magnitude of Structural, Clinical, and Physician and Patient Barriers to Cancer Clinical Trial Participation.
