By Professor Craig Underhill.
The COVID-19 pandemic has not only reshaped our daily lives but has also revolutionised the landscape of clinical trials, improving equity of access for patients with cancer. This was the focus of our study recently published in JAMA Oncology.
The study highlights the significant uptake of digital technologies in clinical trial conduct, particularly emphasising the emergence of telehealth consultations and decentralised clinical trials (DCT).
As face-to-face interactions became limited due to pandemic restrictions, the healthcare sector rapidly embraced digital solutions to ensure continuity in patient care and trial operations. This surge in digital adoption, driven by the need to minimise in-person interactions, has resulted in transformative applications in the conduct of clinical trials.
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The Victorian Teletrial Collaborative was formed by Alfred TrialHub, Regional Trials Network Victoria and Victorian Comprehensive Cancer Centre Alliance, aiming to develop a number of practical tools, templates and guidelines for the implementation of telehealth in clinical trials in oncology in Australia.
We developed a 2 year work plan and also liaised with the Australian Teletrial Program to avoid duplication with the important work they are doing in this field.
One of the first things we discussed was terminology – there are lots of different terms being used and they can mean different things to different people. The study underscores the importance of standardised terminology to avoid confusion and facilitate widespread adoption of digital trial models. It also highlights the potential of teletrials, particularly in addressing disparities in access to clinical trials and improving clinical outcomes, especially in rare cancer and disease contexts.
We developed this paper to review the literature to create definitions for Digital Trials, Teletrials (TT), Decentralised Clinical Trials (DCT), Networked Clinical Trials Virtual and Remote Trials.
DCT has emerged as the leading term in the Northern hemisphere and TT in Australasia. The main difference appears to be the existence of the “supervision plan” in the Australasian TT model championed by COSA, which is like a delegation log across sites enabling a trial to be conducted across a network. In some ways, it is a safer, more developed and more inclusive version of DCT. DCTs can simply be all of the protocol procedures conducted in the main institution with the patient at the end of the digital technology. TT enables the upskilling of clinicians across the network and safer, closer-to-home care for the patient where possible throughout the trial.
We realised that many of the perceived barriers to doing TT are in fact generic issues of multisite trials which we need to solve together – which the Victorian Teletrial Collaborative will continue to work upon.
Digital technologies will be pivotal in shaping the future of clinical research, offering opportunities for improved patient care and equitable access to innovative treatments. As such, we need a global consensus in adopting terminology while advocating for the integration of teletrial principles to enhance the safety, efficiency and accessibility of clinical trials.
I hope you enjoy the paper and we look forward to the discussion. Tell us your thoughts!
GLOSSARY OF TERMS:
Teletrial: A teletrial uses telehealth technology to communicate between the primary site and satellite site/s for some or all aspects of a clinical trial. This supports a principal investigator (PI) to supervise associate investigators who conduct a clinical trial at a satellite site, geographically remote from the PI’s primary site. The PI remains responsible for the conduct of the trial across the cluster. A detailed supervision plan is required, in addition to a delegation log required by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice. The supervision plan defines responsibilities for conduct of the study across sites. The delegation log defines responsibilities at each site trial. Participants may have trial visits at both the primary and
satellite sites, as determined by the protocol and as outlined in the participant information and consent form. The conduct of the trial is detailed under a head agreement, using a clinical trial research agreement/clinical trial agreement between the sponsor and the PI’s institution and a subagreement between the primary site and the satellite site institutions. Synonyms for teletrial include networked clinical trial.
Virtual trial or remote trial: A virtual trial includes patient recruitment, consent, and data collection done remotely. By that definition, a true virtual trial would be one where there were no physical sites and no
face-to-face interactions with patients. Others defined a fully virtual trial as one where there would be no human-to-patient interaction at all.
Decentralized clinical trial: A decentralized clinical trial is one in which components of a trial are done away from a central research facility. Patients complete their clinical trial visit at a remote location, either
through virtual tools, such as video calls and patient-reported electronic assessments, or by face-to-face interactions. The relevant feature is the location of the patient interaction. Teletrials are a subset of decentralized clinical trials but emphasize the use of a supervision plan to ensure responsibilities are defined a priori. Although digital health technologies are often used in decentralized clinical trials,
digital technology is not their defining feature. Decentralized clinical trials can use paper forms exchanged by mail or through house calls, for instance, but digital health technologies are preferred. In fully decentralized trials all trial procedures take part in nontraditional trial settings such as patients’ homes or local health facilities. Hybrid decentralized clinical trials use nontraditional settings in part.
Digital trial: A digital clinical trial uses no paper during the conduct of the study. There may be paper forms associated with the patient prior to study initiation, but they would be digitized and
Paper: Underhill, C, et al. Decentralized Clinical Trials as a New Paradigm of Trial Delivery to Improve Equity of Access. JAMA Oncology. Published online February 15, 2024. Jamaoncology.com
Permissions: Table reproduced with permission from JAMA Oncology
