January 26, 2023
We didn’t get meaningful adoption of DCTs until the pandemic, when we actually had to get people to do it differently because the sites were closed. The status quo is all that people are willing to go with until there is something that forces them to change.
In a 2021 meeting of the directors for NCI-designated cancer centers, FDA regulators demonstrated enthusiasm and embracement of DCTs. In addition to predictable benefits like improved recruitment, they identified these benefits of DCTs:
• Data capture outside of the healthcare setting.
• Continuous data rather than snapshots.
• Objective measurements.
• Reduced missing data.
• Capturing rare events.
Recognizing the advancement of DCTs, the FDA’s Oncology Center of Excellence is now evaluating how modifications made to oncology clinical trials, during the COVID-19 pandemic, can be assessed for quality of evidence and future trial guidance.
The Sidebar queried Dr. Pamela Diamond, Chief Medical Officer of CURAVIT, on her experience regarding the FDAs’ uptake of DCTs. She noted:
An impetus was the COVID-19 response. In late 2021 and early 2022, the FDA published guidelines on DCTs: services and on the use of digital health products in trials. Those guidelines have been very helpful.
I think it is good advice to sponsors, CROs–anyone designing and executing DCTs–to consult the FDA early and often. It’s helpful to get the input of the FDA about the protocol design and product-specific questions, garnering the FDAs advice on the selection of technology that might be used in conducting the research trial.
Are the Central Stakeholders Ready to Pivot?
DCTs can’t progress without their two main stakeholders embracing the transition: patients and clinician-researchers. In 2021, Labcorp™sponsored a survey of US and UK oncology clinician researchers’ and patients’ perceptions of DCTs. The by oncologists revealed they were reticent about possible decreased oversight, increased patient responsibility, and quality of samples.
Patients, on the other hand, revealed their general concerns were related to the potential for side effects to occur, distance from the hospital, or not receiving the therapeutic drug (receiving a placebo). Confirming The Sidebar’s observations, of the patients surveyed, 90% revealed they would not travel over 10 to 50 miles to participate in a research study.
Regarding exclusions to patient participation in research, Dr. Ray Dorsey, Professor of Medicine at the University of Rochester recounts his philosophy:
We have cared for patients in 5 states, and 6 continents. Since 2007, we have performed at least a dozen decentralized studies involving thousands of individuals with and without Parkinson’s disease and other conditions over the last ten years.
How do we do that? We don’t do that by embracing the status quo. We do that by developing new approaches that leverage technology to bring care to patients and research opportunities to participants. When we do that, we get a more equitable system, better health, and better knowledge that can fuel better treatments!
DCTs: Broadening Access, Enhancing Equity
Clinician-researchers and patient advocacy groups recognize the challenges and limitations of traditional clinical trials, which has inadvertently excluded patients in diverse socioeconomic and cultural strata. The onset of the COVID-19 pandemic pushed industry stakeholders, researchers, and patients to view clinical trial participation in a new light.
These broadened perspectives are buoyed by increased clinician support and patient acceptance for digital therapeutics’ role in supporting healthcare and DCTs. With increasingly creative DCT designs, even patients with limited digital access have the opportunity to participate in emerging treatments. DCTs are now ‘center stage’ in effecting clinical trials—facilitating rapid progress in crucial drug development, enhancing diversity and interpretability of trial results, and enhancing equity in patient access.
In Part II of our series, Natural Allies: Decentralized Clinical Trials and Digital Therapeutics, we will explore how DTx and DCTs are inter-reliant, augmenting patient participation in the worlds’ best investigational solutions.