Decentralized Trials: Bringing Clinical Trials Closer to the Patient
While participating in clinical trials can provide substantial benefits to people with lung cancer, the resources required to do so may pose significant hurdles, especially to those who don’t live close to where trials are held, such as academic medical centers or major oncology network sites. Decentralized clinical trials remove some hurdles to trial participation for patients and are thus important for improving trial access for larger and more diverse groups of people. The U.S. Food and Drug Administration (FDA) recently issued a draft guidance outlining recommendations and important considerations to further increase the uptake of decentralized clinical trials.
Clinical trials are used to establish the safety and efficacy of newly developed therapies before they enter the market and become available to patients. They can give people access to novel and potentially life-saving therapies. In addition to potentially being one of the first to benefit from innovative therapies, trial participants also get close monitoring and expert medical care.
Though clinical trials give significant advantages to participants, there are many barriers that make participation hard or impossible. A major hurdle of traditional clinical trials is that procedures and visits take place in person at a central location, such as a large academic medical center.
Participants must consider the time and money required for travel to and from the trial site, food and lodging while there, childcare/eldercare/pet care while gone, time away from work, and more. Together, these items can make trial participation harder or impossible for those who don’t live close to the trial site and/or those with limited resources.
These hurdles to trial participation can be lowered by having trial-related activities take place at healthcare settings local to the participant, or even in the participant’s home, in what is known as a “decentralized clinical trial.”
Decentralized clinical trials, which bring the trial to the patient, create a more level playing field by making it easier for those who don’t live near the trial location to participate. Additionally, decentralized trials could lead to greater participation by historically underrepresented groups in clinical trials. Greater adoption of decentralized trials is therefore an important step in both reaching more patients with lung cancer and reducing lung cancer disparities.
Trial decentralization is not a new idea, but its adoption has been slow, especially in oncology. Using elements of decentralized trials in ongoing and new clinical trials was accelerated during the COVID-19 public health emergency to minimize interruptions to clinical research and exposure of patients and research staff to COVID-19.
For example, study visits were done via telehealth and/or in-home nurse visits, therapies were shipped directly to patients, and electronic informed consent forms were used to get consent remotely. Anecdotally, these adaptations made it easier for patients to participate in clinical trials without posing a risk to patient safety.
Even before COVID, LUNGevity was working to increase the use of decentralized and hybrid trials—those in which some trial activities are done local to the patient while others require travel to the main site. In 2019, we surveyed thoracic oncologists and found they were open to having certain trial procedures like CT scans and laboratory blood tests done at medical centers closer to the patient.
LUNGevity has also hosted discussions and led working groups with trial sponsors, investigators, and regulators to identify and try to remove administrative burdens associated with running decentralized/hybrid clinical trials. Together with the National Brain Tumor Society, LUNGevity recently published an assessment of remote informed consent use at academic medical centers, and called for greater consistency and transparency among policies for remote consent.
Federal agencies are also working to increase decentralized clinical trial usage while ensuring they meet regulatory requirements and patients are kept safe. Since 2020, the National Cancer Institute (NCI) has worked to assess whether decentralized procedures adopted during the pandemic could be made more permanent. They have worked with experts and surveyed relevant stakeholders to identify remote procedures (e.g., informed consent, telehealth use) that could be adopted as standard clinical trial practice moving forward.
Building on lessons learned during the pandemic, the FDA recently released draft guidance for trial sponsors, investigators, and other stakeholders that outlines considerations for the appropriate design of decentralized trials, the use of remote informed consent, and safety monitoring plans, among others.
The FDA draft guidance is open for public comments until August 1, 2023. LUNGevity is submitting comments sharing key insights from discussions with experts as well as efforts the Foundation has undertaken to optimize the design and conduct of decentralized clinical trials for the ultimate benefit of patients with lung cancer.