Cancer Trials Have a ‘Need for Speed’ — Decentralization Could Help
Oncology trials are bogged down by a number of serious challenges that significantly impact sites and research timelines. Decentralized trial (DCT) approaches could simplify many of these complexities, but hesitancy about adoption still remains.
The difficulties inherent in today’s cancer trials, including complex designs and treatment paradigms, high amounts of protocol deviations and data, fierce competition and a low rate of trial participation, mean that there are also unique challenges for patient recruitment and retention. And trial participants often find themselves overwhelmed by cancer trials and change their minds.
The numbers are startling: only around 5 percent of oncology patients choose to participate in a clinical trial, while only 50 percent of cancer trials recruit within their planned timeline, according to Archana Sah, senior vice president of Medable. Approximately 30 percent of patients in cancer trials will quit, leading to massive cost and time implications for sites and sponsors.
“The need for speed in oncology is really, really high. We have the highest number of trials open on ClinicalTrials.gov and high competition for sites and for these patients,” Sah said.
Currently, Sah is aware of DCTs being used in both solid and liquid cancer indications, including common multiple myelomas, breast cancer, renal cancer, prostate cancer, melanomas, chronic lymphocytic leukemia and acute myeloid leukemia, among others.
Luisa Sansalone, former clinical research manager at Austin Cancer Center, named patient compliance and retention as one of the site’s greatest challenges. Immunosuppressed patients, for example, often experience adverse events (AEs) or serious adverse events (SAEs) that make it hard to complete in-person study visits and the study itself. For these cancer patients, the remote capabilities afforded by DCTs and hybrid trials could be a godsend.
“I feel that a decentralized or hybrid trial allows for more remote visits that can help alleviate the patient burden of having to travel to the clinic while experiencing an AE and being able to maintain compliance,” she said.
Like virtually all therapeutic areas, the pandemic forced oncology trials to implement remote approaches that were rarely used before in research. While that doesn’t mean remote approaches are yet the established norm in oncology research, it’s anticipated that cancer trials will see a further increase in the use of these technologies in 2022 (CenterWatch Weekly, Dec. 6).
Making cancer trials more patient-centric by offering DCT options can deliver a host of benefits for both sites and participants and provide urgently needed acceleration. For instance, it frees up oncologists and investigators to devote more time to patients, whether that’s virtual or in-person, and cuts down clinic wait times for patients who still need or want to meet on site. And using a centralized platform for data capture simplifies time management for sites, who can navigate electronically through a protocol and access needed tools in a single location. Additionally, gathering data electronically can help reduce protocol deviations, something that has been shown to improve patient retention and compliance, according to Sansalone.
The complexities of oncology research mean that not all tasks can be done remotely — such as dosage titrations or imaging — but there are simpler things that can be implemented in cancer trials to reduce patient and site burdens, she said. eConsent, electronic clinical outcome assessments (eCOAs) and electronic patient reported outcomes (ePROs), for instance, can all be deployed relatively easily at sites and have a big impact on site workloads and patient stress.
“From the site perspective, we have found that our patients are really more receptive to remote visits … because it removes the burden of traveling and any expenses related to that, and it also removes the risk of being exposed to potential viruses,” Sansalone said.
In terms of site preparation for DCT approaches in cancer trials, some have taken the initiative to invest in technology of their choosing and train staff accordingly, while others are looking to sponsors for tools and training. Sites should view DCTs and remote monitoring as “the trend of the future” and those on the fence should keep an open mind, Sansalone advised.
“I think it’s a mindset for other sites to accept that concept. I think once a site is on board and trained properly by the CRO or sponsor, the benefits speak for themselves.”
Regulators appear in strong support of using remote tools in cancer trials — the FDA issued guidance on oncology trial PROs in June — but industry still hasn’t fully bought in yet.
On one side of the spectrum, certain organizations have fully recognized the benefits of DCT solutions in cancer trials, with top tiers of leadership calling for, at the least, technologies that are easy to use and implement to be included in every protocol, Sah said. But on the flip side, some are still hesitant to use DCT technology in their oncology trials. Convincing them will require further education and the sharing of best practices and case studies that show how successful and useful DCTs can be in cancer research.
It’s also critical, Sah said, to remember that these remote technologies require a fit-for-purpose approach based on what’s being assessed in the protocol. That means critically thinking before moving to adopt a solution so that new technology doesn’t have the opposite effect of adding unintended burden on sites and patients. Sah called for a “mindful implementation of these DCT technologies where we’re actually making a difference to simplify the patient experience [and] the site experience.”
Going forward, as DCT approaches continue to increase in use not just in oncology but across all therapeutic areas, Sah urged sites to start preparing now if they haven’t already.
“I would encourage [sites] to get on the train, leveraging and utilizing these tools. If you have not invested, make sure that you are spending the time to learn about the tools the sponsors are bringing to you. Get yourself trained, become familiar with this,” she said. “We will be benefiting all around, every single stakeholder, whether it’s a sponsor or a site or a patient. There are just tremendous amounts of opportunities and benefits that we can’t stand to ignore. We need to be developing these [cancer] medicines faster — the patients are waiting and it’s our duty to leverage all these tools.”
As early as the pre-site selection visit, it is helpful for sites to know if a study design is a DCT or hybrid trial. If that isn’t mentioned by the sponsor or CRO, the site should ask so they know what to expect and prepare for — preferably during the startup time before the site initiation visit, Sah advised.