Improving Access to Cancer Clinical Trials by Reimagining Clinical Trial Conduct
Esther Howard

ar too many cancer patients are not getting the treatment they need because they do not know about, do not have access to, or are not able to participate in a clinical trial. It is estimated that fewer than 5 percent of adult patients participate in clinical trials, and yet approximately 70 percent of cancer patients are willing to do so. This gap between participation rates and the willingness to participate is one the clinical research industry is dedicated to resolving.

To bridge the gap, two changes would make a significant difference:

  1. More sites need to be able to participate in research, especially in communities that are too far from academic institutions where most oncology clinical research is conducted.
  2. Clinical trial design needs to be reimagined to simplify patient participation and personalize their experience in a trial.

In 2020, the US Food and Drug Administration issued guidance that supports decentralized clinical trials (DCTs). Clinical trials can now consider remote collection of trial data outside of the traditional in-person clinical trial site visit. These options include electronic informed consent, remote clinic visits via telehealth technologies, visits in the patient’s home, delivery of investigational product to the home, and obtaining laboratory or imaging assessments locally rather than centrally at the site.

In addition to FDA guidance, on Oct 4, 2022, the Accelerating Clinical Trials in the EU (ACT EU) program hosted a workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives. In a discussion with THREAD Research DCT experts who attended the event, Sherry Autwal and Sinead Callinan, two key takeaways from the event were:

  1. DCT is not a clinical trial methodology in itself; however, the application of technology affords us an opportunity to re-think how we solve for all the challenges conducting studies in oncology. To innovate, we need to imagine how technology can allow us to transform and simplify the participant and site experience.
  2. The power of the trusted relationship between participant and their healthcare providers cannot be underestimated, thus even with the ability to leverage technology to streamline, automate, and digitize, we cannot neglect the value of human-to-human interaction which should be central to the design of any study. The challenge should be to evaluate how a digitally enabled trial can create a greater opportunity to develop that trusted relationship.

In the workshop, the EU DCT project group presented the work of the European medicines regulatory network on DCT collaboration, discussed the planned publication in Q4-2022 of a recommendation paper on the use of DCT elements.

With regulatory support, there is no better time than now to collaborate with the agencies and be part of the necessary modernization of clinical research for cancer patients. Other therapeutic areas are already adopting these decentralized options, but it is well known that the oncology research industry has been slow to adopt DCT design, primarily because of the need for cancer patients to go to a site for necessary scans and procedures. Plus, it is difficult and costly for a site to participate in clinical research, and thus community centers often don’t participate because they don’t have the funding to support the required infrastructure and resources.

Community centers need government and pharma industry support to add research to their practices, both with funding and with other experienced centers leading. Clinical research organizations (CROs) could also play a role in supporting community centers by providing additional training programs and developing partnerships that create new networks of sites.

Sites like Carolina Blood and Cancer Center Associates (CBCCA) are already paving the way for other community centers to learn how to ask for funding and support. In addition to his initiatives to bridge the disparities of care, Dr. Kashyap Patel, CEO of CBCCA, has worked hard to create a template of training and resources community centers can use to get the support they need to bring clinical trials to more cancer patients.

Following the model of CBCCA, more community cancer centers could be opened up to research and an entirely new set of patients might have access to the care they need.

In addition to adding sites, and with global regulatory support and guidance for DCTs, oncology research can become more patient-centric by focusing on how to simplify a patient’s life. Factors such as social support and connections, financial resources, education, and ethnicity play a role in their choice. Ultimately, each cancer patient will have varying degrees of stressors in life that inhibit their mental strength and ability to participate in a clinical trial, and the clinical research industry can help.

A few areas in which clinical trials can be reimagined using a DCT framework that will simplify life for cancer patients are 1) the informed consent process, 2) the use of telehealth and home health visits, and 3) supportive tools to reduce life’s stressors and enable participation.

Even if it’s best for a cancer patient to be on-site for the informed consent conversation and signature, there are electronic options for supplemental training and materials that can be included in support of a patient’s ability to share and discuss with family and social supporters. For example, TransCelerate offers basic guidance for sponsors and CROs to consider as the informed consent is being developed and administered to the patient. While eConsent and using technology to supplement consent is still not widely adopted in oncology clinical trials, plenty of evidence shows the benefits of cognitive learning via multimedia and well-established companies are deploying these methods specifically for clinical trials.

Even if scheduled visits should ideally occur on-site, as has been the tradition, optional and supplemental telehealth and home health visits can be included as an element of DCTs. The value and patient convenience impact of even one less on-site visit should not be underestimated. If a patient needs support between visits, these options can greatly improve their quality of life and care and improve their clinical reported outcomes—specifically adverse events that are often “lost” because, for example, the patient did not remember to mention a prior fall or a headache during their regularly scheduled on-site visit.

Supportive tools to reduce life’s stressors for patients in clinical trials can be solutions as simple as incorporating concierge travel support or access to childcare and apps that specialize in strengthening the support of immediate friends and family. Designing a trial to ensure that data collection is conducted in the easiest way and understanding the needs of the patient so they can participate in the trial successfully may significantly improve clinical trial retention.

For cancer patients, hope grows when clinical trials are an option for their care. There is no better time than now to collaborate with regulatory authorities and other stakeholders to make this option a reality for all cancer patients.