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Inclusivity

How a Decentralized Clinical Trial Model Can Enhance Diversity in Oncology Research

Dallas Miles

When a patient is first diagnosed with cancer, their entire world changes. Fear and anxiety immediately set in because so much is unknown. They worry about their treatment options, their quality of life and how long they have left to live. Their friends and family are affected. Fortunately, however, research is bringing new treatment options to patients every day. A cancer diagnosis even five or 10 years ago could have been a death sentence. Today, that same patient can have a good quality of life.

The main difference between oncology research and every other therapeutic research area is that for a cancer patient, a clinical trial is the only option left after standard of care options are exhausted. The unfortunate fact is that most cancer patients still do not have access to clinical trials as further hope for treatment because of where they live. Furthermore, oncology clinical trials are extraordinarily expensive. They require patients to come into visits for frequent scans and they are usually only available in major centers around the world. It is not possible for every clinical trial to be available to every patient who needs that trial.

As decentralized clinical trial (DCT) designs become better, oncology clinical trials can start adopting them to bring clinical trials to more cancer patients as a care option. The opportunity to open more satellite sites becomes possible. More than 90% of oncology clinical trials are in the early phase stage, still just finding dose and safety. These trials do not enroll a lot of patients so there is a perception that they are not good for a DCT design. The fact is that these trials can be the perfect clinical trials for a DCT design. Imagine a world where these early trials can move quicker, and decision makers can move a trial into phase two and three faster or kill it quickly and pivot to a more effective trial faster. The quicker we can make decisions on early phase trials, the faster we can get larger phase three and four trials launched globally to help more people.

Another problem with oncology clinical trials is that fast enrollment is usually prioritized over diversity of enrollment. The timelines are more important than a robust data set. With the FDA’s new guidance where researchers are now required to submit a plan for diversity, researchers will now realize the benefits of a DCT design because it will enhance diversity by using technology to find a wider set of patients and be able to recruit sites that have not historically participated in clinical research.

How DCT technologies can enhance diversity and benefit both the patient and their families:

  • The use of technology can connect patients and caregivers to each other and ensure full circle support as the patient goes through their difficult journey
  • Telehealth and home health visits can be offered to enhance medical support, reduce anxiety, and ensure timely reporting of adverse events (rather than waiting for the next clinic visit)
  • Wearable devices and sensors can be used and sent home with the patient to provide continuous data collection, allowing for immediate recognition of changes or adverse events that were previously not detected. Also, this eases the burden of the patient needing to stay in clinic long days just to monitor events like heart function.
  • For every data point that is collected remotely, it is one less data point requiring the patient to travel and is one more datum point being collected in real time to help decision making during early phase clinical trials.
  • By using technology in a DCT design, sites that could not participate in clinical trials previously, can now be added to improve access to clinical studies to a more diverse range of patients and enable more inclusive and representative patient populations.

Esther Howard

Oncology Advisor, THREAD

Esther oversees THREAD’s oncology strategy and collaborates directly with clients to help them build the best oncology solution in a DCT design that integrates with THREAD’s platform. She is committed to the mission of improving the lives of cancer patients, globally. Esther has twenty years of experience in the healthcare and clinical research industry.