Science demands more patient centricity in oncology research
It’s simple: a clinical trial health system that enrols more patients will lead to faster treatment advances and, therefore, better outcomes for people with cancer.1 But, as it stands now, less than 5% of adult cancer patients participate in oncology trials.2,3
This low enrolment rate is only getting harder to overcome with the rise of precision medicine. Due to increased demand for diagnostic innovation, technology advances, and a desire to avoid specific drug resistance, the global precision oncology market is expanding rapidly, at an estimated compound annual growth of 9.7% through 2023.4 As it grows, it will necessitate clinical trials studying smaller and smaller subtypes of cancer, further limiting the already-limited patient pool.
Even if we, the research industry, can find such specific patients, we will still be faced with the challenge of accessing them. After all, most cancer patients aren’t close to traditional research centres, presented with trial opportunities, or comfortable with their assumed risks of participation.
Perhaps the solution is in an already-trending concept: patient centricity.
A positive trend
Making oncology trials more patient friendly can help increase enrolment, even for trials with limited patient pools. One report found that, on average, trials described as “patient-centric” took about four months to recruit 100 participants, while traditional trials took seven months, and that patient-centric rare disease trials recruited 100 participants 20% faster than other trials.5 By making it easier for patients to participate, clinical trial sponsors can recruit more patients faster. When trials enrol quickly, they are more likely to remain on schedule, which will speed up bringing new treatments to market and ultimately improve outcomes for people with cancer.
But what does “patient-centric” really mean? How can we make oncology trials more patient-centric?
Here are a few ideas.
Make research part of the stand of care
For many cancer patients, clinical trials are often viewed as a last resort, reserved for when they have exhausted all other treatment options or have run out of money. However, trial participation should not be thought of as a last-ditch effort, but instead as an integral part of the cancer care journey.
To make clinical trials part of standard of care (SOC), we must bring research to more healthcare-first sites, meaning primary care physicians, specialists, small hospitals, and other community healthcare facilities that don’t traditionally serve as research sites. This approach has several advantages. First, when trusted healthcare providers mention research as a care option, their patients are more likely to enrol in clinical trials - just like we’re more likely to buy a pair of shoes when a friend recommends them versus when we see an ad for them on TV. Second, patients who do enrol per their physician recommendation can then participate close to home and with their trusted provider. Finally, enabling healthcare-first sites to participate in research through training, infrastructure, and technology can increase diversity in clinical trials - a benefit that might soon become a mandate thanks to the Diversity Action Plan guidance in the FDA’s Omnibus Reform Act of 2022 (FDORA).6 By expanding clinical trials beyond research centres, we make it possible for more doctors, patients, and traditionally under-represented communities to participate in the research process, not only meeting FDORA guidelines, but also creating products that are safe and effective for all.
Reduce the burden of participation
Clinical trials are essential, but participating can be challenging for patients, especially those with cancer. These difficulties run the gamut from travel burden to the risk of spending time in a large healthcare facility when immunocompromised. We can employ several strategies to reduce the burden of clinical trial participation:
- Enable more healthcare-first sites, as visiting a local doctor for study visits is much easier and less risky than travelling to a far-away hospital or research centre
- Make trial protocols hybrid-friendly to reduce the need for travel, while still maintaining data integrity and patient safety
- When hospital or research centre visits are necessary, alleviate the patient burden by supporting their caregiver and providing travel assistance
Make the benefits of participation crystal clear
Many patients are hesitant to participate in clinical trials because they’re afraid of the risks involved, whether that means worrying about how the trial will affect their health or questioning the possibility of being randomly assigned to a placebo group. To alleviate hesitancy, we must address these common concerns and ensure patients fully comprehend the benefits of trial participation.
One proven way to do this is by using patient-friendly language that is both sensitive to the patient’s diagnosis and easy to understand. Effective communication between healthcare providers and patients can help overcome the existing barriers and increase participation in clinical trials.7 It’s also important to be clear about what patients can expect to gain from participating in the trial, such as free access to new treatments, why the trial is better than SOC, and playing a crucial role in advancing medicine and saving more lives in the future.
Patients are people
Making clinical trials patient-centric is not as easy as simply completing a checklist. Every patient is different, and so is every cancer. Making research a part of standard care, reducing burden, and clearly addressing benefits can make trial participation a more appealing option for patients, but only if those steps are tailored to every trial and every patient.
At its heart, patient centricity is treating patients as people first. Sometimes, it’s the little things that make all the difference. Creating a sense of normalcy by having breakfast waiting for them after a visit or seeing the same doctor every time can go a long way in building trust and reducing the stress of trial participation. When we take steps to address each patient’s individual needs and experiences, we will make trials a more positive experience and increase participation rates.
The bright future of patient-centric oncology research
As treatments become patient-specific, trials need to be patient-centric. And, if the industry continues to prioritise patient centricity in clinical trial design, it’s easy to envision a future where cancer treatments have fewer side effects and patients can enjoy their lives while undergoing treatment. By focusing on patients and their needs in research, we can make the journey through treatment a little easier and, ultimately, improve outcomes for patients and families affected by cancer.
1.Unger, J.M., et al. Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. Am Soc Clin Oncol Educ Book. 35:185-98. 2016.
2.Murthy, V.H., et al. Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities. JAMA. 291(22):2720–2726. 2004.
3.Heriberto, T., et al. Representation of African-Americans, Hispanics, and Whites in National Cancer Institute Cancer Treatment Trials. JNCI: Journal of the National Cancer Institute, Volume 88, Issue 12, 19, Pages 812–816. June 1996.
4.Precision Oncology Market Size, Share & Trends Analysis Report By Product Type (Diagnostics, Therapeutics), By Cancer Type (Breast Cancer, Cervical Cancer, Prostate Cancer, Lung Cancer), By End-use, By Region, And Segment Forecasts, 2023 – 2030. Grand View Research. Accessed 2023 May 4.
5.THE INNOVATION IMPERATIVE: THE FUTURE OF DRUG DEVELOPMENT. The Economist Intelligence Unit. Published 2023.
6.H. R. 2617. Authenticated U.S. Government Information GPO. Accessed 2023 Feb. 17.
7.Krol, D., et al. The Development of the Oncology Center of Excellence Patient-Friendly Language Glossary of Oncology Clinical Trial Terms. The Oncologist. 2023 March 7.