Cancer Patients Prefer Decentralized Trials
Author: Dr. Shaalan Beg
Decentralized clinical trials have officially become the norm – at least when it comes to cancer research.
This year, 73% of clinical research executives expect their oncology studies to be agile (hybrid) trials or fully decentralized, according to a new survey conducted by Science 37. This is up from just 49% in the previous 12 months.
It’s a powerful indication of the benefits that decentralized clinical trials bring to oncology research, which accounts for almost one-third of global clinical research budget.
These studies face many obstacles that can slow research progress and delay patient recruitment – which was cited as the number one challenge oncology trials face. And as competition for patients increases, sponsors are using decentralized clinical trials to make their research more appealing and accessible to the patients they want to recruit.
Why Patients Love Decentralized Clinical Trials.
Decentralized trials enable sponsors to reach new patient communities, while reducing the travel burden and healthcare risks associated with frequent trips to study sites. Hybrid trials, which combine elements of decentralized designs with some on-site visits, enable much of the data collection and interactions to occur virtually via electronic patient reported outcomes (ePROs), wearable devices and telemedicine. They may also leverage mobile nurses, and the patients’ own oncologists and local labs to conduct some tests and assessments that require a medical setting.
This agility can be appealing for oncology patients who may have high symptom burden and have built trusting relationships with their oncology teams. Allowing them to maintain these care connections while limiting the frequency of site visits can accelerate recruitment and aid in retention of these patients throughout a study.
This approach is equally appealing for sponsors who see increased patient retention (67%), greater patient diversity (54%), and faster patient recruitment (50%) as the leading benefits of decentralized trials, according to the survey.
Regulatory bodies are also open to hybrid clinical trials for oncology and other studies. Regulatory bodies, including the US Food and Drug Administration¹ and the European Medicines Agency² acknowledged the benefits of using decentralized components during the pandemic, and have begun publishing guidance documents on where and how decentralized models can be used in the future.
The FDA supports the idea that decentralized approaches may encourage participation for those who do not live close to study sites, and recently issued draft guidance³ for increasing the diversity of clinical trials, which we know is a key benefit of agile approaches.
Every Decentralized Trial is Unique
Though when adopting decentralized elements, sponsors need to be certain that their trial designs and technologies meet the needs of the patients, the sites, the protocols, and local regulations. Those choices will vary for every trial.
For example, the adoption of wearable devices has increased 113% as sponsors seek better faster ways to collect patient data. These devices give sponsors a way to access more data faster than was previously possible. However they need an effective data management system to integrate the data into the study workflow.
According to the survey, most sponsors plan to use the wearable data to track safety events (70%), secondary endpoints (55%) and treatment efficacy (33%). Each of these goals will require a different cadence of data collection, review and analysis to be sure they can correlate and analyze it in a meaningful way.
That requires technology that is custom designed for the clinical research environment, and partners who can help sponsors leverage technology to rapidly analyze that data to support decision making.
Having a strong decentralized strategy and experienced partners can help sponsors get the most value from this innovative approach to clinical research – as was the case in a recent breast cancer study.
HER2+ Study gets Agile Makeover
In 2020 Science 37 had an opportunity to support a breast cancer trial for people with HER-2 Neu positive disease that was originally planned as a traditional ‘on-site’ study. The therapy featured a fixed dose combination of treatments to be delivered as a subcutaneous injection. The original trial design required treatment administration safety and adverse event assessments be conducted at traditional office visits. These visits included echo-cardiography and cardiac monitoring. But because of the pandemic, sponsors and sites needed a more agile approach that would reduce the number of site visits, without disrupting the treatment or monitoring process.
Science 37 helped develop and operationalize an alternative approach by offering patients the option of at-home administration of the injectable medication and monitoring via mobile nursing teams. The mobile nurses were trained in the study protocol as well as how to identify and respond to adverse events.
The agile study design was deployed and it was a success. Preliminary results of this study were presented at the American Society of Clinical Oncology 2022 Annual Meeting4. When given the option, 94% of participants with early stage breast cancer, and 66% of metastatic breast cancer patients opted to receive their medications at home. They cited increased convenience and reduced risk of COVID infections as the major drivers for making that decision.
The study recruited 164 patients, and as of May, 2022 1,442 number of home visits have been completed. The use of a decentralized model also helped trial sites enroll patients from a diverse background, with 27% of participants belonging to Black, Hispanic, or Asian populations.
This study is an example of how decentralized trials can deliver value for both sponsors and patients. It also highlights the importance of creating custom plans and working with teams that have expertise in decentralized trials to meet the unique needs of every study. In this case, the use of the Science 37 technology platform and mobile nurses supported traditional sites to enable a seamless and compliant study experience.
An Agile Future
Five years ago, the life sciences industry was barely dabbling in decentralized clinical trials. But as the survey shows, decentralized trials have now become a permanent part of the oncology research landscape. This rapid adoption may have been triggered by the pandemic, but now that sponsors and patients have experienced the benefits of patient-centric decentralized trials, they aren’t going back. It is an agile approach to research that makes it easier for patients to participate, which speeds recruiting, enhances retention, and delivers high quality data. We see it as a pivotal innovation for clinical research that promises to enhance trial experiences for everyone involved.
To learn more about Science 37’s recent report on the future of oncology clinical trials, click here.
- FDA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
- EMA: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials-human-medicines#clinical-trial-management-during-the-covid-19-pandemic-section
- FDA: https://www.fda.gov/media/127712/download
- ASCO: https://meetings.asco.org/abstracts-presentations/209609/poster