Did you know only 3% of cancer patients participate in clinical trials? And a whopping 85% of cancer patients – the group who would benefit most from these studies – aren’t aware that they can participate in them*? Researchers at Cedars-Sinai, the largest non-profit hospital in the western United States, are working tirelessly to change these statistics and overcome the challenges of clinical trial recruitment.
Using DocuSign for their online cancer research registry and e-consents, the Women’s Cancer Program at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute has seen a 4x increase in clinical trial sign-ups. Dr. BJ Rimel, Jenny Lester and colleagues recently published research documenting that their online registry is enrolling study participants 27% faster than traditional paper-based registries. The industry has noticed: in 2013, Cedars-Sinai received the Award for Best Practices in Human Subjects Protection from the Health Improvement Institute for their use of patient-friendly e-consents.
Inspired by the impact and innovation at Cedars-Sinai, we caught up with Dr. BJ Rimel, Gynecologic Oncologist and Associate Director of Gynecologic Clinical Trials in the Cedars-Sinai Women’s Cancer Program. Read on to learn how Cedars-Sinai is leading the way for clinical trials – and please consider giving your vote of confidence to support their quest for a Clinical Innovation Prize.
What was the impetus for this research?
I am a women’s cancer doctor, and my practice is treating women with gynecologic cancers with surgery or chemotherapy or both. All of these treatments came from the results of clinical trials: research designed to test the effectiveness of new treatments against old treatments. These studies help to bring improvements in the treatment of cancer to my patients, but very few patients actually participate in them. In the US, about 3-5% of adult cancer patients participate in clinical trials. There are many reasons for this, but one of the most prominent in our area was lack of timely information about research studies, lack of understanding about their ability to participate in relevant studies, and difficulty in connecting interested women with the researchers who are conducting the studies. We designed the registry to link interested women with research studies in which they could actually enroll.
You highlight some compelling statistics in your paper. How have these results shaped your approach to trial recruitment and research?
The incredible increase in participants and our ability to link these women with studies faster based on the use of digital technology has opened the door to using these methods to simplify research participation and research conduct. For example, we are now applying the same digital transaction model, drawn from our success with the registry, to sign and distribute informed consent documents to participants. This model allows us to offer interested participants a digital copy of the consent form that they can read anywhere or send to a family member for review. It also allows us to instantly send digital copies of signed consent forms to our medical records so that the participant’s signed form can easily be found in their medical record for reference by their physician.
How did accessibility of the registry from mobile devices improve trial recruitment?
Since more than half of all internet searches are now performed from mobile devices, the ability for women to sign up from their mobile device is critical. We worked closely with our web designer and with DocuSign to ensure that the registry enrollment process could be done from a mobile device. This has allowed more women to participate in the registry and thus more women have been matched to studies.
What did you learn that surprised you?
Almost everything surprised me about this project, since it was a huge departure from all of my previous training and research. However, the remarkable change in demographics of the women who enrolled on the paper registry versus the digital registry struck me as an incredible and powerful surprise. This change has sparked a new line of investigation for our group to help us better reach out to ALL women, and we continue to identify use cases that harness the power of the digital model compared to the paper one.
What are some of the areas you’re exploring to further boost registry sign up and trial enrollment?
We are testing new ideas with social media to help make the registry more visible to potential participants and are also connecting the registry to our patient electronic medical record portal. These connections could help both women who are already patients at Cedars-Sinai Medical Center and outside of Cedars-Sinai Medical Center find studies that interest them.
What feedback have you received from your colleagues and peers? Any plans to expand to other types of research or use cases?
We have received an overwhelming amount of positive feedback. Our current plans are to expand the registry to include both women and men, to connect it to our electronic medical record patient portal, and to ultimately use this digital transaction technology to make research participation easier and safer for patients.
Where do you think the healthcare industry could benefit most from investing in digital transaction management?
Personally, I think this technology could enhance the patient’s ability to keep all her records and health care information in a convenient format that could be more easily shared between all her providers. One of the biggest hurdles I face in treating cancer patients is the unbelievable amount of paper documents that patients are asked to hold onto and to keep organized. The gravity of this problem increases when patients are moving between multiple physicians that are not all in the same health system and don’t share a single electronic medical record. This is more often the case with patients who are participating in clinical trials; they often move from one health system to another to get a particular treatment. Managing paper is a very difficult thing and documents can be redundant or even lost. Digital transaction management that includes an audit trail and a collated file for the patient and physician to see all the documents would be incredibly helpful. It would have immense impact given the significant volume of patient and physician facing documents.
What advice do you have for other physicians and clinical researchers looking to adopt digital solutions?
Look for reliable partners. Ask researchers who have been successful in designing strategies that keep human subject protection as their number one goal. Choose a digital transaction strategy that is validated, secure, regulatory compliant—and one that you can understand.
Thank you so much for taking the time to elaborate on your groundbreaking research. We are delighted to be partnering with you and are confident that Cedars-Sinai will continue to improve clinical trials and advance cancer research to benefit the global patient population.
Note to readers: If you have a brighter outlook on patient care after reading this interview, we encourage you to vote for Cedars-Sinai, a finalist for the Clinical Innovation Prize supported by Free to Breathe and the Bonnie J. Addario Lung Cancer Foundation. Voting ends August 3!
*Source: National Institutes of Health