Closing the Loop
Can industry attract more oncology patients into genotype-matched trials?
A recent report from MD Anderson Cancer Center shows a troubling trend in the recruitment of genomic-profiled cancer patients to clinical trials. The study, which explores the use of genomic testing to facilitate enrollment into patient-matched clinical trials, found that 789 of 2000 patients tested (39%) had at least one mutation making them eligible for a clinical trial designed to treat their specific tumor mutation. Yet only 11 percent of those patients went on to participate in these genotype-matched trials at MD Anderson. It is a disappointingly low number both for the oncology patient community who are missing out on a vital care option, and for the biopharma industry, which struggles with the burden of efficiently recruiting patients to these trials. Similar results have been reported from other academic medical centers that are routinely profiling oncology patients with broad gene panels.
Patients cite many reasons why they do not enroll in these trials. For some, it is timing – trial spots aren’t open when they are available. While others decline because they live too far away, they’d prefer non-investigational treatment, they entered other types of trials, or they simply never return to the testing site to learn more about their options. In addition, physicians may not discuss the findings with the patient or enter the results into the patient chart, perhaps because the trial is investigating a new regimen at the center.
Beyond test results
The uptake of genomic (NGS) profiling of cancer patients, especially in indications such as lung cancer, is growing exponentially, as is the development of targeted drugs for patients with specific genomic alterations. However, none of this will be of much use if we cannot recruit enough patients into the trials to demonstrate the drug’s safety and efficacy.
Recruiting continues to be one of the biggest challenges across the oncology research space, and the industry has been actively seeking ideas to better engage patients and help them overcome the fears and obstacles to trial participation. One of the key innovations to emerge from these efforts are a series of new recruiting platforms designed to be more patient-centric – they reach out to patients where they spend time, provide them with data about their own conditions, and alert them to research opportunities using language and information that is meaningful to them. For example:
- Cure Forward invites cancer patients to get tumor genomic testing, then offers information about their specific test findings, and opportunities to share their information on the Clinical Trial Exchange so that researchers can reach out to them when they are a match for a clinical trial. Stakeholders are hopeful that these kinds of active trial exchanges between patients and researchers will begin to close the loop on trial enrollment.
- Patients Like Me provides users with a platform to connect with other patients, a place to share real-world data about their condition, and an opportunity to receive targeted messaging about trials for which they might be eligible, based on their profile data. It originally began as a site for ALS patients, but has since expanded into other conditions.
- TrialReach is a trial matching site that is standardizing clinical trial eligibility criteria and providing a search engine to patients to help them find trials based on their disease and location. The site prides itself on eliminating jargon, using simple language messaging, and giving patients the tools to learn about clinical research and what their experience will be like before they enroll.
- M2GEN is focused on accelerating development of personalized medicine by driving stronger collaborations between patients, physicians and the research community. Its projects include Total Cancer Care, a medical registry with more than 120,000 patients who have donated clinical data and tissue for molecular analysis and agreed to be contacted for future studies; and the Oncology Research Information Exchange Network (ORIEN) a partnership among cancer centers who share multiple data sources in order to match patients to targeted treatments.
These are just a few of the platforms in development that have the potential to change the way we use technology, data and the internet to augment our recruiting efforts. These platforms may never replace traditional recruiting efforts in oncology, but they could fill an important gap in the process. Conducting patient outreach in the online marketplace, pushing clinical information to patients, and standardizing and simplifying eligibility and study information all serves to increase patient engagement in the clinical research process which can help lower the time, cost and risk of enrollment. However, patient engagement alone may not be enough. Services to follow the patients through to enrollment, such as concierge services, genetic counselling and trial recruitment reporting and fee schedules, may help close the loop that starts with testing.
About the Author:
Brad Smith, PhD is Vice President, Advisory Services at Quintiles. In this position, Dr. Smith leads biomarker and companion diagnostic strategy and planning interactions throughout the organization including clinical, laboratory, consulting and commercial projects.
Dr. Smith has more than 20 years of experience in biological research in academia, biotechnology and clinical services including five years of experience in planning and design of clinical development plans and protocols for drug development.
Prior to Quintiles, Smith spent 10 years at Cell Signaling Technology responsible for technical and corporate development of biomarker and diagnostic businesses. He is the author of multiple basic research, translational medicine and clinical publications and patents. Dr. Smith’s scientific background includes research positions at Stanford University and University of California, San Francisco focused on cellular signaling mechanisms of disease. He holds a Doctoral degree from Stanford University and Master’s and Bachelor’s degrees from University of California, Santa Cruz.
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