Closing the loop
By: Brad Smith, PhD | June 02, 2016
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 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:
These are just a few of the platforms in development that have the potential to change the way we use of 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 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.