Low clinical trial recruitment rates can be a barrier for developing new treatments for certain conditions and patient populations. For patients, the clinical trial system can be tough to navigate; it can be difficult to find open trials, or figure out the patient criteria and what choices are available. These recruitment barriers can slow research progress and add costs for life sciences companies, limit the type of findings, or lead to the trial being stopped prematurely. A recent analysis of cancer trials registered on clinicaltrials.gov, the registry and results database of publicly and privately supported clinical studies of human participants conducted around the world, shows 20 percent of the 7,500 Phase II and III studies were not completed between 2005 and 2011. The most common reason for this was the inability to recruit participants.
Some patient advocate groups are taking on the challenge of developing tools and programs that are patient-focused and help patients navigate the research process. The National Brain Tumor Society (NBTS), a nonprofit focused on the brain tumor community in the United States, recently launched a clinical trial finder tool on its website, with the goal of connecting brain tumor patients with open trials that might be appropriate for them to consider. The tool aims to help patients navigate through the available trials easily. Someone who had previously battled a brain tumor led the web development and design. The NBTS says that the tool is the first phase of a major patient engagement program it is rolling out, to help support patient-centered research and drug development; empower patients to play an active role in the research and treatment process; and improve brain tumor clinical trials.
University of California at San Francisco (UCSF) also recently deployed a clinical trial finder tool that distills information from clinicaltrials.gov and makes it more user-friendly for patients who might be interested in enrolling in a trial. UCSF is hosting more than a thousand trials, with more than 600 open and recruiting patients. The tool makes it easier for the public to understand which trials are open, the criteria, and enrollment instructions, including explaining hard-to-understand consent forms. The university has also developed a process to identify eligible study participants using the electronic health record and let patients know about available studies.
Another innovation in clinical research is in asthma at the Icahn School of Medicine at Mount Sinai. A team of researchers used the ResearchKit from Apple Inc. to study if the use of smartphones aided in recruitment and data collection. The ResearchKit is medical software designed to streamline patient recruitment and data collection. The Mount Sinai team created a mobile application to gain new insights into people diagnosed with asthma.
The team launched the study in 2015, and more than 50,000 mobile phone users downloaded the app in the first six months. More than 7,000 completed the consent process and enrolled in the trial. Approximately 2,300 users completed the consent process, enrolled in the trial, and completed regular surveys to answer questions about their condition and how symptoms affected their daily lives. The team found that an increase in daily asthma symptoms in Washington state was concurrent with an outbreak of wild fires occurring in the area, and provided feedback to patients around air quality alerts and symptom management. The study demonstrated that mobile health tools can be useful in clinical research to recruit participants, inform clinical practice, and improve patient care.
Analysis: The drug and device discovery, development, and approval journey for life sciences companies has never been static or straightforward. The shift towards prioritizing new kinds of data, including real-world evidence, and adopting a more patient-centered focus, will likely continue to shape the strategic choices life sciences companies make. As researchers and the industry adapt to these changes, the health care system as a whole is driving toward delivering value in a digital environment, an increased focus on making processes easier for the consumer, and an emphasis on measurement and performance. Researchers and companies that invest in digital platforms and approaches may see faster recruitment, and improved patient engagement and retention in clinical studies, that may in the long run reduce costs and improve patient experience.
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