Patient Recruitment is Often the Holy Grail for Clinical Research…Could Virtual Trials Improve our Chances of Reaching it? | Deloitte US has been saved
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By Dawn Anderson, managing director, Deloitte Consulting LLP
The inability to recruit enough patients for clinical trials might be one of the biggest factors keeping many drugs from getting to market faster…if at all. Efficient and adequate patient recruitment has long been the holy grail of clinical trials, and it hasn’t improved much since I started in this business more than 30 years ago.
On February 19, I’ll be in Orlando for the SCOPE Summit where I’ll be part of a panel that will explore the role digital and virtual trials can play in improving clinical trial recruitment and retention. As I mentioned in my blog last summer, one of the primary benefits of digital clinical trials is the potential to improve recruitment. Patients and clinicians are becoming more receptive to the idea of using digital solutions, which can reduce the number of office visits. Similarly, virtual clinical trials might help to reduce some of the burdens (e.g., time, travel, expenses) on patients who participate.
Deloitte estimates that about half of all clinical trials are delayed due to recruitment issues, and about 80 percent of those trials are delayed more than a month. Moreover, about 10 percent of trials fail to enroll even one patient. A recruitment period that stretches longer than expected adds more expense to the process and results in more delays in bringing a product to market. The cost of a delay can top $8 million per day for a potential blockbuster drug.
Over the past 10 years, pharmaceutical companies have watched their returns steadily decline, according to Deloitte’s annual Measuring the Return from Pharmaceutical Innovation report. During that time, the cost to develop a new product has nearly doubled, while the time to bring it to market has increased substantially. Enrolling patients more quickly could reduce the time it takes to bring a new product to market.
Barriers to participation range from lack of awareness, fear of experiments, and time commitments. The time commitment often goes well beyond the typical course of treatment. Moreover, research facilities tend to be located in metropolitan areas, which might be difficult for some people to reach. Even local travel can be complicated and costly. Anecdotal evidence suggests that a patient typically travels more than two hours each way to and from a clinical research facility. Health plans and drug companies do not typically pay for travel expenses. Sometimes patients drop out of a trial once they learn about the upfront costs and time involved.
Although more opportunities exist, some pharma companies have improved the recruitment process by:
Almost every pharmaceutical company I know is trying to improve its clinical trials. Giving patients a way to participate using digital and virtual visits could help eliminate some recruitment friction. Effective recruitment strategies will likely become increasingly important as therapies become more personalized and clinical trials need to draw smaller pools of patients.
The incremental changes noted above could help, but clinical researchers might also consider working with a broad coalition of technology partners and consumer-focused organizations that could help reimagine clinical trials by integrating telemedicine, connected medical devices, and digital therapeutics. Sponsor organizations should be thinking about their investments in foundational platforms that could help enable a new era of clinical trials. Such a change will likely require interactions with players throughout the health ecosystem. While technology could be leveraged to improve patient recruitment, it also could help support patients beyond the clinical trial and throughout their care journey.
At the SCOPE Summit 2020 in February, ConvergeHEALTH by Deloitte launched its patient-centered digital health platform to support global clinical trials. Learn more about MyPath for Clinical.
Dawn is a managing director in Deloitte Consulting LLP’s life sciences consulting practice. She has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with biopharma and CRO clients to design and deploy global operating strategy, performance improvement, and technology implementations across drug development. Over the past 10 years, Dawn has led strategy and operations solutions including a focus on clinical transformation, and clinical innovation, operating model optimization, organizational redesign, process re-engineering, insourcing/outsourcing strategy, vendor performance management, digital, advanced analytics, cognitive automation and artificial intelligence, and the design and implementation of enterprise clinical system solutions. Dawn is a frequent speaker on CROs, clinical transformation and the future of clinical trials including topics around adaptive design, protocol complexity, risk assessments and technology: virtual trials, digital, mHealth, clinical analytics platforms, and cognitive automation.