Posted: 06 Feb. 2020 14 min. read

Patient recruitment is often the holy grail for clinical research…could virtual trials improve our chances of reaching it?

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:

  • Empowering patients: In focus groups, some patients have indicated that they might consider a clinical trial if an experimental therapy might improve their condition. Others say they would participate if their contribution might help future patients who suffer from the same condition. But our focus groups also indicate that patients are less likely to consider a clinical trial if they don’t feel they will get something in return. Researchers might be able to interest potential participants by engaging with them as research partners rather than test subjects. This patient empowerment could include sharing more details about the purpose of the research or finding ways to incorporate patient feedback into study design. Using digital tools like an app that alerts patients who might qualify to participate in a clinical trial or shares personalized patient-education materials could also empower patients and make participation more attractive.

  • Tapping social media and community groups: Some clinical researchers are turning to social media to advertise upcoming trials and find patients who might be willing to participate. At this point, only 11 percent of clinical trials are using social media to recruit patients (and with varying levels of success). Social media might give pharmaceutical companies a way to create targeted messages and deploy more flexible ad spend. Working with patient community groups is another recruitment tactic, but not all therapeutic indications or organizations might be suited to this approach.  Many biopharma companies have found that using a combination of social media, community groups, and other digital means can help reach a broad community of potential research patients.

  • Sifting through EHRs and other digital data: The ability to sift through electronic health records (EHRs), genetic data, biomarkers, and other types of digital data to identify patients who might be eligible for a clinical trial could help biopharmaceutical companies create more meaningful data and reduce recruitment cycle times. However, a lack of interoperability between (and sometimes within) health systems can create challenges when working with unstructured data. Physicians within the same health system, for example, might use different terms in their notes to describe the same thing, which can make word searches challenging. While one physician might use “date of birth” another might use the abbreviation DOB. Search tools might not understand these terms mean the same thing.

  • Incorporating virtual elements: Designing trials with more virtual elements (e.g., remote monitoring and consults with nurses and other clinical staff) could encourage a more diverse set of patients to join clinical research. Since most major clinical trial centers are located in metropolitan areas, having studies designed with fewer visits requiring travel, parking, and waiting can increase patient enrollment. Advances in telemedicine, the use of home health aides, and connected medical devices can mean more data can be collected from patients while they are at home. 

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.

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Dawn Anderson

Dawn Anderson

Managing Director | R&D Life Sciences Consulting

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.