2019 is the year of the patient. Here’s how CROs and sponsors can tap into patient-centric models to improve trial recruitment and retention.
With 85% of clinical trials failing to recruit enough patients and 30% of patients dropping out of studies once they enroll, many CROs and sponsors are focusing on improved trial design and implementation. In the coming year, the industry is likely to see a continued shift toward patient-centric strategies and innovation.
To boost patient recruitment and retention, clinical trials need to prioritize the patient experience. Many are already investing in new technology — such as telemedicine and remote monitoring — to meet patients’ needs, as well as providing additional convenience services that make trial participation more feasible.
Given the changing research landscape, here are four patient-centric measures CROs and sponsors should be thinking about in 2019:
1. Changing Data Protections
The EU’s General Data Protection Regulations (GDPR) and other initiatives are impacting how clinical trials collect and store patient data. Sponsors and CROs may be required to increase security systems in order to comply with new regulations. As 2019 is likely to see increased scrutiny, clinical trials should take all precautions to meet global requirements.
2. Removing Logistical Barriers
Transportation is often cited as a barrier to clinical trial participation, especially among underrepresented patient groups. In order to make it easier for patients to reach testing sites, many hospitals and clinics have partnered with ridesharing services like Lyft and Uber. By eliminating the cost and burden of securing transportation, clinical trials can remove a significant obstacle for patients. The success of these initiatives suggests that ridesharing partnerships will likely become a standard in 2019.
Clinical trials are also making use of cutting-edge technology like telehealth and remote monitoring to eliminate the need for patients to travel to investigator sites. Many CROs and sponsors are implementing at-home trials that rely on wearable devices like Fitbits and Apple Watches. Patients can also use technology to check in regularly with their doctors and transmit data directly to researchers.
3. Modernizing Eligibility Criteria
Many patients who are interested in joining a clinical trial are unable to enroll because they don’t meet the eligibility requirements. For example, in the case of cancer studies, patients with cancer and comorbidities are frequently left out of clinical trial offers and participation.
However, there is an increased focus on modernizing and expanding eligibility criteria for a variety of trials. This process requires continuous evaluation as trial design is updated to conform with the latest clinical knowledge, but it can open up the patient pool substantially. For cancer trials in particular, removing ASCO-recommended comorbidity restrictions could result in over 6,000 new patient trial registrations each year.
4. Keeping Patients Engaged
In order to reduce trial dropouts, it’s important for CROs and sponsors to keep patients invested and engaged. Technology and data analysis can be used to drive retention and adherence solutions by identifying at-risk patients. Plus, with the help of targeted insights, trials can take a more proactive approach to managing patient needs and expectations. Researchers can now remotely monitor patient signals and identify early warning signs of a relapse or other adverse event. These measurements allow staff to re-engage the patient, ensure they’re healthy, and get them back on track.
As these patient-centric initiatives become standard practice, CROs and sponsors can continue to improve recruitment and retention efforts. By strengthening data security, removing barriers to participation, and enhancing the patient experience, trials are likely to experience steady growth — and a boost in enrollment — throughout 2019.