Clinical Researcher—January 2018 (Volume 32, Issue 1)
RECRUITMENT & RETENTION
Nicki M. Norris, MBA
In the U.S., pharmaceutical and biotechnology companies sponsor the majority (75%) of clinical trials. In total, these companies spent approximately $40 billion on clinical research in 2014.1
Clinical trials are the first point of interaction between a clinical research patient and a sponsor company; however, clinical teams frequently overlook this fact when planning the scientific and operational components of clinical trials. Increased regulatory requirements also often influence how a trial will be executed, leaving sponsors’ hands tied.
The results may include burdensome trial protocols, avoidable inconvenience on patients already in a challenging situation, and subsequent low or delayed recruitment. Each day that a drug development program is delayed costs the sponsor $600,000 to $8 million in potential revenue.2
Spotlight on Recruitment Challenges
When 100 clinical trial site staff were asked about their experiences with recruitment and enrollment, about 75% of respondents said they failed to meet enrollment targets from 5% to 25% of the time, and 16% reported failing more than 25% of the time.3
Subject enrollment can be problematic. “The biggest challenges we see in patient recruitment are 1) awareness—the majority of potential participants aren’t aware of clinical trials or don’t know how to get started, and 2) patient burden—all the hoops we make people jump through to get involved and remain in a clinical study,” says Tony Averbeck, vice president of business development at SubjectWell, a risk-free clinical trials marketplace for patient recruitment.
To enhance the probability of meeting enrollment targets, one of the best decisions sponsors can make is to allow enrollment and engagement in trials to be as easy and convenient as possible for patients. However, while terms such as “patient centricity” and “patient-centric trials” have become industry buzzwords and made their way into various publications and presentations, there is still much to do when it comes to implementation.
Integrating the patient perspective into clinical trial planning and activities is not an easy task, but can be well worth the investment. Throughout the trial design, recruitment, and even during the active retention phase, thoughtful understanding of the needs of study participants is essential to the establishment of patient-centric practices.
According to Averbeck, “What we found is that, any time you can remove participation burdens, you see an increase in willingness to enroll.” By incorporating in-home, alternate site, or remote visits within the trial design, sponsors lessen the burdens on the participants and improve overall results.
“Having homecare visits as an option in a study makes our job in recruiting easier because it lowers the patient burden and increases geographic reach,” Averbeck adds.
Home is Where the Healthcare Is
Symphony Clinical Research’s services are frequently used by patients who have difficulty traveling. Symphony CEO Nicki Norris explains, “While our services can be used in all phases and therapeutic areas of clinical trials, we specialize in providing homecare for patient populations that have trouble traveling due to disease state, age, or other priorities and responsibilities.”
Examples include Alzheimer’s and dementia patients, or those with other neurological or musculoskeletal disorders; patients with rare diseases who must travel across the globe to see specialized physicians; elderly patients who have difficulty traveling; and pediatric and adolescent patients who have school demands and whose parents/caregivers have other commitments. Many types of patients benefit from an in-home and alternate site clinical service offering.
One of the many advantages of such services is the acceleration of patient recruitment. This advantage was fully recognized by one particular Symphony customer. In this instance, the enrollment projection for patient recruitment when using traditional sites was 12 months, but the actual enrollment when adding the convenience of homecare services was four months. This saved the customer eight months in expected enrollment time. This level of accelerated patient recruitment, along with the time and cost savings it produces, is beneficial for any study sponsor (see Figure 1).
By changing the setting of clinical trial procedures to the patient’s home, office, or travel destination, study sponsors are better equipped to quicken the pace of their trial by improving enrollment. The in-home visit has effectively transformed the face of clinical trials by associating the clinical trial process with a place of comfort and convenience, with caring and compassion delivered by the homecare clinician. Bottom line—decrease the patient burden and you improve recruitment.
- Getz K. 2014. The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial. https://www.amazon.com/Gift-Participation-Informed-Decisions-Volunteering/dp/0615156649
- ISR Reports. 2016. Tech + Patient Recruitment. https://www.isrreports.com/free-resources/tech-patient-recruitment/
- Insight Pharma Reports. 2015. Patient Enrollment & Recruitment Market Study. insightpharmareports.com/Patient-Enrollment-Recruitment-Study/
Nicki M. Norris, MBA, (email@example.com) is Chief Executive Officer of Symphony Clinical Research in Vernon Hills, Ill.