A Family Affair
Recruiters took a substantially different approach to recruit two- to five-year-old patients for a five-site Phase IV pharmacokinetics
study of a cough/cold respiratory medication. Patient profiling revealed that media-based recruitment tactics would not likely
be successful. So the agency devised a fine-tuned approach designed to generate referrals from public and private health and
community organizations as well as family members and caregivers. A key patient profile factor was the mothers' reluctance
to enroll their infants in a clinical study.
In this case, the recruitment agency initiated a three-part community outreach program to develop top-of-mind awareness and
stimulate referrals of specific subjects. First, the agency recruited bilingual patient educators to explain the clinical
research program directly to parents. Second, it sent a direct mail postcard to mothers of young children living near each
of the five sites. Third, it used a team of outreach specialists to
- promote awareness of the study in nearby children's clinics
- place informational posters in high traffic areas
- distribute educational materials about the study to school nurses and clinics in surrounding communities.
Ninety-two percent of the study's randomized subjects were found through the agency's community outreach program within the
specified timetable, and FDA accepted the sponsor's findings as sufficient for filing.
Potential clinical trial patients who are hospitalized or in residential care facilities present other unique recruitment
challenges to sponsors and agency specialists. A Phase III clinical trial of a drug for the prevention of colorectal polyps
required 1,900 subjects distributed across 80 US sites. A narrow protocol with difficult inclusion and exclusion criteria
also contributed to enrollment delays, and the sponsor decided to retain a clinical trial recruitment agency.
To determine if those objectives could be achieved in time to complete the trial, the recruitment agency launched a six-week
test phase "rescue mode" clinical awareness initiative. In this case, community-based resource centers such as hospitals,
clinics, and specialty health centers proved useful in generating referrals. And, because investigators are often asked to
refer patients for multiple projects, it was crucial to raise investigators' awareness of specific studies. The agency also
deployed a nationwide physician-based clinical outreach team to
- raise the study's profile among investigators
- develop relationships with community physicians
- encourage the mining of principal investigator databases
- make educational presentations and deliver study materials
- discuss tactics to recruit patients.
One of the team's goals was to apply the best practices of the top recruiting clinical sites to those that were less successful.
Although only a pilot test was initiated, the clinical recruitment intervention program increased patient randomization metrics
by 32 percent.
In other instances, patients who stand to benefit from an investigational drug are unable to self-refer or even consent to
participate. In a combination of Phase III clinical trials of a drug to treat bipolar disorder, researchers and the recruitment
consultant faced formidable challenges in enrolling subjects at 44 sites: a target population who, because of their disease,
could not self-select and were at high risk of dropping out.
The agency developed and executed outreach and awareness programs that targeted community-based psychiatrists, mental health
clinics, and hospitals. It also leveraged pre-existing relationships with local government-operated agencies for help with
referrals. Meta-analysis of the agency's metrics demonstrated that 80 percent of the bipolar patients randomized through its
field-based recruitment initiatives successfully completed the studies. Currently, 502 patients are enrolled and the study
is on track with sponsor objectives. (See "Community Project.")
Many factors, including involvement in concurrent clinical studies, can distract clinical trial processes and procedures.
But the consultant agency-because it is not subject to those distractions-can direct attention exclusively to patient recruitment
and on-time trial completion.
Pharma companies that regard customized patient recruitment programs as a strategic investment from the outset stand to reap
substantial economic benefits in terms of accelerated trial completion and on-time delivery of new compounds to the marketplace.
With projected revenues of blockbuster drugs reaching a million dollars a day, pharma company collaboration with a recruitment
specialist becomes ever more compelling.