Trends in Clinical Trial Site Selection and Patient Recruitment | Page 6

Patient barriers to trial participation in the U.S. include lack of health

Figure 6.

Length of Trial Delays Due to Patient Recruitment8

insurance. Another barrier is committing to additional evaluations,
therapies and clinic visits beyond the normal course of treatment, which
can be burdensome for older and very ill patients and their caregivers.
Also, many people have negative perceptions about clinical trials,
feeling trials are too risky, they will receive a placebo, or that trials
are for rare or unknown diseases or only for those who have failed

PHASE I

42%

PHASE II

30%

PHASE III

31%

with other treatments. More complicated protocols create additional
barriers to patient participation, increasing the time it takes to fully
enroll a trial. In addition, certain insurers only cover participation in
studies for treatment efficacy.
after trial initiation to enroll the first patient. Increasingly, sponsors
Minimal efforts by healthcare professionals to recruit subjects can

and CROs start looking into patient recruitment at the onset of the trial

be due to limited information they have on available trials and how to

launch, rather than waiting for investigators to become involved. These

access them. They may also be unaware of the trial design and reporting

parallel efforts of recruitment and site start-up can speed the enrollment

requirements, or concerned about loss of control over their patients.

process, improving the overall trial timeline.

Among other reasons for trial delay is that in global trials, not all sites
will start enrolling patients at the same time or rate mainly because of

As trial recruitment shifts to a more patient-centric model, drug and

differences in regulatory requirements. Also, more-specific, sophisticated

device developers identify several study centers with the potential to

medicines, such as dual-mechanism treatments and personalized

participate in their trial and complete initial regulatory documentation,

medicines, are making it more difficult to find qualified patients

but do not activate a site until an eligible patient is identified. When a

Some sites may never enroll a single
patient or take months after trial initiation
to enroll the first patient.

site is activated, it generally enrolls subjects within a few days. This
model channels important resources to productive sites and considers
recruitment earlier, achieving significant gains in efficiency.
Recruitment Tactics

Improving Recruitment Efficiency »

Choosing a site with a large patient population that aligns with the study

From Site-Centric to Patient-Centric

on the trial protocol, standard but still viable ways to recruit patients

In a traditional model, patient recruitment is not considered until after
research sites and investigators have been identified and prepared and
all research documents are collected – a time-consuming, costly process.
Moreover, some sites may never enroll a single patient or take months

protocol will significantly facilitate patient recruitment. Depending
include advertising in traditional media, and direct communication to
patients by investigators and their staff, by the area medical community,
and by site personnel (such as hospital marketing staff). Some physicians
offer seminars to educate patients about clinical trials.
clinipace.com

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