Trends in Clinical Trial Site Selection and Patient Recruitment | Page 3

The clinical stage of drug and device development is time-consuming and costly,

Figure 2.

Site Selection by Study Phase

beginning with a small group of about 20 people (Phase I) to test side effects with
increasing doses and ending with larger trials of about 5,000 people (Phase III) to
test efficacy. Companies may opt for an additional trial (Phase IV) after a drug is
approved and marketed, enrolling several hundred or several thousand volunteers.

PHASE I &
PHASE II

Build relationships
with experienced
academic sites

With a single clinical trial costing more than $100 million, it is not surprising that
the expense of successfully bringing a single drug to market has risen to between
$350 million and $1.2 billion.1 Over the last decade, companies that have brought

PHASE II &
PHASE III

four to 13 drugs to market have seen the costs soaring to more than $5 billion.2

For Phase I or II trials, it is advisable to build a relationship with high-level
academic sites known for their expertise, thought leadership, and history of
breakthrough models in various therapeutic specialties. Moving into Phases II and
III, most sponsors and CROs cast a wider net for site selection based on the study

Study protocol

Cast a wider net

Site Selection Considerations and Challenges »

Economics

protocol, economics, and the site’s experience in successfully conducted trials in
the same disease area. Site selection may also depend on the location of a large
population with the condition being studied, availability of specialists in a narrow

Therapeutic experience

disease specialty, and access to testing laboratories or specialized equipment.
Sponsors and CROs are competing for high-performing sites in the most
common disease areas of clinical research. Currently, according to The Center

Consider location
of large population

for Information and Study on Clinical Research Participation, the highest number
of trials are for oncology and immunomodulators, central nervous system,
anti-infectives, cardiovascular, and diabetes treatments.3 Finding sites with a
demonstrated track record of good performance in trials similar to your study
and site personnel with strong credentials increase the probability of effective

Specialist availability

recruitment and a successful trial. Another challenge of site selection is identifying
the site’s correct qualifications. Many new technology tools are now available
for sites to disclose their qualifications and credentials to sponsors and CROs.

Access to testing labs,
specialized equipment

clinipace.com

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