industry’s key bottlenecks. Data suggest that in
North America, for example, more than 90% of
clinical trials must extend the enrollment period
beyond established timelines because of incom-
plete enrollment (Borfitz, 2004).
Patient recruitment and enrollment target goals
are set by the sponsor but become the responsibility
of the selected investigative sites once they commit
to conducting specific trials. If a site contracts to
enroll 15 patients, for instance, it is committed to
reaching that goal.
Oftentimes, a site expects to fill its enrollment
quota from its own internal patient database, but
statistics suggests that most of the time, this
approach is less than successful. To improve their
chances for recruitment success, site managers
need to determine how to go about recruiting and
enrolling patients if the database falls short.
Sites in some regions of the world, such as the
United States, attempt to boost enrollment through
active patient education and recruitment cam-
paigns, including advertising the study in electro-
nic and print media as well as the Internet. Other
locales have been more conservative, generally
relying on practitioners to inform patients ofappro-
priate clinical trial opportunities. That approach is
starting to change, however, as more countries are
allowing patient recruitment activities in their reg-
ulatory guidelines.
The EU, for example, permits patient recruitment
activities for the member states as described in a
detailed guidance put forth by the European Com-
mission in April 2004 (European Commission,
2004). Section 7.4 of the guidance, entitled ‘Adver-
tising for Trial Subjects’, lists various aspects to
be included in advertisements (Figure 11.6),
provided they are reviewed and approved by an
ethics committee.
Once patients are recruited, retaining them
becomes the next hurdle. Data suggest that only
70% of subjects enrolled in phases I–III trials com-
plete those trials (Lamberti, 2005). That retention
figure is likely to increase if study volunteers are
satisfied with the care and treatment they are receiv-
ing (Miskin and Neuer, 2002). Proper treatment
starts from the beginning, from the minute volun-
teers enter the site, extends to follow-up reminder
telephone calls or postcards about upcoming visits
and continues by making them feel valued at every
step of the process, essentially treating them like
important customers (Neuer, 2003).Budgeting
The clinical trials industry is a competitive busi-
ness. Although thousands of clinical trials are
ongoing at any given time, there are thousands of
investigative sites competing for that business. Yet,
despite the strong competition, sites need to avoid
rushing to accept studies before taking the time to
determine if they make financial sense.
The clinical staff and financial manager need to
evaluate (Gerschet al., 2001)the study of study visits;the number and cost of procedures, that is
physical examinations, chest X-rays, electrocar-
diograms, stress tests and blood draws, includingAll advertisements for trial subjects should be
included in the submission for approval by the
ethics committee. The review by the ethics
committee might also include the procedures to
take care of subjects responding to the
advertisement.The advertisement might contain information on the
following points:- The research nature of the project
- The scope of the trial
- Which type/group of subjects might be
included - The investigator clinically/scientifically
responsible for the trial, if possible or if
required by local regulations - The person, name, address, organization,
to contact for information - That the subject responding will be
registered - The procedure to contact the interested
subjects - Any compensation for expenses
- That a response on the part of a potential
subject only signifies interest to obtain
further information
Figure 11.6 Section 7.4 – Advertising for trial sub-
jects [Source:Detailed Guidance on the Application
Format and Documentation to be Submitted in an Appli-
cation for an Ethics Committee Opinion, April 2004]134 CH11 SITE MANAGEMENT