Traditionally, physicians recruited clinical trial subjects, but pharmaceutical companies have become ever more involved through centralized campaigns. Physicians are vital to a trial and the pharmaceutical effort helps shift some of the recruitment demands away from the site to allow them to focus on the subjects. Thus, it is practical to understand if different recruitment methods could change or skew the study population. This study determines if differences or similarities occurred between subjects recruited by physicians and pharmaceutical companies. It discovered that some of both occurred. The pharmaceutical company efforts helped recruit potential subjects from the general population that were similar to subjects recruited by the physicians, but this particular campaign was limited by language which affected recruitment of Hispanic subjects. The social impact of this study provides insight about pharmaceutical company recruitment. Since the National Library of Medicine has indicated that clinical trials should reflect the broader diseased population, the efforts of the pharmaceutical company can help support the physicians’ efforts by recruiting from the broader population. Together, both efforts can create a global good by allowing the trial to reflect the population of post-approval use. These findings still raise a question about the proper balance between the two recruitment groups so that the intended characteristics of the diseased population are maintained. Because differences between physician and pharmaceutical recruited subjects can exist, the potential of one group to bias the trial results exist. As such, some analysis by recruitment method can help ensure that variations in the study population are minimal without skewing the data to create positive study results.

1. INTRODUCTION
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Five research questions assessed similarities or significant differences in the study populations based upon
recruitment of the subjects through physician efforts or a centralized recruitment campaign. The questions
focused on the likelihood for enrollment, compliance to treatment, completion of the clinical trial,
physiological symptoms, and psychological characteristics of the subjects.
The source data provided 1,204 screened subjects, which represented 591 enrolled subjects and 613 screen
failures. Of the 591 enrolled subjects, 424 subjects completed the clinical trial and 167 discontinued from
the clinical trial (Table 1). The central advertising campaign was anticipated to provide approximately 50%
of the enrolled subjects for the clinical trial. Minor adjustments were made to account for missing data or
incomplete information. Based upon the overall sample size and distribution or frequency of adjustments,
these changes were not considered significant enough to change the analysis of the results.
OBJECTIVES
The objective of this study was to determine the practical
applications for using pharmaceutical recruitment and physician
recruitment and if there were differences in five key areas of
comparisons for the study population based upon the recruitment
method. The population characteristics for specific assessment were:
• Likelihood to enroll into the clinical trial (Enrollment)
• Compliance to blinded treatment (Treatment Compliance)
• Likelihood to complete the clinical trial (Trial Completion)
• Physiological characteristics (Physiological Symptomatology)
• Psychological characteristics (Psychological)
By reviewing these characteristics by recruitment method, it could be
determined if the pharmaceutical-recruited subjects were similar or
different from the physician-recruited subjects.
CONCLUSIONS
Traditionally, physicians recruited trial subjects, however the use of
centralized advertising campaigns by pharmaceutical companies have
become ever more utilized for recruitment efforts. While physicians
remains vital to a trial, the efforts by pharmaceutical companies help
shift some of the recruitment demands away from the site; allowing
them to focus on the subjects. It is therefore practical to understand
if different recruitment methods might change or skew a study
population. This study determined if potential differences or
similarities occurred between subjects recruited by the physicians and
a pharmaceutical company. It found that some of both occurred. The
pharmaceutical company efforts helped recruit potential subjects
from the general population that were similar to subjects recruited by
the physicians, but this particular campaign was limited by language
which affected recruitment of Hispanic subjects. The social impact of
this study provides insight about pharmaceutical company
recruitment. Since the National Library of Medicine has indicated that
clinical trials should reflect the broader diseased population, the
efforts of the pharmaceutical company can help support the
physicians’ efforts by recruiting from the broader population.
Together, both efforts can create a global good by allowing the trial
to reflect the population of post-approval use. These findings still
raise a question about the proper balance between the two
recruitment groups so that the intended characteristics of the
diseased population are maintained. However, since some differences
between physician and pharmaceutical recruited subjects can exist,
the potential of one group to bias the trial results also exist. As such,
some analysis by recruitment method can help ensure that variations
in the study population are minimal without skewing the data to
create positive study results.
Raymond Panas is a former student and current faculty member of Walden University and is
also current faculty at The George Washington University. He is a former employee and current
consultant for Sucampo Pharmaceuticals, Inc.
REFERENCES
1. Sergeant, E. (2007). Methods of clinical trial recruitment that have and will impact the
pharmaceutical industry. Drug Development 2007, 1, 38-40.
2. Longstreth, G., Hawkey, C., Mayer, A., Jones R., Naesdal, J., Wilson, I., Peacock, R., &
Wiklund, I. (2001). Characteristics of patients with irritable bowel syndrome recruited from
three sources: implications for clinical trials. Alimentary Pharmacology & Therapeutics, 15,
959-964.
3. Panas, R. (2008). Differences Among Subjects in a Pharmaceutical Clinical Trial as
Determined by Recruitment Method. Berkley, CA: The Berkeley Electronic Press.
4. Babbie, E. (2004). The practice of social research (10th ed.). Belmont, CA: Wadsworth.
5. Drossman, D., Patrick, D., Whitehead, W., Toner, B., Diamant, N., Hu, Y., Huanguang, J., &
Bangdiwala, S. (2000). Further validation of the IBS-QOL: A disease specific quality of life
questionnaire. American Journal of Gastroenterology, 95, 999-1007.
6. Bushnell, D., Reilly, M., Carmen, G., Martin, M., Ricci, J., Patrick, D., & McBurney, C.
(2006). Validation of electronic data capture of the Irritable Bowel Syndrome-Quality of Life
measure, the work productivity, and activity impairment questionnaire for irritable bowel
syndrome and the EuroQol. Value in Health, 9(2), 98-105.
Blinded data from a Phase 3 Irritable Bowel Syndrome clinical trial was retrospectively evaluated based upon a
quasi-experimental design since there was not a true control group for comparison.4
The original clinical trial
was a double blind, multicenter, randomized controlled trial conducted under strict guidelines that applied to
clinical drug trials involving human subjects. For this retrospective study, subjects were assigned to one of two
groups based upon their recruitment method (Figure 1) into the original trial. Subjects recruited by the
recruitment methods of the investigational sites were pooled to form the physician-recruited group (pseudo
control group). Recruitment through the centralized advertising campaign of the pharmaceutical company
made up the pharmaceutical-recruited group (study group of interest). The source data for this study analysis
was accessed from clinical trial enrollment reports, progress reports, and SAS datasets. Individual subject data
was captured via the IBS-QOL5,6
surveys, electronic case report forms, and electronic diaries.
Descriptive statistics was used for the demographic data. A Fisher’s Exact Test or t test (95% confidence level)
was utilized to test a hypothesis for the five key comparisons of the study population based upon the
recruitment methods – physician or centralized campaign. Enrollment used a count of screened and screen
failed subject and a two-tail Fisher’s Exact Test to determine if there was a significant different among the
recruitment groups. Treatment Compliance used data of enrolled subjects from the exposure dataset to
calculate overall compliance rates for each group based upon actual and expected monthly compliance.
ACKNOWLEGEMENT & CONTACT
This study was made possible by the support of Drs. Hadi A. Danawi, Chester S. Jones, and
William M. Barkley of Walden University and Drs. Ryuji Ueno and Sachiko Kuno of Sucampo
Pharmaceuticals, Inc. Contact: rpanas@shayconsulting.com
Drugs, both prescription and over-the-counter, are approved based
upon pharmacologic, safety, and efficacy data gathered from clinical
trials so pharmaceutical companies spend millions each year gathering
sufficient information to for this approval. The need to recruit
subjects to a clinical trial can create be very time consuming and
efforts to shorten the overall recruitment timeline can impact the
duration and costs of the trial.
Advertising for subject for a clinical trial is one way a pharmaceutical
company can helps accelerate subject recruitment and completion of
a clinical trial.1
Through advertising, pharmaceutical companies are
able to (a) enhance awareness about clinical trials, (b) refer subjects
to physicians conducting clinical trials, and (c) accelerate enrollment
into clinical trials, thereby shortening the timeline needed to conduct
clinical trials. Traditionally, physicians recruit patients for
participation in clinical trials from their own clinical practice,
referrals from other physicians, and their own local advertising
efforts,2
as outlined in Figure 1.
Figure 1. Subject recruitment and subject flowchart.3
RESULTS
METHODS
DISCLOSURES
A two-sample, two tailed t test was used to determine if there was a significant difference in the treatment
compliance rates of the two groups. Study Completion data from enrollment reports on enrolled subjects
determined the count of completed and discontinued subjects. A two-tail Fisher’s Exact Test was used to
determine if there was a significant difference in the two groups. For Physiological was assessed from baseline
data of enrolled subjects in the assessment, diary and bowel movement frequency datasets and to calculate an
IBS symptomatology composite score (abdominal discomfort, abdominal bloating, stool consistency, bowel
straining) and weekly bowel movement frequency. A two-tail t test determined if there was a significant
difference between the symptomatology composite scores for each group. In the event that a significant
difference was found, a comparison of individual symptoms for each group was made using a two-tail t test to
determine which individual symptoms were significantly different. A two-tail t test assessed the difference for
the weekly bowel movement frequency for each recruitment group. For the Psychological comparison, the first
IBS-QOL assessments of enrolled subjects was used from the IBS-QOL dataset to determine the overall
composite score for and individual domain scores of each group. A two-sample, two-tail t test determined if
there was a significant difference in composite score of each recruitment group. In the event that a significant
difference was found, a comparison of individual domains scores for each recruitment group was made using a
two-tail t test to determine which of the individual domains were significantly different.
Demographically, the population was typical for an IBS
study (Table 2). The two recruitment methods were
similar for subjects except for race. However, the
centralized advertising campaign was not translated
into Spanish which limited the potential to enroll
Hispanic subjects.
Physiological symptoms were mixed with similar
findings for a composite symptom score (Table 6) of
abdominal bloating, abdominal discomfort,
straining, and stool consistency, but a minor
difference for bowel movement frequency (Table 7)
with the centralized campaign subjects averaging
about one bowel movement more per week. No
significant difference was found for the
psychological assessment.
Overall results indicated that both recruitment methods found subjects who were similar in the likelihood to
enroll into the clinical trial (Table 3), treatment compliance (Table 4), and clinical trial completion (Table 5).
Potential Differences in Subjects from Physician Recruitment versusPotential Differences in Subjects from Physician Recruitment versus
Centralized Recruitment Campaigns in a Clinical TrialCentralized Recruitment Campaigns in a Clinical Trial
Principal Consultant, Shay Consulting, LLC
Faculty, The George Washington University & Walden University
Raymond M. Panas, PhDRaymond M. Panas, PhD