Patient Recruitment in

Clinical Trials

Dr Pravina K,
ICRI, Bangalore
March 8, 2006
 Glossary
Subject / Trial Subject:
An individual who participates in a
clinical trial, either as a recipient of the
investigational product(s) or as a
control.
Recruitment of patients

Recruitment period

Recruitment target
 GCP: Investigator’s
responsibilities
Adequate patient resources
The investigator should be able to
demonstrate a potential for recruiting the
required number of suitable subjects
within the agreed recruitment period.

(ICH E6: 4.2.1)

 Medical care of trial subjects
by Investigator (ICH E6)
4.3.2 : Ensure adequate medical care

4.3.3 : Information to the primary physician

regarding subject’s participation in the
trial

4.3.4 : Ascertain the reasons for withdrawal

4.4.1: Subject recruitment procedures

require the approval
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 SMO/ CRO role play
in patient recruitment
 Innovative recruitment procedures
 Database of potential study participants

(regularly updated medical records)

 Key strategic alliances with Universities,
Hospitals & GPs
 Patient education
 Patient recruitment;
contributing factors
Availability
Cost effectiveness
Genetic diversity
Strong doctor-patient relationship
Good public health infrastructure
 Patient recruitment: gaps
Geographical distance
Language barriers
Cultural differences
 Reasons for missed trial
deadlines
Nearly 80% of clinical trials conducted
in US between 1993 – 98 missed their
deadlines

Patient enrollment: treatment naïve

population

Recruitment: 85 - 95 % of failure
 Accelerated patient
recruitment
• Fast access to pre-qualified condition
sufferers
• Innovative methods to educate patients to
take part in clinical research
• Empowering the patients (qualityhealth.com)
• Detailed screening & targeted recruitment
• Compliance support and participation
assessment
• Pay-for-performance model
 Recruitment: search tools
Hospital medical health records
Patient registry
eDatabase
 HIPAA compliance

Health Insurance Portability &

Acountability Act, 1996.
 Targeting options
Health condition/ailment
Staging
Prescription / OTC usage
Zip code penetration
Past experience with clinical trials

Specialized targeting
Geo targeting
 Recruitment ;search tools
Hospital medical health records
Patient registry
eDatabase
 Patient education
Patient is the central focus in CR
Patient information – research, need to
follow protocol instructions, communication to
contact personnel, etc
Patient motivation
Measures to improve compliance
 Site selection
All sites can’t be involved in all studies

Strong and weak sites

Rank sites based on patient population

statistics
 Delays in clinical trials
• Difficulty in recruiting patients is the most 
frequently cited cause for delays in clinical 
trials…..(Reproduced from McKinsey Quarterly “A cure for clinical trials” 
May2002)

Lost days
SDV
IRB/IEC 
Approval
18 13
Difficulty in
Collection 19 Recruiting
27
CRF data Patients

23

DCFs
 Potential gains of
meeting deadlines
Saving $50,000 per day by reducing
study completion time
Earning of $ 1 million per day by patent
sales by making drugs available earlier
Accelerated market positioning
Keys to success in clinical research

Quality

Time Cost
 Clinical recruitment trends
60
% patients from non core countries

50

40

30

20

10

0
1997 1998 1999 2000 2001 2002
Year
Core countries:  Canada, France, Italy, Germany, Japan, Spain,
UK and USA