Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Jul-Sep;7(3):137-43.
doi: 10.4103/2229-3485.184820.

Challenges in recruitment and retention of clinical trial subjects

Rashmi Ashish Kadam  1 , Sanghratna Umakant Borde  1 , Sapna Amol Madas  1 , Sundeep Santosh Salvi  1 , Sneha Saurabh Limaye  1
Affiliations

Challenges in recruitment and retention of clinical trial subjects

Rashmi Ashish Kadam et al. Perspect Clin Res. 2016 Jul-Sep.

Abstract

Background: Successful recruitment of patients is known to be one of the most challenging aspects in conduct of randomized controlled trials. Inadequate patient retention during conduct of trial affects conclusive results.

Objective: To assess the level of challenges faced by Indian investigators in recruitment and retention of trial subjects.

Methods: We developed a survey questionnaire on challenges encountered by investigators in subject recruitment and retention which was hosted on a web portal.

Results: Seventy-three investigators from India participated in the survey. The frequently encountered challenges in subject recruitment were complexity of study protocol (38%), lack of awareness about clinical trials in patients (37%), and sociocultural issues related to trial participation (37%). About 63% of participants strongly agreed that creating a positive awareness about clinical trials among people through press and media, having a dedicated clinical research coordinator for trial (50.7%), and designing a recruitment strategy prior to study initiation (46.6%) would enhance recruitment. Almost 50.7% of participants agreed that interacting with medical community in vicinity of the study site and educating patients about clinical trials during routine outpatient department visits (46.6%) would enhance recruitment. Experiencing a serious adverse event, subject's fear for study procedures (47%) and side effects (44%) were thought to have a moderate effect on subject retention.

Conclusion: Our survey has put forth factors related to negative publicity by media, lack of patient education about clinical trials; complex study designs are barriers to clinical trial recruitment in India. It is essential to devise innovative and effective strategies focusing on education of public and mass media about clinical research in India.

Keywords: Indian; investigators; recruitment; retention; subjects.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Challenges faced by Indian investigators in subject recruitment process (n = 73)
Figure 2
Figure 2
Factors affecting subject retention in clinical trials
See this image and copyright information in PMC

References

    1. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9. - PMC - PubMed
    1. Watson JM, Torgerson DJ. Increasing recruitment to randomised trials: A review of randomised controlled trials. BMC Med Res Methodol. 2006;6:34. - PMC - PubMed
    1. Harris PA, Lane L, Biaggioni I. Clinical research subject recruitment: The Volunteer for Vanderbilt Research Program www.volunteer.mc.vanderbilt.edu. J Am Med Inform Assoc. 2005;12:608–13. - PMC - PubMed
    1. Frank G. Current challenges in clinical trial patient recruitment and enrollment. SOCRA Source. 2004:30–8.
    1. Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: Literature summary and annotated bibliography. Control Clin Trials. 1997;18:328–52. - PubMed