Home  |  About us  |  Editorial board  |  Ahead of print  | Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 6383Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 11  |  Issue : 2  |  Page : 81-85

Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five-year audit


Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India

Correspondence Address:
Nithya J Gogtay
Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai - 400 012, Maharashtra
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_198_18

Rights and Permissions

Introduction: A key determinant of the success of any study is the recruitment and subsequent retention of participants. Screen failure and dropouts impact both the scientific validity and financial viability of any study. We carried out this audit with the objective of evaluating the recruitment and retention of participants in clinical studies conducted over the last five years at our center. Methods: Studies completed between 2014 and 2018 at our center were included. Screening ledgers and study trackers were hand searched for screen failures and dropouts. Four pre-identified predictors were evaluated – risk as per the classification of Indian Council of Medical Research 2017 Ethical Guideline, nature of funding, study design, and nature of participants. Association of the predictors with screen failures and dropouts was determined using crude odds ratios along with 95% confidence intervals. All analyses were done at 5% significance using Microsoft Excel 2016. Results: A total of n = 19 completed studies had n = 2567 screened and n = 2442 enrolled participants with a screen failure and dropout rate of 5% and 4%, respectively. We found 59% screen failures due to abnormal laboratory values. The main reasons for dropouts were lost to follow-up 86 (88%). High-risk and interventional studies were the predictors for both screen failures and dropouts, but pharmaceutical industry-funded studies and healthy participants were predictors for only screen failures. Conclusion: Risk, funding, study design, and nature of participants are important to be considered while planning studies to minimize screen failures and dropouts.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed513    
    Printed40    
    Emailed0    
    PDF Downloaded60    
    Comments [Add]    

Recommend this journal