Journal of Molecular Biomarkers and Clinical Trials

Clinical Trials Recruitment Challenges

*Dr. Borges JLC
Department Of Molecular Biomarkers, Universidade Católica De Brasília, Brazil

*Corresponding Author:
Dr. Borges JLC
Department Of Molecular Biomarkers, Universidade Católica De Brasília, Brazil
Email:jlborges@metabolismo.com.br

Published on: 2015-09-22

Abstract

Recruitment is a challenging phase of clinical trials due to its relevance to research success. Failure in reaching recruitment goals might implicate in trials early termination, loss of statistical power and financial wastes. For the well-trained research centers there are several key points that might be addressed as recruitment challenges: first, finding new trials in the site therapeutic area and getting proper approval at local Institutional Review Board; secondly, having a self-sustainable research institution that can hire and train high qualified staff, and lastly, getting and retaining the potential patient the consent in participating. Mistrust, communication, and cultural barriers are common reasons why patients decided not to enroll. On the other hand, altruism, access to better care and closer clinical monitoring are common motives to consent. Understanding reasons why patients decide to participate or not in clinical trials can reduce the evident gap between registered trials and studies with posted results. The objective of this work is to discuss the recruitment challenges; it’s reasons and implications as well as share our barriers and strategies.

Keywords

A clinical trial, Registered trials, Physical fragilities, Visual and hearing deficits

Introduction

Achieving the recruitment goals in a clinical trial plays a critical role for the investigators and sponsors once the success of the trials is directly dependent on proper enrollment. Not recruiting the desired number of patients within the established timelines leads to trials delays that can result in early trial termination, loss of statistical power and inability to draw conclusions [1]. These grim outcomes have ethical implications once participants were exposed to a risk that cannot lead to scientific knowledge [1]. An impaired recruitment also results in time, funds and resources wasted both for the patient and for the research team which can harm investigators and institutions credibility and drive to further frustration and burnout of those who take the recruitment responsibility [1,2].