Recruitment and Retention
Recruitment and retention of appropriate number of clinical trial participants is vital for the successful timely completion of the study and its conduct in order to maximize the research outcomes. This is because poor turn-out of participants may hinder the achievement of study objectives or even results to its termination before completion. Thus the necessity to identify and exploit positive factors pertaining to recruitment such a proper inclusion and exclusion data, as well as suitable recruitment methods, and find a way to deal with negative elements affecting the subjects’ recruitment like misconceptions, fear of uncertainties by prospectors, biasness and unbalanced enrollment as implied by DeRenzo & Moss (2006).
Enticing clinical participants with money is a common practice yet it is not appropriate. Friedman, Furberg & DeMets (2010) believes that such a practice is unethical as it dismisses the self-worth of subjects since it reduces people to objects that can be bought and sold. Furthermore, no amount of money can compensate for the risks the subjects are being exposed since most clinical trials are extremely dangerous health wise and could even lead to loss of lives in case the outcome is undesirable. Payment of participants also encourages exploitation which is a human right violation.
Soliciting clinical trial subjects through advertisements in newspapers is appropriate as long as the advertisements complies with the FDA regulations regarding research advertising. This is because advertisements ensures a wider coverage thus is an easier way to spread the information and access a large number of potential participants. IRB plays a major role in participants’ recruitment as they evaluate the recruitment methods described in the research design protocol to ensure they comply with the privacy rules and FDA regulations thus approving or disapproving their implementation as indicated by DeRenzo & Moss (2006).
Digilova, A. (2015). FDA in the twenty-first century. Columbia University Press.
Friedman, L. M., Furberg, C., & DeMets, D.L. (2010). Fundamentals of clinical trials. New York:Springer.
Mickelberry, S. (2006). A general survey of clinical trial participants ages 18 and older looking at looking at demographic data, research participation, and opinion of the research process.
Pressler, & Taylor R, Y. (2012). Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools. (BioMed Central Ltd.) BioMed Central Ltd.