Background
ICH
RECRUITMENT
Randomized controlled trials (RCTs) are widely acknowledged as the design of choice for evaluating the effectiveness of healthcare. Methods to increase recruitment in randomized trials are priorities for methodological research [Informed consent is an important part of ethical clinical research. The consenting process is both legal and ethical in nature requiring a lot of consideration during the trial design phase. According to the International Conference on Harmonization Guideline for Good Clinical Practice (ICH GCP) [Low patient retention rates and the consequent missing data during trial follow-up can compromise the internal and external validity of the trial and introduce attrition bias, leading to inadequate sample sizes and reduced statistical power, which can affect the reliability and validity of outcomes [Several studies evaluated the consent process when recruiting participants for a trial. Grady et al. claimed that concise consent had no significant effect on improving the comprehension or satisfaction of the participants [More studies are required to identify strategies to improve recruitment and the consent process within randomized trials. While these studies may only have modest effectiveness, together they could have a crucial impact on the costs or duration of a study. According to a survey performed in the USA of 1024 clinical research coordinators, the length of the clinical trial was the main factor in poor retention (60%), followed by participants’ perceptions of the infectiveness of investigational interventions (43%) [There is an argument to be made that a participant who consents on the same day could be more determined to join as they already understand the benefits of the study, whereas undecided participants would tend to delay their joining and probably not be fully convinced of the benefits, causing higher attrition rates. There is, however, a counterargument that participants who took longer to give their consent, only gave their consent after full studying of the material and without feeling coerced thus enabling the participant to make an informed decision to participate, making them more determined to continue with the study with less attrition. Thus, there is a need to study whether or not the timing of consent has any impact on retention and participation in a clinical trial.