What is the study about?

At the start of a trial, Site Initiation Visits (SIV) are often conducted to deliver training to the Principal Investigator and their local research team to open the site to recruitment. The time required to visit all sites, particularly for large trials, can be burdensome during the resource intensive period of trial set-up. However, there is currently little evidence about the best way to deliver trial training to sites for sites to perform well. Evaluating methods of training was the top priority identified by trialists at a workshop looking at recruitment and retention of participants to trials [1]. Two systematic reviews have been undertaken investigating training in clinical trials. The first showed there are a variety of different training methods described in trials [2] and the second concluded that more research is needed to determine what kind of training and support can improve recruitment [3]. A small study which retrospectively reviewed recruitment data and data completeness collected for two trials showed that, whilst face-to-face training (either at SIV or by a group training session) was associated with better recruitment than remote training (i.e. telephone or DVD), no difference was seen between the two types of face-to-face training [4].

Who can take part in the study?

FEED 1 recruiting sites

What is being tested in the study?

To compare group-based training during the set-up of a trial versus visiting the site to conduct a Site Initiation Visit (SIV) to investigate the impact of the training method upon key site performance metrics.

Funder

National Institute for Health and Care Research - Health Technology Assessment (NIHR - HTA)

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