Updated on 5 September 2013
Even with well-motivated sites, the potential for problems is compounded by the double digit annual inflation in the number and complexity of trial procedures and in the administrative burden on trial sites. Many protocols require site staff to become expert in managing diverse portals for Education Development Center (EDC) and Interactive Web Response System (IWRS), central laboratories and other centralized assessments from different vendors.
However, site staff is still most commonly presented with training at investigator meetings, although it is well known that these are ineffective, poorly attended by key study personnel and very expensive. They often are held long before a patient is recruited, are in a foreign language and their message ebbs away with time. They do not address turnover of study staff on trial. At the end, sponsors have little insight into the competence of sites often until it is too late. Intelligent on-line interactive tools are now readily available, which can allow tracked self-paced training, accessible throughout the duration of a trial. This returns invaluable data on site training behavior to the sponsor and has been shown to greatly improve site performance for those who use it well.
Effective training of staff, to accomplish complex tasks well, is not something that can be delivered just once, at a single point in time. Subject visits in clinical trials often occur infrequently and many sites work at the same time in several disparate studies.
There is great potential for confusion between studies, for instance in dealing with toxicities. Thus, investigator site staff needs simple and ready access to details of an imminent study visit on a just-in-time basis. It is time to fundamentally re-think how we instruct site staff on performing trials, how we maintain their competence from beginning to end and how we support them visit-by-visit.