Training Tips to Keep Your Trials on Track
Some sponsors spend years developing new products but surprisingly little time planning the training for their clinical trials. What they fail to understand is that study training, more than any other factor, will determine the ultimate success (or failure) of any clinical trial. A thoroughlytrained investigator will have fewer screening failures, faster and higher enrollment, better protocol compliance, fewer data errors, and earlier completion. But how do you get a thoroughly-trained investigator?
The US Code of Federal Regulations (Title 21), Section 312.50, requires that study sponsors provide investigators “with the information they need to conduct an investigation properly…ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND”. In other words, a sponsor must tell each investigator what to do, why they are going to do it, when and in what order they will do it, how to do it, and what to do if something unexpected happens.
Unfortunately, that is not as easy as it sounds. Training can be conducted in various ways, and each method has its advantages…and shortcomings.
Some sponsors prefer to train each investigator individually at their clinic. In many cases, this is a less expensive approach that minimizes the time commitment of each investigator. It also affords the opportunity to train every member of each clinic’s staff. Training additional clinic staff often aids subject recruitment and helps enforce study confidentiality. The disadvantage to on-site training is that the training venue is an active clinic with ringing phones, client appointments, shift changes, and emergencies. The resulting interruptions often translate to protocol deviations, higher data error, and inaccurate test article accounting once the study is in full swing.
Moreover, when investigator questions during later training sessions result in protocol amendments, all of the investigators trained earlier must be retrained on the revised protocol.
In addition, the data management team must be notified which versions of the data forms were completed by each site pre- and post-amendment. In a recent study, this scenario played out after each of the first three training sessions!
For most studies, I prefer centralized training because its admittedly higher up-front cost pays hefty dividends throughout the study. In my mind, there is no substitute for the direct, focused, uninterrupted interaction that occurs when all members of the study team (i.e. sponsor, contract research organization, laboratory representative, clinical supplies distributor, downstream services provider, etc.) are assembled in one location.
Every investigator hears the same explanation of the protocol, as well as questions and comments from other investigators.
I have seen many problems uncovered and remedied during these sessions which, in turn, resulted in better study performance by all investigators.
A satisfactory compromise for some studies is to train via webinar. This is a more economical approach that often allows the sponsor to address all members of the study team at one time.
Webinar participants can ask questions and offer suggestions by phone or chat lines. Required protocol amendments can be edited in real time with hardcopy editions sent to each investigator after the webinar. The big disadvantage to the webinar format is the freedom it gives each participant to do something else during the session, thereby diluting their attention.
Study design, inclusion and exclusion criteria, test article pharmacology, data form completion, GCP guidelines, enrollment strategies, laboratory procedures, adverse event reporting, visitspecific activities, monitoring schedules, close-out, FDA audit preparation, test article shipment, communication plans, test article dispensing, and emergency unblinding are just some of the important topics covered during the typical training session.
Whether training occurs on-site, at a central location, via webinar, or through a combination these options, its importance to the overall success of the trial cannot be overstated.