Ten Tips To Tremendous Trials #4: Rigorous Training – A Continuing Series

Welcome to the fourth installment of this series! The goal of each article in this series is to improve the quality of all clinical trials by reminding you, the reader, of another important step that will increase the likelihood that your next study will be completed on time, within budget, and with a minimum of complications.

Welcome to the fourth installment of this series! The goal of each article in this series is to improve the quality of all clinical trials by reminding you, the reader, of another important step that will increase the likelihood that your next study will be completed on time, within budget, and with a minimum of complications.

Sadly, this is a goal that few studies reach. What they get instead are slipped timelines, poor communication, faulty data, lost study subjects, unexpected costs, and frequent protocol deviations. But why? As I noted in the beginning of last month’s article, the underlying problem is one of focus…not so much a lack of focus as one that is misdirected.

Too many in our industry believe that “experience” is the key to a successful trial. So, they put their faith in “experienced” investigators and field monitors. In their rush to get started, they never bother to confirm whether the professed “experience” is relevant to the planned trial or had produced quality results in the past. They forget that the mastery of valuable skills and the accumulation of bad habits both qualify as “experience.”

To be truly successful, the focus before, during, and after the trial must be primarily on the desired results and then on the process necessary to produce those results. This series will help you refine your focus and design your process for superior results on your next trial.

Before we start, though, let’s do a quick review:

Tip #1. Clear Expectations. One of the most effective ways to prevent problems during a clinical trial is to set clear expectations for all study project team members before the study even begins.

Tip #2. Comprehensive Planning. Planning for each phase of the clinical trial must involve all members of the project team and be comprehensive, detailed, and unambiguous.

Tip #3. Effective Investigators. Not every veterinarian will be an effective study investigator…regardless of their “experience.” Only those who truly understand Good Clinical Practice Guidelines, actively recruit study subjects, and then closely follow the protocol will produce the superior results you expect.

Now, on to Tip #4: Rigorous Training.

VICH GL9 (Guidance for Industry, Good Clinical Practice) includes 35 specific responsibilities that the investigator “should” do. However, to paraphrase Yoda from the Star Wars movies, I believe that, in successful clinical research, there is no “should.” Only “must.” Therefore, study training must ensure that each investigator understands each of their 35 responsibilities and agrees to fulfil them to the best of their ability. So, how do you make that happen? Let me count the ways.

There are three main training formats: a centralized training meeting for all participants, individual on-site training sessions at each investigator’s clinic, and an online webinar presentation.

A centralized investigators’ meeting is, by far, the most effective training format. It assembles all of the study participants in one location for an intensive one- to two-day discussion of the pharmacology of the test article, the study design, the protocol, case report forms, and important administrative matters. Everyone sees and hears the same material at the same time. Everyone has an opportunity to ask their questions of the sponsor, as well as hear the questions of other attendees. Investigators and technicians interact, sharing experiences, ideas, and concerns. It is not unusual for these exchanges to result in protocol amendments that improve the study design or simplify data forms. The drawbacks to centralized investigator meetings are the difficulty of coordinating travel, accommodations, and facility issues for a large number of people and, of course, the associated costs. Nevertheless, for certain complex studies, the benefits of such training far outweigh these drawbacks.

Many sponsors prefer on-site training because it gives them the opportunity to see each participating clinic, to evaluate its operation and recruitment prospects, and to interact directly with each investigator and their staff. This interaction also lets the trainer assess each investigator’s and technician’s understanding of the protocol and other important study requirements. The on-site format does, however, take the most time of any training method, which can be a serious problem for studies on a tight timeline. It also involves a substantial amount of travel and associated expenses.

The on-site format also presents one other problem that occurs more often that one might expect. Let’s assume that, during the training of the third study site, the investigator raises an issue that results in a protocol amendment. Then, at the eighth training session, that investigator asks a different question that results in a second protocol amendment. If the appropriate notices are quickly sent to all sites, and assuming that all participants make the necessary changes, there should be few protocol deviations. Even so, the data will have been collected under three versions of the protocol, which adds another layer of complexity to the data review and statistical analysis. You might think that this scenario is rare. Maybe so, but I recently experienced it in two separate studies.

Training via webinar is the fastest, easiest, and least expensive format to develop and conduct. It allows greater scheduling flexibility than the other two training formats, and it blends nicely with the current digital orientation of many younger participants. It does require, though, that every site have a business-grade broadband connection and adequate viewing space in their clinic. A potential downside to the webinar format resides in the fact that all participants are scattered among the various participating clinics and, therefore, are invisible to the trainer. This separation between trainer and trainees makes it virtually impossible to verify who is attending, who is paying attention, and who has absorbed the material. Consequently, webinar training is the least effective of the three formats. That is why I recommend that all project managers expect to provide remedial training from time to time at most sites.

Regardless of format, study training must impart a thorough understanding of the protocol to each and every participant. Anything less will result in ineligible subjects, incomplete or inaccurate data, and frequent protocol deviations. To ensure a thorough understanding, your training materials must be simple, clear, unambiguous…and repetitive. Remember that research has shown that people need to “hear” new material seven times before they really hear (i.e., absorb and process) it.

Put your training through a dry run with seasoned project managers and field monitors to uncover missed topics and weak explanations. Brainstorm data entry scenarios to anticipate problems and errors. Then, during the actual training session, use lots of examples and ask lots of “What if…?” questions. At the end of training, whenever possible, test the participants to assess their comprehension of key points. Remember that the more effort you put into training development and preparation, the less effort you will have to expend in data clean-up.

Once the study starts and subject enrollment begins, you will get a feel for how well you have trained the sites. If errors spike at a particular site, or if there are repeated or similar errors at multiple sites, initiate remedial training immediately. If necessary, schedule a monitoring visit for more concentrated training. Keep all sites informed about common errors and their prevention or correction. In clinical research, training ends only when the last subject has completed their last study visit.

And, speaking of study subjects…that’s the topic of my next article. I hope you’ll join me!

In the meantime, please let me know your thoughts, comments, and suggestions regarding these tips…or the clinical trial process in general…and how we, together, might make it better for all of us.

Thank you and see you next month!