Meeting the Growing Need for Clinical Training

Feature Story – By Michael W. Young

There is no greater need for tailored training than ensuring proper compliance and execution of clinical trials.

The realm of scientific, therapeutic and applied clinical training for the effective conduct of clinical trials has greatly expanded in the past few years. While there are some common grounds with commercial training, there is no greater need for tailored training than in ensuring the proper compliance and execution of today’s clinical trials.

Successful trials (those that optimize the enrollment of patient subjects, perform the protocol steps correctly and are completed on time) are few and far between. Protocol deviations (oversights and errors) regularly occur and the cost to the sponsoring pharmaceutical company can be hundreds of thousands of dollars and months of time. Ultimately, the results of these deviations are delayed revenue and, most importantly, patients who must wait longer for potentially life-saving therapies.

Ensuring that all members of the study staff working on the trial are trained and qualified is a prerequisite. In addition, training, or re-training, should be provided at the pointof-need, when required. Staff should be well-versed in good clinical practice (GCP) guidelines, institutional (particularly Institutional Review Board) policies and study visit procedures. Assessments tied to real-time analytics should be performed to determine whether the study team members have been properly trained on their roles within the study and on how to perform designated tasks.

As pointed out by the chief editor of Clinical Leader:

“Protocol specific training, however, should be provided for CRAs (clinical research associates) …This type of training should be customized to ensure understanding of the protocol and the disease which is being investigated … and with the addition of clinical trials being more complex, it requires a broader understanding around the disease and treatment.”

So, what are the principal challenges?

1. Increasing Complexity Of Clinical Trials

From every perspective, clinical trials are growing in complexity. Studies that compared various complexity metrics for clinical trials conducted in 2001–2005 versus those in 2011–2015 show, on average, that trials are 60 percent more complex. The number of endpoints collected is up 86 percent, procedures are up 70 percent and eligibility criteria are up 61 percent.

As the complexity of trials increases, so does the number of trials. The historical and projected number of trial starts in the United States will increase annually by more than 10 percent. In five years, we expect twice as many trials as today, and four-times the number of trials as just five years ago.

Yet, with all the effort focused on improving the efficiency of clinical trials, the time to complete a trial remains nearly constant. U.S. trials still fail to meet patient enrollment goals two-thirds of the time, thereby requiring more sites to be recruited around the world.

2. Protocol Training

For a 100-page protocol, training site personnel usually provide a 100- slide PowerPoint deck to the principal investigator (PI) and study coordinator at an investigator meeting and then again at site initiation visits. Often, medical science liaisons (MSLs) are pressed into service here. The problems with this approach are well-known and widespread:

All aspects of the study are treated equally; no special emphasis on highest risks for protocol deviations.
The most significant training is at the investigator meeting, but other critical site personnel are not present. Subsequent training is passed down — the CRA, to the study coordinator, to functional personnel (e.g., pharmacists, MSLs) — and training consistency diminishes.
New hire training then requires a site visit, so onboarding personnel is not scalable and slows the trial.
PowerPoint presentations, whether delivered live or via webinar, are well-documented to be only marginally effective as a training delivery approach.
Within weeks post-presentation, their value is almost completely lost.
All training is upfront, often months before the information is needed.

3. Revised ICH GCP E6(R2) Regulations Add Burden

In just the last year, new regulatory guidelines holding the sponsor company responsible for ensuring not just protocol training but comprehension assessment. The FDA and European Medicines Agency (EMA) have embraced these changes in order to encourage improved approaches to trial conduct, recording, and reporting. Once the highest-risk aspects of a protocol are identified, then a risk mitigation plan is needed. Aspects include:

Emphasized training focused on the highest risks for protocol deviation.
Measuring and recording the site personnel’s understanding of the protocol.

Further, the Clinical Trials Transformation Initiative (CTTI) has issued draft guidance stating that site training should be:

Targeted to trial, role and experience.
Self-directed, just in time, practical and relevant.
Placed in a platform to record completion and understanding.

Tailored Protocol Training

Instituting learning support for site personnel on protocol items that are deemed highest risk for deviation vs. the standard PowerPoint approach has been shown to reduce protocol deviations. This training should:

Focus on key potential problems. For one protocol it could be inclusion criteria, another may be sample management and a third may be the schedule of assessments.
Eliminate the variance of training given by multiple people with interactive, instructionally developed, multimedia material that keeps the learner engaged and improves comprehension and retention.
Be available as a cloud-based resource because many trials involve global sites.
Be available 24/7 through brief, mobile-enabled, microlearning segments, which deploy training when and as needed during a trial, and as new personnel onboard. This is particularly important in rare disease trials where months may pass between enrolling appropriate patients.
Assess understanding of the trial by all site personnel so that an auditable record is stored, and so that misunderstandings are identified early to focus additional training where needed before deviations occur.

Tailoring and deploying innovative training software and proactively anticipating areas for likely deviation will ensure better trial results.

Michael W. Young is chief marketing officer at ScienceMedia. Email Michael at
mwyoung@sciencemedia.com.