The Heart of the Matter – Having Ridden the Veterinary Learning Curve, Where To Next?

In the February issue’s article, Riding the Veterinary Learning Curve, I noted the influence of study training on investigator performance and explored the connection between investigator learning styles and study training effectiveness. I also summarised the comments of eleven current and former veterinary school professors (who had been recommended by thirteen practising veterinarians I had interviewed) regarding their teaching strategies. As I promised at the end of that article, I will share my suggestions for more effective study training sessions based on what I learned from those two surveys, as well as from my own experience over the last 30 years.

Investigator training is a critical factor in any clinical trial, and incomplete or ineffective training severely compromises the study’s chances for success. While the length of the investigator training meeting is dependent on the complexity of the study, the agenda items are fairly consistent: overview of the experimental product being evaluated, review of the protocol (study objectives, study design, test article details, owner consent, study procedures, adverse event procedures, protocol modifications, statistical analysis, publications, regulatory and sponsor audits, laboratory specimen procedures, good clinical practice guidelines, data collection procedures, and study communication).

Many people believe that the responsibility for training results is shared between the sponsor, as educator, and the investigator, as student. However, my experience in conducting multiple training sessions using each of the three training formats (webinar, on-site sessions, and centralised investigator meetings), as well as this most recent research, supports the oft-quoted dictum that 100% of the responsibility for effective communication lies with the communicator. That does not mean that the investigator is merely a passive participant in study training, but it does place the bulk of the learning burden on the sponsor to ensure that each investigator fully understands the protocol and other study requirements. Whether a sponsor achieves that objective depends on many factors. However, one consideration that is frequently overlooked is the fact that not all investigators absorb material in the same way. Therefore, for maximum effectiveness, all training sessions should be designed to accommodate different learning styles.

From a regulatory standpoint, good clinical practice, VICH GL9, assigns several specific training responsibilities to the study sponsor.

Section 2.4
Each individual involved in conducting a clinical trial should be qualified by education, training, and expertise to perform their respective task(s). These individuals should demonstrate, in a manner that is evident from the study documentation, the highest possible degree of professionalism in the recording and reporting of study observations.

Section 3.1.2
The investigator should have sufficient knowledge, scientific training and experience…to conduct clinical studies to investigate the effectiveness and in-use safety of investigational veterinary products in the target species. The investigator should be familiar with the background and requirements of the study before taking receipt of the investigational veterinary product. Section 4.2.8.1 The sponsor should ensure that all investigators conduct the study in strict compliance with the study protocol agreed to by the sponsor and if required, by the regulatory authority.

Section 4.2.8.2
The sponsor should ensure that the data capture system is designed to capture the required data at all multicenter study sites.

Section 4.2.8.3
The sponsor should ensure that all investigators are given uniform instructions on following the study protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings and on capturing data.

Section 4.2.8.4
The sponsor should ensure that communication between investigators is facilitated.

Sponsors may conduct study training in a variety of ways, depending on cost, time, staff availability, past experience, and other factors. Some sponsors favour webinar training because it is a relatively low-cost way to train all investigators and site personnel at the same time. However, this format affords little control over participant attention, and it is not conducive to investigator interaction, role-playing, or handson practice. It also limits the sponsor’s ability to assess investigator and site personnel understanding of the protocol until the study has begun and enrolment and data collection are underway.

Other sponsors prefer individual on-site training, even though it is more expensive than webinar training. This format allows them to visit each site before the study begins, often combining site qualification, site initiation, and study protocol training in one visit. On-site training also allows technical demonstrations and hands-on practice but permits little, if any, interaction with investigators at other sites. It does, though, provide the sponsor a better assessment of investigator and site staff understanding of the protocol. However, because it is sequential in nature, individual on62 International Animal Health Journal Volume 2 Issue 3 Clinical Studies site training sometimes uncovers the need for one or more protocol amendments after some, but before all, sites have been trained and begun enrolling study subjects. This may increase the number of protocol deviations, as well as complicate data review and subsequent statistical analysis because some study subject visits will have been completed under different versions of the protocol.

By far the most effective, though usually the most expensive, training format is a centralised investigator meeting. Having all of the investigators in the same room fosters more attentive and active participation, encourages attendee interaction, elicits more feedback on the protocol and study design, allows technical demonstrations and handson practice, and maximises investigator and site personnel understanding of the protocol and potential complications. Topics requiring additional explanation or instruction are more readily apparent to those conducting the training and can be addressed before the end of the meeting. Many sponsors believe that the benefits of this training format (fewer protocol deviations, reduced queries, faster enrolment of eligible study subjects, and cleaner data) far outweigh the added cost. From long experience, I tend to agree.

Regardless of the training format selected, it is essential to remember that investigators, just like the broader population, learn best in different ways. Some are visual and learn best by seeing or reading. Others are auditory and respond well to verbal explanations and lectures. Still others require physical involvement and/or hands-on practice to fully absorb new material. So, given these different proclivities, how does a sponsor ensure that study training gives each investigator a clear and thorough understanding of the protocol and their responsibilities during the study? One approach would be to have three different training sessions, each structured to appeal to one of the major learning styles. Aside from being costly and rather impractical, this approach would require each investigator and site personnel to be aware of their preferred learning style. Another solution would be to present each topic in three different ways to accommodate the varied learning styles. That, too, would drive up the cost of study training. So, what’s a sponsor to do?

To paraphrase an old saying, “Variety is the spice of training.” Reliance on any one method of presentation is a sure prescription for problems once the study is underway. Webinar training is perhaps the most difficult to design with all learning styles in mind. As a study monitor, I recall many webinars that were based on a series of bland PowerPoint slides, crammed full of small text, which the moderator reads word-for-word. Few things induce sleep faster than this type of presentation.

cat-nurse

Instead, webinar trainers should limit the text on each slide to no more than three or four key points, each expressed in as few words as possible, and displayed in a large font. Send the slide deck to each investigator in advance, along with any important reading material (e.g., the test article’s pharmacology and relevant safety data). Also, arrange digital or telephone connections to make the webinar interactive. During the training session, present several new slides that require participants to supply answers or render opinions in multiple choice and/or fill-in-the-blank formats. After every participant has submitted their answers, report results realtime in a sidebar on the screen. Follow with discussion of the results and, if warranted, additional instruction or explanation. Also, create sample scenarios and ask individual investigators to describe how they would handle them. Then, solicit 64 International Animal Health Journal Volume 2 Issue 3 feedback from the other participants. Conclude the webinar with a test to assess each investigator’s understanding of the training material. Use the test results to follow up individually and, if necessary, add more tailored supplemental instruction to the agenda for the respective site’s initiation visit. By increasing the level of interaction between presenter and each participant, you may be able to reduce, or even eliminate, the tendency of many participants to answer email, review records, or attend to other clinic business during the webinar.

dog-nurse

On-site training gives the sponsor more opportunities to present material in different ways, quickly assess participant learning styles, and test individual comprehension. It also is much easier during on-site sessions to role-play different scenarios to determine the investigator’s and site personnel’s understanding of the protocol, inclusion/exclusion criteria, dosing regimen, and other study requirements. It may even be possible to schedule the on-site training to coincide with enrolment of the first subject. What better way to see the investigator in action under true field conditions. Then, if remedial instruction is warranted, it can be provided immediately and thus limit future protocol deviations, data queries, and lost cases. Also, if a protocol amendment is required, immediately notify already-trained sites to cease enrolment until the amendment is received and, depending on the extent of the amendment, schedule retraining.

In my opinion, the gold standard for study training is the centralised investigator’s meeting. It also is the format that most easily accommodates varied participant learning styles because every teaching method can be employed at some point during the training meeting. The pharmacology of the investigational product can be a scientific discussion supported by PowerPoint slides and/or video segments. Breakout sessions for smaller groups can be structured using different presentation methods to enhance the learning experience and maximise absorption and retention of the material. In addition, since not all investigators and site personnel have the same level of technical knowledge or clinical trial experience, a centralised training meeting facilitates the transfer of information, methodology, and advice from the more knowledgeable investigators and site personnel to those newer to the clinical trial process. A centralised meeting is the ideal setting for detailed demonstrations, hands-on practice, and role-playing of sample cases and challenging situations. Centralised training meetings also accommodate the widest variety of testing options to ensure that every participant has mastered the material that was presented. Such measures usually increase the overall cost of the training meeting. However, that additional investment almost always pays handsome dividends in terms of accelerated enrolment, fewer protocol deviations, higher quality data, and faster study completion.

I accept the fact that not every study warrants or can support the cost of centralised training. However, to the extent possible, study sponsors should develop creative components for the alternative training formats that enhance the learning experience. As experimental therapies become more complex, and regulatory requirements grow more stringent, training methodologies must evolve to ensure that each investigator can follow the protocol exactly, quickly enroll the requisite number of eligible subjects, and collect complete and accurate data. Only then will each clinical trial be a true success. Only then will promising new therapies receive quick and uncontested regulatory approval. Only then will the continued health and wellbeing of our four-legged friends be assured. And that is the heart of the matter.