Training for PI's and study staff has to change now

Did you catch our recent blog on cultural safety? Today, we’re back on the topic of study site training. And that’s because we need to make sure sites are equipped to help studies succeed from the get-go.

Good Clinical Practice (GCP) training has been a longstanding part of running clinical trials at sites. GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of people. Although its principles remain strong and important, the training itself runs the risk of simply becoming a box-ticking exercise. We need to make sure sites receive training that truly focuses on meeting needs.

What does investigator site training meets needs look like?

Well, it could involve tailoring training to a specific study and going beyond the basic GCP elements that most people already know anyway. For example, training could cover potential problems with clinical trials like recruitment and retention, and highlight any potential areas for concern. Training for investigator sites should also cover diversity and inclusion and give an introduction to cultural safety.

In the real world, training could be a study that has an inherently small potential patient population due to being a rare disease, and specific training and guidance could be in place to support recruitment to such a study. Or, the study could involve a condition that affects a specific ethnic group more than others, and that needs to be considered in the recruitment strategy.

What role do study sponsors have in investigator site training?

Study sponsors need to support sites to be able to engage, recruit and retain patients from all ethnic groups in a culturally safe way. And achieving culturally safe clinical trials isn’t only about ethnicity. Sites should be supported and equipped to recruit diverse patients, regardless of age, gender, socioeconomic status, sexual orientation and many other factors too. And that can be made much easier with effective training. Not only does this kind of training start to eliminate unconscious bias among site staff, it also helps improve the patient experience.

Changing perceptions of clinical trials

While the reasons for this are often to create inclusive clinical trials, the industry has a lot of work to do to improve awareness and public perceptions of clinical trials.

For every person who has a positive interaction with clinical trials, previously disengaged people can become connected with research, the word spreads, and something very powerful can happen.

Clinical research staff often have to attend multiple training sessions on the elements of GCP from multiple sponsors, rather than being able to focus on the specifics of how it applies to their study and practical implementation. By improving the focus of site staff training, compliance may become easier. Study sites and their staff are often under scrutiny from the FDA for not adhering to the study protocol, over-delegation and lack of documentation of principal investigator oversight. It’s not uncommon for sites to demonstrate inadequate compliance and poor understanding of a study or GCP, but by improving training for sites, this could easily change.

This blog was first published here.