Communicating with clinical sites can be a challenge for any pharma company. Still, proper communication is necessary to ensure your trials are conducted according to the defined protocol. Communication will also help ensure monitors are properly trained, protocol deviations are prevented, and data is collected timely and accurately.
But what best practices can you employ to ensure you and your site personnel are seeing eye-to-eye? Carrie Melvin, VP of Global Clinical Operations at TESARO, addressed the topic at the 2018 Clinical Leader Forum in Philadelphia.
“One of the first things you must do is ensure everyone at the site understands your protocol,” says Melvin. “The best way to do that is to engage them right from the beginning. If you can engage sites while you’re still in synopsis/protocol development stage, they are able to weigh in on some of the complexities identified in the trial. In the area of oncology, companies can produce pretty complicated protocols; oftentimes you cannot avoid that. For that reason, it is really important for sites to understand their requirements.”
At TESARO, the Medical Affairs team has put together training programs. Melvin notes TESARO performs a lot of work in ovarian cancer (as well as other indications), and she does not assume that all sites and/or CRO personnel will have the same knowledge or experience. Training information is sent to sites and provides needed information via PowerPoint slides. The training enables sites to have a more in-depth understanding of the protocol and the tests and procedures required.
“We owe them this information,” says Melvin. “As the sponsor company, we know the drug and the protocol better than anyone. It only makes sense to provide everyone working on the trial with the same background information that we have.”
Early Involvement Is Important
Melvin stresses that you can train site personnel on the trial protocol after it has been developed. This is important to ensure complete understanding of the protocol requirements. However, she believes an important step in protocol development is to engage with sites early, so as to have study coordinators, nurses and investigators be part of the actual protocol development process.
In a prior company, Melvin worked on a study where no investigator input was solicited prior to protocol finalization. The study was opened and when sites were asked why enrollment was not progressing, they noted concerns with inclusion/exclusion criteria.
Melvin learned that when asking sites to perform a study, it’s important to make sure they understand what is being asked of them and that they are confident they can enroll the study. Another best practice she recommends is to never assume sites will be able to execute your protocol just because they agreed to participate in the study.
“You can’t always remove certain inclusion or exclusion criteria from a protocol,” says Melvin. “However, you may be able to discuss the criteria with investigators and perhaps relax or lighten the criteria a little. The worst case scenario is that you can get investigators to understand why certain criteria are necessary, and why they have to be kept in place. Either way, it’s always easier to have those discussions and buy-in upfront, prior to finalizing the protocol whenever possible. ”
Keep It Simple
In working with sites, another best practice is to not make your protocol training overly complicated. Some sponsors will learn this lesson the hard way. Melvin remembers working for a company that was having difficulty with one particular site. The site eventually asked to take another look at the slide deck used during the initiation visit for a refresher.
A team had looked at the slides repeatedly, and in their minds it was clear what they were asking the sites to do. Melvin felt it was important to have another set of eyes look at the slides, so she requested and reviewed them.
“I got the slide deck, and it included a total of 186 slides!” says Melvin, incredulously. “I have a visceral reaction when I see 186 slides presented to a site during an initiation visit. Once I was able to calm myself down, I flipped to the slides that seemed to be causing the confusion. I felt the slides were unclear in what we were asking sites to perform.” The confusion may have resulted in the site incorrectly enrolling some patients into the trial as they were relying on the initiation slides for the information.
When performing any kind of training with sites, Melvin recommends never including more than 50 slides in a deck. Any more than that and the individuals being trained will start losing focus. She notes it is easy to lose your audience by the thirtieth slide. To hold their attention, the presentation has to be engaging and interactive. Holding any one’s attention for 186 slides is all but impossible.
Perform Investigator Meetings
Investigator meetings are important and serve a valuable function. Some believe they are a necessary evil, but Melvin has always welcomed them and found these meetings to be valuable and informative. She cautions companies to not look at these meetings as just presentation opportunities. Rather, they should be a learning experience for both sides, as the meetings are an opportunity to engage with and learn from each other.
Melvin also offers a bit of advice on the investigator meetings: Do not have them at the very beginning of the study unless you have a large percentage of your sites open at the same time. Investigator meetings are more effective if they are conducted after the trial has been up-and-running for a few weeks or months, depending on site activity.
“These meetings are an opportunity to discuss what has worked well and what has not worked well,” says Melvin. “We can also discuss the challenges we have seen and talk through them together. We can even use this opportunity to bounce ideas off of each other for potential future protocol amendments. These meetings should never be taken lightly. If you want to understand what your sites are going through, this is one of the best learning experiences you can have.”