User Group Forum Recap – Standardized Rater Training with Dermavant

Dermavant: A Dermatology Biopharma expanding with InvestigatorSpace

At the 2020 Trifecta User Group Forum we were joined by Nancy Haire, Associate Director Clinical Operations and Mike McLaughlin, Associate Director Clinical Operations at Dermavant, who presented on innovative ways to reduce investigator burden in their clinical trials.  Trifecta Clinical and Dermavant have worked together to streamline clinical trial processes in four key objectives:

 

  1. Minimizing Redundant Training
  2. Standardizing Rater Training Scales
  3. Centralizing Training Records in the Trial Master File
  4. Develop Site Relationships

Challenge

 

Minimize Redundant Training
One of the greatest inefficiencies in the clinical trial process is the redundant training that raters must go through in order to administer a study. Highly qualified raters often find themselves spending time repeating training on the same scales, which takes away from the most important part of a trial: the trial itself.

 

Standardize Rater Training Scales
It is important that Dermavant’s various short-term studies roll smoothly into the overarching long-term study. Team at Dermavant decided they wanted to use the Physician Global Assessment (PGA) scale and find a way to standardize rater training in a Psoriasis study.

 

Centralize Training Records in the Trial Master File (eTMF)
Dermavant’s Psoriasis study needed to roll smoothly into a long-term study, so InvestigatorSpace was utilized to centralize and organize audit-ready clinical trial documentation and qualification data — in a single source of truth.

 

Develop Site Relationships
The stronger the site relationships, the stronger the results — investing in site relationships is crucial and will facilitate studies and drive positive outcomes that will fuel clinical innovations. Developing innovations such that sites can reduce the amount of administrative burden they face and focus more on the aspects of the trial that need their immediate attention.

It was pretty seamless
It went so smoothly. The sites all were able to gain access. They gave us the names of the people who were going to be rating and we informed Trifecta, and they sent them a link and they went in and were able to do their training. It was pretty seamless - Nancy Haire

Solution/Results

 

Minimize Redundant Training
With the support of Trifecta’s technologies, Dermavant was able to plan rater and protocol training, implement a certification database and produce live meetings. In-person investigator meetings were recorded, edited, and made available on-demand to the InvestigatorSpace platform. The required training also included standard topics such as Good Clinical Practices (GCP Training),  a unique benefit of InvestigatorSpace is the ability to pre-credit investigators who have already taken GCP Training on previous studies with other sponsors.  Through admin portion of the platform, Dermavant could review site staff progress of their training, and once performed, a certificate of completion would show exactly what training they completed. Following this, the certificate could be printed and put on file for current and future trials.

 

Standardize Rater Training Scales
Running multiple studies requiring the Physicians Global Assessment (PGA) presented opportunities for efficiencies. Trifecta was able to implement a process in which this assessment became standardize without the need to customize for each study requirements. Working diligently with scale authors and KOLs has proved successful for a number of sponsors looking to simplify the site experience while maintaining quality rater training. Trifecta Clinical assists in standardizing of commonly used rater scales, for more information contact us about our process.

 

Centralize Training Records in the Trial Master File
With InvestigatorSpace, Dermavant was able to add GCP and protocol-specific training for each study and take advantage of Trifecta’s training equivalency across the feeder study and the extension. They were also able to add clinical outcome assessments (COA) for those attending the live Investigator Meeting.

 

Develop Site Relationships
Throughout its 100+ sites, Dermavant has found that Trifecta’s InvestigatorSpace has helped them break down communication barriers and allow them to work between the site, CRO and Dermavant more efficiently.  Investigators benefit from single-sign-on regardless of study or sponsor, making only one account to manage less burdensome.   Reducing the number of training requirements and allowing investigators to focus more time on patients is a core promise that site staff have greatly appreciated.  Finally, having a resource on-demand to re-review protocol training and documents has been immensely helpful to investigator sites.  Site relations, leveraging relationships and being responsive and available helps you get a lot farther with your studies.

Trifecta is helping us do that.
It’s relationship building with sites I haven’t seen many times over the course of my career, and Trifecta is helping us do that. - Mike McLaughlin