September 19th 2017 Minutes

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Attendees: Bharath, Eric, Ingleborg, Jasmine, Karnika, Mike, Paul, Sharon, Sri, Zachary

Group 1 scope-

Key activities explore the feasibility and benefits of interactive analysis approach Address the best practice and provide a guidance Collaboration framework between a sponsor and FDA We will provide interactive tool + all TFLs to FDA We will make recommendation as to which TFLs we can drop based on this POC

Zak- Hard to keep the interactive tool out of scope we will still have to submit something
Ingleborg- Define a format and tool requirement

Eric- Discuss the method of delivery and preserve the confidentiality if it is going to be posted on a sponsor’s server Need to consider method of delivery. FDA wants to make sure they are not being followed - could be an issue with web based tool. We could ask the FDA to review a study already submitted. FDA is using Jreview internally - we could provide them the configuration files for Jreview. Medical Reviewers don’t want Pharma to know what they are doing. This could be an issue if we provide a web-based tool.

Paul-

Different groups within FDA use different tools to conduct reviews Jreview is used by clinicians. Statisticians use SAS or R. (Some use Stata and Minitab.) Jreview is not on a powerful server Emphasis is on a review clock Might want to try Oncology - they are trying an interdisciplinary review process. Need to show a benefit. Identify a target for the VA. People will not want to learn to use a new tool while under pressure for medical review. Sponsor should approach the FDA reviewer for the POC Good contact: Popat, Vaishali <Vaishali.Popat@fda.hhs.gov (Teresa Mullen's shop), Eileen Navarro OCS is open to VA, OSI is not as open. OSI concerned about unethical reverse engineering when sharing their own tools. Start with a specific compound and group and identify who would be willing to work with that, this will depend on the types of tasks which need to be completed. What company, sponsor and team would be willing to try that reach out to multiple groups involved Various of interpretations of CDISC standards. Tools that may work well with one data set may not necessarily work with another tool even if they are CDISC compliant.

Sharon-

We need to have an FDA sponsor who is an advocate Crystal interested? Paul - Crystal (OCS) is a project manager; not a reviewer Start small: Replace listing with interactive tools? How to move the project forward is a challenge- Potential filling activities who are the people involved and what are the questions we should address Potential filling team from a sponsor company send the filling package and the interactive tool

Zak-

Identifying the compound and the study team who are willing to use their submission for this project as this will determine what department in the FDA we target this will also determine the study we nominate Matching results between report and the "raw data" is really important. Need to take this into account for VA tool. One of the challenges with showing the benefits is that we will also provide the traditional TFLS, try to pull people away from what they are used to using Building a use case Will this communicate back to the FDA? What information will we share with the PhUSE team? What’s confidential to our sponsor and what will we share with the larger group ?Can we sell our project to potential reviewers?

Mike- Not a limited interaction but under the confidentiality rules it will be shared with the PhUSE community and used as a learning experience that will be shared with key share holders