CDISC for Medical Device Companies: 4 Take-Away Tips

Last night I attended the 7th in a series of Silicon Valley BioTalks Events hosted by Clinovo. The panel in South San Francisco included three CDISC experts from leading pharmaceutical and medical device companies:

  • Dan Diprimeo – BioMarin Pharmaceutical, Director of Statistical Programming
  • Carey Smoak – Roche Molecular Diagnostics, Senior Manager of SAS Programming, CDISC Device Team Leader
  • Peng Yang – Santen Pharmaceutical, Associate Director, Head of Statistical Programming

Why The Long Cycle Times for Standards Adoption?

Ale Gicqueau (Clinovo, President & CEO) moderated the discussion and pointed out that although pharma has been working since 1998 to implement CDISC to over 50 unique domains (15 long years!), the challenges to apply similar recommendations to device/diagnostic submissions has been an uphill battle (with an insufficient number of soldiers…).  While there are over 25,000 registered device/diagnostic companies, most are less than 50 employees.  Just getting the word out and mobilizing the right people for standards development has been a challenge.

Other barriers to standards adoption include the perceived upfront costs, additional resource requirements, and training obstacles.  Generally, in a regulated industry, there is resistance to change.  Some of that stems from a lack of knowledge of options. There are other concerns like, “What are the global agencies positions on new standards?” and how clear are the regulations. One very legitimate concern involves large volumes of legacy data and all the accompanying hurdles for statistical programmers to retrofit legacy data to a new standard for exchange.

Data is Data is Data?

Carey Smoak, a CDISC for medical device charter member, co-founder, and standardization-evangelist explained that the CRF data for medical devices or diagnostics is actually pretty limited and not the largest part of a submission. The DX Domain does not even apply.  Entire trials are run without a single subject enrolled (think of a rack of samples where the endpoint is to determine precision of an assay, no subject exposure). Lab data and other electronic or instrumentation outputs make up the majority of the submission. 

CDISC: Know what you don't know

CDISC: Don’t be afraid to know what you don’t know

Take-Away #1 of 4: Network for Knowledge

If you want to learn more about CDISC standards, attend FDA phUSE (this conference is in MD and over 20% of the attendees are affiliated with the FDA, much higher reviewer presence than DIA).  Have face-to-face interaction with your peers in the industry at events like Clinovo’s Biotalks. get involved with the CDISC Implementation Group.  Conferences are a great way to learn more and gain deeper knowledge, especially if you are working for a small company and the expertise is not available in your working group.

Take-Away #2 of 4: Engage FDA Early & Often

The entire panel agreed that you need to meet with FDA statistical reviewers early in your development program.  How will the integrated analysis be done as you embark in a new molecular entity or even with a device or diagnostic product?  Find out what tools you should use (and compare those to the tools you can use).  If you are introducing complexity when you are implementing standards then talk with the reviewers and see if they are open to a more simple presentation.

Take-Away #3 of 4: Trust but Verify

Not unrelated to point #1, the onus is on you to educate yourself.  It is fine to use consultants, but as you call in subject matter experts also build internal expertise.  Who is the expert now?

Take-Away #4 of 4: Get it Right in the Beginning

Build standard libraries and templates for collecting data on the front end. Implement these standards at the CRF level. Do it from the very first trial and keep it consistent throughout the development program in all subsequent trials.  Stick with the same endpoints. Go for the same method of capture. Don’t capture free-text – Do insist on drop-downs. Re-use, Recycle, and Repeat so that your statistical programmers are free to do more advanced analysis rather than hacking together disparate data-sets.  Realize the efficiency as statistical programs can be more easily adapted across programs.

CDISC Implementation is not so scary

CDISC Implementation is not so scary but this event space at South San Fransciso’s, Capgemini was all decked out for Halloween!

What Does the Future Hold?

Taken right from the FDA website: Study Data Standards for Regulatory Submissions Position Statement “FDA does not foresee the replacement of CDISC standards for study data and will not implement new approaches without public input on the cost and utility of those approaches.” Olivier Roth, Marketing Manager at Clinovo writes, “One of my other key learning is that the next round of the MDUFA should give CRDH the authority to require CDISC standards for medical devices by 2020. Now is the time to get ready for CDISC!”

Clinovo’s next event will be in January and I am definitely planning to attend.  See you there!

If you’d like to continue this topic discussion, please reach out via email or in the comments.

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About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

2 Comments

  • Jeremey Giltner

    October 18, 2013

    Good stuff, Nadia. I specialize in salvage, and my business wouldn’t exist if sponsors followed #4. Luckily, the constant revision of data expectations keep my current contract in the black. If this sponsor had taken control and effectively managed the program from acquisition- well, I might just be pushing a hot dog cart.

    • Nadia

      Nadia

      October 18, 2013

      HI Jeremey, thanks for following along on the blog and for your perspective as a consultant. If people like you weren’t reading and exchanging great ideas then I guess I would have to go get my own hot dog cart – funny!

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