FDA BRIEF: Week of May 16, 2016

Voice

FROM COMPETITION TO COLLABORATION: precisionFDA CHALLENGES

Taha Kass-Hout

Zevana Tezak

Elaine Johanson

 

 

 

 

 

Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer, Director Office of Health Informatics

Zivana Tezak, Ph.D., Associate Director, Science and Technology, Office of In Vitro Diagnostics and Radiological Health, CDRH

Elaine Johanson, precisionFDA Project Manager, Deputy Director Office of Health Informatics

  • precisionFDA : online, cloud-based, virtual research space
  • Allow external parties to collaborate on creating tools for “reading” DNA – next generation sequencing (or NGS)

2  COMPETITIONS

  • Consistency Challenge, Use informatics software to identify genetic variants and check for consistency in provided datasets of whole genome sequences from a known human sample, sequenced at two different sites. WINNERS to be announced soon
  • Truth Challenge, to identify genetic variants in one known and one unknown sample dataset

precision

 

READ


 

WebMD: Better information. Better health.

WebMD INTERVIEW: EXPERT Q&A: BOOSTING DIVERSITY IN CLINICAL TRIALS 

Jonca Bull, MD, Assistant Commissioner for Minority Health

John Whyte, MD, MPH, Director of Professional Affairs and Stakeholder Engagement, CDER

Importance of  diversity

  • Understand variability in drug response
  • Clinical trials enroll intended population (including elderly) and explore whether there might be a difference in drug response
  • Help physicians decision making

Improve diversity in clinical trials and overcome barriers to involvement

  • Using tools – social media, blogs, brochure for physicians
  • Working with sponsors, stakeholder groups, patient advocacy groups, health professional organizations
  • Improve improve clinical trials – minority physicians involvement, recruitment by mobile van
  • Consider whole clinical trial enterprise: simplify enrollment, target underserved and underrepresented.

Ensure safety and efficacy of drugs for everyone

  • Important to acknowledge clinical trials never encompass entire range of patients
  • Monitor post-approval drug safety after approval- men vs women, age above and below 65, race

Ensure patient safety during clinical trials

  • Institutional review boards
  • Data monitoring safety boards
  • Trials on hold if safety concerns
  • Report death, serious adverse events in a timely manner

Information on participating in  clinical trial

www.clinicaltrials.gov.

READ

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