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Compliance Corner – News Round Up

September 28th, 2017 by Sharon L Nelson, MSN, RN, CNS, CIP, Executive Director, Consulting and Compliance Services

provision logoWhether you are settling into the new academic year or taking stock of 2017 before the winter holiday season takes over, this is often a good time of year to reflect on lessons learned and apply them forward. In that spirit, in this month’s news round up we’re looking at status updates for a couple of large projects with notable goals.

 


 

How do you convince 1 million people to provide biological samples, health records, and social security numbers to the National Institutes of Health? Now increase the complexity by aiming to enroll more than half of those participants from communities historically underrepresented in research and mistreated by science. Such are the challenges undertaken by The All of Us Research Program, the data gathering effort for the NIH’s precision medicine project.

In NIH Tries to Win the Trust of Communities Mistreated in the Past, Lev Facher explores these challenges and NIH’s approach to addressing them. Fear of experimentation, mistrust of biomedical researchers, complicated paperwork requirements, limited computer literacy, no internet access – all are study recruitment realities the NIH faces with this project. To reach out to potential subjects, the NIH has taken to the road, traveling to cities in a truck staffed by research marketing professionals – the “mobile-engagement unit.” In the truck is a multilingual exhibit including videos explaining precision medicine, staff to address questions, and e-technology to complete consent procedures onsite. Facher notes, “This is the kind of community outreach the NIH views as essential to recruit participants beyond the typical research study sample – disproportionately white, educated, affluent, and male.”

Have the efforts been successful? According to Facher, All Us Program Director Eric Dishman said “the beta sample, to date, is more diverse than a typical biomedical research study.” (For more discussion of diversity in clinical research, check out our February News Round Up.)

The NIH hopes that the trove of information could one day enable doctors to use increasingly precise diagnostic tests. Eventually, scientists could shape treatments based on an individual’s genetic characteristics.

Read here to learn more about All of Us and its contributions to NIH’s goal to “uncover paths toward delivering precision medicine.”

 


 

The FDA’s Expanded Access program provides a pathway for patients to gain access to an investigational drug for a serious condition/disease, outside of a clinical trial. Of the expanded access requests to the Center for Drug Evaluation and Research, how many go on to be approved by the FDA?

A team of FDA officials attempted to answer this question in a recently published study. Michael Mezher, of Regulatory Affairs Professionals Society (RAPS), discusses the study’s findings in his article FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved and shares the following highlights:

  • Between 2010-2014, FDA received 5,394 unique requests; 5,298 of which were allowed to proceed.
  • Of those permitted requests, the study authors identified 408 unique drugs and fixed-dose combinations.
  • By 30 September 2015, 122 (30%) of those drugs had been approved by the agency for at least one indication, though not necessarily for the indications sought in expanded access requests.
  • 6 of the top 10 most-requested drugs went on to be approved.

To view the FDA authors’ methods, results, and discussion, including discussion of the recent FDA efforts to improve the Expanded Access process, explore here.

 


 

Which health care system is the best in the world? Take a look at the results of a tournament created by Aaron Carroll and Austin Frakt in the New York Times. Carroll and Frakt selected eight countries – Britain, Canada, US, Singapore, France, Australia, Switzerland, and Germany – and gathered a judging panel. You too can play along by clicking here.

Spoiler alert: Per Carroll and Frakt, “The US could do better at balancing health care costs with access, quality and outcomes. But there are many ways to reach that goal, and there will always be trade-offs. Learning about them from other systems and debating them honestly would probably do us a lot of good.”

 


 

So far we’ve reflected on recent progress—how about taking a look “way back” to the early days of modern medicine? Dr. Stanley B. Burns has amassed thousands of historic photos and daguerreotypes of early medical science, and a portion of his collection will be for sale next month. Dr. Burns’ collection is a fascinating reminder of how far we’ve truly progressed with modern medicine. Read more about the sale and how Dr. Burns came to collect these images, or explore more of his medical photography collection here.