Tuesday, March 8, 2016

IOM Releases Report on Biomarkers for Therapies: Unlocking Precision Medicine

On March 4, 2016, the IOM released a new ebook, Biomarkers for Targeted Therapies: Unlocking Precision Medicine.   The 231-page PDF ebook is available as a free download, here (click on box in upper right, free PDF, download).

In addition, on March 10, 2 eastern, the IOM will hold held a webinar about the book, find out more and register here.

A two pager summary of the 10 goals/recommendations is in PDF form, here.  My summary of the ten goals after the break.

A belated OpEd on this IOM book appears in the NEJM, July 7, 2016 (here).

Note: The ebook was downloaded about 1300 times between March 8 and March 18.

Even more briefly than IOM states its ten goals, I would summarize them as follows:
  1. Establish common evidence standards for clinical utility (clinical trial & other evidence).
  2. More coordinated federal process for test regulation.
  3. Clarify communications to providers & patients about test performance.
  4. Strengthen laboratory oversight & accredition (for tests for targeted drugs).
  5. Ensure that ongoing assessment occurs (e.g. post marketing).
  6. Ensure use of EHRs is fully coordinated for biomarker therapies.
  7. Create a sustainable national database of tests.
  8. Promote equity in access.
  9. Enhance specimen handling & documentation.
  10. Improve the updating of clinical practice guidelines.
The IOM's one paragraph web summary is clipped below:
Every patient is unique, and the evolving field of precision medicine aims to ensure that the right treatment is delivered to the right patient at the right time. To achieve this, health care providers are increasingly turning to advanced technologies known as biomarker tests for molecularly targeted therapies.   
These tests can identify molecular variations specific to an individual patient and help determine the most effective therapy for a patient’s disease or avoid treatments that may be ineffective or harmful. The Institute of Medicine of the National Academies of Sciences, Engineering, and Medicine appointed a committee of experts to examine this question. 
In this report, the committee recommends an integrated set of actions aimed at addressing clinical practice, regulatory and reimbursement policy, and data challenges through the framework of a rapid learning system.
For a direct download of the 231 page book from the cloud, here.