On Friday, May 23, 2014 the Federal Register announced a notice that in an effort to increase the quality and efficiency of clinical trials, the Food and Drug Administration (FDA) was planning to grant a one-year, $7,500,000 grant to Duke University’s Translational Medicine Institute (DTMI) (renewable up to a total of five years, $37,500,000). This grant would primarily go to fund the public-private partnership Clinical Trials Transformation Initiative (CTTI).  CTTI  was originally created as a partnership between the FDA and Duke University in 2008, but now includes more than 60 organizations with representatives from government agencies, industry, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.

Recently, the United States Department of Health and Human Services and the National Institute of Health (NIH) issued two proposed rulings that may have a profound impact on how results of clinical trials are made more transparent to the public.  However, before we discuss these proposals, we should discuss briefly how the public has access to clinical trials.

It’s an unfortunate reality in clinical research; Oftentimes sites struggle to recruit subjects.  Frustration trickles down from the principle investigator and on down to the coordinators as sponsors put pressure on sites to enroll, enroll, enroll.  What are the barriers to recruitment and how can they be overcome?

I ran across an interesting article in “The Gray Sheet” on strategies to increase the enrollment of women in clinical trials.  The FDA notes that adequate and appropriate populations of women are needed to support 510(k) clearances and PMAs.

MYTH 1: My doctor wouldn’t have told me about the clinical trial if he/she didn’t think it was in my best interest

We ran across an interview with Owen Faris in The Gray Sheet, acting clinical trials director for CDRH.  The position was established to help implement the several CDRH strategic priorities in 2014-15 that were announced in February focusing on speeding up the IDE review process and encouraging more IDE trials in the U.S.

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset.  The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank.

Currently hypertension affects 30.4% of the American population and is projected to cost the nation 91.4 billion dollars a year in 2015.  A subset of hypertensive patients have what is referred to as resistant hypertension.  This refers to a patient receiving three or more anti-hypertensive medications without receiving adequate benefit.  Because of this arbitrary definition, the number of people afflicted with resistant hypertension has varied between 5% in general medical practice and 50% in nephrology clinics. As an alternative to additional anti-hypertensive medication, renal denervation has been used as a therapy to combat high blood pressure.

In a clinical research, patients are the most important key to a study. Subject retention is vital for data integrity, and lack of subject participation can have costly delays for the Sponsor.  Since research sites spend a great deal of time and effort finding qualified subjects, they should also be equipped with reasons subjects withdraw to help prevent this from happening.

Monitoring clinical trials at a high level requires a unique set of traits, skills, and abilities. While monitors often have diverse backgrounds and experiences, there are specific attributes that characterize great monitors and separate them from the rest of the pack. The following list identifies those attributes and explains why each is instrumental to clinical monitoring. This list is not ranked in any particular order and is not meant to be all inclusive; please share your thoughts!