Compliance In Focus

There has been a recent trend in clinical research toward the use of central Institutional Review Boards (IRBs) or Ethics Committees (ECs) for multi-center trials. 21 CFR Part 56.114 outlines the following on cooperative research:

Currently, trial results for are only required to be submitted to the online database for cleared or approved devices.  However, a November 19th proposal from the National Institutes of Health which would require trial results and descriptive information for devices and device indications that have yet to be cleared or approved by FDA would be posted on the public ClinicalTrials.gov website.  The proposal would give trial sponsors up to three years between the completion of the trial and when results need to be submitted to NIH if they are legitimately working towards reaching the market.

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.

When it comes to the Battle of the Sexes you may be surprised to hear this competition is a popular one in the field of health research. On Tuesday, September 22, 2014 the National Institutes of Health (NIH) announced that it will be distributing $10.1 million in grants to scientists and research facilities studying a host of topics, from drug addiction to migraines.  These funds are intended to help support the inclusion of more research subjects, particularly females, in studies that require a little more representation of the XX chromosomes in their laboratory subjects. This means the participation of more female animals, even cell lines, in research laboratories.  The remainder of the awarded money will be used to supplement analysis of gender differences in the studies’ resulting data.

If you’re at all familiar with the scientific community then you’ll probably recognize the National Institutes of Health, also known as the NIH, as scientific research’s biggest advocate. Part of the U.S. Department of Health and Human Services (HHS), the NIH serves as our nation’s premiere medical research agency, granting greater than 80% of its budget to research and academic institutions through the distribution of almost 50,000 competitive grants. With such a generous hand for developing research, there is no question as to why so many academic and medical professionals both welcome the support and praise the involvement of the NIH in their research ventures.

Originally named the Hygienic Laboratory, the National Institutes of Health (NIH) was founded by Joseph J. Kinyoun of the Marine Hospital Service (MHS) in 1887. From humble beginnings, this one-room laboratory relocated to Washington, D.C. in 1891, and a new building was constructed in 1901. The NIH’s founding legislation was unceremoniously part of an appropriations act approving the $35,000 building for the laboratory to investigate “infectious and contagious diseases and matters pertaining to the public health.” They Hygienic Laboratory was restructured and granted funding in 1902, and remained at the first official building until 1941.

Recently, the National Institutes of Health (NIH) published this article regarding renal artery stenting, a common surgical procedure to treat patients with renal artery stenosis.  As noted in the article, renal artery stenosis occurs in 1 – 5 % of people who have hypertension, an extremely common disorder affecting approximately 78 million Americans.  For those with hypertension who exhibit signs of renal artery stenosis, many times the renal arteries are stented, to prevent further injury to the kidneys.  When untreated, renal artery stenosis can lead to chronic kidney disease, which comes with its own symptoms and comorbidities.

There is a new development in the story of Henrietta Lacks, the woman whose cancerous cells were obtained without her consent and developed into the immortal HeLa cell line.  You may recall that Henrietta presented to John Hopkins in Baltimore Maryland in 1951 and was treated for cervical cancer.  During her treatment, her doctors obtained a sample of healthy cervical cells along with a sample of the cancerous ones for testing.  Unexpectedly, Dr. George Otto Gey was able to keep the cells alive in a culture and they have been used without Henrietta’s permission in numerous research studies ever since.  In fact, you can still obtain a sample of HeLa cells today.  Unfortunately, Henrietta was never even informed of this and it wasn’t discovered until over 20 years later when Johns Hopkins contacted her children to see if they would be willing to give blood samples in order to better understand the immortal cells.  Not only has the Lacks family had no say in how Henrietta’s cells could be used, but they themselves have struggled to receive adequate medical care because the family has never been compensated in any way for their mother’s contribution to science.

We live in a wireless world; wireless headphones, wireless speakers, wireless ear buds, wireless cable TV, wireless phones and printers. There are many obvious advantages to the wireless world we’ve all become accustom to, and many more wireless advances are surely around the corner… like our brains?

What is the ultimate goal for every clinical trial?  High-Quality Data that proves safety and/or efficacy endpoints while safeguarding clinical trial participants. How can data integrity be ensured? This requires a combination of a few key players during the course of a study.