We live in a fast-paced world; a world where new technology and innovation develops in rapid succession.  We are always seeking the “latest and greatest” in technology.  Intertwined in this world of technology and innovation, lies the world of clinical research.  People who are ill or disease-ridden have faith and hope that a miracle cure or life saving device is just around the corner.  But what happens when society as a whole loses faith in clinical research?  Who will volunteer for research studies when trust in the system fails?

With all due respect to this iconic Hawaii5-0 quote, an interesting thing happened recently at work, IMARC’s CEO Sandra Maddock was taken away in handcuffs!  Check out IMARC's Facebook page for pictures of our jail-bird being “arrested”.  Not such an unusual story in todays post-ENRON world, but this “arrest warrant” involved raising “bail money” for the Muscular Dystrophy Association’s “2012 West Cleveland Executive MDA Lock-Up™”.   The Muscular Dystrophy Association (MDA), nationally headquartered in Tucson, AZ is the largest non-governmental sponsor of research investigating the causes of and effective treatment for neuromuscular diseases.

The NY Daily News recently published an article which suggests that our industry is falling short in the realm of clinical trials. The article focuses on a report from the Journal of the American Medical Association that was conducted by the FDA and top leaders at Duke University. The objective, as stated in the abstract, was to “examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database.”

I recently came across this article describing the benefits to having a shortened informed consent form. As a monitor who has had experience with reviewing informed consents, as well as a former research coordinator who has obtained consent from study participants, I have mixed feelings on the topic.

CBS recently revisited an important consumer health topic – the misrepresentation of stem cell treatments on the internet. In the 60 Minutes investigation, Dr. Joanne Kurtzberg of Duke University comments that there are ‘huge dangers’ of injecting unregulated stem cell treatments into a patient’s blood or spinal fluid because “little fragments and debris would get trapped somewhere in the blood stream and could cause a stroke, or in the brain [they] could cause an inflammatory reaction.” You can read the transcript here, and find the videos from the previous installments of the story from 2010 here and here.

The Code of Federal Regulations define vulnerable research subjects, and how those vulnerable subjects should be protected. 21 CFR 50.53 describes the circumstances under which children may participate in an investigation involving greater than minimal risk and no prospect of direct benefit . In order for these subjects to participate in clinical research trials, it is the researcher’s duty to ensure that these special protections are respected. It is unimaginable that these federally mandated laws and regulations could be discounted and ignored.

Today there is no national standard for the competence or credentials of healthcare vendors. There is no specific requirement for licensure, certification, registration, or education of healthcare vendors. However, the Joint Commission recognizes a few standards that affect anyone who may directly impact the quality and safety of patient care. Clinical monitors are not directly involved in patient care, but we can have impact on the safety and quality of the care of patients being treated in clinical research trials. In fact, GCP is our standard for ensuring data is accurate and credible and that trial subjects are protected from harm. Because of this influence, some healthcare institutions are considering monitors as healthcare vendors. Thus we are faced with the same dilemma the pharmaceutical and medical device representatives are dealing with at this time – vendor credentialing.

Recently the FDA issued a draft guidance on the study and evaluation of gender differences in medical device clinical studies. The guidance is issued with hopes to increase the number of female subjects enrolled in clinical trials.

It is not unusual for a monitor to come across upwards of a dozen Notes-to-file at a monitoring visit. At some sites it can seem as though the art of the Note-to-file is perfected as a Magic Eraser with regard to explaining away regulatory discrepancies. The regulatory purist in me shudders at this practice; but at my last monitoring visit, I stepped out of my normal comfort zone and recommended that my site staff colleagues compose several Notes-to-file to document resolution efforts that would otherwise be doomed to follow-up item purgatory. A Note-to-file should not be the immediate solution to a nagging regulatory issue, but there are several instances that can elevate this documentation tactic to preferred status.

On November 10th, a FDA press release announced they issued a draft guidance aimed at fostering early-stage devices within the U.S.  The guidance contains new approaches toward early feasibility studies, which are conducted in a small number of patients early in device development, while providing appropriate human subject protection.  The FDA is seeking a small number of companies that could pilot the new approach, as the results of the pilot will help inform the final guidance.