Archive for the ‘clinical trials’ Tag

New Webinar: “Mistakes Commonly Made on NIH Grant Applications”

In an effort to provide cost-effective training to the broadest group possible, I am launching a series of webinars in the upcoming months. The first of these will be in early February, and the goal will be to help grantees recognize and correct common submission mistakes.

Unlike many who conduct NIH submission training programs, I myself work on NIH submissions full time. I see clients make the same types of mistakes repeatedly– mistakes that are easily avoided.

Each year I am fortunate to have dozens of clients share their Summary Statements with me. Because I regularly read reviewer comments from a multitude of study sections, I can easily identify trends in pink sheets. I also keep track of evolving trends at NIH based on information I find in FOAs, Notices, and Appropriations Testimony. Study sections change, funding priorities evolve. It is important to understand NIH’s priorities right now.

I have helped clients land over $200 million in federal funds in the past five years. Your NIH submission will entail several hundred hours of work by you and others. Why not learn strategies to optimize your success on this and future submissions?

What: Webinar entitled “Mistakes Commonly Made on NIH Grant Applications

Who: Ideal for faculty preparing to submit a K, R21, R03, or R01 in an upcoming cycle, and the senior faculty and administrators who advise them.

When:Wednesday 4 February 2015, 11am-12:30pm EST or
Thursday 12 February 2015, 11am-12:30pm EST
Cost: $149
Takeaways: At the end of this 90-minute session, participants will be able to:
1) Predict some key criticisms reviewers may make
2) Identify problems in their or their colleague’s draft applications
3) Utilize that information to write stronger drafts

Ketamine — A New Drug Treatment For Depression?

Koratmember

Credit: Koratmember at FreeDigitalPhotos.net

Remember ketamine, the old veterinary (and sometimes street) drug? Apparently it rapidly and significantly reduces anhedonia in those with treatment-resistant bipolar disorder, according to a new study.

Anhedonia, which is a lack of interest in activities that once gave a person pleasure, is a key feature of treatment-resistant bipolar disorder. According to a recent NIH-funded clinical trial, ketamine restored pleasure-seeking behavior independent of its other antidepressant properties in these patients. What’s more, it did so about 40 minutes after a single infusion, and the effect lasted as long as 14 days.

To me the most interesting part of this study is that ketamine did not act on the midbrain areas typically involved in depressive symptoms. Rather, PET scans on patients in the depressive phase of bipolar disorder showed that after ketamine infusion, there was activity in the dorsal anterior cingulate cortex (dACC). This region lies deep within the brain, resting on the medial surface of the frontal lobes. Its precise role remains somewhat elusive, though it is thought to govern conscious control of goal-directed behavior. The most recent significant study I could find on its function was a 2012 paper in Nature suggesting that the dACC is involved in optimizing behavioral adaptations to continuously evolving demands by predicting the difficulty of a task.

“Our findings help to deconstruct what has traditionally been lumped together as depression,” explained Carlos Zarate, M.D., of NIMH. “We break out a component that responds uniquely to a treatment that works through different brain systems than conventional antidepressants — and link that response to different circuitry than other depression symptoms.”

Imaging studies similar to the one just published are underway in patients with major depression, though results are not yet available. Other studies have suggested that ketamine may be exerting these effects through glutamate and dopamine pathways. Research is underway to explore easier methods of drug delivery, such as nasal spray.

Of late, ketamine has been studied for its rapid antidepressant properties, providing relief within hours rather than the weeks required for traditional medications to work. At present, ketamine is not FDA approved for treatment of depression and it is still used primarily in a veterinary setting.

Ketamine is an NMDA receptor antagonist, though it also inhibits reuptake of dopamine, serotonin, and norepinephrine. It was developed in 1962 and has been used in both humans and animals. It is categorized as a dissociative agent. It has been used for general anesthesia, sedation, and as a pain killer. Side effects include amnesia and agitation, and its street use has led to hallucinations, delirium, and death.

Seven-Year, Multi-Center Clinical Trial Award 2014

Credit: terapun at FreeDigitalPhotos.net

Credit: Teerapun at FreeDigitalPhotos. net

Meg Bouvier Medical Writing is pleased to announce that our client has been awarded a seven-year Cooperative Agreement from the National Institutes of Health (NIH). The team, working at four participating medical centers, will conduct clinical trials to accelerate the discovery of treatments for critically ill patients. The work will be conducted as part of a highly prestigious, multidisciplinary clinical research consortium at NIH. While the size of the award will depend on the clinical protocols chosen, a typical seven-year clinical trial award runs in the tens of millions of dollars. Dr. Bouvier was the lead writer, editor, and advisor on the U01 submission team from Meg Bouvier Medical Writing.

Patient-Centered Clinical Research Network (PCOR-net)

As we all know, comparative effectiveness research is smokin’ hot right now. We are all anxious to see what PCORI funding produces in the upcoming years. In December they unveiled PCOR-net, a highly innovative, clinical data sharing network. In a recent blog post, Dr. Francis Collins (who sits on PCORI Board of Governors) stated, “This initiative will provide an unprecedented opportunity to streamline clinical trials, empower patients, and build a solid foundation for personalized medicine.” He goes on:

“PCORnet will be made up of two types of data networks: Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs). CDRNs include academic health centers, community hospitals, health plans, inpatient and outpatient hospitals and providers, Veterans’ Administration clinics, pediatric hospitals and providers, private electronic health record companies, and many other health care groups. Utilizing electronic medical records, all of these organizations will build patient databases and a clinical trial infrastructure that can be accessed by researchers from many different organizations (including NIH), while protecting patient privacy and confidentiality.

“As the name suggests, PPRNs are patient-oriented groups united by a certain disease or condition. The successful groups receive support from PCORnet, and are charged with outreach, expanding networks of patients, and collecting standard patient data—all of which are critical for researchers looking to recruit volunteers for a clinical trial.”

In December, PCORI distributed $93.5 million to 11 CDRNs and 18 PPRNs who will conduct pilot studies on data models over the next 18 months.

If successful, this single, overarching network has the potential to include over 100 million people across the US of all ages, ethnicities, and SES who have agreed to participate in clinical research.

Read the complete blog post here.

%d bloggers like this: