University of Kentucky starts new clinical trial

The University of Kentucky will start a clinical trial for an anti-seizure injection. They will be testing an auto-injector that will allow medicine to enter into the bloodstream of a a seizing patient before the medicine of an IV begin to work. They will be testing both methods.

The UK research team was selected along with 16 other prominent research institutions across the nation to conduct the emergency medicine trial known as RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) within the Neurological Emergencies Treatment Trials (NETT) Network. The network, formed by the National Institutes of Health, conducts large, simple clinical trials to reduce the burden of very acute injuries and illnesses affecting the brain, spinal cord, and peripheral nervous system.

For more on the story, read here.

Pushing past the placebo: Legislating for a new kind of clinical trials

From amednews.com:

In January, a study published in the Journal of the American Medical Association on the first two commercially available drug-eluting stents found no significant differences in clinical outcomes.

In August, a report in the New England Journal of Medicine concluded that patients with stable angina who underwent percutaneous coronary intervention showed slightly more improvement over those treated with medication. But that added benefit disappeared by 36 months.

Then in September, a study in the NEJM found that arthroscopic surgery for osteoarthritis of the knee provided no additional benefit over physical and drug therapy.

What these very different studies have in common is that they compare the effectiveness of one treatment option with another instead of on its own. Although more of this type of research is being conducted than ever before, physicians, insurers and consumer groups widely agree that not enough comparative-effectiveness data exist on pharmaceuticals, medical devices and procedures.

For the rest of this article, please click here.

Will Change in Washington Bring Change in Clinical Research?

On January 20, 2009 change will come to Washington. Will a new resident in the White House have implications for drug development? Here are a few areas of possible impact:

Investments in Health Information Technology
Both Obama and McCain featured increasing investments in Health Information Technology as part of their healthcare reform proposals, and the recent Max Baucus reform proposal continues the trend. While the intent from the politicians is to decrease medical costs, reduce errors, and improve quality, there is great potential for clinical research as a by-product. The proliferation of electronic medical records and personal health records can bring transformation in the conduct of clinical research -- new opportunities to find patients, integration of EMRs and electronic data capture (EDC), running virtual trials, identifying biomarkers, the list goes on.

Personalized Medicine
Obama demonstrated awareness of the potential for personalized medicine back in 2006 when he introduced the Genomics and Personalized Medicine Act. And while the act never became law, the passage of GINA earlier this year did bring some protection around the use of genetic information. Outgoing HHS secretary Michael Leavitt has left a note to Obama emphasizing personalized medicine as a potent tool for repairing the healthcare system, which should be a good reminder to the new president that there is still work left undone. Increased investment in personalized medicine will bring more companion diagnostics into clinical development with each new drug, affecting everything from sample size to study logistics.

Continuing Focus on Drug Safety
Most feel the pendulum has swung and the FDA is focusing on safety over accelerating drugs for efficacy. With the media focusing on everything from safety of drug imports (including ingredients used to manufacture drugs) to what seems like every anecdotal report, there is no sign of this trend changing. For clinical development, sponsors will continue to aspire to accelerated approvals -- but will plan for the realities of studies large enough to demonstrate safety (to prove that every needle has been found in the haystack).

Beyond Safety and Efficacy -- Comparative Effectiveness
Once upon a time it was sufficient to run a development program to demonstrate safety and efficacy. Lessons learned from the UK's National Institute for Health and Clinical Excellence (NICE) have taught us the future adds a third endpoint -- comparative effectiveness. In fact, recent healthcare plans in Washington suggest creating an independent "Comparative Effectiveness Institute" for the United States, tasked with head-to-head comparisons of quality and cost for one drug vs. another. Be sure to have a few more voices at the table when writing that next registration study protocol (outcomes research, evidence-based medicine, etc).

Autism and Vaccine Safety Research
Obama and McCain were both enjoying the response of crowds on the campaign trial when raising the potential link between autism and vaccines. Assuming this campaign themes travel from Chicago to Washington in January, there is certainly the suggestion of additional research for vaccines new and old.

Stem Cell Reversal
Most seem to be anticipating an Obama reversal of the Bush restrictions on stem cell research. If this happens and if this research is successful, it would still be several years before one would see any heightened impact of stem cells in clinical research. But clinical trials of stem cells would certainly bring heightened planning -- from dose setting to safety monitoring.

New FDA Leadership
Other far more qualified political sources have taken educated guesses at naming the next FDA commissioner (including Scientific American's proposal of Stephen Colbert). We will need to wait and see in a few weeks, but the new leadership will certainly be expected to bring change within the agency -- which in turn will bring it's impact on clinical research.

Doing More with Less (and less and less...)
We have heard it time and time again. Big pharma are being hit by loss of patent protection to generics coupled with a weak pipelines and the growing risk of reimportation. And now small biotechs are expected to see challenges in raising capital to maintain their development work due to the credit crisis. This conspires to mean a familiar message for clinical development -- the need to do more (more products, more trials) with less. Except the "more" seems to keep growing and the "less" keeps shrinking.


What will come to fruition? Time will tell. But at last check we still have an aging population in this country, and plenty of unmet medical need to go around. (Personally, I am going to make sure I know what HIT, EMR, and PHR all stand for...)

Co-posted from www.pharmasherpa.com
Image: Flickr

New clinical trial for eye device

Doheny has partnered with Second Sight Medical Inc to develop a device that could help people suffering from night blindness and blindness caused by old age.

Rajat Agrawal, an assistant professor at Doheny commented, “We are creating an artificial retina. We are creating an artificial device where that function (is) to be superseded so that you are able to simulate the impluses to go on to the optical nerve and to the brain.” For more information, read here.

Successful clinical trial reported by Abbott

Yesterday, Abbott reported that a two year study showed that:

a bioabsorbable stent successfully treated coronary artery disease and was absorbed within the walls of arteries.

It was proven by:
data from 30 patients showed the drug-eluting stent left behind blood vessels "that appeared to move and function similar to unstented arteries."

Eighty patients will be included in the next stage of the clinical trial and Abbott hopes to release this drug to the European market by 2012, followed by the United States.

Online Recruitment is Key to Patient Recruitment

Recently Healthcare IT News, reported on the evergreen problem of patient recruitment. The article stated that 90% of drug trials are delayed due to poor patient recruitment. This problem doesn't stop there; drug companies are pouring money into these trials only to earn little results.

The solution? Recruit online.

Like we've seen in countless other avenues, online can prove to be a fast and cheap way to drive traffic. In this case, drive traffic to the recruitment pool.