Clinipace

Clinpage really nailed it. Great article on FDA’s Special Protocol Assessment. Here is an excerpt…

An SPA, they explained, is a declaration from the FDA that an uncompleted Phase III trial’s design, clinical endpoints, and statistical analyses are acceptable for support of regulatory approval later, after the trial has concluded. It’s the FDA’s way of saying: If you execute this trial exactly as you promise you will, and the data are there, this drug will get approved.

And that’s bind. Unless the science around the research changes or a new public health concern emerges that impacts the agreement, the FDA has to honor it once the Phase III trial is done. That is, as long as the sponsor has followed the agreed-upon protocol to the letter, and the data support the efficacy and safety of the product.

Worth a read.

Academics, research networks, and industry received another big push by the government in support of patient registries. The Agency for Health Research and Quality (AHRQ) is making $48M available for patient registries to further support safety, effectiveness, and other quality care initiatives. This is in addition to the $300M the agency has already committed to comparative effectiveness programs. According to an article in Government Health IT…

AHRQ said in the recent announcement that it expects to begin funding the projects in spring 2010. Identifying what treatments are most successful for specific conditions should improve the quality of health care and reduce costs. Clinical registries, clinical data networks and other health IT can help providers generate or obtain outcomes data.

Surely this is welcome news to spur investment in observational research.

We recently published a great client success story and wanted to share it more broadly. ImproveCareNow’s mission is to enable pediatric gastroenterologists in North America to work together to find the best treatments for these diseases. The ImproveCareNow Research Collaborative, formerly the PIBDNet Trailblazer Improvement Collaborative, allows selected practice sites to work together to improve the care and outcomes associated with Crohn’s disease and ulcerative colitis.

The most common serious chronic pediatric gastrointestinal disorders, these conditions affect 100,000 children and adolescents in the USA.

With sites across the US from Maine to California, the collaborative has already enrolled over 2,000 patients, with plans to expand to 75 practice sites within 5 years.

After exploring a number of options, Dr. Colletti’s team selected the Clinipace technology-driven data management solution. “Clinipace services are more affordable and provide the ability to make changes in a flexible and timely manner.”

To date, the collaborative has succeeded in improving the detection of nutrition and growth failure; standardizing disease diagnosis and initial evaluation; and building assessment of disease severity and extent into every patient visit.

The full story is posted in our resource center.