Clinipace

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Everyone involved in conducting clinical research should read this article (Odds Are, It’s Wrong) published on sciencenews.org. We don’t take sides, but the discussion is fascinating since our industry is based on these very truths. Here are few of the more interesting excerpts, but you are highly encouraged to read the full article.

It’s science’s dirtiest secret: The “scientific method” of testing hypotheses by statistical analysis stands on a flimsy foundation. Statistical tests are supposed to guide scientists in judging whether an experimental result reflects some real effect or is merely a random fluke, but the standard methods mix mutually inconsistent philosophies and offer no meaningful basis for making such decisions. Even when performed correctly, statistical tests are widely misunderstood and frequently misinterpreted. As a result, countless conclusions in the scientific literature are erroneous, and tests of medical dangers or treatments are often contradictory and confusing.

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Over the years, hundreds of published papers have warned that science’s love affair with statistics has spawned countless illegitimate findings. In fact, if you believe what you read in the scientific literature, you shouldn’t believe what you read in the scientific literature.

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Conflict between frequentists and Bayesians has been ongoing for two centuries. So science’s marriage to mathematics seems to entail some irreconcilable differences. Whether the future holds a fruitful reconciliation or an ugly separation may depend on forging a shared understanding of probability.

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“What does probability mean in real life?” the statistician David Salsburg asked in his 2001 book The Lady Tasting Tea. “This problem is still unsolved, and … if it remains un­solved, the whole of the statistical approach to science may come crashing down from the weight of its own inconsistencies.”

Welcome to our newest client!  NitricBio has selected the company to manage and deploy multiple studies in support of medical applications of topical nitric oxide gas (gNO).

NitricBio is a mid-stage specialty pharmaceutical company focused on the dermatology and podiatry markets, with two unique drug delivery technologies.  The company awarded Clinipace Worldwide a four-project engagement, including data management, statistical services, and medical writing for two phase 2 trials as well as providing fully-integrated clinical research services to manage and conduct two phase 3 trials.

Read the full release.

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.

We recently sat down with Mark Uehling, founder and editor at Clinpage to talk about Clinipace since our focus has evolved since the last time we met with Mark. As all great journalist do, Mark listened more than he spoke. Several weeks later that interview was published in Clinpage with a very interesting title. Mark choose the word - Manifesto - which, in hindsight, is very appropriate. We certainly didn’t intend to make a publish declaration, but i guess that’s exactly what occurred during our interview.

Being different in an established industry has its challenges. Usually the “rules” are set by others (established firms), so folks expect to operate in a way to benefit those who set them. Clinipace is a bit different, in our approach and use of technology as our manifesto states.

Sometimes you have to get on the soapbox and declare yourself so folks hear you loud and clear.