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Osteoarthritis Imaging in Clinical Trials Challenges

The last few blogs I posted have been about the Alzheimer's Disease NeuroImaging Initiative. However, there is a second public/private partnership that has been going on longer – the Osteoarthritis Initiative (OAI). Last week there was a major release of new 4 year data from nearly 4,000 osteoarthritis clinical trial participants. Furthermore this coincided with the 5th Annual Osteoarthritis Imaging Conference, which this year was held in Salzburg, under the chairmanship of Prof Felix Eckstein. As usual, this was an excellent workshop with some great dialogue on osteoarthritis imaging in clinical trials.

The requirements for obtaining approval by the FDA or EMA for a new pharmaceutical or biologic as a disease modifier (rather than just for pain) is still joint space narrowing (JSN) as measured by X-ray. There was a continued debate on the use of MRI and which end points would be more useful in osteoarthritis clinical trials. The challenge lies in the requirement by the FDA for any new end point to have clinical correlation and these kinds of studies take many years to complete. Hence the OAI and its need to answer this question.

The other challenge with developing a Disease Modifying Anti-Osteoarthritis Drug (DMOARD) is that since osteoarthritis is a non-life threatening condition which can be treated in its end stage by surgical implant, any DMOARD has to have an extremely good safety profile. There is a graveyard of drugs that litter this field, the most prominent arguably being Risedronate, (although this was not for safety, as it is already on the market for treating osteoporosis). This has led to a paucity of companies tackling this area of unmet medical need, but bravely being led by Novartis and Pfizer at the current time. The Novartis program with Calcitonin has recently stated that the futility end point was missed, which means that the placebo group did not show evidence of JSN. This is caused by one of two issues: either the patient population was incorrectly selected or the osteoarthritis image QC was very poor. Knowing the challenge of ensuring good QC for osteoarthritis imaging in clinical trials, I can well believe this was the primary issue (by inference, the reader can appreciate that BioClinica was not involved in any part of this study).

Osteoarthritis Imaging Insights

The good news was that for the first year there were a number of new companies sponsoring the workshop in Salzburg. The interest in this therapeutic area is growing again, and I believe we have a far better understanding of the QC required for osteoarthritis imaging in clinical trials since the failure of the Risedronate and Calcitonin studies. Each year new OAI data is released and we gain further insight into the etiology of this crippling disease.

Next year's conference will held in Hilton Head under the co-chairs of David Hunter and Ali Guermazi. It promises to be a landmark workshop. If anyone requires more info or an email notification for the workshop, please let me know and I can ensure your contact details can be added to the preliminary mailing.

Changing subjects briefly, we have a new "guest" blog starting up by an old friend and ex-colleague, Dr. Stuart Jackson. Stuart has been involved in the medical imaging field for over 35 years, and working in England, USA and Canada. He is now based in Canada as an independent consultant and has a wonderful historical perspective on the growth of the industry. It is my pleasure to welcome him to the BioClinica blog page and provide vignettes into some of the historic perspectives and history on osteoarthritis imaging, medical imaging as well as a variety of other topics. I hope you enjoy reading Stuart’s historic perspectives… As Steve Turner once said, "History repeats itself, has to, nobody listens."

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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