I have a backlog of RSS and Google Alert items to blog about, so here goes!
Weiner D and Hovde M, “Critical Mass for Critical Path?”, Pharmaceutical Executive, May 1st 2007.
From the perspective of the authors, “Everyone agrees that it’s the road to
pharma’s future, but no one’s rushing to take it. Yet with growing FDA
advocacy and new advances in biomarkers and drug-disease modeling, the
rewards of collaboration now look greater than the risks”
Lots of interesting stuff in here, about the potential risks and benefits of sharing data for pharm companies. I don’t know how much of the article I can excerpt under “fair use.” If only the article were open access!
Here are a few teasers from the free full text:
…Ultimately, voluntary collaborations are doomed to fail unless each partner can find a satisfactory answer to “What’s in it for me?”
…when sharing technical data, legal permissions must be obtained, standard definitions and data structures hammered out, and a trusted
intermediary assigned to convert it all to an agreed-upon format. And where full data sharing is not possible, there must be explicit
disclosure of what is missing, so that users may judge reliability and limitations. This thicket of immediate drawbacks tends to obscure the bright-but-delayed promises of working in new ways. ..Every drug maker has to painstakingly
gather its own high-quality, high-cost data in tightly supervised
preclinical and clinical trials. The more data
there are, the more powerful the information is—and that leads to
faster, better decisions and less late-stage attrition. By almost any
measure, sharing data, analyses, and models is a win-win.
…Other nettlesome practicalities can bog down a collaboration. For instance, drug firms only rarely start research programs at the same time. Some companies accumulate data and expertise much faster than others. And it’s unlikely that any two companies will enter a new collaboration with equal amounts to contribute.
…According to a recent survey by Don Nichols, clinical pharmacology site head at Pfizer at Sandwich, most
companies report that they are willing to share summary-level placeboor active-control data, but they remain close-fisted about detailed information on individual patients taking the investigational drug
…FDA’s pharmacometrics group is
busy building and sharing models from aggregated sponsor submissions of patient data. For a variety of legal reasons, the data used by FDA must be held confidential. By sharing the model designs—but hiding the data—FDA can finesse sensitive patient-confidentiality issues and make
available a number of models to promote progress in diseases such as HIV, Parkinson’s, obesity, non-small-cell lung cancer, type II
diabetes, osteoarthritis, and Alzheimer’s.
…Still,there is no budget or infrastructure for data sharing, and an
organization serving as data custodian would require scientific
leadership and serious funding to get off the ground.