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Widener Univ. School of Law

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Friday, March 3, 2006

Who is in Clinical Trials?; Also Really Obvious Conclusions

A critical part of most pharmaceutical litigation is the clinical trial information.  The selection criteria of the investigators are often a focus, with parties contending that those criteria either do or do not fairly reflect the likely patient population or do or do not provide data that will reveal likely adverse events.

Another factor in trials, though, is the self-selection process -- i.e., which people who would be eligible under the selection criteria to participate actually do so.  A new study provides some interesting information about what barriers come into play in cancer studies:

The following issues were identified most often by patients as barriers to participation in a clinical trial:

    •     fear that their quality of life might be reduced
    •     reluctance to accept the chance that they might get a placebo
    •     concern about potential side effects
    •     concern that treatments under study in the trial are not their best option

These do not obviously lend themselves -- at least to me -- to an argument that the people who do end up signing up for clinical trials (under three percent of cancer patients, according to the report) are not more or less representative of the full group, but these sorts of barriers to volunteering could be interesting to explore, especially if there are differences between the sample group and the general population that would not be captured in screening for selection criteria.

In other recently-publicized federal press releases that could reasonably be identified as coming from the Bureau of Really Obvious Things (with apologies to The Onion for stealing the concept):

Helmet Use Associated With Reduced Risk of Head Injury For Skiers and Snowboarders

Even a Minor Stroke Might Lead to Stress and Anxiety

http://lawprofessors.typepad.com/tortsprof/2006/03/who_is_in_clini.html

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