Tea leaf reading for clinical research


Now that the Democrats have taken over Congress, a lot of analysts (professional, amateur, and armchair) have tried to noodle out what this means for Big Pharma. And, of course, whatever happens to Big Pharma is going to impact what’s going to happen in clinical research.

“Forbes”:http://www.forbes.com has examined “six pieces of legislation”:http://www.forbes.com/2006/11/16/fda-congress-bills-biz-cz_mh_1116fda.html?partner=yahootix that Democrats are likely to push through. Some of these will involve sweeping changes, some may not be so serious. I’m going to take a stab at analyzing what these are going to mean to me as a biostatistician in clinical research, who sometimes does work for big pharma but usually for little biotech/pharma. In addition, there were additional bits throughout the article that deserve comment.

|*Legislation*|*Projected impact on big pharmaAccording to the Forbes article*|*Projected impact on clinical research*|
|Medicare reform|Could allow government to force lower drug prices|Shrinking budgets for Big Pharma will probably mean shrinking R&D budgets for large CRO(clinical research organization)s. This is less likely to directly impact smaller CROs, but the indirect impact will be felt. Given that Big Pharma is facing shrinking pipelines, they are looking to buy compounds or whole companies from little pharma. The smaller R&D budgets will mean that Big Pharma is more risk averse, and will probably want to buy compounds during Phase III trials rather than Phase II or Phase I. Small and agile CROs will be able to adapt to this environment rather quickly. The larger ones such as Quintiles or Kendle will have to adapt as well, and may find themselves in an uncomfortable position at times. However, it will merely be uncomfortable.|
|Drug importation|Probably minimal, but the industry would lose face|I see little impact|
|PDUFA reauthorization|A delay could slow the FDA; drug safety laws could be attached to it|Drug safety is a hard problem, and our ways of describing it are rather old. Legislation could either motivate biostatisticians to innovation for drug safety analysis, or simply require the establishment of more safety databases. It really depends on whether the emphasis of drug safety is placed solely on post-marketing, or on pre-marketing as well.

PDUFA will almost certainly be reauthorized in time, because the Democrats don’t want to be seen as being ineffectual as well, but if it’s not, it could put the squeeze on pharma and clinical research for an uncomfortable year.|
|Patent reform|Limits on whether big pharmaceutical firms can make deals with generic drug makers are possible.|This won’t have an impact on clinical research except through R&D budgets.|
|Medicaid reform|Many prescription drugs, like those for schizophrenia, actually have much of their market share here.|Again, this won’t have an impact on clinical research except through R&D budgets.|
|Enzi-Kennedy bill and competitors|May be attached to PDUFA IV, or stand on its own, or some combination of the two.|Several provisions stand out as impacting clinical research. Perhaps the most major is the possibility for a five-year post-marketing re-evaluation for all drugs. This may drive innovation in data mining of adverse events, or it simply may mean setup and maintenance of more post-marketing safety databases with some additions to a report each year. It will, however, burden the FDA with more reviews, and will definitely drive up costs. At any rate, CROs could either benefit if they position themselves correctly, or they will lose out because pharma companies would insource post-marketing safety and put a further crimp on R&D budgets.|

At any rate, shrinking R&D budgets are the major concern from my standpoint, because that’s what pays for my services. The trick is going to be embracing and adapting to the new drug development environment by using such initiatives as the Critical Path, adaptive designs, and the emerging pharmacogenomics efforts as well as designing new ways of describing and assessing drug safety.

One thing’s for sure. Drug development will be changing. The question is: will it be a source of adventure or fear?

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