Pharmaceutical industry clinical trial support

Safety evaluation does not cease being an essential element in the success of the pharmaceutical industry once a product is on the market. It is also essential to support marketed products and ensure that their use is not only effective but also safe and unclouded by unfounded perceptions of safety problems. This requires not only that clinical trials be monitored during development (Spector et al., 1988), but also that experience in the marketplace be monitored. 

There are slight differences in the requirements for the European Union, the United States, and Japan. Duration to support Phase III trials in the EU, when they differ from the other data, is given in parentheses. Readers are referred to Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, EDA, Rockville, MD, 1997. http //www.fda.gov/cder/guidance/1855fnl.pdf [accessed September 20,2007]. 

As another example of someone familiar to me from my work as a product liability expert, Jan Fawcett has conducted numerous clinical trials for drug companies over the years. He lists himself as a consultant to ten pharmaceutical companies, as a Speaker s Bureau member for eight pharmaceutical companies, and as recipient of grants and research support from eight pharmaceutical companies. Curiously, Fawcett lists a ninth institution, the NIMH, under industry affiliations, confirming my view that NIMH is now a part of the psychopharmaceutical complex and might as well be considered a branch of the pharmaceutical industry. 

A stability survey was done in 2007 by AAPS Stability Focus Group, benchmarking industry standards and practices of their stability operations within the pharmaceutical and biopharmaceutical industry. It noted that the majority of the industry has used ambient room temperature as the long-term storage condition to conduct stability studies to support clinical trial application. 

After the cancer history with BCG and interferon, all other tumor immunotherapy measures emerged outside the MDACCC. It was combination chemotherapy that continued to receive a disproportionately overwhelming support at the DDT of MDACC and elsewhere. Discoveries made outside the MDACCC (doxorubicin cytosine arabinoside, or cytarabine) received prompt supportive funds to be tested in clinical trials at the DDT of MDACCC, while support for tumor immunotherapy was left way behind. Early efforts at it failed to receive any support from the NCI/NIH at the DM through the entire 1970s. Cancer chemotherapy proved itself to be a remission-inducer modality of treatment, and thus it was supported in full. The pharmaceutical industry started to pay consultation fees to academic physician principal investigators of chemotherapy protocols at academic institutions. Emil Frei HI, the head of the DDT, published in Cancer Research in 1985 his famous paper Curative cancer chemotherapy , appearing after he left M.D. Anderson for Dana-Farber [2287]. 

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