Pharmaceutical Companies and How Their Health Information is Managed Through Clinical Trials Essay

Clinical Trials are critical to how pharmaceutical companies manage health information. Through the years the Federal Drug Administration saw many problems with the use of clinical trials and worked at fixing them. Regulations and guidance was put into place to ensure that sponsors of clinical trials; medical researchers, ethic committees and pharmaceuticals understand how they can efficiently carry out the trials while complying with federal law. Pharmaceutical companies rely heavily on these trials to determine how the health information gained is used for research and marketing on a variety of levels within the company including their main purpose of drug development. The clinical trial is an investigational product in human volunteers to examine effects from experimental drugs, medical device, or biologic, such as a vaccine, blood product, or gene therapy (Bren, 2007, 23). The main problem of many clinical trials in the past was the possibility of bias. Meaning any factor that distorts the true outcome of a study, that leads to overestimating or even underestimating the effect of a drug that was being investigated. But now with better FDA regulations stricter guidelines help to prevent this type of bias. When a pharmaceutical has a drug to market it must first submit an application to the FDA that shows data from controlled clinical trials. FDA then reviews the application to make a decision on whether the clinical trials are well-control or if they show the effectiveness of the product. It must also show that all available data show that the product is safe enough to allow it on the public market. Before 1938 pharmaceutical companies could market a drug without submitting any information to the FDA or for that fact any agency. â€Å"The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 was passed when over 100 children died from taking a sulfa drug that had not been tested in humans† (Bren, 2007, 24). The FDA adopted the standard, after this incident, that the benefits of a product outweigh the risks. In 1962 new law created made pharmaceuticals responsible to prove that their drugs were both effective and safe if they wanted to market them to the public. Making clinical trial more efficient was needed. In an article â€Å"The Advancement of Controlled Clinical trials† Bren discusses the future of clinical trials in which the FDA see a future of improving clinical trials by standardizing and automating trial procedures, conduct and data processing. Another addition to the trials would be to use patient reported outcomes. â€Å"For systematic diseases, what really matters is how you feel, not how the doctor feels about you† (Bren, 2007, 28). Another important advancement in managing pharmaceutical companies is how they manufacture and the distribution of medication. This was called the Critical Path Initiative. This focuses on the path which medical products must travel from development to patients. The Critical Path Initiative is FDA’s effort to stimulate and facilitate a national effort to modernize the sciences through which FDA regulated products are developed, evaluated, and manufactured† (Bons, Aubert & Bonnely, 2000). Pharmaceutical companies had already recognized that there were weaknesses that needed improvement in clinical trials and that some could be easily improved while others would need a different type of organization, but in general that none of them were really difficult to address. Choosing an independent institute for conducting surveys and trial would give them an opportunity for impartial opinions in clinical trials. Human subjects is an important key in clinical development and investigators are the spokesperson for that study so improving investigator participation in clinical trials would help to improve subject participation and the quality of the whole trial. So looking at the clinical trial in itself would be how pharmaceutical manage the health inf