Fda Regulation

In today's healthcare environment research is one of the most critical arrears in regards to the advancement of medical treatment. Clinical studies has to have a specific structure to follow and the structure must be able to produce quality data that will show how the assessment of safety and efficacy is controlled and followed so that the participants whom will be using the treatment. It is mostly opposed that the clinical trial sufficiently balances all costs and benefits to physicians and prospec¬tive trial participants so that every aspect of the trial can run and ensure continued sufficiency in the areas of researchers and its subjects. Integrity must also have a major part within the study so production of scientifi¬cally reliable and accurate results are reached, the participants are always kept safe, and everyone are trusting of the clinical trial system and will be willing to participate.

Within the clinical trials financial remuneration is also a concern in integrity and safety of all participants. The Food and Drug Administration (FDA) is issuing regulations requiring the sponsor of any drug, including a biological product, or device marketing application (applicant), to submit certain information concerning the compensation to, and financial interests of, any clinical investigator conducting certain clinical studies (Food and Drug Administration(1998). In September 22, 1994 the FDA implemented the regulation 59 FR 48708 in regards to all financial interest made in regards to a clinical trial study. In this document, FDA proposed to require disclosure by applicants of the following types of financial interests and arrangements: Compensation made to the clinical investigator in which the value of the compensation could be affected by the study outcome; a proprietary interest by the investigator in the tested product, such as a patent; a significant equity interest in the sponsor of the covered study; or significant payments by the sponsor of the covered study of other sorts, such as a grant to fund ongoing research, compensation in the form of equipment, or retainers for ongoing consultation or honoraria (Food and Drug Administration(1998).

In the recent FDA act (January 2007 'FDAAA'), under Title 8, Section 801, 'The Expanded Clinical Trials Registry Data Bank', there is a detailed description of a mandated publicly available clinical trial registry. Further, not later than 18 months after date of the enactment, the Director of NIH shall ensure the public may search the entries of the registry data bank (of all) 'clinical trials primary or secondary outcomes'...'as the Director deems necessary on an ongoing basis'(Klein, D., Glick, I. (2008). Because of all the financial gain there is to obtain within clinical trials the FDA had to implement some regulations. Clinical investigators such as doctors and nurses can make up to 10 times the salary amount they may obtain in general