Abstract

Transparency is one of the most critical element of scientific research. Therefore, to avoid a nexus bias, coercion and possible falsification of data it is very important to promulgate transparency among the research teams in order to reach the major milestone.  It will allow scientist to foster steps toward restoring the public trust while maintaining the highest level of research integrity (Hamrell, & Dombey, 2012). Ultimately, the safety, well-being or privacy of any human subject in a clinical research must not be compromised or become a proprietary brand or trademark only known by the sponsors or the owners and yet kept as a secret from participating subjects. Subject’s personal information and privacy must be protected at all cost by the sponsor and any affiliated body involved in a research. The objective of this paper is to analyze the key benefits and improvements of clinical trial (CT) transparency database (www.clinicaltrials.gov) and to evaluate how this database could help in enhancing public trust and encouraging potential human subject participation in clinical study (CT. 2012).

Transparency in Scientific Research

The most important aspect of transparency is to promote public trust and subject participation in clinical research or trials, and in part to discourage clinical misconduct and secrecy (Hamrell, & Dombey, 2012). Hence, the CT.gov database was established to mitigate the issue of mistrust and secrecy within research study. In addition, the information provided is user friendly and may represent a real-time cause of action on an ongoing clinical study and subject enrollment (CT. 2012). The public including potential subjects, scientists, investigators, or consumers are provided with the opportunity to access clinical research information.  This platform will foster scientific knowledge, and encourage scientific-based public awareness in any given clinical research or medicinal product.

For instance, Protandim has been promoted and marketed as a supplement, which lowers free radical in the body. A product whose efficacy and safety have been promoted by its pioneer. The inventors of Protandim claim that the product significantly reduces Thiobarbituric acid reactive substances (TBARS) and Oxidative stress, thus decreasing free radical that cause cells to age (ABC, 2010). Based on the CT database, there are three different US patent claims on Protandim which include the alleviation of inflammation and oxidative stress in mammal (#US007241461B2), antioxidant-promoting defense and antioxidant enzyme activity (#US007384655B2) and reduction of C-reactive protein levels in subjects (#US007579026B2) (USPTO. 2012).

The validity of the product’s efficacy or claims/scientific results are compelling and may change the retrospective healthcare practices to a prospective and preventative care system. Nonetheless, research claims does not mean anything if there are no scientific data to support any claim or prove its potency with minimal adverse event within the studied population.  Thus, if all the clinical studies on this product were reported in the CT database, it will be an invaluable public asset and an unquestionable evidence to support the scientific claims. It is, however, very interesting and surprising that inventors may choose not to report negative findings or results from their clinical studies. The acts of such omission or commission of information and reports makes it very difficult to analyze scientific claims or evaluate its transparency, if any.   Consequently, consumers may not have enough valid information to make an informed decision on the product’s safety and efficacy. The CT database is structured to provide sample size for all the reported trials, which may also be indicative of how well a trial study is/was. However, lack of such information may not suggest that the product in question is not efficacious or effective or efficient. Perhaps, larger population sample is a matter of statistical validity and reliability of the inclusion criteria in regards to the polymorphism variability parameters defining the inclusion aspect of a clinical research.

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