Disclosure of negative trial results: A call for action
3rd World Congress on Pharmacology
August 08-10, 2016 Birmingham, UK

Annalisa Capuano

Second University of Naples, Italy

Posters & Accepted Abstracts: Clin Exp Pharmacol

Abstract:

In the past few years the scientific community has discussed on how to tackle research misconduct. However, little progress has been made in another important and relevant issue that can lead to incorrect assessments to be on the clinical efficacy of treatments, the reporting of negative clinical trials. The file-drawer effect influences publication of research results more than rejection by journals. The file drawer effect is the non-reporting of results, often negative or neutral, from clinical trials in a specific area of research. There is evidence to support that editors tend to reject research where the results are not statistically significant. Moreover, it has been suggested that clinical trials with significant positive results had a higher probability of being included in meta-analyses than studies showing negative results. The trend to publication bias, the so called positive-outcome bias, is very common because reviewers and editors are less likely to publish negative results and findings that are not statistically significant. Withholding results are an example of misconduct research which can result in the use of drug therapies that are harmful, ineffective, unethical, and expensive; since clinical research that doesn�??t confirm the expected benefits of those treatments and their related clinical trial data remain unpublished. The key to avoiding underreporting and hyper-claiming research should be to motivate investigators to submit all good quality studies for publication and, to contribute to the education of journal editors, reviewers, and investigators alike that null or negative findings are as important as positive ones. To date, one of the most significant concerns of clinical trial databases, such as trail registries, consists in the difficulty of reporting research findings held by the sponsor. Therefore, the data are often not available for public access. Unfortunately, only two registries currently existing (Clinicaltrials.gov and the EU Clinical Trials Register) work to ensure clinical trial documentation. In order to avoid withholding results, there is an urgent need to improve the policies of scientific Journals for publication and access to clinical trial data.

Biography :

Email: aly.capuano@gmail.com