Clinical Trial Disclosure and Data Transparency: obligation or opportunity?
Massimo Zaninelli, Maxer Consulting CEO, has published on PharmaStar the article Clinical Trial Disclosure and Data Transparency: an obligation or opportunity?
The publication of interventional clinical studies is mandatory both in the European Union and in the USA. The author intends to highlight the benefits that this activity offers to the commercial and non-commercial subjects that carry them out (sponsor, according to the European Medicine Agency, responsible parties, according to the Food and Drug Administration).
Besides offering appreciable benefits to patients and society as a whole, the studies’ publication protects sponsors from the risks of economic and regulatory sanctions by the competent authorities.
Finally, the article suggests how the sponsors can deal with the activities related to clinical trials’ transparency on an organizational and operational level.