As seen on MedCityNews.com - Posted Sep 20, 2018 - Original Article
As clinical trial compliance and disclosure remain in the spotlight and more and more countries continue to establish regulations, it is more important now than ever for sponsors to adopt a Global Transparency Policy.
There are over 90 countries that require some form of public disclosure of clinical trial data with new requirements and regulations coming into effect every year. As public expectations on disclosure, in addition to these regulations evolve, many organizations are developing holistic clinical trial transparency policies to keep up. These policies include positions on study registration and results disclosure, data sharing, publications, lay-summaries, and sharing of individual patient data.
Current global requirements on clinical trial disclosure weave a complicated web that includes a different scope of studies that require disclosure, different timelines, various types of data, and a myriad of standards for submitting the data. Evaluating each of these requirements in isolation results in complexity and confusion. A better solution is a comprehensive Global Transparency Policy, which can produce three significant benefits to an organization.