Clinical trial transparency is a hot topic in the pharmaceutical industry. It means public access to information about clinical trials, like which trials take place and what the results are. It is expected by payers, physicians, patients, and investors. The 2018 update of its Public Disclosure Declaration aligns Grünenthal worldwide with the currently most stringent transparency standard and goes beyond what is legally required or the industry standard. It is another step towards our goal of being one of the top 10 companies for clinical trial transparency.
Sharing information from clinical trials is fundamental to the good functioning of healthcare services, to patients’ safety, and to advancing research and improving public health. The information is used to make decisions about which treatments work best. But there is a problem: results of clinical trials are routinely and legally withheld from payers, physicians, and patients. This problem is long-standing, and it is time that it is overcome.
The updated Grünenthal Public Disclosure Declaration clearly states our promise to meet the highest standards of clinical trial transparency worldwide. For example, Grünenthal will:
- Register all clinical trials in publicly accessible internet registries endorsed by the World Health Organization; clinical trials from 2003 that were not registered in such registries will be retrospectively registered by end-2018.
- Give external researchers easy access to the Clinical Study Reports for all clinical trials from 2003 onwards; this includes trials for licensed drugs (including off-label uses) and unlicensed drugs.
- Publicly post expert summaries of the results of all pre-defined clinical trial endpoints, irrespective of whether the outcomes are positive or negative.
- Publicly post lay understandable summaries of key clinical trial results in the languages used in the trial.
- Submit the results of all pre-defined clinical trial endpoints for publication in journals, where possible in journals which can be accessed for free.
- Publicly report compliance with these commitments.
This update is another step towards our goal of being one of the top 10 companies for clinical trial transparency based on the AllTrials Transparency Index which ranks all of the world’s major drug companies, and a selection of smaller firms, by the commitments they make to clinical trials transparency.
“The updated declaration goes beyond what is legally required or the industry standard. For example, we will share complete Clinical Study Reports for clinical trials for off-label uses of licensed drugs and unlicensed drugs. Very few companies share these reports. We will also implement the stringent EU clinical trial results reporting standard due for implementation in 2019/2020 already in 2018 and we will apply it for all our trials worldwide.” says Christopher Marshallsay, Head of Medical Writing & Public Disclosure.
The updated declaration will be made public on the Grünenthal Clinical Trial Portal.