Merck KGaA Policy on Clinical Trial Registration and Results Disclosure
Merck KGaA is a global pharmaceutical company committed to developing innovative products that treat unmet medical needs and to improve the lives of people with serious medical conditions. In that pursuit, Merck conducts well-designed and well-conducted clinical trials worldwide to evaluate the efficacy and safety of its products in development and on the market. Merck conducts these trials in adherence to the principles of Good Clinical Practice and the Declaration of Helsinki.
Merck is also committed to transparency and will provide important information about its clinical trial programs and make the results of its trials available to the healthcare community, adhering to the principles of Good Publication Practice1. For that reason, we are joining with other companies in our industry in implementing the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registration and Databases2, published on January 6, 2005.
By making such clinical trial information available, Merck intends to contribute to the following goals:
- Enable eligible patients to easily identify and participate in appropriate clinical trials for which they may qualify
- Facilitate the compilation of evidence needed for meta-analyses and systematic reviews
- Accelerate the development, availability and appropriate use of novel medical products
- Publish the results of its clinical studies in peer-reviewed biomedical journals
- Promote a better understanding of product efficacy, safety, and appropriate use and the practice of evidence-based medicine
- Become full participants and partners in the scientific community
This policy describes two separate endeavors, clinical trial protocol registration and public disclosure of clinical trial results.
Clinical Trial Protocol Registration
Since the implementation of the Food and Drug Administration Modernization Act (FDAMA),
EMD Serono, Inc., Merck’s US affiliate, has been registering its US clinical trials that meet the FDAMA requirements on the registry provided by the US National Institutes of Health, http://www.clinicaltrials.gov/.
On July 1, 2005, Merck KGaA will begin registering all US and non-US clinical trials, other than exploratory trials, on clinicaltrials.gov at trial initiation. Non-exploratory trials are also referred to as hypothesis-testing trials or confirmatory trials, as defined in the ICH Harmonised Tripartite Guideline E93. Whereas exploratory trials serve to set direction (i.e., to generate hypotheses) for possible future studies, hypothesis-testing trials examine pre-stated questions or hypotheses using statistically valid plans for data analysis and provide firm evidence of safety and/or efficacy.
EMD Serono, Inc., Merck’s US affiliate, has been registering its US clinical trials that meet the FDAMA requirements on the registry provided by the US National Institutes of Health, http://www.clinicaltrials.gov/.
On July 1, 2005, Merck KGaA will begin registering all US and non-US clinical trials, other than exploratory trials, on clinicaltrials.gov at trial initiation. Non-exploratory trials are also referred to as hypothesis-testing trials or confirmatory trials, as defined in the ICH Harmonised Tripartite Guideline E93. Whereas exploratory trials serve to set direction (i.e., to generate hypotheses) for possible future studies, hypothesis-testing trials examine pre-stated questions or hypotheses using statistically valid plans for data analysis and provide firm evidence of safety and/or efficacy.
Links to the clinical trial registry will be provided from a clearly marked page of the Merck corporate website.
Clinical Trial Results Disclosure
In January 2006, Merck / EMD will begin posting the results of all clinical trials, other than exploratory trials, completed after January 2005 for products marketed globally or regionally (first marketing authorization in the EU, Japan, or USA). Exploratory/pilot trials in any phase will be excluded unless the results are medically important, the trial was listed in a clinical trial registry upon initiation, and the results impacted the product’s labeling. Trial results of an investigational product that has failed in development will be disclosed if of significant medical importance.
Trial results will be posted within one year after first marketing authorization and, thereafter, within one year of study completion. Results will be posted in the database developed by the Pharmaceutical Research and Manufacturers of America (PhRMA), http://www.clinicalstudyresults.org/. If a publication of the results is pending, there will be a database posting to that effect. Following publication of the primary manuscript, the publication citation will be provided.
Links to the clinical trial results database will be provided from a clearly marked page of the Merck corporate website.
Trial results will be posted within one year after first marketing authorization and, thereafter, within one year of study completion. Results will be posted in the database developed by the Pharmaceutical Research and Manufacturers of America (PhRMA), http://www.clinicalstudyresults.org/. If a publication of the results is pending, there will be a database posting to that effect. Following publication of the primary manuscript, the publication citation will be provided.
Links to the clinical trial results database will be provided from a clearly marked page of the Merck corporate website.
- References
Wager E, Field E, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opinion 2003;19:149-154. - International Federation of Pharmaceutical Manufacturers & Associations. Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registration and Databases. Available at http://www.ifpma.org. Accessed June 9, 2005.
- ICH Harmonised Tripartite Guideline E9. Statistical Principles for Clinical Trials. Stats Med 1999;18:1905-42.
