Our Standard on clinical trial data transparency


Rationale

With respect to the principles set forth by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Declaration of Helsinki and applicable laws and regulations (including requirements as defined by the Clinical Trials Regulation (EC) No 536/2014), we will inform the public about the designs and results of our clinical trials in a timely and balanced manner, regardless of the outcome.

We welcome the efforts to make in-depth information on clinical trials available to the public. Access to detailed information on clinical trials, irrespective of their outcome, can significantly improve the positive impact of clinical studies on the progress of medical research and development. Hence, the new transparency requirements in clinical research will primarily serve patients’ well-being and advance public health.

In accordance with current laws and regulations, we take great precautions to ensure the privacy of participants in our clinical trials. We also protect intellectual property, keep contract rights as well as current national practices in patent law.

Our company is thoughtfully integrating our commitment to transparency and disclosure into our clinical development opportunities in the following ways:

Section 1: Posting of clinical trials and results in web-registers

Section 1: Posting of clinical trials and results in web-registers

We disclose relevant clinical trial information for interventional and non-interventional studies in compliance with applicable laws and regulations.

The protocol design information of Phase II-IV trials initiated after 2005 and all Phase I trials initiated after 2015 is registered in advance of the clinical trial start on ClinicalTrials.gov and EU Clinical Trial Register, as required. Posting takes place following approval of the final protocol and prior to the first subject consenting to participate in the trial. Posted information is reviewed periodically to ensure it remains up to date. The results of registered trials are reported according to the required timelines and in compliance with applicable laws and regulations. Our clinical trial disclosure policy has been in place since 2005 and it is updated periodically to reflect ongoing changes in the law and our industry.

Section 2: Plain language clinical trial result summaries

Section 2: Plain language clinical trial result summaries

Since 2017 we have communicated results of Phase I-IV trials in plain language format to show our appreciation to the patients participating in our trials, meet public needs and increase support for clinical research. A plain language summary translating the technical results of a single clinical study into easy to understand language, is provided to study participants, and may be posted to a public website.

Section 3: Responsible clinical trial data sharing

Section 3: Responsible clinical trial data sharing

We believe that the sharing of information related to company sponsored clinical trials is central to our mission. The sharing of clinical trial information enables the medical and scientific community to further develop the medical and scientific knowledge base and permits the public to make informed healthcare decisions. It is also one of the best ways to inform prescribers and patients about scientific findings relating to our medicines. 
Since January 1, 2014 we are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with: 
(a) safeguarding the privacy of patients;
(b) respecting the integrity of national regulatory systems; and
(c) maintaining incentives for investment in biomedical research.

3.1 Clinical investigator access to data and review of results
We value the significant contribution of each clinical investigator, without whom advancements in medical science would not be possible. We seek to provide our investigators access to clinical data from the studies in which they participate.

  • Individual investigators in multi-site clinical trials will have their own research participants’ data, and will be provided with the randomization code after conclusion of the trial.
  • We will provide a summary of the study results to the investigators.
  • Any investigator who participated in the conduct of a multi-site clinical trial will be able to review data for the entire study at the sponsor’s facilities, or other mutually agreeable location in response to a reasonable scientific inquiry.
  • Investigators who are authors of study-related manuscripts will be given study data as needed to support the publication.

3.2 Information shared with external independent researchers
We share trial protocols, anonymized or pseudonymized patient level data and redacted clinical trial reports with qualified scientific and medical researchers. This is done upon researchers’ request, following approval of a new product or a new indication for products approved in both the EU and the US after January 1, 2014. Data will not be shared with competitors.

Such requests must be submitted in writing to the company’s portal and will be internally reviewed regarding criteria for researcher qualifications and legitimacy of the research purpose.

A summary of our “Responsible Data Sharing Policy for Researchers” and instructions for requesting data are outlined here.

3.3 Publishing clinical study report synopses 
The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration, European Medicines Agency, or national authorities of EU member states after January 1, 2014 will be made publicly available upon the approval of a new medicine or new indication. All synopses disclosed under our commitment shall respect patient privacy, as well as third party agreements, and shall be redacted of all confidential commercial information.

Section 4: Medical publication of clinical trial data

Section 4: Medical publication of clinical trial data

We are committed to publishing outcomes of all company-sponsored phase II-IV and selected phase I clinical trials, regardless of positive or negative outcome, unless there is a strong reason why publication is not appropriate (e.g., a clinical trial is prematurely terminated for legitimate medical reasons; or data quality does not allow conclusive insights). Publications shall typically take the form of either a manuscript submitted to a peer-reviewed journal or an abstract, resulting in a poster or talk presented at a medical/scientific congress or meeting.

This commitment also pertains to investigational medicinal products whose development programs have been discontinued.

Aligned with the ‘Joint Position on the Publication of Clinical Trial Results in the Scientific Literature’ from IFPMA (2010), we commit to submit the results of all phase III clinical trials and any investigational clinical trial results of significant medical importance for publication in a peer-reviewed journal or presentation at a congress wherever possible within 12 months and no later than 18 months of:

  • In the case of already marketed medicinal products, the completion of clinical trials; 
  • In the case of investigational medicinal products:
    • The regulatory approval of the new medicine; or
    • The decision to discontinue development.

Section 5: Clinical trial documents disclosure through European Medicines Agency (EMA)

Section 5: Clinical trial documents disclosure through European Medicines Agency (EMA)

In Europe, there are two specific policy documents in place to ensure widest possible access to EMA documents following request from the public and publication of clinical data submitted by pharmaceutical companies.

Section 5.1: EMA policy on access to documents (0043)
We respect and support the release of clinical trial data in the context of the EMA access to documents policy (EMA/110196/2006). In alignment with EU law, under this policy the EMA is committed to providing access to its documents following requests from the public. The EMA also ensures that it will protect information held on individuals and the commercial interests of the marketing authorization holders that it works with. As a general rule, the EMA releases documents once a marketing authorization procedure has been finalized.

Section 5.2 EMA policy on publication of clinical data for medicinal products for human use
Our commitment to Clinical Trial Transparency continues through the EMA Policy 0070 (EMA/240810/2013) which requires all clinical reports and certain associated documents used in the submission for approval of medicinal products in the EU be publicly disclosed. Personal protected data and commercial confidential information may be redacted in these documents.

We have implemented a procedure to comply with the process for publication of redacted clinical documents as per EMA policy 0070. 

 

US/NPR/0517/0230(1)a(1)d   

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