Transparency and Trust
Promoting the needs and rights of patients, employees and society at large is vital to us at Ipsen and it is exactly the objective and essence of our Corporate Social Responsibility Strategy. Our vision is to harness the power of our employees to have a responsible and sustainable impact on patients, society and the environment. We need to act with integrity, meaning that we must build relationships based on trust.
Transparency is also vital to building trust with patients, policy-makers, healthcare professionals (HCPs), healthcare organizations (HCOs) and citizens. We are committed to meeting the growing and legitimate expectations of healthcare companies in society. This is why we seek to enhance understanding about the way our sector operates.
We conform to the highest ethical standards, in compliance with the ruling laws, regulations and industry codes. As such, we disclose information concerning:
- The transfer of values to HCPs/HCOs
- Clinical trials
- Scientific publications
- Interactions with policy-makers
- Support to Patient Organizations
Clinical Trials and Data Sharing
Pharmaceutical companies are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with the following principles:
- Safeguarding the privacy of patients
- Respecting the integrity of national regulatory systems
- Maintaining incentives for investment in biomedical research.
Clinical Trials and Transparency:
In 2000, ClinicalTrials.gov was launched as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA required the U.S. Department of Health and Human Services, through the National Institutes of Health (NIH), to establish a registry of clinical trials information for all trials conducted under investigational new drug (IND) applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions, irrespective of funding source. The FDA Amendments Act (FDAAA) of 2007 (section 801) was also a key law in driving the submission of protocols and results to ClinicalTrials.gov.
The European Medicines Agency (EMA) established the European Clinical Trials Database (EudraCT) in 2004. Prospective registration of trial details in EudraCT is required for clinical trial authorisation and Research Ethics Committee approval for a study. On 21st July 2014, the EMA imposed mandatory requirement for sponsors to post clinical trial results in EudraCT.
To be considered for publication, the International Committee of Medical Journal Editors (ICMJE) requires, and recommends that all medical journal editors require, registration of a clinical trial in a public registry at or before the time of first patient enrollment. This policy resulted in increased compliance and an increase in the number of trials being disclosed for peer-reviewed journal publication.
- EU Directive 2001/20/EC (effective today) and the paediactric Regulation
- FDAAA 801
- CT transparency policy
Ipsen Clinical Trial Transparency Policy
Ipsen is fully committed to providing patients, healthcare professionals and researchers with information about the clinical trials it sponsors. Our objective is to foster scientific discovery while respecting patient confidentiality, in compliance with applicable legislation, the global industry trade association’s Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing.
Protocol Summary Disclosure
Protocol summaries of Ipsen sponsored clinical trials are made publicly available on the US Clinical Trials Registry (ClinicalTrials.gov) and on the EU Clinical Trials Register (www.clinicaltrialsregister.eu) at initiation of the clinical trial.
For Post-Authorization Safety Studies (PASS) and Post-Authorization Efficacy Studies (PAES) that are outside the scope of Directive 2001/20/EC, protocol summaries are posted in the EU electronic Register of Post-Authorisation Studies (EU PAS Register) at initiation of the clinical trial.
Ipsen also provides clinical trial information to other national clinical trial registries or databases according to local requirements/legislation.
Clinical Trial Results Disclosure
The results of Ipsen clinical trials are publicly posted to the results database after completion or termination of a clinical trial. Clinical trial results are usually available within 12 months of the trial completion or termination date. Results of clinical trials that are subject to FDAAA 801 legislation have been posted on ClinicalTrials.gov since June 2009. Since January 2014, Ipsen posts here the results of all Ipsen sponsored interventional clinical trials in patients.
From 21st July 2015, results summaries of Ipsen sponsored interventional clinical trials in patients conducted in the EU/EEA that completed from 21st July 2013 are available on the EU Clinical Trials Register. Results of interventional clinical trials are published one year after completion. From 21st July 2016, it is expected that all trials that started since May 2004 and completed before 21st July 2013 will also be made available here.
Sharing of Clinical Trial data with qualified researchers
Ipsen is committed to sharing information on clinical data with qualified medical researchers willing to advance science for human health. Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results of an Ipsen-sponsored clinical trial publication that has been published in a peer-reviewed journal. Anonymised data from clinical studies that have not been published in a peer-reviewed journal will also be shared, provided that this does not jeopardise subsequent publication of the study findings. In such cases, data will be shared after publication of primary results.
Qualified researchers with a valid research question should submit a request by email to: DataSharing@Ipsen.com. Proposals will be assessed by a scientific review board. Data are available beginning 6 months and ending 5 years after publication of the results; after this time, only raw data may be available.
Informing the public
Ipsen is collaborating in the US and in the EU with regulators via its trade associations to help the public understand the results and evidence used in clinical research. Ipsen will make available synopses of Clinical Study Reports (CSRs) submitted to FDA and/or EMA for indications approved after 1st January 2014. All information will be made available consistent with the need to protect patient privacy, publication rights, and confidential commercial information through appropriate redaction.
TO LEARN MORE ABOUT CLINICAL TRIALS, SEE:
R&D – Clinical Trials www.ipsen.com/research-development/clinical-trials/