LEO Pharma is transparent about information and results from our clinical trials. Our aim is to enable patients and health-care professionals to make informed decisions about treatment facilitated by the availability of historical as well as of the latest clinical trial information. As a company focused on helping people achieve healthy skin, LEO Pharma recognises the public health benefits associated with increased clinical trial transparency to further advance research and the scientific understanding of skin diseases.
Our commitments apply to interventional clinical trials (incl. drug-device combination trials) sponsored by LEO Pharma and they currently meet, and in some cases exceed, existing requirements from authorities and major industry associations regarding disclosure of clinical trials. The commitments cover the following aspects:
• Registration of clinical trials
• Reporting of clinical trial results:
- Public data registries
- LEO Pharma’s corporate website
- Peer-reviewed journals
• Disclosure of clinical documentation in market authorisation applications
• Access to anonymised data from trials in approved products and discontinued projects
Our undertakings for increased clinical trial transparency carefully take the confidentiality of our trial participants into account and their anonymity is maintained by protection of sensitive information.
Registration of clinical trials
LEO Pharma registers all interventional clinical trials in the global US-based public data registry (www.clinicaltrials.gov), including Phase 1 trials. The trials get registered before enrolment of trial participants.
We also register trials in the EU Clinical Trials Register (EU CTR; www.clinicaltrialsregister.eu) and in various national registries, when required, and in addition, our clinical trials can be found on the WHO Clinical Trials Registry Platform (www.who.int/trialsearch).
Reporting of clinical trial results
LEO Pharma considers result reporting of clinical trials to be an ethical and scientific responsibility. By ensuring that all our clinical results are accessible, we minimise the risk for biased and selective reporting.
A fundamental component of LEO Pharma’s endeavours for increased clinical trial transparency is to guarantee return of clinical trial results to the patients. Our trial participants are informed where and when the trial results will become available as well as that we express our sincere gratitude in writing for their valuable contributions.
Public data registries
The clinical trial results of LEO Pharma are reported according to applicable laws and regulations and international recommendations in:
• various national registries
Reporting is performed after completion or termination of the clinical trial and the results of the trial are reported regardless of outcome.
LEO Pharma’s corporate website
Posting of results on LEO Pharma’s corporate website comprises clinical trials in healthy subjects and patients, and covers Phases 1 – 4. These clinical trial results are posted in two formats:
• Clinical trial reports, excluding appendices
• Clinical trial report synopses (i.e. short report summaries)
Results are posted for trials dating back to 1990* as outlined below.
The synopses are posted within 12 months after trial completion. However, for paediatric clinical trials synopses are publicly disclosed within 6 months. The clinical trial reports from trials investigating approved products in approved indications are posted after the results have been presented in an original research article in a peer-reviewed journal.
LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. Results from exploratory and post-hoc analyses, and clinical trials outside Phase 3, will be published if deemed scientifically or medically important.
Hyperlinks to the peer-reviewed journals publishing results from our clinical trials from 2014* and onwards are made available on LEO Pharma’s corporate website.
Disclosure of clinical documentation in market authorisation applications
LEO Pharma complies with current regulatory requirements to publicly disclose submission documentation being part of authorisation applications.
Access to anonymised data from trials in approved products and discontinued projects
LEO Pharma recognises that new scientific discoveries can be made from existing data sources, including the individual patient-level data from our clinical trials. We support clinical research, and encourage the use of our data to expand the understanding of and ability to treat dermatological and other diseases.
It is thus possible for external researchers to request access to anonymised patient-level data from clinical trials sponsored by LEO Pharma, investigating approved products in approved indications (trials from 2000* and onwards) or projects where the development has been discontinued (trials from 2014* and onwards). Requests can be made when the clinical trial report has been posted on the corporate website.
LEO Pharma also offers access to anonymised trial-level data, to the extent that the data have been prepared for the clinical trial report.
For application forms and instructions on how to request access to data, see the corporate website.
The Patient and Scientific Review Board
The evaluation of the data request and the decision on access to data is made by the external Patient and Scientific Review Board. The Patient and Scientific Review Board comprise three highly experienced scientists while two seats are allocated to representatives of patient associations.
The Patient and Scientific Review Board evaluate whether the research proposal has a valid scientific rationale, is non-commercial, and is in the best interest of patients. The decision by the Patient and Scientific Review Board is made independently of LEO Pharma. For detailed information on the composition and processes of the Board, see its Charter.
FOR MORE INFORMATION
In case of questions, contact email@example.com
*Refers to the year of the clinical trial protocol.