Our Company / Ethics&transparency / Scientific transparency
Clinical Trial Data Sharing
At Alfasigma, we believe that transparency in clinical trials is essential to advance science and medicine.
Alfasigma is committed to Clinical Trial Data Sharing according to the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing.
Access to clinical trial data will be provided in full compliance with all applicable laws and regulatory guidance to safeguard commercially confidential information and patient privacy.
- How to make a data sharing request
All data sharing requests are funneled through Vivli, an Independent Data Sharing Platform: Vivli - Center for Global Clinical Research Data
Available studies are listed and searchable on the Vivli Platform.
Data requestors should use the Vivli Data request form to request company’s data package(s). If approved, requesters will need to sign a Data Use Agreement and the anonymized data will be shared in the Vivli secure research environment.
- Studies listed for sharing
We will provide access to anonymized, patient-level and study-level clinical trial data and other information (such as protocols and clinical study reports) from in-scope Phase 1-4 clinical studies for medicinal products that have received an initial marketing authorization, on approved indications or on indications where the drug development program was terminated.
- When Studies are available for sharing
Studies are considered to be available if all the following conditions are met:
- Study is completed as per protocol.
- Summary results have been published on ClinicalTrials.gov (CT.gov) and/or the European Union Clinical Trials Register (EU-CTR).
- Primary manuscript disclosing study’s primary endpoints, key secondary endpoints, and safety data is published.
After the first European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA) approval – not applicable if development program was terminated.
- Data Request Review Process
Consistently with expectations of good scientific practice, researchers can request access to our studies by providing a research proposal with a commitment to publish their findings. The research proposal is reviewed by an independent review panel. This is a team of external independent experts.
- What information will be provided
The following documents will be provided to the Researcher:
- Study Protocol
- Study data package documentation including information on the dataset structure and data dictionaries
- Statistical Analysis Plan
- Anonymized/redacted Clinical Study Report (CSR)
- Anonymized IPD dataset
Optional:
- Anonymization Guidance
- Analytic code
- Analysis ready IPD data set
- Case report forms
- Questions or enquiries
Questions can be sent to Alfasigma by means of the Vivli Enquiry process.
- Anonymization Standards
Risk-based approach (both qualitative and quantitative) to minimise risk of patient re-identification, derived from the industry best practices from PhUSE, TransCelerate, and Regulatory Guidance from EMA and FDA. The overall aim is for a pragmatic balance, ensuring an acceptably low risk of re-identification whilst retaining data utility.
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Supporting existing assets and developing new indications to address unmet needs is our Research & Development Department focus.