In recognition of its commitment to research and development, BIAL is an affiliate member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and abides by EFPIA guidelines and regulations in all its R&D activities, as well as all the relevant current International Conference on Harmonization (ICH) guidance documents, protection of patient rights and privacy in each country and generally all regulations and procedures regarding research as they evolve.
In alignment with the five guiding principles established by EFPIA and the Pharmaceutical Research and Manufacturers of America (PhRMA) for the responsible sharing of clinical study data (view PDF), BIAL commits to the following:
Enhancing Data Sharing with Researchers
BIAL undertakes to share, upon request, anonymized patient-level, study-level clinical trial data (analyzable data sets), and other information (such as protocols) from clinical trials in patients for medicines and indications approved in the United States (US) and the European Union (EU), to qualified researchers as necessary for conducting legitimate research.
We are currently updating our internal processes for sharing the above-described data with qualified and scientific researchers. Each request will be evaluated by an independent Scientific Review Board and will be based on criteria that balance the need for scientific development with the need to protect patient privacy.
If you are a medical or scientific researcher interested in obtaining access to such data, kindly email us your name, research affiliation, phone number and email address to email@example.com.
Enhancing Public Access to Clinical Study Information
Following approval of a new medicine or new indication for an approved medicine, BIAL will make available the synopses of Clinical Study Reports (CSRs) for clinical studies in patients submitted to regulatory authorities on or after January 1st, 2014. This information will be made available in a redacted form that is consistent with the need to protect patient privacy, publication rights, intellectual property, trade secret and confidential commercial information.
Sharing Results with Patients Who Participate in Clinical Studies
We are working to provide a factual, easy to read, lay-language summary of clinical trial results for those who participated in clinical trials. We will continue to collaborate with academic institutions, industry groups and regulators to establish standards for creating these easy to read summaries to ensure they are useful and informative to patients and healthcare providers.
Please note that the above referred information does not, in any way, replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, Healthcare Professionals should consult the current prescribing information approved in their country. Patients seeking information should consult with their Health Care Professional about the product and the approved written patient information that may be available.
Certifying Procedures for Sharing Clinical Study Information
BIAL undertakes to set up all policies and procedures to implement the data sharing commitments as established with EFPIA/PhRMA.
Reaffirming Commitments to Publish Clinical Study Results
BIAL will continue to register all BIAL-sponsored clinical studies with patients on the public repository https://clinicaltrials.gov/, and all trials conducted in the EU on https://eudract.ema.europa.eu/ and on national registries as required at the country level. Furthermore, BIAL will continue to ensure clinical trial results of all Phase III clinical trials and any trial results of significant importance are submitted for consideration as abstracts during congresses and for publication in peer-reviewed journals, regardless of the results of the study http://www.ncbi.nlm.nih.gov/pubmed.