Mar 13, 2015

One step more to combat publication bias

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and The Pharmaceutical Research and Manufacturers of America (PhRMA) have recently bolstered their pledge to improve public health by embracing “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers,” whose objective is for additional information to be accessible to all people who may be concerned.

These groups are ultimately looking for the blessing of patients by maintaining patient privacy and the veracity of regulatory systems as well encouraging investigation in biomedical research.

As said before, these commitments (not quite right word here) will be focusing on enlarging the total amount of information available in accordance with these aspects:

  • Patient-level and study-level clinical trial data, as well as full clinical study reports and protocols from those clinical trials. (Medicines accepted in the United States and European Union will have to be shared with qualified scientific and medical researchers, protecting patient privacy and confidential commercial information.) In addition, scientists with such clinical trial data will be encouraged to publish their results. 
  • Companies will publish an accurate summary of clinical trial results for patients who participate in them with the help of regulators. 
  • Clinical Trials abstracts proposed to the Food and Drug Administration [FDA], European Medicines Agency [EMA], or national authorities of EU member states will be published once a new medicine or an indication has been approved. 
  • Biopharmaceutical companies will also state their purpose and clinical trial results, even if the conclusion is not successful, for public disposal. 
These commitments show that clinical trial data results are essential for patients, healthcare and the economy. The Principles are available at and These principles were instituted on January 1, 2014.

Written by Dr. David Alcantara and Paula Ruíz for The All Results Journals.

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