Pfizer statement on PhRMA-EFPIA principles for responsible clinical trial data sharing

PfizerThe Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have published new commitments for responsible data sharing practices by biopharmaceutical companies. The new commitments are designed to expand access to clinical trial data and advance science. They propose ways of sharing data that will protect patient privacy, respect the regulatory process, and preserve incentives to undertake novel medical research for the benefit of patients. We believe the solutions offered by PhRMA and EFPIA provide a responsible alternative to other approaches currently being discussed in Europe.

Pfizer has been an active partner and supporter in the development of these industry commitments, which we fully support and will adhere to in our policies and practices. We have been and continue to be aligned with the actions outlined in the commitments as part of our ongoing efforts to optimize the use of our clinical data to further medical research and improve the quality of health care. Many of our practices already meet or exceed the standards established by PhRMA and EFPIA.

Pfizer participates in numerous data sharing initiatives, publishes all clinical trial results within 18 months of study completion, and provides existing clinical data in response to legitimate requests from researchers and regulators.

We also have been a leader in making results available and accessible to clinical trial participants and will continue to expand our sharing of information in meaningful ways to inform and empower patients.

We are currently reviewing our policies to ensure they fully reflect the new commitments. An update to our public disclosure policy will be issued later this year. We welcome this opportunity to reaffirm Pfizer's dedication to ensuring that the data collected in the trials we conduct are appropriately used in the service of public health.

About Pfizer Inc.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

Most Popular Now

Pfizer and BioNTech complete submission to Europea…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted biva...

AstraZeneca to acquire TeneoTwo and its clinical-s…

AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluatio...

Bayer to sell men's health product Nebido™ to Grün…

Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer's men's health product Nebido™ (testosterone undecanoate), for a purchase price ...

Demonstration of a potent, universal coronavirus m…

The SARS-CoV-2 that causes COVID-19 has killed 6.3 million people worldwide since 2019, painfully highlighting the vulnerability of humanity to novel coronaviruses. Re...

Pfizer and BioNTech advance COVID-19 vaccine strat…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to...

New needle-free nasal vaccine shows promise for CO…

New research shows that a needle-free mucosal bacteriophage (phage) T4-based COVID-19 vaccine is effective against SARS-CoV-2 infection. The findings were published in mB...

SARS-CoV-2 hijacks nanotubes between neurons to in…

COVID-19 often leads to neurological symptoms, such as a loss of taste or smell, or cognitive impairments (including memory loss and concentration difficulties), both dur...

Anti-inflammatory compound shows potential in trea…

An anti-inflammatory compound may have the potential to treat systemic inflammation and brain injury in patients with severe COVID-19 and significantly reduce their chanc...

Vaccine-induced immune response to omicron wanes s…

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substan...

Scientists develop new biomimetic formulation for …

Glioblastoma multiforme (GBM) is an aggressive brain cancer with a poor prognosis and few treatment options. New and effective approaches for GBM treatment are therefore ...

Disparities in United States COVID-19 vaccine dist…

When reports showed COVID-19 vaccination rates were lower among racial/ethnic minority groups, most discussions focused on mistrust and misinformation among these populat...

GSK signs agreement to support pandemic preparedne…

GSK plc (LSE/NYSE: GSK) announced it had signed a framework contract with the European Commission's (EC) Health Emergency Preparedness and Response Authority (HERA) for t...