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Pipeline Clinical Trials Clinical Trial Data Sharing Extended Access Program


Clinial Trial Data Sharing Policy

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information. Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

Annual Update

2022

Two research proposals were submitted to the company.
  • The first proposal was approved, a Data Sharing Agreement was executed, anonymized individual datasets were prepared and delivered (efficacy data excluded). The research is ongoing at the time of this update and is expected to conclude in 2023.

  • The second proposal is still under consideration.

Last updated on January 10, 2023
Corporate Fact Sheet

Puma Biotechnology, Inc.

10880 Wilshire Blvd., Suite 2150
Los Angeles, CA 90024
424-248-6500 Main
424-248-6501 Fax