Who Owns Patient Data in Clinical Research?

A Q&A with Charlotte J. Haug, MD, PhD, MSc, International Correspondent, New England Journal of Medicine; Senior Scientist, SINTEF Techology and Society; Adjunct Affiliate, Stanford Health Policy; Oslo, Norway; charlottejohanne@gmail.com

Originally published October 25, 2017

Q: Many people are coming to believe that active patient participation will be a key to more rapid movement forward in cancer research. Data sharing can help. But who owns the data? And what rights and responsibilities are thus conferred? Your recent NEJM article provides helpful background. Can you help us better understand?

A: Exchange of data between patients and doctors is essential for the practice of medicine – and patient data are essential for medical research and progress.

Traditionally, doctors collected patients’ health information (typically the medical history, laboratory tests, drugs prescribed, outcome of treatment, etc.) and sometimes shared that information, in confidence, with colleagues to seek advice and advance science. The medical record was the physician’s property, and still is in many countries and legislations. But do physicians own the patient data? Continue reading…


Sharing Clinical Trial Data: Benefits and Concerns

Policymakers and regulatory agencies are increasingly pushing for more public access to clinical trial information. Requiring clinical trial sponsors to be more transparent about their findings would provide greater accountability and discourage unethical trial practices, suppression or selective reporting of results, or misleading analyses. Data sharing would also prevent unnecessary duplication of studies. However, disclosing clinical trial data also risks compromising the privacy of trial participants. Moreover, making a sponsor’s trial data freely available could give unfair advantages to competitors, who could potentially use the data without incurring the cost of producing it. This may discourage companies from performing trials altogether. Clinical trial data sharing therefore needs to incorporate reasonable safeguards for participant privacy and companies’ intellectual property.


Sharing Clinical Trial Data: Benefits and Concerns

Policymakers and regulatory agencies are increasingly pushing for more public access to clinical trial information. Requiring clinical trial sponsors to be more transparent about their findings would provide greater accountability and discourage unethical trial practices, suppression or selective reporting of results, or misleading analyses. Data sharing would also prevent unnecessary duplication of studies. However, disclosing clinical trial data also risks compromising the privacy of trial participants. Moreover, making a sponsor’s trial data freely available could give unfair advantages to competitors, who could potentially use the data without incurring the cost of producing it. This may discourage companies from performing trials altogether. Clinical trial data sharing therefore needs to incorporate reasonable safeguards for participant privacy and companies’ intellectual property.


Sharing Clinical Trial Data: Benefits and Concerns

Policymakers and regulatory agencies are increasingly pushing for more public access to clinical trial information. Requiring clinical trial sponsors to be more transparent about their findings would provide greater accountability and discourage unethical trial practices, suppression or selective reporting of results, or misleading analyses. Data sharing would also prevent unnecessary duplication of studies. However, disclosing clinical trial data also risks compromising the privacy of trial participants. Moreover, making a sponsor’s trial data freely available could give unfair advantages to competitors, who could potentially use the data without incurring the cost of producing it. This may discourage companies from performing trials altogether. Clinical trial data sharing therefore needs to incorporate reasonable safeguards for participant privacy and companies’ intellectual property.