DATA MANAGEMENT TECHNOLOGY &
globally with trial data privacy, expectations of privacy and what the future will bring.
What’s more important: privacy or human benefit from drug trials? This is really at the crux of all clinical trials data protection activities, and the guidance and regulatory responsibilities about them. Let’s engage in the following thought experiment. Alice is going in for an experimental drug
treatment for her perilous oncological condition. Alice’s husband Bob accompanies her. After signing her informed consent documents, Alice subjects to a blood sample and then immediately undergoes experimental therapy:
During the course of the trial, Alice seems to have responded spectacularly well to therapy. The researchers want to unblind her data, and interrogate her blood data and physiological parameters. But the trial is still under way. Is she just a random spontaneous recovery? A response that could have been expected by chance within the trial? A true ‘super-responder’? None of those answers are immediately clear and peeking at the data will compromise the integrity of the scientific method applied to pharmaceutical trials.
Alternatively, let’s say that Alice perishes during the trial. The researchers are rushing to find meaning in anecdotal signals through the trial, where there is a strong compulsion to peek at the data. They have also been developing, in-parallel, a competitor treatment with a different drug delivery and want to use Alice’s prior blood sample to provide data to support their discovery, and development strategies. Because Alice consented to be treated, should they retest her blood for the new experimental therapy?
In the second case above, the answer is quite
clearly no, they cannot retest Alice’s blood for a secondary benefit if they only had consented from her for the first drug. It is Alice’s blood and she owns her data, and from the perspective of a bioethicist it cannot be retested without her permission – which she can no longer provide. In the first case, this is the very reason there is blinding and database protections, and database locking activities – to preserve the integrity of the clinical trial data. Breaching these principles of integrity for one data point is to compromise the universe of data that
exist across all trials. This is why data integrity is such an important topic in the industry – and such an oft- invoked 483 theme for FDA warning letters.
“A person’s health data is their data. No one else should be able to make decisions about them without their knowledge or permission. Nor should they be used or shared without their consent or permission.”
Whose data is it really? Some of this ‘ownership’ of data is what legislation like Healthcare Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation, EU (GDPR) are designed for. A person’s health data is their data. No one else should be able to make decisions about them without their knowledge or permission. Nor should they be used or shared without their consent or permission. But there are certainly global-scale cases, such as Google, which now has the health data of millions of citizens worldwide. It has it because of loopholes in collection practices, which occurred as they were administrating other healthcare data transfer activities in partnership with Ascension through Project Nightingale.
Outsourcing in Clinical Trials Handbook | 63
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