S P E C I A L I S T I N S I G H T
Elliot Zimmerman is the CEO of Real Life Sciences – an American-based software development company , supporting organisations share clinical data and meet global regulatory requirements .
Zimmerman leads the team at Real Life Sciences in advancing Clinical Trial Transparency for Sponsors , CRO ' s and the Disclosure and Transparency community at large . He retains a pharmaceutical and clinical technology background with previous experience as COO at goBalto – before its acquisition by Oracle in 2018 .
Zimmerman also serves on the Steering Committee of CRDSA ( Clinical Research Data Sharing Alliance ) and is passionate about accelerating the clinical trial process and making it easier for pharmaceutical companies to share and disclose trial results .
Here , he speaks to us about clinical trials and how enterprises can balance the transparency and privacy of data . . .
Pharmaceutical manufacturers are in the midst of a strange intersection when it comes to data related to their clinical trials and they need to effectively navigate the crossroads to be successful in the coming years .
On the one hand , companies are being called upon to be more transparent than ever , sharing data containing the results of clinical trials with research organisations , their partners , internal teams and the public at large .
On the other hand , they need to be compliant with a growing number of rules and regulations designed to safeguard the data privacy of patients or ‘ data subjects ’ and other individuals . Further , the sharing of trial results may also implicate what pharmaceutical manufacturers consider commercially sensitive , or Commercially Confidential Information ( CCI ).
The desire to be more transparent was magnified by the development of the COVID-19 vaccines . These initiatives brought more attention to the clinical trial process , as millions of people worldwide followed developments , they knew would have a major impact on the global health crisis .
Pharma companies want to be seen in a positive light , to demonstrate they are at the service of humanity and
– BALANCING about progress via their websites and other channels . And these companies are being evaluated on how open they are with information . For example , an organisation called Bioethics International offers a ‘ Good Pharma Scorecard ’. It ranks pharmaceutical companies ’ performance in areas including transparency and data sharing .
These companies also need to share lots of data with partners , such as universities and other research organisations involved in efforts such as the COVID-19 vaccine development effort . One of the reasons the vaccines were developed so quickly was because pharma companies had the ability to leverage existing research within the community . The idea of data sharing gained a lot of traction .
While we ’ re seeing a push for more transparency and data sharing with clinical trials , the emphasis on data privacy that began several years ago continues to gain momentum .
Regulators worldwide are implementing laws to protect the privacy of individuals ’ data . This is especially true for personally identifiable data that an adversary , or hacker , could potentially use for financial gain . Efforts to safeguard data about individuals is not new . The Health Insurance Portability and Accountability Act ( HIPAA ) has been in place for years .
More recently , laws such as the General Data Protection Regulation ( GDPR ), California Consumer Privacy Act ( CCPA ), Health Canada ( HC ) PRCI , Regulation EU No 536 and others have broadened data privacy rules .
Further , Health Authority regulations such as Health Canada ’ s Public Release of Clinical Information ( PRCI ) and European Medicines Agency Clinical Trials Regulation ( CTR ) mandate that pharmaceutical organisations publicly release information about their clinical trial results .
Specifically with regard to pharma and clinical trials , efforts such as sharing data about the location , personal identifiers such as sex , age and weight and resulting clinical outcomes for people who are taking a particular medication can potentially run afoul of privacy laws .
For instance , when a pharma company or researcher shares the results of a trial , it ’ s possible that an individual taking part in the trial could be re-identified because all the data is out in the public domain . Data re-identification is the practice of matching anonymous data with publicly available information in order to discover the individual to which the data belongs .
ACY are working to get treatments out as quickly and safely as possible , as well as eager to keep the public informed
An adversary , such as a criminal hacker could leverage publicly available data and documents to figure out that a particular individual was involved in the trial and based that can uncover various personal information
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