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A 3D View of Responsible Clinical Data Sharing

Abstract DNA background

Substantial progress has been made towards responsible clinical trials data sharing in the past years.  Last year, Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced new industry principles towards responsible clinical trial data sharing. More information on this is available on EFPIA’s Responsible Transparency Platform: http://transparency.efpia.eu/.

The industry very much recognises the important public health benefits associated with making clinical study information publicly available to healthcare practitioners, patients, and others. Such disclosure, however, is complicated because it must maintain protection for individual patient privacy, intellectual property including commercially confidential information, and contract rights. There are important duties of care with any data that is released to ensure that it is not misinterpreted or misused.

Imagine how devastating it would be for harm to come from some well-meaning, but misleading, interpretation of data that is released. As such, data sharing should not be considered a “free-for-all”. Safeguards are needed to protect patient privacy, maintain trust in the regulatory system, safeguard against misinterpretation, and protect future biomedical research.

A 3D perspective should be taken when reflecting on the topic of clinical trial data sharing, assessing the: 1) Diligent ongoing industry efforts; 2) Developments of external regulatory and legislative; and 3) the need to align Divergent approaches.

Diligent, ongoing industry efforts towards increased data-sharing are exemplified by the EFPIA-PhRMA Principles for Responsible Clinical Trials Data Sharing. These Principles outline steps for:

  • Enhancing data sharing with researchers: a dramatic expansion of data is being made available to researchers, through provision of anonymised patient-level data, study-level data, protocols and Clinical Study Reports (CSRs) to qualified requesting researchers. Each company will establish a scientific review board, consisting of non-employees, to safeguard against public health risks of “junk science” from invalid interpretation or dissemination of data. To protect patient privacy, patient-level data will not be provided if there is any reasonable chance of re-identification.
  • Enhancing public access to clinical study information: following approval in the US and EU, companies will post CSR synopses, as a minimum, and will supplement data required to be posted on the website www.clinicaltrials.gov and the parallel on EC/EMA site.
  • Sharing results with patients who participate in clinical trials: provide factual summaries of clinical trial results to research participants.
  • Certifying procedures for sharing clinical trials information: companies will certify on a public website that they have established policies and procedures to implement data sharing commitments.
  • Reaffirming commitments to publish clinical trial results: all company-sponsored trials should be considered for submission, irrespective of results.

Developments in new regulatory approaches to data-sharing must take on board existing measures in place. It is simply not true to state that the pharmaceutical industry is not sharing its data. The fact is that it is, and in abundance. If sharing of data in the industry was not happening, the industry would not flourish in the ways it has and certain discoveries and innovations would not be brought to the world.

The concept of ‘Open Innovation’ has been around for decades and has allowed the industry to thrive from expanding brainpower and investigation of data. ‘Open Innovation’ provides platforms for idea-sharing and reduces barriers for collaborations between investigators working inside and outside an organisation. Free exchange of ideas between investigators across traditionally impregnable organisational walls contributes to the advancement of science.

Divergent approaches in determining the best way to expand clinical trials data-sharing are to be expected – however, we will see the best success when industry and other data-generators come together to decide on a unified approach. Across the globe, governments, health ministries, and regulatory agencies are exploring this issue. By converging policies, we can streamline resources and align systems, ultimately helping to ensure greater efficiency.

There is already a lot of information in the public arena. Indeed, the debate should now shift from a 3D to a 4D perspective and address how available data can be best used, allowing Determination to make life better for people around the world.

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Written by

VP Global Regulatory Affairs International, Eli Lilly and Company

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