Professor Sally Hollis, PHASTAR’s Head of Statistical Consultancy, was a panellist on an EFSPI/PSI webinar on Data Sharing recently (recording available here: https://youtu.be/V8lsPLck5xI). This is an area which has been rapidly evolving over the last decade. The EMA first outlined steps towards proactive disclosure of data in an article published in 2012 (http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001202).
Following a process of consultation, the EMA published a policy on publication of clinical data in October 2014, the first phase of which came into force in January 2015. This provides access (via the EMA website) to documents relating to submissions, including the individual study reports with redaction of personal data, supporting documents such as the protocol and amendments, CRF and analysis plan, and the clinical overview and summary. In a second phase, the EMA are consulting with stakeholders to find the most appropriate way to make Individual Patient Data (IPD) available, in compliance with privacy and data protection laws.
The pharmaceutical industry has proactively put in place commitments for responsible sharing of clinical trial data. From January 2014, EFPIA and PhRMA members are sharing individual patient data and supporting documents for medicines approved in both the EU and US, under approved research proposals reviewed by an independent panel (http://transparency.efpia.eu/uploads/Modules/Documents/data-sharing-prin-final.pdf).
In the questions section of the webinar, someone asked whether there are financial penalties for not meeting the regulatory requirements for registering trials. Sally responded that the FDA can impose fines (up to $10,000 a day), but that an even more important aspect for companies to consider is the reputational impact of any perceived lack of transparency. Although improvements in transparency have been seen over time, gaps still remain. For example, a review by Miller et al (http://bmjopen.bmj.com/content/5/11/e009758.full) found that nearly two-thirds of clinical trials supporting new drugs approved by the FDA in 2012 were publicly disclosed, which they viewed as perhaps encouraging, but below both legal and ethics standards. They found wide variation with several large companies’ drugs superseding legal requirements, but others having low rates of transparency.
An important theme of the webinar was understanding the potential benefits of access to shared data. There are now many sources of Clinical Study Reports available publicly or on request which can provide valuable information and insights for drug development planning and trial design.
PHASTAR can provide support across many elements of data sharing, such as assessment of completeness of reporting, anonymization of data for sharing, advice on sources of shared data, and membership of independent review panels. Let us know if you would like to discuss any aspect of this area.