include protected patient health information that could be used to identify individuals.
Another risk of data sharing is that reanalysis of data may produce phantom risk and health scares. Neither regulators nor industry like to be blindsided by reports that a drug or vaccine has an unreported side effect, but Eichler predicted that many licensed drugs could come under attack based on such reanalyses. As an example, he cited a meta-analysis of a drug called tiotropium bromide that found a slightly increased risk (relative risk of 1.6) of adverse cardiovascular events in chronic obstructive pulmonary disease patients using the drug (Singh et al., 2008). In this case, however, the company responsible for the drug had a study under way looking at long-term clinical endpoints that ultimately found no increased risk (Michele et al., 2010). This is a risk of meta-analyses and the use of observational data. How many beneficial drugs will be lost through mistaken analyses, and how will people be persuaded to participate in postmarketing trials of drugs if they perceive a possibility of drug-related harm, Eichler asked.
Despite the risks of data sharing, there are clearly considerable benefits to patients and the research community. Open science could support the development of predictive models for patient selection to appropriate treatments or doses based on patient characteristics. A second advantage is that different therapies could be compared to determine relative efficacies without the expense of direct comparison trials. “This will be a boon for comparative effectiveness research,” said Eichler.
EMA is still in the process of determining how best to make data available, and it is engaging many stakeholder groups in this discussion. However, Eichler said that data will not be released until the agency has made a regulatory decision on the product based on its assessment of the data. Also, EMA intends to ask for the preregistration of protocols for data reanalysis to avoid data dredging that is unlikely to produce meaningful results. EMA wants to know in advance whether studies on requested data will be exploratory or confirmatory in nature.
Shortly after the workshop summarized in this volume, EMA conducted its own workshop to bring together stakeholders to provide input to the development of its policies. Issues addressed included standards for storing and sharing of data, the level of data to be released, standards for protection of personal data, quality standards for meta-analyses, and rules of engagement among stakeholders (EMA, 2012).
The implication of the EMA policy change for the Food and Drug Administration’s (FDA’s) policy of nondisclosure was raised during the