Ray of Light: Access to clinical trial data

Arete-Zoe – October 26, 2016

The European Medicines Agency (EMA) has taken the initiative to develop a policy on publication of clinical data. The rationale for such step is article 80 of Regulation (EC) No 726/2004:

The clinical data publication website was developed to implement EMA Policy 0070, and is maintained by the EMA communications department.

The policy covers clinical data, both clinical reports and individual patient data, submitted under the centralized marketing authorization procedure after 01-Jan-2015, and extension of indication / line extension applications submitted after 01-Jul-2015, or as part of a procedure under Article 58 of Regulation (EC) No 726/2004, or data submitted by a third party in the context of a Market Authorization Application (MAA) or post-authorization procedure, or as additional clinical data for scientific assessment.

There are two categories of access to the published clinical data:

  • The general information purposes terms of use are for general information and other non-commercial purposes.

  • The academic and other non-commercial research purposes terms of use are for academic and other non-commercial research purposes. This type of access allows more rights but requires some additional procedural steps.

The terms of use by definition exclude all commercial research as well as investors and sponsors who could use the data to analyze available evidence and to assess performance and value of new therapies under development and compare them to the current standard of care. Since many insurers and payers are commercial entities as well this resource is not available to them either. Many hospitals and research centers are public-private partnerships, would they count as non-commercial entities? The terms of use also exclude consultants who could use the resource to analyze and benchmark their clients’ data.

Clinical reports include the following types of documents:

  • Clinical overview: a critical analysis of the clinical data submitted in the dossier, that presents the risks and limitations of the study, the study results, analysis of benefits and risks of the medicinal product, and description how the study results support the prescribing information;

  • Clinical summary: a detailed factual summary of the clinical information, including information provided in clinical study reports from any meta-analyses or other cross study analyses, as well as post-marketing data for products that have been marketed outside of the EU;

  • Clinical study report: a detailed scientific document about the methods and results of a clinical trial addressing safety and efficacy. Protocol and protocol amendments describe the objectives, design, methodology, statistical considerations and organization of a clinical trial. Sample case report form is a questionnaire used by the trial sponsor to collect data from each participating site. Finally, documentation of statistical methods provides a description of the planned methods for collection, analysis, interpretation, presentation, and organization of the data.

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