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Clinical Trial Directive

This page shows the latest Clinical Trial Directive news and features for those working in and with pharma, biotech and healthcare.

Resistance is futile?

Resistance is futile?

Debating the inevitability of transparency. The ethics and practicality of data collection and sharing, whether in clinical trials, doctors' performance or a country's defence programme, is a common issue in ... Parliament Committee vote on amending the

Latest news

  • Leaked EFPIA memo reveals transparency strategy Leaked EFPIA memo reveals transparency strategy

    Includes plans to use patient groups to support campaign against greater access to trial data. ... As a company we are absolutely committed to sharing clinical trial data and we don't support this approach,” a GSK spokesperson told PMLiVE, while also

  • EMA commits to disclosure of data from trials EMA commits to disclosure of data from trials

    Seeks feedback on clinical trial data access policy. The European Medicines Agency (EMA) released a draft policy on access to clinical trial data as it tries to strike a balance between ... The shift to greater openness seems inevitable in the wake of

  • Ben Goldacre: No escape from trial transparency Ben Goldacre: No escape from trial transparency

    Speaking exclusively to PMLiVE, he said the recent European Parliament committee vote on amending the Clinical Trial Directive proves the direction of travel “cannot be held back”. ... On May 29 the European Parliament's Committee on Environment and

  • EU Parliament panel backs updated clinical trials regulations EU Parliament panel backs updated clinical trials regulations

    The proposals introduce a series of new measures, including the creation of a public EU-wide database for all clinical trials of new medicines, with a single portal for clinical trial ... that the preliminary draft of the revisions to the Clinical Trials

  • A Mission (mis)statement

    However, we also know that clinical trial populations are usually a homogenous group of participants, due to their strict entry criteria. ... While the EMEA's mission statement does not refer specifically to benefit-risk, we know from the Clinical Trial

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