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    ICH survey shows strong level of guideline implementation

    Most of the 55 guidelines from the International Council on Harmonisation that relate to quality, safety and efficacy, as well as multidisciplinary guidelines, have been adopted among its 10 non-founding members and observers and 30 pharmaceutical companies, according to the results of a new survey.   The survey was designed to monitor the adequacy and level of implementation to ICH guidelines by regulators and industry and complements one released in 2019 on the adopt...
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    FDA Updates on Two ICH Guidelines

    The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of the common technical document (CTD) and changes to ICH's list for permitted daily exposure (PDE) to solvents. For the first update, FDA issued a draft guidance for public comment in line with ICH's revised guideline on the efficacy portion of the CTD, M4E(R2) – Efficacy , w...
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    Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations

    The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology. Such mobile technology can offer new ways to collect objective measurements of clinical trial participants as they go about their daily lives. And though the use of such novel endpoints, whi...
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    FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds

    For drugs approved by the US Food and Drug Administration (FDA) based on limited evidence, a recent study published in the British Medical Journal found “noticeable variability” in the degree to which novel drugs were studied in the postmarket period. The authors, including Yale University professors Harlan Krumholz and Joe Ross, urged FDA to take a cautious approach in increasing its reliance on surrogate markers, smaller and shorter trials, and evidence derived ...
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    European Regulatory Roundup: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The text deals with how to mitigate the risk of false positives arising when clinical trials look at multiple treatment groups and endpoints. EMA’s guideline is applicable to most clini...
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    Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance

    Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. Background On 12 January, FDA issued a 54-page draft guidance to provide sponsors and review staff with the agency’s thinking on the problems posed by multiple endpoints in the analysis and i...
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    Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry on the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials. The 54-page draft guidance looks to provide greater detail than ICH’s E9 Statistical Principles for Clinical Trials and clarify when and how multiplicity due to multiple endpoints should be managed to avoid re...
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    Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns

    The Senate on Wednesday passed the 21st Century Cures Act by a vote of 94-5. President Barack Obama praised the bipartisan efforts and said he will sign the bill. The bill’s path to success, following the House’s positive vote last week, took a unique route, with the House also passing a previous iteration back in July 2015, and then the Senate trying to craft its own package of bills, which stalled and looked to be dead as recently as September. The wide-ranging, nea...
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    When can Non-Inferiority Trials Establish Efficacy? FDA Explains With Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the non-inferiority margin and how to test the non-inferiority hypothesis. The 56-page guidance, which finalizes a draft from 2010 and supersedes the 2010 guidance known as "Antibacterial Drug Products: U...
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    Ulcerative Colitis Drugs: FDA Offers Draft Guidance on Clinical Development

    Pharmaceutical companies looking to understand FDA’s current thinking on efficacy endpoints for clinical trials to develop new ulcerative colitis (UC) treatments will be interested in new draft guidance released Friday. And though the guidance spells out what primary endpoints should be used, the agency also bemoans the fact that there are not well-defined and reliable clinician-reported, patient-reported and observer-reported outcome instruments for clinical trials. Ba...
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    Researchers Propose Framework to Validate Surrogate Endpoints

    A team of researchers and health officials, including European Medicines Agency (EMA) Executive Director Guido Rasi, are proposing a three-step validation process to enhance the use of surrogate endpoints in regulatory and reimbursement decision-making. The issue, they say, is that poorly validated surrogate endpoints can lead to products being approved or reimbursed that have little or no benefit, and in some cases even harm patients. In recent years, drugmakers have i...
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    FDA Revises Draft Guidance on COPD Drug Development

    The US Food and Drug Administration (FDA) on Thursday released a revised version of its draft guidance intended to help pharmaceutical companies develop products to treat the lung disease known as chronic obstructive pulmonary disease (COPD). Specifically, FDA says the guidance is meant to assist sponsors in determining the efficacy of new drugs to treat the disease in Phase III clinical trials, and includes new information on using health-related quality-of-life instrum...