Endpoint adjudication — a standardized process for ensuring that assessments of the safety and efficacy of the investigational product are consistent, objective and unbiased — add new stakeholders, procedures and unique considerations to a traditional trial as well as increased attention from regulators and sponsors.
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Any successful clinical trial begins with a solid research plan that lays out the research project, its importance and how it will be conducted. It can include everything from big-picture objectives and methodologies to details about equipment and personnel requirements, but if the plan is incomplete, unclear or inaccurate it can result in delays, budget overruns, protocol deviations or errors that render data useless.
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The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database.
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The European Medicines Agency (EMA) is seeking industry’s thoughts on a new draft guidance on general considerations and challenges for single-arm trials that serve as the key source of efficacy data.
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Following up on 2013 guidance, the FDA has issued a new question-and-answer guidance with additional recommendations for trial monitoring approaches, monitoring plan content and follow-up/communication of issues caught through risk-based monitoring.
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The FDA has published the fourth and final guidance in its patient-focused drug development series, offering stakeholders recommendations for incorporating clinical outcome assessments (COA) into trial endpoints.
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The FDA has issued draft guidance outlining the process for FDA/Office for Human Research Protections (OHRP) reviews of pediatric trials that are ineligible for IRB review and approval.
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Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance.
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations, including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information.
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