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• #CLINICAL STUDIES TRIAL#

The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial participants are protected and the results of clinical trials are credible. the use of affected clinical trial results for regulatory purposes.Ĭlinical trials are studies intended to discover or verify the effects of one or more investigational medicines.methodological aspects relating to their trials.Sponsors can also contact either EMA or the national competent authorities for scientific advice on: Questions relating to national guidance should be addressed to the relevant national authority. Sponsors with specific questions relating to EU guidance can contact EMA using the Send a question form. Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trialsĮMA advises sponsors to also check any guidance available at national level.Guidance on clinical trial management during the COVID-19 pandemic.Guidance on clinical trial management during the COVID-19 pandemic is available below. ICH E9 statistical principles for clinical trials.Points to consider on the impact of the war in Ukraine on methodological aspects of ongoing clinical trialsĮMA strongly encourages sponsors to capture data affected and unaffected by the war, and to use the ' estimand framework' described in the ICH E9 (R1) guideline for dealing with events impacting the trial:.Guidance is also available from EMA's Biostatistics Working Party on actions sponsors of affected clinical trials can take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority: Heads of Medicines Agencies - Recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials.Advice to sponsors on managing the impact of the war in Ukraine on clinical trials ()Īdditional recommendations for sponsors are available from the Clinical Trials Coordination Group (an HMA group uniting clinical trials experts):.The European Commission, EMA and the Heads of Medicines Agencies (HMA) issued this initial advice for sponsors on 30 March 2022: They can also apply the approaches and flexibilities agreed in the context of the pandemic. Sponsors can adjust the way they run clinical trials that have been affected by the war in Ukraine using the experience gained during the COVID-19 pandemic. Management of clinical trials impacted by the war in Ukraine Although clinical trials are authorised at national level in the European Union (EU), EMA plays a key role in further developing the EU as a competitive centre for innovative clinical trials, and in maintaining IT systems for the coordination of clinical trials. The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines.