not approved for marketing) after first patient is enrolled. Results and adverse events must be reported for these studies (if Studies phases 2 through 4 required) within 1 year of completing data Studies with at least 1 U.S. site collection for the pre-specified primary outcome. or conducted under IND/IDE September 2008. Results reporting launched with optional adverse event reporting. Results and adverse event reporting September 2009. Adverse event information is required for studies that meet the became required. above registration requirements if they study drugs, biologics, or devices that are approved, licensed, or cleared by the FDA. ICMJE[3] The following must be registered in July 1, 2005. Studies initiated after this date ClinicalTrials.gov or other approved must be registered before first patient enrolled; registry: studies initiated before this date must be retrospectively registered to be considered for Interventional studies of any publication. intervention type, phase, or geographical location No results reporting requirements EMA[4,5] The following must be registered in May 1, 2004. EMA launched EudraCT ClinicalTrials.gov or other approved https://eudract.ema.europa.eu/ registry: The EU Clinical Trials Register Interventional studies of drugs March 22, 2011. was launched by the European Medicines or biologics (whether or not approved for marketing) Agency (EMA). (https://www.clinicaltrialsregister.eu/) Phase 1 studies (pediatrics only); Studies in phases 2 through 4 Studies taking place in at least 1 European Union site Results reporting required for all studies that meet registration requirements. * Adapted from [1]. For complete descriptions of policy requirements, see the references cited. EMA denotes European Medicines Agency; FDAAA, Food and Drug Administration Amendments Act; ICMJE, International Committee of Medical Journal Editors; IDE, investigational device exemption; IND, investigational new drug application. Based on these requirements, the following are examples of characteristics that may influence the likelihood that a study is included in the ClinicalTrials.gov registry: Interventional studies are more likely to be registered than observational studies. Studies that began before the ICMJE requirement in July 2005 are less likely to be registered, especially if their results are unpublished (e.g., negative studies). Studies with drug, biological, or device interventions are more likely to be registered than studies of other interventions.
not approved for marketing) Studies phases 2 through 4 Studies with at least 1 U.S. site or conducted under IND/IDE Results and adverse event reporting is required for studies that meet the above registration requirements if they study drugs, biologics, or devices that are approved, licensed, or cleared by the FDA. after first patient is enrolled. Results and adverse events must be reported for these studies (if required) within 1 year of completing data collection for the pre-specified primary outcome. September 2008. Results reporting launched with optional adverse event reporting. September 2009. Adverse event information became required. ICMJE[3] The following must be registered in ClinicalTrials.gov or other approved registry: Interventional studies of any intervention type, phase, or geographical location No results reporting requirements July 1, 2005. Studies initiated after this date must be registered before first patient enrolled; studies initiated before this date must be retrospectively registered to be considered for publication. EMA[4,5] The following must be registered in ClinicalTrials.gov or other approved registry: Interventional studies of drugs or biologics (whether or not approved for marketing) Phase 1 studies (pediatrics only); Studies in phases 2 through 4 Studies taking place in at least 1 European Union site Results reporting required for all studies that meet registration requirements. May 1, 2004. EMA launched EudraCT https://eudract.ema.europa.eu/ March 22, 2011. The EU Clinical Trials Register was launched by the European Medicines Agency (EMA). (https://www.clinicaltrialsregister.eu/) * Adapted from [1]. For complete descriptions of policy requirements, see the references cited. EMA denotes European Medicines Agency; FDAAA, Food and Drug Administration Amendments Act; ICMJE, International Committee of Medical Journal Editors; IDE, investigational device exemption; IND, investigational new drug application. Based on these requirements, the following are examples of characteristics that may influence the likelihood that a study is included in the ClinicalTrials.gov registry: Interventional studies are more likely to be registered than observational studies. Studies that began before the ICMJE requirement in July 2005 are less likely to be registered, especially if their results are unpublished (e.g., negative studies). Studies with drug, biological, or device interventions are more likely to be registered than studies of other interventions.
aact201403_statistical_points_to_consider.docx