FDA and EMA clinical research guidelines: Assessment of trial design recommendations for pivotal psychiatric drug trials (Protocol)

This is a protocol for the project entitled "FDA and EMA clinical research guidelines: Assessment of trial design recommendations for pivotal psychiatric drug trials". ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement None. ### Author Declarations All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes We will make available our full dataset on the Open Science Framework upon publication of the final report in a peer-reviewed medical journal. There may be restrictions on what we can share of documents obtained through the Freedom of Information Act requests.