Clinical trials are all about the data, but when that data includes participants’ protected health information (PHI), researchers, study coordinators and other staff must ensure that they are compliant with a growing myriad of patient privacy laws and regulations.
A clinical trial is far from done once the last trial participant completes the last visit and the database is locked; there’s still a long list of tasks and procedures to work through, from accounting for leftover investigational product to wrapping up final reports. Failing to conduct all of those closeout activities can put a site out of compliance with FDA regulations, IRB requirements, the contract with the sponsor or even their own established policies and procedures.
Acknowledging the ever-evolving technological and clinical research landscape, the FDA has published a new draft question-and-answer guidance on using electronic systems, records and signatures in clinical trials, providing greater direction on validation, digital health technologies (DHT) and the applicability of regulatory requirements.
The European Medicines Agency (EMA) has published a comprehensive final guidance that offers general principles for specific computerized systems, processes and data in the areas of validation, user management, security and electronic data as well as computerized systems implemented at the site level.
The FDA has published draft guidance on developing neovascular age-related macular degeneration drugs, offering recommendations on trial eligibility criteria, efficacy endpoints and trial design considerations.
The European Medicines Agency (EMA) has issued a new question-and-answer document that clarifies requirements of the Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR).
The European Medicines Agency has created an addendum to its current guidelines on trials of venous thromboembolism (VTE) treatments that is intended to help sponsors expand studies to pediatric populations.
The FDA says trial sponsors and investigators may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance.
A new FDA draft guidance for sponsors developing drugs to treat early Lyme disease focuses on trial designs for treatment of erythema migrans, a rash that often appears as one of the first symptoms in the disease’s early stages.
The FDA has finalized guidance on trials of human drugs containing cannabis and cannabis-derived compounds, offering updated direction on federally authorized sources for cannabis and providing references to relevant quality considerations.
Oncology drug trials should consider a wide range of dosages and how they impact a wide variety of participants, rather than immediately titrating patients up to the maximum tolerated dose (MTD), the FDA said in a new draft guidance.
