The two-year transition to the new EU Clinical Trials Regulation (EU-CTR), set to begin Jan. 31, 2023, may be off to a rocky start, according to several experts that attribute much of the concern to the function of the Clinical Trials Information System (CTIS) at the heart of the new regulatory scheme.
Standard operating procedures (SOP) are not just necessary for keeping a trial on track, they are mandatory for the FDA and the first documents requested during an inspection. They must be clear, comprehensive and — most important — followed to the letter if a site is to survive close scrutiny.
In trials using decentralized elements, sponsors and investigators have ultimate responsibility for ensuring the integrity of the data generated, says a draft EU guideline, placing additional oversight duties on their plates.
The FDA says a single, well-controlled trial may be used to support a drug candidate for treatment of pulmonary tuberculosis (TB) if additional confirmatory evidence is available, in a revised draft guidance.
The FDA has issued two proposed rules on investigational new drug applications (IND) that would require more detailed IND reports and exemptions for clinical trials for drug uses of a food, dietary supplement or cosmetic product.
In an effort to improve the efficiency of late-stage and post-approval trials, the FDA has endorsed the International Council for Harmonization’s (ICH) E19 guidelines, which offer considerations for selectively collecting safety data, in recent final guidance.