Patient engagement is one of the hottest buzzwords in the clinical research arena. Over the past several years, sponsors, research sites and regulators have all focused more and more intensely on involving patients in clinical trials, not only as participants but as crucial partners in drug and device study development and execution. And that means research sites need to have patient engagement programs in place that will mesh well with both ongoing sponsor efforts and regulatory demands. Read More
Adverse event (AE) reporting is a crucial part of patient safety protection in the clinical research world. The FDA and other regulators require that clinical trial sponsors file reports on AEs, both to regulators and back to research sites. But in recent years, both the FDA and research sites have struggled under a veritable flood of AE reports that principal investigators must review to determine causality. Read More
Newly confirmed and sworn-in FDA Commissioner Robert Califf spelled out some of his priorities in a Feb. 17 memo to the agency’s staff and repeated them in a series of tweets from his brand-new Twitter account — @DrCaliff_FDA. Read More
The UK’s National Institute for Health Research (NIHR) has announced it will allocate £161 million (about $214.5 million) to early-phase trials. Read More
The FDA expects early-phase CAR T-cell therapy trials to focus primarily on the risks of toxicity, according to a new draft guidance that also addresses manufacturing and preclinical considerations in developing CAR T-cell therapies. Read More
Sponsors of gene therapy trials using genome editing (GE) should focus on enrolling patients with severe or debilitating disease, according to a draft FDA guidance that also advises long-term follow-up of trial participants. Read More
The FDA’s Center for Drug Evaluation and Research’s (CDER) guidance agenda for 2022 includes eight draft guidances for clinical trials the center hopes to release before the end of the year. Read More
The European Medicines Agency (EMA) has launched a network of databases containing sources of real-world data (RWD) approved by the EMA for use as evidence in clinical trials. Read More
The chair of the House Energy and Commerce Committee health subcommittee along with two of her House colleagues have introduced bipartisan legislation that would require sponsors to report clinical trial enrollment targets by demographic group, including age, race, ethnicity and sex. Read More
A new consolidated, online clinical trials database that became active Jan. 31 in Europe will allow drug sponsors in the EU to run clinical trials in all 27 member states with a single documentation filing. Read More
Commenters praised the FDA’s recent draft guidance on using electronic health records (EHR) and medical claims data in trials, but they hope the agency will acknowledge issues inherent to real-world data (RWD), offer clarity in certain areas and be flexible as sponsors and sites adjust to the new recommendations. Read More
