Clinical trial agreements (CTA) are a leading cause of delays in study startup. Miscommunication, misunderstanding and mistrust can drag out a contract negotiation far beyond sponsors’ and sites’ original timelines. Read More

Sites, sponsors and IRBs all agree that informed consent forms (ICF) need to be shorter, less technical and more readable for the lay person, but there can be tradeoffs in any kind of change. Explaining medical terms in plain language requires more words, adding to the length of the document. Removing legalese can make ICFs shorter but may leave a sponsor open to liability issues. Read More

Clinical research sites often turn to community-based organizations (CBO) when it’s time to identify and recruit patients from specific populations for clinical trials. And while those local connections are a great source for finding diverse participant pools and for publicizing new studies, CBOs can be a valuable, long-term resource for research sites in other ways, too. Read More

Regulatory agencies and the clinical research industry as a whole have put increasing emphasis on diversity among trial participants. But there’s much less urgency around building diverse research teams, even though evidence shows that doing so can benefit everything from participant recruitment to trial operations to innovation and collaboration. Read More

With clinical trials becoming more complex and generating ever-increasing healthcare data, the risk for protocol deviations, errors and other problems is growing, too. One solution: increased specialization among clinical trial staff and a greater focus on training and education. 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

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

To operate in a state of control and ensure the validity of their trials and the safety of their patients, sites must be keenly aware of and monitor vendors’ participation. Read More