One of the key skills of a clinical trial leader is the ability to develop — and stick to — a budget. That means taking into account the cost of executing study protocols, understanding personnel requirements and other trial costs, and identifying potential cost increases and opportunities for cost reduction. Read More

Quality metrics and their role as part of an overall quality management system (QMS) are an important component of clinical research, but not all sites use quality performance tracking tools to their maximum advantage: tracking quality performance and identifying areas for improvement. Academic and institutional researchers haven’t fully embraced the concept of taking methodical steps to examine operations across individual studies. Read More

An FDA draft guidance released June 9 provides sponsors of anticancer therapies with a list of five core areas that patient-reported outcomes (PRO) measures should focus on to demonstrate a therapy’s effect on survival, tumor response or disease progression. Read More

The International Council on Harmonization (ICH) said the third revision of its good clinical practice guideline will likely be delayed into 2022 as the group wades through 1,300 comments from the public about the revision. Read More

The FDA has updated its guidance on Form 1572, the FDA’s Statement of Investigator, to clarify what sponsors can or should do if a foreign investigator is unable or unwilling to sign the form. Read More

The FDA issued draft guidance June 24 for trial investigators and sponsors, recommending that patients with incurable cancers be considered for oncology trials regardless of whether they have received existing alternative treatment options. Read More

The Biden administration unveiled its first unified agenda of proposed regulatory actions in June, publishing a set of goals that include rules to synchronize FDA regulations with requirements of the Common Rule. Read More

The FDA published a new draft guidance June 25 aimed at helping sponsors comply with expedited safety reporting requirements for drugs and biologics. Read More