Clinical trials in all therapeutic areas are increasing in complexity, but oncology trials are outstripping the rest of the field due to enrollment challenges, protocol deviations and a burgeoning amount of data that are adding months to their timelines. Read More
Delays to study startup caused by the pandemic have eased with institutional sites now saying they’ve been able to reduce time needed for the process from six months on average to two or three months. Read More
The FDA said last week that it plans to gradually resume on-site clinical trial inspections beginning in July with the intent to be back to normal operations by September. Read More
Informed consent forms used for COVID-19 vaccine clinical trials were unnecessarily long, difficult to read and required recipients to have at least a ninth-grade reading level — compared to a norm of sixth-grade — to fully comprehend, according to a new study. Read More
Sponsors of drug trials should publish clinical trial reports without redacting confidential information, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) said in a statement last week. Read More
Sponsors say direct-to-patient (DTP) distribution of clinical supplies, including investigational drugs, is an important service to offer and nearly two-thirds say it’s essential to successful execution of a clinical trial, according to a new survey, especially as trials become more virtual. Read More
