Gottlieb encourages drug sponsors to provide expanded access

FDA Commissioner Scott Gottlieb and his top aides are encouraging drug sponsors to continue providing a study drug that may have provided a benefit to especially needy clinical trial patients, after the study ends and before the new treatment is officially approved. (CenterWatch)

Cost of pivotal clinical trials varies around the globe

Little is known about how trial site costs vary around the world. In this sample, most patients (60%) and sites (57%) enrolled were outside of North America. In Africa, Central Europe, Middle East, and Latin America, the cost per site was about 50% of the cost per site in North America. (PubMed)

Recently Published Book: Clinical trials and the African person

This book explores ethical issues with clinical trials. When clinical trials, much of which are conceived in the Global North, involve other cultures, particularly Africa- in the Global South, where many of the trials are often offshored to, there is a need to apply some additional considerations, because the significance of the person in the African setting differs from the Western perspective. (blog of the APA)

Participants in failed Alzheimer’s trials react

Biogen and Eisai recently stopped two phase 3 trials of the Alzheimer’s treatment aducanumab after 36 months due to lack of efficacy. The 3,200 people in the trials and their families reacted with a sense of hopelessness and resign, particularly as there is no other treatment or clinical trial option for them. (STAT)

Protocol amendments may be unnecessary

According to an expert, the rise in the number of protocol amendments occurring before the first patient has even received the first dose reflects a failure in planning trial design. Amending a protocol often involves making the study more complex, which impacts study costs and participant satisfaction. (CenterWatch)

Use of surrogate end points shortens cancer trials

The use of surrogate end points (progression-free survival) (PFS) in oncology trials reduced the time needed to conduct clinical trials by 11 months compared to the study duration required to assess the overall survival (OS) benefit of a cancer drug. (MedicalResearch.com)

Bias in referral to Phase 1 cancer studies

This case-control registry study in Denmark found that novel anticancer therapies seemed to be tested on a socially selected group of patients with cancer. Patients with long distance to the Phase 1 unit, less education, and belonging to the lowest income quintile were less likely to be referred to Phase 1 trials. (PubMed)

Eating churros and chocolate in Madrid!