Clinical trial registration is the practice of documenting clinical trials before they are performed, in order to combat publication bias and selective reporting. Clinical trial registration is required in some countries, and ClinicalTrials.gov (U.S.) remains the largest and most widely used online registry for clinical trials. (Wikipedia)
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)
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)
Indian association seeks greater investment in clinical research ecosystem
The Indian Society for Clinical Research (ISCR) is seeking greater investment in research and urging stakeholders to strengthen the clinical research ecosystem in the country to address India’s growing disease burden. India has the second highest population and highest disease burden in the world, but only 1.2% of clinical trials are done in India. (The Times of India)
Only 10% of those harmed in clinical trials in India receive compensation
Since 2005, nearly 17,000 clinical drug trials were conducted in India. It is estimated that nearly 5,000 people lost their lives in clinical trials in India, and hundreds developed serious side effects, but only 10% of those affected received compensation. (Pharmafile)
Australia plans to implement GCP inspection program
Clinical trials in Australia are initiated based on approval of a Human Research Ethics Committee, not Australia’s Therapeutic Goods Administration (TGA), and TGA also lacks a routine inspection program to check whether clinical trials are complying with good clinical practice (GCP). TGA is now planning a GCP inspection pilot program as a stepping stone to a permanent, routine GCP inspection program. (Regulatory Focus)
China overhauling its clinical trial and drug processes
Clinical trial sponsors have long found a disconnect between the country’s potential and reality as a research location. Recently, however, Chinese authorities have been overhauling its clinical trial and drug processes, which now make it possible to get drugs approved in China using data generated overseas, and improved the process for sponsors that run trials in the country. (PMLIVE)
The EMA’s 5 goals: Fostering innovative trial design, exploiting AI, and other recommendations
The EMA recently outlined five strategic goals with a focus on fostering clinical trial innovation, optimizing capabilities in modeling and simulation, as well as exploiting AI and investing in special populations, among other objectives. (Outsourcing-pharma.com)
Trial in China of high-tech headband raises privacy concerns
The Massachusetts-based startup BrainCo has partnered with a Chinese school for a trial of its high-tech headband to monitor the brains of schoolchildren in class to make sure they are concentrating. The Focus 1 headband uses electroencephalograph (EEG) sensors to detect brain activity when the wearer is engaged in a task. The devices were worn by 10,000 schoolchildren aged 10-17 during a recent 21-day trial in China. (DailyMail.com)
Sloppy followup of Chinese gene-editing experiments worries Crispr-Cas9 inventors
Chinese scientists have been forging ahead in experimenting with gene-editing on humans in the last few years, using a powerful tool called Crispr-Cas9 to edit the DNA of dozens of cancer patients. However, no federal body is overseeing these trials in China, and at least one such trial has lost touch with patients whose DNA was altered. Long-term followup of these patients is essential because unintended consequences of gene therapy could surface years later. (The Wall Street Journal)