New Common Rule – FAQ Changes to the Common Rule, the principal rule regulating human subjects research, go into effect on July 19, 2018. A number of Pearl IRB policies and procedures will be updated as a result of the changes to the rule. Please note that only...
The shift within the pharmaceutical industry from a risk-averse approach to overseeing clinical trials to a risk-based approach is “earthshaking”, a 2017 Avoca Group survey published on Outsourcing-Pharma.com states. A November 2016 guidance from the International...
There are over 2,000 immunotherapy drugs currently in development. However, a meagre 5% of cancer patients partake in clinical trials, according to a PBS News Hour report. Consequently, America’s second leading cause of death, cancer, continues to claim more lives...
Clinical trial exclusion criteria have increased nearly 60% over the past three decades, according to a recently published study. The steadily increasing exclusion criteria may decrease the likelihood of successful trial completion and generalization of results...
Note: Pearl IRB updated this blog on August 9, 2021, and we will continue to update this in the future as necessary. Formal review procedures for human subject studies were established in reaction to unethical research practices in the 20th century. The Code of...
The National Institutes of Health (NIH) is awarding $18.9 million towards research aiming to accelerate the use of genome sequencing in clinical care. The new awards will verify that the genomic medicine can be applied to all individuals and groups including diverse...
