IRBs react to new model for registering proposed gene trials
On April 27, the National institutes of Health (NIH) enacted a new administrative model for the review of proposed human gene trials; the new guidelines upend a process that has been in place for more than 40 years. Predictably, reaction throughout the industry is mixed. Larger firms are adjusting quickly to the change and retooling their processes to comply with the new model. At the other end of the spectrum, some IRBs, including IntegReview, declined to comment on the changes, stating that the matter is still under internal review.
Clinical research in India: Despite setbacks, opportunity continues
India has 16% of the world’s population and accounts for 20% of the world’s disease burden, yet less than 1.4% of global clinical trials are conducted there. A series of blemishes in clinical research has shaken worldwide confidence—but experts say positive steps have been taken to bring hope for the future. The latest setback came in April from the World Health Organization (WHO), which sent a notice of concern to the Indian CRO Semler Research, alleging data manipulation in a number of bioanalytical studies uncovered during site visits in December and January. WHO said its findings question the validity of studies performed for 12 products and that companies including Mylan, Lupin, Micro Labs and others may need to repeat trials conducted by the CRO.
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