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Using contract research organizations (CROs) can help clinical trial sponsors speed up the drug development process without compromising research quality, according to a new study that finds CROs are playing an increasingly larger role in drug development.
Race, ethnicity and genetics affect how patients respond to certain HIV drugs, according to a study that could lead to the creation of personalized HIV therapies.
Clinical trial sponsors risk losing out on the competitive and regulatory advantages of electronic data capture (EDC) in their clinical trials by failing to address their own corporate cultures, skimping on training and failing to set clear goals before attempting to implement a program, experts told CTA recently.
Gentium has launched a Phase II/III trial with Defibrotide to prevent veno-occlusive disease (VOD), a complication of bone marrow and stem cell transplantation (SCT), in pediatric patients.
Sponsors can better protect patients in clinical trials by building ethical safety nets into the protocols, such as breaking the blind when patients are not getting better, said an industry expert.
Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, has asked the FDA for assistance in his ongoing probe into alleged abuses of clinical trial participants in for-profit testing centers.