It’s back to school and back to work! Get into the swing of things by catching up on the latest news in the research ethics world (which never goes on vacation)!
Aveo Reeling after FDA’s Rejection of Kidney Cancer Drug: Aveo Pharmaceuticals spent seven years and $300 million developing tivozanib, a kidney cancer drug, which was recently rejected by the Food and Drug Administration (FDA). The panel cited concerns about the trial design, the data, and the interpretation of the data. Critics of the ruling claim that the FDA unfairly changed the criteria that Aveo needed to meet in order to gain approval. The FDA’s decision prompted Aveo to let go of more than 60 percent of its staff, and shareholders have filed lawsuits claiming the company issued misleading statements about the drug. The Securities and Exchange Commission is now investigating.
Questions in India Cancer Study Still Lingering: A National Cancer Institute (NCI)-funded study of cervical cancer screening in India continues to generate controversy as questions about the trial design remain. Researchers conducted simple, inexpensive vinegar tests to screen for cervical cancer on half the enrollees, and the remaining subjects were placed into an unscreened control group. In 2012, the Office for Human Research Protections (OHRP) found that the informed consent documents used were inadequate because they did not explain to enrollees in the control group the alternatives for receiving cervical cancer screening; this problem has since been corrected. Many believe that it was unnecessary for researchers to have an unscreened control group; however, investigators, as well as NCI, have defended that decision, arguing that “since the standard of care for cervical-cancer screening in India is no screening, [researchers] were ethically justified in having a no-screening control.”
Scientists to Sequence Genomes of Hundreds of Newborns: The Genomic Sequencing and Newborn Screening Disorders multi-site research program, funded by the National Institute of Child Health and Human Development and the US National Human Genome Research Institute, will sequence the genomes of 480 infants, half from healthy babies, and half from babies in neonatal intensive care units. The aim of the study is to see whether full genome sequencing is better than conventional newborn screening for detecting genetic disorders that affect drug metabolism, immune function, and hearing. Different sites will report different information to the parents of enrolled subjects; some will follow the American College of Medical Genetics and Genomics recommendation to report results of mutations in 57 genes, which are linked to various health conditions, even if they are not linked to subjects’ diagnoses. Other teams are planning to give parents information on genetic defects relevant to babies’ diagnoses and other mutations which might be “medically actionable.”
Bias Detection: Study Identifies Instruments for Evaluating Animal Studies: University of California, San Francisco researchers have identified 30 assessment instruments to evaluate the risk of bias in animal research, including randomization, concealment of allocation, blinding, and accounting for all animals. The study team searched 3,371 articles from the past 45 years of MEDLINE in compiling their data. Commentators have called the study an important step in reducing the risk of bias.