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NEJM Retracts Five Studies, Revises A Sixth, After Trial Sampling Errors Discovered

June 18, 2018

The New England Journal of Medicine has retracted five separate papers and reissued a sixth with corrections, nearly a year after an anesthesiologist raised public questions about whether the volunteers in each of the studies had truly been randomly assigned to different treatments. British anesthesiologist, JB Carlisle, built a computer model that helped him analyze sampling in clinical trials. After examining nearly 5,100 trials, he claimed that two percent of them had used nonrandom sampling when researchers claimed the opposite. Carlisle flagged studies in eight journals, 11 of them having been published in the New England Journal. On June 13, the Journal announced that it was retracting five of those studies. A sixth — a 2013 study on the benefits of the Mediterranean diet — was retracted but republished after researchers “reanalyzed” their data.

Children’s Hospitals Team Up For Immunotherapy Clinical Trials
Leaders at four children’s hospitals are teaming up to create an immunotherapy clinical trials pipeline. Doctors and researchers from Seattle Children’s, Children’s National in Washington, DC, BC Children’s Hospital in Vancouver and Children’s Hospital Los Angeles hope their CureWorks collaborative will lead to more widespread production of immunotherapy treatments, but also make it easier for parents to enroll their stricken kids into trials. Member hospitals will be able to participate in clinical trials organized by CureWorks. Participating hospitals will then collect immune cells from patients and send them off to Seattle Children’s so that researchers there can reprogram to express CAR proteins, the groups said. The reengineered cells will then be sent back to the “home” hospital for infusion. “CAR T-cell therapy has been called the single greatest therapeutic advance in childhood leukemia in a generation,” Alan Wayne, M.D., director of the Children’s Center for Cancer and Blood Diseases and Children’s Hospital Los Angeles said in a statement. “We expect to speed the development of this important new therapy to provide more effective treatment for children and young adults afflicted with many types of cancer in the U.S. and around the globe.

Focus On Quality of Life In Cancer Studies, Dutch Researchers Urges Fellows
Cancer patients and researchers alike would be well served by focusing on quality-of-life data in future efforts, a Dutch scientist is arguing. Even “the most basic level of quality-of-life assessments can aid in the monitoring of the effect of standard therapies on the daily lives of patients, often with an eye toward improving the ways in which treatments are delivered,” Neil K. Aaronson writes in a recent paper published in the latest edition of Monographs European School of Oncology. “When carried out on a sufficiently large scale, descriptive quality-of-life studies can help to establish norms regarding both the short-term and long-term psychosocial adjustment of patients,” Aaronson argues. “In turn, such norms can be used in screening programs aimed at identifying high-risk groups or individuals who might benefit most from targeted psychosocial interventions. Conversely, the results of clinical trial based quality-of-life investigations can sometimes challenge widely held beliefs. For example, it has often been argued that breast-conserving therapy, while holding certain psychosocial advantages over mastectomy, nevertheless increases a woman’s fear of recurrence. Yet, empirical investigations have not generally lent support to this contention.”

Gates Foundation Launches $100 Million Nonprofit Biotech to Develop New Drugs
The Bill and Melinda Gates Foundation have formally opened a new, nonprofit biotech company that organizers hope will help develop medicines and vaccines for malaria, tuberculosis and diarrhea. The Bill & Melinda Gates Medical Research Institute in Boston has been underway for nearly a year and has cost $100 million to develop. It will be led by Penny Heaton, a former vaccine developer at Novartis. Some advocates have argued for years that nonprofit clinical trials may be more efficient than for-profit ventures because the pressure for return on investment is eliminated, allowing researchers to focus merely on what works rather than on what is profitable. Some 2.6 million people die every year from TB, malaria or diarrhea. “These studies need to be done,” Heaton told Forbes, “but this is a very inexpensive vaccine, and there’s not a big market — there would be no incentive for a private partner to take on a study of this nature.”