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Participatory PartneringEmily Kramer-Golinkoff, who was  trained as a bioethicist from the University of Pennsylvania, is “the engine behind a multi-level approach to changing the game for the advancement of treatments for patients with certain protein production mutations of Cystic Fibrosis (CF) called nonsense mutations – all while living with the condition 24/7,” according to an article by Joe Kim in Lilly Trial Guide. Kramer-Golinkoff provides funding for many phases of scientific research, advocates for patients with Cystic Fibrosis, participates in clinical research, influences th...

Complete PictureThe three primary U.S. government sources of data about clinical research investigators -- National Library of Medicine: ClinicalTrials.gov, FDA: Bioresearch Monitoring Information System (BMIS)and CMS: Open Payments (Sunshine Act) -- provide incomplete and inconsistent data not linked to data in the other databases. While the FDA is aware of the problems, researchers have used the databases to understand investigator demographics and activities. Two researchers, Ronald Ranauro and Romiya Barry, have conducted a study to determine the “extent it is possible to combine data fr...

Data-Driven ProgressThe U.S. Food and Drug Administration (FDA) has established a new objective for itself: “to become the international leader in medical device safety through better use of big data,” according to an article by Conor Hale in FiercePharma. The agency has made a commitment to quick device safety responses “using real-world data and active surveillance,” Hale explained.The FDA has promised to put first among the world’s regulatory agencies in “identifying and reacting to” device safety concerns by making the transition to an active surveillance system supported by ...

Far Out!Depending on who is administering it and how it is being used, psilocybin, the active compound in hallucinogenic mushrooms, could be reclassified from a drug with no known medical benefit to a drug with the properties of prescription sleeping pills. In a review to assess the safety and abuse of medically administered psilocybin, researchers at Johns Hopkins University made a case for doing just that, possibly opening up possibilities for the psychedelic drug to be used to treat depression and anxiety and help people stop smoking.According to a New York Times article by Laura M. Holson,...

Blockchain BonanzaCaron Dhillon, a health care analyst at Results Healthcare, believes that the use of blockchain technology could solve many of the challenges of the clinical trials process, according to an article in Outsourcing Pharma by Melissa Fassbender. As Fassbender said, the technology enables “real-time visibility into the entire clinical trial supply chain.” When data is entered into a blockchain, it “cannot be deleted and all changes are tracked.” Because of this accountability, there is value throughout the supply chain -- drug safety, patient safety, and clinical trials m...

Litmus Health, a real-world data firm, has created a census of wearable devices for clinical research. The firm is profiling the body and wrist-worn hardware devices from more than 190 brands and manufacturers, according to an article by Conor Hale in FiercePharma.The company recommends its 15 top devices based on a rubric that scores the transparency of data collection, battery life and aesthetic appeal for study participants. It also looks at factors such as how well it helps investigators to meet federal regulations for maintaining electronic records and audit trails. Litmus is planning to ...

Brain BiopharmaUS pharma giant Pfizer and private equity firm Bain Capital have joined forces to create  Cerevel Therapeutics, a new privately held biopharmaceutical company. The new company aims to develop drugs to treat central nervous system (CNS) disorders. In addition to securing $350 million from funds affiliated with Bain Capital Private Equity and Bain Capital Life Sciences, there will be further capital available if needed in the future.New York-based Pfizer, which will hold a 25 percent stake in Cerevel Therapeutics, is providing a portfolio of pre-commercial neuroscience assets, in...

A recent study led by University of Pennsylvania nursing professor Linda Aiken has found that hospitals have improved somewhat from the findings of a landmark report from the Institute of Medicine 20 years ago that determined that thousands of patients die in hospitals each year from preventable medical errors. Still, according to a new issue of Health Affairs devoted to that topic, various studies show that hospitals have more work to do.Aiken and her team surveyed 535 hospitals in Pennsylvania, New Jersey, California and Florida. She found that 29.6 percent of nurses rated patient safety at ...

In July a consumer rights group, Public Citizen, with 64 doctors, bioethicists and academics, called on the US Food and Drug Administration (FDA) to investigate the Hennepin County Medical Center in Minnesota because of concerns involving informed consent. What resulted was the suspension of a clinical trial, Ketamine Versus Midazolam for Prehospital Agitation.According to www.clinicaltrials.gov, “This research study is being done to figure out the best approach to treatment of pre-hospital agitation. It will compare two tiered dosing treatment protocols, one ketamine-based and one midazolam...