This month’s Research Ethics Roundup looks at why French authorities launched an oversight unit specific to first-in-human research, a massive study on golden retrievers and the implications for clinical research, Bioethics International’s work on improving trial transparency for phase I human subjects, and a new incentive program from the US Department of Agriculture’s Animal and Plant Health Inspection Service (USDA, APHIS) designed to improve communication between government investigators and facilities.
French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials
Michael Mezher reports for Regulatory Focus that France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) will be creating a unit to oversee first-in-human and other early phase clinical drug trials involving healthy subjects. French authorities are establishing the unit in response to a 2016 first-in-human trial that left one subject dead and five others hospitalized in northwestern France. The new unit will be charged with overseeing compliance with French regulatory procedures as well as the European Union ”voluntary harmonized procedures.” The unit will not oversee trials related to medical devices, vaccines, organs, tissues, cells, and gene therapy.
How 3,000 Very Good Golden Retrievers Could Help All Dogs Live Longer
In this Washington Post piece, Karin Brulliard highlights the Golden Retriever Lifetime Study, which is the first lifetime longitudinal study of pets, and has over 3,000 enrollees. Researchers hope that the biological and observational data collected over the lifetime of the study will yield information on cancer and other canine-related diseases as well as links among genetics, health, geography, and lifestyle. This data could also be translated to human subjects research, as sometimes medications for dogs, including cancer treatments, are also administered to humans.
Pharma Ups Its Game On Trial Transparency But There's 'Room For Improvement'
Forbes’ Arlene Weintraub reports on Bioethics International’s Big Pharma Scorecard, which measured clinical trial data reporting for 19 drugs approved by the Food and Drug Administration (FDA) in 2014. As detailed in its recent BMJ Open article, the group found overall median disclosure rates improved from a previous study of 2012 data; however the median reporting rate for trials including Phase I research remained low at 24% in 2014. Co-author Jennifer Miller contends that sharing Phase I trial data is critical, as it could prevent study sponsors from repeating failures, which would allow them to “innovate more quickly.”
Two New USDA Publications Released to Help Enhance Animal Welfare
In this ALN Magazine article, Elizabeth Doughman reports on two new USDA, APHIS, Animal Care Tech Notes for Animal Welfare Act (AWA) licensees and registrants. One Tech Note details a voluntary incentive program in which USDA’s Animal Care will not cite AWA noncompliance outside the inspection process if certain criteria are met. The second Tech Note shares tips on using daily observation of animals as a tool to detect signs of illness and abnormal behavior. Although neither document contains mandatory regulatory changes, USDA, APHIS, AC, hopes they will encourage regulated facilities to be “more proactive” in their communications with government investigators about the animals’ health. Bernadette Juarez, Animal Care Deputy Administrator, said “Better animal welfare begins with open communication and stronger working relationships.”