PRIM&R’s Response to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations July 30, 2019

In June, the FDA issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs." The issuance of this guidance satisfies a mandate of the FDA Reauthorization Act of 2017 (FDARA), and builds on other recent efforts by the FDA to broaden eligibility criteria for clinical trials and avoid unnecessary exclusions. PRIM&R submitted comments on the guidance this week, and we wanted to share them with you and encourage you to consider submitting your own comments on this important topic—the FDA is accepting comments until August 6. Read more

10
Jun2019

Worry and Hope: A Reflection on Public Perception of Animal Research

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10 Jun

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During the 2019 IACUC Conference, I attended a discussion on engaging the public in conversations about the use of animals in research. In reflecting on this session, I felt both worry and hope. My gut tells me that when regulatory agencies ask for input on items of importance to research, an overwhelming number of responses are from detractors of animal research in support of their personal agenda, while those of us in the research world remain silent, maybe finding comfort in the thought that “someone else will reply”. We have to start speaking openly and honestly about what we do.We have to be strong advocates and build bridges for communicating with the public so that a new generation continues to carry the torch in support of responsible animal research into the future. Read more

4
Jun2019

The Research Animals We Love

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4 Jun

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Those in the field of laboratory animal medicine come to this job with love for animals, but a special kind of love—one that understands that we will be separated, but agrees to love anyway. We give these research animals the best we can give; so they play and are healthy and can serve science and society. Because we understand that a rescued pet is a healthy old dog today thanks to the vaccines and heartworm medication developed using lab animals. We understand that my mother-in-law is healthy today thanks to the surgery, chemo, and radiation developed using lab animals. And we dream that someday, hopefully sooner than later, cancer and diabetes and heart disease will all be diseases of the past, thanks to lab animals. Read more

31
May2019

Rounding up the Belmont Report Retrospectives

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31 May

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Last month brought the 40th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways that a 40-year-old document may be ill-equipped to process the ethical issues brought about by technological, cultural, and political changes. Here, we’ve gathered a range of resources that look back on 40 years of the Belmont Report. Read more

28
May2019

We All Can Relate and Find A Common Ground

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28 May

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Among the speakers at IACUC19, one in particular, Leland S. Shapiro, PhD, touched me in a unique way. A brain tumor survivor and fellow martial artist (I have a brown belt in Tae Kwon Do), Dr. Shapiro related his story in an unusually funny and endearing fashion. He shared his full experience, from his initial symptoms, to his struggle to find a doctor. His frustration and moments of almost giving up, his perseverance and fight—his ultimate triumph. As he explained, he is a living legacy of animal-based research. And I think this is something we can all relate to and find similar stories of in our own circles: family members, friends, neighbors saved by medical interventions made possible by animal research. Read more

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