Events
104 Stellar-Chance, 422 Curie Blvd Philadelphia, PA 19104 United States
Health Policy Work-in-Progress: Rebecca Dizon-Ross, PhD
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2019-05-23 12:00:00
2019-05-23 13:00:00
America/New_York
Health Policy Work-in-Progress: Rebecca Dizon-Ross, PhD
Assistant Professor of Economics and Charles E. Merrill Faculty Scholar, University of Chicago Booth School of Business
104 Stellar-Chance, 422 Curie Blvd Philadelphia, PA 19104 United States
Penn Medical Ethics
1402 Blockley Hall
Penn Bioethics Seminar | Emily Largent, PhD, JD, RN
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2019-05-28 12:00:00
2019-05-28 13:00:00
America/New_York
Penn Bioethics Seminar | Emily Largent, PhD, JD, RN
Granny Get Your Gun: Firearms and Dementia
Older adults in the United States have broad exposure to guns. Of adults aged 65 or older, 33% report that they own a gun; another 12% say that they do not own a gun but live with someone who does. This means that nearly half of older adults have at least one gun in their household. Given current demographic and gun ownership trends, gun ownership by older adults is only expected to increase. As the U.S. population ages, the number of people with dementia is also expected to increase. According to the Alzheimer’s Association, an estimated 5.5 million Americans aged 65 or older are currently living with Alzheimer’s dementia, and that number is likely to reach nearly 14 million by 2020. Dementia presents a unique challenge for gun safety and a source of concern for families, friends, caregivers, and a range of health professionals who care for of persons with dementia. This talk begins to address these issues.
Bio:
https://ldi.upenn.edu/expert/emily-largent-phd-jd-rn
1402 Blockley Hall
Penn Medical Ethics
Austrian Auditorium, Clinical Research Building, 415 Curie Blvd.
Research Ethics and Policy Series (REPS) | Neal Dickert, MD, PhD, FACC
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2019-06-03 12:00:00
2019-06-03 13:00:00
America/New_York
Research Ethics and Policy Series (REPS) | Neal Dickert, MD, PhD, FACC
Consent for clinical research in emergency settings: Patient-centered or pointless?
Informed consent for clinical research in the context of acute and emergent illness is widely recognized as challenging and is often not possible. There is, however, a wide spectrum of acute and emergent conditions and a similarly wide range of potential for patients and surrogates to engage in decisions about research enrollment. Dr. Dickert will focus on research designed to understand and integrate patients’ and surrogates’ perspectives on consent for clinical trials in the context of acute myocardial infarction and stroke. He will argue that involving patients and surrogates in enrollment decisions in many emergency situations is not pointless despite important limitations that must be recognized.
Commentary by
Benjamin S. Abella, MD, MPhil, FAHA
Professor and Vice Chair for Research
Director, Center for Resuscitation Science
Department of Emergency Medicine
Perelman School of Medicine
To learn more about the speaker, check out Dr. Dickert’s bio: http://www.eccri.emory.edu/faculty/dickert-neal.html
Benjamin S. Abella:
https://www.med.upenn.edu/apps/faculty/index.php/g321/p8128370
Austrian Auditorium, Clinical Research Building, 415 Curie Blvd.
Penn Medical Ethics
1402 Blockley Hall
Penn Bioethics Seminar | Daniel Strech, MD, PhD
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2019-06-04 12:00:00
2019-06-04 13:00:00
America/New_York
Penn Bioethics Seminar | Daniel Strech, MD, PhD
Evidence-based risk-benefit assessment of phase I/II trials
Before funding or approving a phase I/II trial experts review its scientific validity, social value, risk-benefit ratio, and other trial-related aspects. But do reviewers also assess whether the preclinical and clinical evidence presented in the study protocol and investigator brochure provide sufficient support for the planned trial? Experts from industry and academia argued that insufficient (preclinical) evidential support plays a major role for the high failure rates in clinical research [1-3]. Our analyses of investigator brochures for phase I/II trials demonstrate that these documents do not allow a meaningful review of the evidential support [4, 5]. Furthermore, we found that FDA/EMA guidance documents as well as textbooks for drug discovery and development do not provide meaningful guidance on the issue of evidential support [6]. In my presentation, I will introduce and discuss the relevant studies. I will further argue that those responsible for the oversight of translational research should develop and implement requirements for reviewing the evidential support of phase I/II trials.
[1] Begley CG, Ellis LM. Drug development: Raise standards for preclinical cancer research. Nature. 2012;483:531-3.
[2] Prinz F, Schlange T, Asadullah K. Believe it or not: how much can we rely on published data on potential drug targets? Nat Rev Drug Discov. 2011;10:712.
[3] Kimmelman J, Federico C. Consider drug efficacy before first-in-human trials. Nature. 2017;542:25-7.
[4] Wieschowski S, Chin WWL, Federico C, Sievers S, Kimmelman J, Strech D. Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment? PLoS Biol. 2018;16:e2004879.
[5] Yasinski E. Study questions animal efficacy data behind trials. Science. 2018;360:142.
[6] Langhof H, Chin WWL, Wieschowski S, Federico C, Kimmelman J, Strech D. Preclinical efficacy in therapeutic area guidelines from FDA and EMA: A cross-sectional study. Br J Pharmacol. 2018.
Daniel Strech, MD, PhD, is a full professor at Charité – University Hospital Berlin and chairs the research group “Translational Bioethics” at the QUEST-Center, Berlin Institute of Health (BIH). He studied medicine and philosophy and worked for two years as a physician and researcher in the field of psychiatry. Since 2006, he worked in the fields of research ethics and health policy analysis at the Universities of Tuebingen, Zurich, and at Hannover Medical School. His work focuses on practice-oriented challenges in risk-benefit assessment, informed consent, and other areas of evidence-based decision making in research and health care. Further information: https://www.bihealth.org/en/research/quest-center/team/research-group-strech/
1402 Blockley Hall
Penn Medical Ethics