News, Resources, and Events Tagged "Clinical Research"
Why do differences in clinical trial design make it hard to compare COVID-19 vaccines?
Complete author list: Lisa Larrimore Ouellette, W. Nicholson Price II (Former Academic Fellow), and Rachel Sachs (Former Academic Fellow), Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center…
An ethics framework for consolidating and prioritizing COVID-19 clinical trials
Full Author List: Michelle Meyer (Former Academic Fellow), Luke Gelinas, Barbara Bierer, Sara Chandros Hull, Steven Joffe, David Magnus, Seema Mohapatra, Richard Sharp, Kayte Spector-Bagdady, Jeremy Sugarman, Benjamin Wilfond, and…
The Lost Decade: Clinical Trials Data Access After Seife v HHS
Realization of the full value of data from clinical trials requires that the data be accessible to the broader research community, not just to the investigators who conducted and the…
Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research
The U.S. Food and Drug Administration (FDA) recently granted an emergency use authorization (EUA) for convalescent plasma to treat patients with coronavirus disease 2019 (COVID-19) (1). Recognizing substantial evidentiary gaps, several…
Right to Try: A ‘well-intentioned’ but ‘misguided’ law
[...] “On its face, it seems as though Right to Try would streamline the process and make it easier for patients, but actually, the FDA approves almost all the requests…
The ‘Nudgability’ Model for More Ethical Clinical Research
The concept of “nudging,” has been thoroughly discussed and debated in the context of health care, and particularly in the public health domain. The use of nudging in…
Lawmakers seek to loosen US FDA drug approval requirements to allow early access
From the article: Making products available under a conditional approval may result in some companies having difficulty enrolling patients in well-controlled phase 3 trials, Holly Fernandez Lynch, assistant professor of medical…
Biomarkers in Cancer Drug Approvals: New Opportunities and Challenges: A Health Policy and Bioethics Consortium
The FDA recently approved Keytruda and Vitrakvi, two cancer drugs targeting biomarkers without reference to the site of the disease. Defining cancer in terms of biomarkers alone may require us…
Apple’s Reach Reshapes Medical Research: The company’s tools enable researchers to track huge numbers of people. But doctors do not yet know if it will significantly improve health outcomes.
[...] The new ingredients allowing the huge scale: Apple’s iPhones, apps and money. Harvard’s new study is just one of three new large research efforts that Apple…
Amid rising concern, pay-to-play clinical trials are drawing federal scrutiny
From the article: “The examples that we have, that get this kind of media attention, it’s obvious that people shouldn’t be asked to pay to…
Organ donor intervention trials and risk to bystanders: An ethical analysis
From the abstract: There are two distinct problems about bystander effects raised by organ donor intervention research. The first is the problem of “bystander organs”—sometimes called …
Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations
From the abstract: Clinical trials for investigational new products to treat rare and ultra-rare diseases typically involve a limited number of research sites recruiting from a small pool of patients…
Scientific Merit Predicates Ethical Review of Clinical Research
From the article: In the United States, federal regulations codified by the Department of Health and Human Services in the “Common Rule”1 address the conduct and oversight of…
Transparency in Health and Health Care in the United States
Read the full introduction online now! This edited volume stems from the Petrie-Flom Center’s 2017 annual conference, which brought together leading experts to reach better understandings of this health…
Simulation and Deliberation to Prepare for Clinical Trials in Infectious Disease Emergencies: Digital Health @ Harvard Series
Description Infectious disease emergencies are opportunities to test the efficacy of newly developed interventions (e.g. drugs, vaccines and treatment regimens), yet they raise many intertwined challenges of politics, logistics,…
Viewpoint: Promoting Patient Interests in Implementing the Federal Right to Try Act
Former Executive Director and Academic Fellow Alumna Holly Fernandez Lynch has co-authored an opinion piece on the federal Right to Try Act of 2017. From the article: On May 30, 2018, President Trump…
When clinical trials compete: prioritising study recruitment
From the abstract: It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is…
Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight
Description Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun…
Precision Medicines Approved More Quickly, With Less Data
From the article: Pivotal trials for precision medicines were scarcer, less likely to be controlled or blinded, and had fewer participants than those for other agents, the study found. The…
Criticism of ‘right to try’ law for experimental drugs after it passes in US
From the article: The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law…
Little Benefit to Breakthrough Cancer Drugs
From the article: In 2012, the FDA created the breakthrough therapy designation to speed up the development and review of drugs intended to treat serious or life-threatening diseases when preliminary clinical…
Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines
From the article: Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient populations. The potential for more immediate signals of efficacy during…
Addressing Financial Barriers to Enrollment in Clinical Trials
From the article: Shortfalls in clinical trial recruitment and retention constitute a major obstacle to scientific advancement. One means of increasing patient participation rates is to reduce associated financial burdens.…
On Scarcity and the Value of Clinical Trials
From the artice: Allocation of scarce goods and resources is a common concern in the health care context, from intensive care unit (ICU) beds, to extracorporeal membrane oxygenation (ECMO) machines,…
House passes right-to-try on second try
From the Article: The House of Representatives passed on party lines Wednesday evening a bill designed to let very sick patients request access to experimental medicines without government oversight. The…
Payments to Study Participants: Experts Discuss Potential Framework
Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School today…
A Framework for Ethical Payment to Research Participants
Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School today…
The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium
Couldn't join us for the event? Check out the panelists' slide presentations below! Description In the past several years, the United States has struggled to respond to viral outbreaks,…
KL2/Catalyst Medical Research Investigator Training (CMeRIT), Harvard Catalyst
General Description: KL2/Catalyst Medical Research Investigator Training (CMeRIT) Request for Applications (RFA) The KL2/Catalyst Medical Research Investigator Training (CMeRIT) award provides two years of salary support at 50-75…
It’s time to levy penalties for failing to report clinical trial results
From the article: I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA)…
Sixth Annual Health Law Year in P/Review
Couldn't join us? Check out the conversation on Twitter: @PetrieFlom #healthlawpreview2018 and some of our speakers' slide presentations below! Description The Sixth Annual Health Law Year in P/Review…
Book Launch: Specimen Science: Ethics and Policy Implications
In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne…
Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial
From the article: As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks. The lead U.S. researcher,…
Research with Biospecimens: Balancing Individual Interests and Social Goods
This panel at the annual meeting of the American Society for Bioethics and Humanities examined issues addressed at Petrie-Flom's 2015 conference "Specimen Science: Ethics and Policy Implications," and the edited…
Who’s Actually Using ‘Right-To-Try’ Laws?: A Texas Oncologist Explains his Experience
'The record with state-level right-to-try laws also suggests lackluster interest from industry. "It's telling that although 37 states have adopted these laws, when asked to provide examples of success stories,…
Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives
On June 21, 2017, Executive Director Holly Fernandez Lynch participated in a panel discussion on "Weighing the Risks of Randomized Controlled Trials and Alternatives," which was part of the conference "The Need…
Quality Improvement/Assurance Manager, University of North Carolina at Chapel Hill
General Description: The University of North Carolina at Chapel Hill is recruiting to fill the position of Quality Improvement/Assurance Manager. The Office of Human Research Ethics (OHRE) is responsible…
IRB Local Context Coordinator, The Emmes Corporation
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development,…
Clinical Trialist, Dartmouth-Hitchcock - Norris Cotton Cancer Center
The Norris Cotton Cancer Center and the Geisel School of Medicine at Dartmouth are seeking exceptional physician clinical investigators with research interests in early phase clinical research. The successful applicant…
Private Investment vs. Public Funding in Therapeutic Development: A Health Policy and Bioethics Consortium
Panelists Bhaven Sampat, PhD, Professor of Health Policy and Management, Columbia University Mailman School of Public Health Terry McGuire, MS, MBA, Founding Partner, Polaris Partners Learn more about the Health…
2017 Petrie-Flom Center Annual Conference: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits
Couldn't attend in person? You can still check out the conversation on Twitter: @PetrieFlom #transparencyinhealth! And check out many of the speakers' slide presentations below! Description Transparency is a…
Four-year Post Doctoral Research Position, Institute of Ethics (Dublin City University)
General Description The Institute of Ethics at Dublin City University is seeking a postdoctoral researcher for a 4-year fixed-term contract to work on the EnTIRE project and do research…
Assistant Professor of Bioethics and Medical Humanities, Center for Bioethics and Medical Humanities in the Institute for Health and Equity at the Medical College of Wisconsin
The Center for Bioethics and Medical Humanities in the Institute for Health and Equity at the Medical College of Wisconsin invites applications for a full-time faculty member at the rank…
Ethicist, Trillium Health Partners
Job Description: Position: Ethicist Status: Full Time Dept/Health System: Ethics Site: Trillium Health Partners Hours of Work/Shifts: Primarily Monday…
Project Manager - SMART IRB, The Harvard Clinical and Translational Science Center, Harvard Medical School
Job Description: Harvard Catalyst | The Harvard Clinical and Translational Science Center facilitates clinical and translational research throughout the 27 Harvard Schools and Academic Healthcare Centers by educating and training investigators, providing…
Summer Internship, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), located in Harvard Square, has an opening for a Harvard Law graduate student for…
Fifth Annual Health Law Year in P/Review
Couldn't make it to the event? Check out some of the speakers' slides as well as the Health Affairs blog symposium! Description The Fifth Annual Health Law Year in…
Clinical Ethics Faculty (open rank), The Center for Medical Ethics and Health Policy, Baylor College of Medicine
Clinical Ethics Faculty Due to tremendous growth, the Center for Medical Ethics & Health Policy at Baylor College of Medicine is seeking an experienced candidate to join their faculty …
Clinical Trial Data Sharing and Reproducibility: A Health Policy and Bioethics Consortium
In January, the International Committee of Medical Journal Editors proposed requiring that investigators make de-identified trial data available six months after publication as a precondition of consideration. Many data scientists…
The Animal Welfare Act at 50
Overview The Animal Law & Policy Program at Harvard Law School hosted The Animal Welfare Act at Fifty, a conference that brought experts together to assess the first fifty years…
Review of Human Subjects Research Regulation: Perspectives on the Future: edited by I. Glenn Cohen (Faculty Director) and Holly Fernandez Lynch (Executive Director)
From the review: Overall, the editors present an intriguing look at the concerns currently facing human subjects research regulation and provide a number of suggestions for how to go about…
EVENT POSTPONED: HLS Library Book Talk: Charles Fried on Medical Experimentation: Personal Integrity and Social Policy - New Edition
Wednesday, November 9, 2016 at noon Harvard Law School Room WCC 2036 Milstein East B/C 1585 Massachusetts Ave., Cambridge Lunch will be provided. More About Medical Experimentation: Personal Integrity and Social Policy: New…
Cluster Randomized Trials: Ethics, Regulations, Statistics & Design: Harvard Catalyst Regulatory Symposium
Description Please join Harvard Catalyst for a free half-day symposium on the topic of Cluster Randomized Trials: Ethics, Regulations, Statistics & Design. We will provide a general overview of Cluster…
Petrie-Flom seeks RA for project on human subjects research, Petrie-Flom Center, Harvard Law School
The Petrie-Flom Center for Health Law and Policy, Biotechnology, and Bioethics seeks a part-time research assistant for a project with Harvard Catalyst (Harvard Clinical and Translational Science Center)…
Health Law Workshop: Patricia J. Zettler
Presentation Download the Presentation: Pharmaceutical Federalism About the Presenter Patricia J. Zettler is associate professor of law at Georgia State University College of Law. She has expertise in the regulation…
The Ethical Involvement of Patients in FDA Regulatory Evaluation of New Products: A Health Policy and Bioethics Consortium
Description There is a growing push to incorporate patient voices more directly at the FDA in decisionmaking about investigational drugs, but what are the optimal parameters of patients' contributions? How…
Promoting Healthcare Innovation on the Demand Side
Abstract: Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products…
Therapeutic Misconception in ALS
Event Description Some subjects who participate in trials of novel therapies mistakenly believe that the trial is designed to maximize benefit to the individual subjects -- thus laboring under the…
A Conversation with Margaret A. Hamburg, FDA Commissioner 2009-2015
Description The Petrie-Flom Center hosted a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel…
Symposium on “Ethical Risk Assessment in Biomedical Big Data”
Please register via the event website. Description In biomedical research, the analysis of large datasets (Big Data) has become a major driver of innovation and success. ‘Biomedical Big Data…
Health Law Workshop: Seema Shah
Presentation Download the presentation: "Uncertainty and the Eighth Amendment" About the Presenter Seema Shah is a faculty member in the National Institutes of Health Clinical Center Department of Bioethics and…
Reflections in Honor of the Life and Influence of Professor Alan Wertheimer
Description This conference was an afternoon of reflection on the life, work, and enduring influence of Professor Alan Wertheimer (1942-2015). Professor Wertheimer was a leading philosopher of law and bioethics,…
Non-Human Primates in Research: Legal and Ethical Considerations
Description This discussion explored critical legal, ethical, scientific, and social issues raised by research involving non-human primates and the research centers that house them. Topics included what the current regulatory…
Petrie-Flom Welcomes New Harvard Catalyst Fellow in Clinical Research Ethics
We are pleased to announce our newest addition, Luke Gelinas, who will be serving as the first Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics. Luke earned his PhD…
ReSourcing Big Data: A Symposium and Collaboration Opportunity
March 23: Symposium 9:00am-5:00pm Joseph B. Martin Conference Center Harvard Medical School Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus…
Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions,: A Conference
On January 19 - 21, 2015, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard…
A Conversation with the HHS Office of the Inspector General
A conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections. The OIG has…
Introduction to Translational Medicine
Course themes: Preclinical Discovery Clinical and Experimental Pharmacology Conflicts of Interest Leadership and Team Dynamics in Research Ethics of Human Research Academic/Industrial Relationships in Drug Development Eligibility: MD, DMD,…
Post-Trial Responsibilities: Ethics and Implementation
Conference Description Who: Clinical research sponsors, investigators, funders, regulators, trial participants, and other stakeholders Introduction / Background: The term “post-trial access” is used broadly to connote a wide range…
Clinical Trials and the Right to Remain Silent
I. Glenn Cohen has coauthored a new Invited Commentary piece in JAMA on access to clinical trial data. From the article: In this issue of JAMA Internal Medicine, Kernan et…
Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings
Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem…
Public Workshop: Strategies for Responsible Sharing of Clinical Trial Data
Petrie-Flom Center Faculty Director I. Glenn Cohen will participate in a session on "Operational Principles for the Governance for Sharing Clinical Trial Data" on Monday, May 5, at 1:30pm. From the…
Michelle N. Meyer Named to Board of Directors of PersonalGenomes.org
Academic Fellow alumna Michelle Meyer, J.D., Ph.D., currently Assistant Professor and Director of Bioethics Policy in the Union Graduate College-Icahn School of Medicine at Mt. Siniar Bioethics Program,…
The First Issue of Journal of Law and Biosciences Is Now Available!
We are pleased to announce that the first issue of Journal of Law and the Biosciences (JLB) is now available online. The articles are: Knoppers, Bartha M., Edward S. Dove, …