Tag: comparative effectiveness research

Bioethics Blogs

PCORI Announces Funding Opportunities for Human Subjects Protections Research

The Patient-Centered Outcomes Research Institute (PCORI) supports research that provides high-integrity, evidence-based information to patients, clinicians, and the broader healthcare community. PCORI funds clinical comparative effectiveness research (CER) that engages patients and other stakeholders throughout the research process. The research we fund aspires to answer real-world questions about what works best for patients, based on their circumstances and concerns.

The post PCORI Announces Funding Opportunities for Human Subjects Protections Research appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Re-Evaluating the Patient-Centered Outcomes Research Institute

Despite extraordinary improvements in medicine and technology over the years, the U.S. health care system often has surprisingly little access to comparative effectiveness research, or CER, which evaluates the effectiveness of medical interventions relative to each other

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Testing Canada’s New Pharmaceutical Transparency Law

Matthew Herder and Trudo Lemmens explore the ways that Canada’s transparency legislation may limit researchers’ abilities to scrutinize drug safety and effectiveness.

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Canadian news sources, including the CBC and the Toronto Star, recently reported on Dr. Navindra Persaud’s success in securing unpublished data from Health Canada about the safety and effectiveness of Diclectin (a widely used treatment for nausea during pregnancy). Health Canada handed him thousands of pages of data from several clinical trials, including individual patient-level data, in order for him to pursue his research. Yet it only did so after Dr. Persaud signed a confidentiality agreement.

The terms of that agreement provide an important test for Canada’s newly enacted transparency law. They may limit researchers’ ability to meaningfully provide much needed scientific scrutiny of drug safety and effectiveness.

In late 2014 Canada passed “Vanessa’s Law”, creating several new powers including the ability to recall drugs from the market and to enforce post-market pharmacovigilance study requirements.

Following pressure from AllTrials and others, Vanessa’s Law was amended during the legislative process to include a requirement that drug companies make certain “prescribed information” (which has yet to be defined) publicly available.

Tom Fruin’s Stained Glass House down by the Brooklyn Bridge. Photo by Joe Shlabotnik.

The Minister of Health was also given the discretion to disclose “confidential business information” to prevent drug related injuries or for the purposes of protecting or promoting human health or public safety.

This new discretionary power in Vanessa’s Law was used to share the Diclectin data with Dr.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

PATIENT-CENTERED RESEARCH CAN IMPROVE CHRONIC PAIN CARE AND ADDRESS OPIOID ABUSE

Going for the Brass Ring

Last year, Joe Selby, MD, executive director of the Patient-Centered Outcomes Research Institute (PCORI), spoke to members of the NIH Interagency Pain Research Coordinating Committee (PCORI) to inform those of us on the committee about PCORI’s intentions to do more funding focused on chronic pain research. Dr. Selby said their interests were possibly in low back pain, migraine, musculoskeletal pain, and/or opioid abuse. I was elated. Then about a month ago (May 14, 2015), Dr. Selby posted a blog on the PCORI website titled, “Patient-Centered Research Can Improve Chronic Pain Care and Address Opioid Abuse.” 

I hope with all my heart that he is right; research or policy that can do both of these things is like grabbing the brass ring while on a merry-go-round. It is certainly a worthy goal but, to many, seems all but impossible. If anybody can do this, however, PCORI may have the best chance. Established by the Patient Protection/Affordable Care Act in 2010, PCORI’s mission is to “examine the relative health outcomes, clinical effectiveness, and appropriateness of different medical treatments” – particularly complex problems that threaten the health and well-being of all Americans. Chronic pain certainly meets that criterion.

In Dr. Selby’s blog, he said, “Since 2012, PCORI has built a sizeable portfolio of studies on chronic pain, two of which specifically address opioid treatment.” He went on to list some of the questions these studies have focused on:

  • How can we improve patients’ ability to communicate confidently with doctors about pain and pain medication?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Why It’s Not Time For Health Care Rationing

In the last few years, the U.S. health care system has seemingly been gripped by “back to the nineties” fever. Back then, we had a Democratic president working to reform the health care system. Experts from across this system were promoting the importance of controlling health care costs; the growth of health care expenditures even slowed considerably around that time. Now we have a Democratic president who not only tried to reform the health care system but also managed to pass a complex health care law. As in the nineties, experts have been promoting the importance of controlling health care costs, and health care expenditures have even slowed over the past four years.

But for those working at the intersection of health care policy and ethics, there is a notable change in professional debates about how to better control health care costs. Discussion of health care rationing, which was hotly debated in the nineties, has become much more muted. The decline of rationing debates may reflect shifting emphases in health care policy. In the nineties, managed care companies (which the Clintons hoped to promote in their reform efforts) were capitating medical care, paying health care providers lump sums to care for panels of patients, thereby giving them a financial incentive to withhold medical care in order to hold on to some of that money. Such a strong incentive to withhold care inevitably sparked rationing fears.1 By contrast, the Affordable Care Act promotes accountable care organizations,2 which for the most part function on an old-fashioned fee-for-service basis, with modest incentives to contain costs while demonstrating high-quality care.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

QI Focus Groups: Ditch Generalizability Criterion

Focus groups of professionals engaged in quality improvement (QI) or comparative effectiveness research (CER) report that the Common Rule’s “generalizable knowledge” standard does not provide clear guidance.

[Whicher, Danielle, Nancy Kass, Yashar Saghai, Ruth Faden, Sean Tunis, and Peter Pronovost. “The Views of Quality Improvement Professionals and Comparative Effectiveness Researchers on Ethics, IRBs, and Oversight.” Journal of Empirical Research on Human Research Ethics, Published online before print, February 23, 2015, doi:10.1177/1556264615571558.]

The focus groups

generally concluded that intent to produce generalizable knowledge or the related intent to publish were not useful criteria for distinguishing what activities should be subject to IRB oversight. Although some participants stated their local IRBs relied on these criteria, most participants felt they were conceptually confusing and ethically inappropriate. Some stated it may be hard to know, early in an activity, whether the results will be worth publishing. Others mentioned it is conceptually hard to distinguish local learning from learning generalizable to other situations as generalizability is a matter of degree. Scholars similarly have argued that it is difficult to ascertain intent and that generalizability is not a binary concept, but falls along a spectrum. Indeed, some suggest eliminating the intent to produce generalizable knowledge criterion from determinations about oversight.

Instead, many participants suggested that considering the risk of harm to participants in a QI or CER activity makes more sense when determining what should be subject to ethical oversight, a view consistent with recommendations in the literature. (Citations omitted.)

The article misstates the language of the Common Rule, which defines research not by whether it is intended to produce generalizable knowledge, but rather by whether it is “designed to develop or contribute to generalizable knowledge.”

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

PRIM&R’s Response to OHRP’s Draft Guidance on Research Evaluating Standards of Care

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors.

In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the federal regulations for the protection of human subjects apply to research evaluating alternative interventions that all meet the standard of care for preventing, diagnosing, or treating a particular condition.

In an earlier post, we provided an overview of the draft guidance, titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care,” and today, we are pleased to make available PRIM&R’s response to the draft. PRIM&R appreciates the OHRP’s efforts to foster public discussion and provide the research community with guidance on how to ensure adequate protections for human subjects in research evaluating one or more interventions that are within the standard of care. PRIM&R believes, however, that the current document does not provide the comprehensive assistance needed by investigators and IRBs, and, in our comments, urges the OHRP to rewrite the document to provide clearer guidance.

Concerns Regarding the Current Draft Guidance

In our response, PRIM&R expresses concern that the draft guidance appears to be limited to research whose purpose is to evaluate the risks of two or more “standard of care” interventions.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

What were you reading in 2014? Highlights from Ampersand

By Anne Meade, senior manager for website and social media

It was a busy year for Ampersand in 2014— we posted 96 blogs, to be exact! We looked back at the past 40 years of research ethics, and remembered those we lost. As we begin 2015, we wanted to know what you found most interesting. Popular topics included draft guidances, protecting subjects, big data, and more. From hard hitting questions to timely topics, let’s take a look back at the most-read blogs of 2014.

1. What’s in a name? Research “participant” versus research “subject” by Ali Hall

2. Unpacking OHRP’s Draft Guidance on Research Evaluating Standards of Care by Elisa Hurley

3. Consent and Autonomy of Human Subjects by Elisa Hurley

4. Ebola, an (Un)ethical Crisis by Brandon Brown

5. Big Data, Commercial Research, and the Protection of Subjects by Elisa Hurley

6. PRIM&R’s Response to the FDA Draft Guidance on Informed Consent by Avery Avrakotos

7. Keys to Protecting Subjects in Qualitative Research by Alexandra Shlimovich

8. Remembering Felix A. Gyi: A Wise, Generous, and Kind Leader

9. 40 Years of Research Ethics: The Drafting of the Belmont Report by Meryn Robinson

10. The SUPPORT study and the future of Comparative Effectiveness Research by Elisa Hurley (A 2013 post that continued to be widely read in 2014!)

We are only a week into 2015 and already have a lot of great blogs scheduled for 2015. If you have a topic idea to share, or are interested in guest blogging about a particular topic, please email us.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Three Items About Human Research Ethics

Much of the day-to-day of bioethics involves specific decisions about the ethics of human subject research.  This week brings three items—ranging from a standard “bread and butter” issue that is particularly topical, on the one hand, to the incredibly bureaucratic and arcane on the other.

The “bread and butter” issue is, under what circumstances is it ethical to use a placebo in clinical research?  The issue is timely with regard to some clinical trials about to start to test experimtal drugs to treat Ebola.  With the outbreak seemingly waning everywhere but Sierra Leone, there is particular urgency to prioritize and test some experimental new drugs in the people who do have the disease.  The problem:  should the people with the disease be randomly assigned to new experimental drug plus current standard of care (SOC), or to SOC plus a placebo?  Or should they all just get experimental drug plus SOC (no placebo arm)?  Ordinarily, a concurrent control is essential, because it makes it easier to tell whether the new drug is safe and effective, and because different people respond to drugs differently.  And this kind of design is normally ethical because everyone gets the best current standard of medical care.  But what if 70% of people still die with SOC, as is the case with Ebola in West Africa?  Just how badly do we need the scientifically “purest” study?  Can we still learn what we want without the concurrent control?  Such is the debate demanding an immediate decision by physicians and scientists running the trials.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Ethics in Neonatology Symposium

Check out this program at the Yale Club of New York on December 5, 2014: “Ethics in Neonatology Symposium.”

The Ethics of Refusing a Parental Request for Treatment
Mark R. Mercurio 

Treating Newborns with Trisomy 13/18: Have Times Changed? 
George Hardart 

Panel & Audience Discussion 
Arthur L. Caplan (moderator)
Stephen R. Latham
Pradeep Mally
George Hardart
Mark Mercurio 

Ethical Concerns in Neonatal Comparative Effectiveness Research: The Controversy Surrounding the SUPPORT Trial
Alan R. Fleischman 

The Ethics of Pediatric and Neonatal Euthanasia. Are the Dutch and Belgians on the Right Track? 
Arthur L. Caplan 

Panel & Audience Discussion 
Mark R. Mercurio (moderator)
Stephen R. Latham
Pradeep Mally
Alan R. Fleischman
Arthur L. Caplan 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.