Tag Archives: Comparative effectiveness

New NIH Funding Opportunity to Support Collaboratory Demonstration Projects

Cluster Randomized Trials, Comparative Effectiveness Research, Funding Opportunity Announcement (FOA), Pragmatic clinical trials, , , , , ,

A new funding opportunity announcement from the NIH solicits applications to support Demonstration Projects that include an efficient, large-scale pragmatic clinical trial. Trials must be conducted across two or more health care systems (HCS) and must be conducted as part of the NIH HCS Research Collaboratory supported through the NIH Common Fund. Awards made through this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible rapid transition to the second implementation phase (UH3) for a pragmatic trial Demonstration Project.

Access the full funding announcement: RFA-RM-16-019

Important Due Dates
   Earliest submission date: May 2, 2017
   Letter of intent date: 30 days prior to application due date
   Application due date: June 2, 2017

Trauma Survivors Outcomes and Support (TSOS) trial publishes design paper

Clinical trials, Cluster Randomized Trials, Comparative Effectiveness Research, Pragmatic clinical trials, Stepped-wedge, , , , ,

The study team for the Trauma Survivors Outcomes and Support (TSOS) trial recently published their study protocol in Implementation Science. TSOS, an NIH Health Care Systems Research Collaboratory Demonstration Project, is an effectiveness-implementation hybrid trial designed to test the delivery of screening and intervention for PTSD and comorbidities across 24 U.S. level I trauma center sites. The study employs a stepped-wedge, cluster-randomized design in which sites are randomized sequentially to initiate the intervention. The study aims to determine if injured patients receiving a collaborative care intervention demonstrate significant reductions in PTSD symptoms when compared with control patients receiving usual care. The study will also evaluate whether intervention patients demonstrate significant reductions in depressive symptoms and associated suicidal ideation, alcohol use problems, and improvements in physical function.

The open access article is available here: An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity

FDA Cites Collaboratory as Part of a National System for Generating Clinical Evidence

Clinical trials, Comparative Effectiveness Research, Data sharing, Data standards, Pragmatic clinical trials, , , , , , ,

In a recent post on the FDA’s “FDA Voice” blog, Associate Deputy Commissioner Rachel Sherman and Commissioner Robert Califf describe how to overcome barriers to data sharing and create a successful national system for medical evidence generation (or “EvGen”). To foster new approaches for creating clinical evidence the authors suggest 3 principles:

“1. There must be a common approach to how data is presented, reported and analyzed and strict methods for ensuring patient privacy and data security.

2. Rules of engagement must be transparent and developed through a process that builds consensus across the relevant ecosystem and its stakeholders.

3. To ensure support across a diverse ecosystem that often includes competing priorities and incentives, the system’s output must be intended for the public good and be readily accessible to all stakeholders.”

Drs. Sherman and Califf point to substantial pioneering work being done in secondary use of data, in which data collected for clinical care are “secondarily” used for research, including projects currently underway through the NIH Collaboratory, PCORnet, and other initiatives and networks. The experience gained from these groundbreaking efforts should provide a foundation for a national system for evidence generation.

Read the full post here.

Recent Collaboratory Publications on Research Ethics

Clinical trials, Comparative Effectiveness Research, Informed Consent, Pragmatic clinical trials, , , ,

The American Journal of Bioethics has recently published three articles authored by members of the Regulatory/Ethics core group describing various questions related to research on medical practices:

  • Is shared decision making an appropriate analytic frame for research on medical practices (Sugarman 2015) discusses the role of shared decision making (SDM) in research on medical practices. The author cautions that “while SDM is in many ways similar to informed consent, there are some important differences, especially in the research setting.” This publication is freely accessible through PubMed Central.
  • Patients’ views concerning research on medical practices: implications for consent (Weinfurt et al. 2015) describes the results of focus group sessions that elicited a range of patients’ views and opinions about different types of research on usual medical practices. The authors state that “our data suggest that effective policy and guidance will involve balancing different patients’ interests and potentially different sets of interests for different types of research studies on usual medical practices.”
  • Ethics of research in usual care settings: data on point (Sugarman 2016) introduces a special five-article supplement in the American Journal of Bioethics, stating that the “growing empirical ethics literature regarding research in usual care settings provides data to inform conceptual and policy debates regarding this research and suggests areas that require further study.”

These publications were supported by a bioethics supplement awarded to the Regulatory/Ethics Core group by the NIH’s Office of the Director.

Office for Human Research Protections Releases Draft Guidance on Disclosing Risks in Standard-of-Care Research

Comparative Effectiveness Research, Informed Consent, Pragmatic clinical trials, Regulatory issues, , , ,

On October 20, 2014 the Office for Human Research Protections (OHRP) released a draft guidance on how to apply the Department of Health and Human Services (HHS) regulations on protecting human subjects (45 CFR Part 46) who participate in research studies intended to evaluate risks of treatments or procedures commonly used by healthcare professionals and recognized as “standard of care.” In standard-of-care research (or comparative effectiveness research), participants are randomized to receive one of two (or more) treatments that are accepted by medical experts as appropriate treatments for a given disease or condition.

Because treatments assigned to some participants might be different than the treatments they would have been assigned if they were not participating in the study, and the risks associated with one treatment might be different from the risks associated with another treatment, the OHRP recommends that these risks be fully described to potential participants as a part of the informed consent process.

Click here for the full draft guidance: Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care

The Institute of Medicine is planning a two-day public workshop in December to discuss human subjects protections in standard-of-care research. Click here for more information.​

 

The Diane Rehm Show Features PCORnet

Comparative Effectiveness Research, Patient-Centered Outcomes Research, Patient-Reported Outcomes, , ,

On Thursday, April 17, The Diane Rehm Show, a nationally syndicated news and call-in program carried on National Public Radio, aired a program titled The Promise and Perils of a New Project to Share Individual Patient Records. Susan Page of USA Today led the discussion on PCORnet: the National Patient-Centered Clinical Research Network, which is supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Joe Selby, the executive director of PCORI, describes how PCORnet will take advantage of the incredible quantity of clinical information in electronic health records to conduct much-needed research on the relative effectiveness of different medical devices, drugs, and other medical therapies. Click here for a transcript of this program, or listen to the full episode below:

Listen now: The Promise and Perils of a New Project to Share Patient Records

PCORI Featured in Health Affairs Blog

Comparative Effectiveness Research, Patient-Centered Outcomes Research, , ,

Joe Selby, MD, MPH, executive director of the Patient-Centered Outcomes Research Institute (PCORI), discusses the promise of PCORI’s research efforts in a recent guest blog post for healthcare policy journal Health Affairs. In his post, Selby explains that PCORI’s mandate is not just to fund comparative effectiveness research (CER) studies that compare multiple therapeutic options, but also to share the results in ways that are meaningful to patients, physicians, and other stakeholders.

Although many of PCORI’s resources are dedicated to supporting CER in reaPatient-Centered Outcomes Research Institute (PCORI) logol-world settings, patient engagement in research is also a cornerstone of PCORI’s efforts. Of the $464 million invested, 62% has been focused on CER, with the rest spread across infrastructure (18%), methods (11%) and communication and dissemination research (8%). PCORI expects to commit $1 billion over the next 2 years to expand their work. As part of their mission, they also hope to improve research methods and build the national capacity for CER.

Grand Rounds (3-26-2014): Why Is the FDA Interested in the Collaboratory and PCORnet?

Comparative Effectiveness Research, , , , ,

Update:

Archived video and slides  from the March 26 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

Photograph of FDA CDER Director Janet Woodcock, MD
CDER Director Janet Woodcock, MD. Photo credit: FDA

The guest speaker for this Friday’s Collaboratory/PCORnet Grand Rounds presentation will be the FDA’s Janet Woodcock, MD. Dr. Woodcock is the current director of the Center for Drug Evaluation and Research (CDER), the division of the FDA primarily responsible for evaluating the safety and effectiveness of both prescription and over-the-counter drugs and biologic therapies marketed in the United States.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, March 26. Details are available here. Archived video and slide sets from the presentation will be available early the following week; links to archived material will be provided in an update to this post.

STOP CRC Study Featured on NPR Health Blog

Comparative Effectiveness Research, Pragmatic clinical trials, , , , , ,

The Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study was recently featured on National Public Radio’s Shots Blog, which is devoted to coverage and discussion of health and healthcare issues.

Picture of U.S. stop sign.
Public-domain image via Wikimedia Commons.

STOP CRC, which is exploring innovative approaches for increasing colon cancer screening rates among low-income and minority populations, is one of the seven UH2 pilot projects supported by the NIH Collaboratory. The demonstration phase of the project will be conducted within a pair of health centers that are part of OCHIN, a community-based network of Federally Qualified Health Centers.

More information about about STOP CRC is available here.