Clinical trial definition has implications for NIH applications

Without a medical school, Miami University has not historically conducted clinical trial research. But that will likely change beginning January 25, 2018, and it’s not because Miami’s researchers are changing what they’re doing. Rather, it’s because the National Institutes of Health (NIH), the world’s largest funder of biomedical research, is changing its definition of a clinical trial.

NIH defines a clinical trial as:

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo of other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

This definition was adopted in 2014. A 2016 initiative by NIH to enhance its stewardship over clinical trials led to the development of new policies based on that definition. These policies will be in effect for applications to NIH solicitations with due dates of January 25, 2018 and after. Beginning on that date, many of Miami’s NIH-funded behavioral researchers, in particular, may suddenly find themselves conducting clinical trials, even though their work may not have met that definition in the past.

Of course, recognizing when a study does meet NIH’s definition of a clinical trial is the first step for any Miami biomedical or behavioral researcher applying to NIH for funding. To help with this, NIH has devised a decision tree:

Title: Decision Tree for NIH Clinical Trial Definition. Question 1: Does the study involve human participants research? A No answer leads to the conclusion that the study is NOT a clinical trial. A yes answer leads to Question 2: Are participants prospectively assigned to an intervention? A No answer leads to the conclusion that the study is NOT a clinical trial. A yes answer leads to Question 3: Is the study designed to evaluate the effect of the intervention on the participants? A No answer leads to the conclusion that the study is NOT a clinical trial. A yes answer leads to Question 4: Is the effect being evaluated a health-related biomedical or behavioral outcome? A No answer leads to the conclusion that the study is NOT a clinical trial. A yes answer leads to the conclusion that this study is a clinical trial.

(The NIH website offers a printable version and an interactive version of the decision tree.)

For those whose work does meet the NIH’s definition, the second step is understanding certain implications of conducting NIH-funded clinical trial research, including:

NIH’s “Overview of New NIH Policies on Human Subjects Research and Clinical Trials” video provides an overview of the upcoming changes. Additional information — including case studies and FAQs — is available on NIH’s “Clinical Trial Requirements” website. NIH encourages prospective applicants who still have questions after reviewing the information on the website to contact their program officers. Miami University researchers can also contact their OARS representative for guidance.


Written by Heather Beattey Johnston, Associate Director of Research Communications, Office for the Advancement of Research and Scholarship, Miami University.

Photos by Miami University Photo Services.

 

A doctor takes the temperature of a patient.

PCORI supports comparative clinical effectiveness research

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The Patient-Centered Outcomes Research Institute (PCORI) was established in 2010 as an independent non-profit, non-governmental, special purpose corporation authorized by Congress.  PCORI’s Congressional mandate is to improve the quality and relevance of healthcare information to help patients and caregivers make informed decisions. Through contracts, PCORI funds comparative clinical effectiveness research (CER) while engaging patients and stakeholders in the research process.

Patients and stakeholders help PCORI  prioritize research questions, advising PCORI on what to fund.  Stakeholders are engaged in the review process and help PCORI share findings with the community at large.

Currently most of PCORI’s $200 million budget supports clinical trial research, with the remainder funding general and targeted areas such as cancer, cardiovascular health, mental/behavioral disorders, and rare diseases.

PCORI supports applications from for- and non-profit entities as well as from entities not located in the U.S. Individuals may not apply.  Applications to PCORI are typically for 3-5 year projects and applications are often invited through a Letter of Intent (LOI) process.  Because PCORI is commitment to working with all stakeholders PCORI staff will work with researchers who did not get funded to strengthen their proposals to better align with the target solicitation.

PCORI funds comparative clinical effectiveness research (CER), so all questions must be comparative in nature.

For more information on PCORI and the types of research they fund, visit their website, pcori.org.


Written by Tricia Callahah, Director of Proposal development, Office for the Advancement of Research & Scholarship, Miami University.

Doctor and patient photo by Amanda Mills, U.S. Centers of Disease Control & Prevention, public domain. Culture photo by Carlotte Raymond Photography for International AIDS Vaccine Initiative (IAVI) via Flickr, used under Creative Commons license.