News Around NIDDK

NIH changes clinical trial policies

Investigators should be aware that NIH revised its definition of clinical trials in 2014 to include many more types of studies (see NOT-OD-015). This revision is especially important to note because, for application receipt dates on or after Jan. 25, 2018, all clinical trial applications must be submitted to clinical trial-specific Funding Opportunity Announcements (FOAs). This requirement is part of NIH’s initiative of Building Better Clinical Trials through Stewardship and Transparency.

"NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency," wrote Dr. Mike Lauer, NIH deputy director for extramural research, in an August email.

Under NIH’s definition, the term "clinical trial" does not apply solely to studies where the investigator is studying the efficacy of an intervention. A clinical trial may also be a study in which the investigator is assigning human participants to receive an intervention to study a biologic and/or behavioral process, rather than studying the efficacy of the intervention.

NIH has developed a resource to help investigators correctly identify if their study meets NIH’s Definition of a Clinical Trial. Researches who are considering a research proposal to NIH that includes human subjects are strongly encouraged to carefully review this resource before developing their application.

Per the email from Mike Lauer to the Grantee Community last August, there are several policy changes intended to enhance the stewardship of clinical trials. These changes include:

• The requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning Jan. 25, 2018. (See Clinical Trial-Specific Funding Opportunities)
• Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017. (See Good Clinical Practice Training)
• Updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after Jan. 25, 2018. (See Clinical Trial-Specific Review Criteria)
• New Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after Jan. 25, 2018, and contract solicitations published as of Jan. 25, 2018. (See New Human Subjects and Clinical Trial Information Form)
• Use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after Jan. 25, 2018. (See Single IRB Policy for Multi-Site Research)
• Expanded ClinicalTrials.gov registration and reporting to include all NIH-supported clinical trials. (See Requirements for Registering & Reporting NIH-Funded Clinical Trials in ClinicalTrials.gov)

The rules associated with clinical trials apply to both new or continuation research projects involving human subjects. NIH has launched tools, training and other resources to help investigators understand whether their research will now be considered a clinical trial, including:

• A podcast, "Understanding the Definition of a Clinical Trial and What That Means for You"
• Questionnaire: "Does your human subjects research study meet the NIH definition of a clinical trial?"
• Video: "Overview of New NIH Policies on Human Subjects Research"
• Training Resources - NIH Clinical Trial Policies.

"We hope these resources help current and potential NIH grantees understand the new requirements associated with clinical trials so that their applications go to the right place at the right time," said NIDDK Director Dr. Griffin P. Rodgers. "It’s important as well for researchers to know that they can always call us if they have questions. We want to help."

NIDDK has issued FOAs for clinical trials. NIDDK clinical trial FOAs and additional resources associated with NIH supported clinical trial research is available on the Human Subjects Research website. Investigators doing or proposing to do research involving human subject should be sure to familiarize themselves with the new policies and should contact the relevant NIDDK program official with questions.

Congressional Black Caucus visits NIH Clinical Center

During a visit to NIH campus in September, Congressional Black Caucus (CBC) members heard from NIH Director Dr. Francis Collins, NIDDK Director Dr. Griffin P. Rodgers, and others on research taking place across NIH. CBC members also toured a sickle cell lab in the NIH Clinical Center and learned about research conducted at NIDDK and NHLBI that may lead to a cure for sickle cell disease. The members also talked with an NIDDK graduate student and other NIH trainees.

Getting to know: Dr. Jessica Lee

Dr. Jessica J. Lee is deputy director in the Division of Digestive Diseases and Nutrition. A pediatric gastroenterologist, she oversees clinical and translational research programs in digestive diseases and serves as senior scientific advisor for clinical and translational research. Lee spoke with Matt Forke about her goal of improving the quality of clinical research:

What was the impetus for becoming a pediatric gastroenterologist?

I became interested in gastroenterology before deciding whether I wanted to be a doctor for adults or children. I was drawn to GI early on in medical school as the field covers the study of the normal function and diseases of so many organs, as well as nutrition. In addition, it is one of the few medical fields where you get to perform procedures yourself to help diagnose and treat patients, so I knew I would never get bored.

I decided that I would rather be a doctor for children than adults, since children are fun to work with and they keep you positive. Pediatric gastroenterologists diagnose and treat most of the same diseases that adult gastroenterologists encounter, so I didn’t see the downside of becoming a pediatric gastroenterologist.

What achievement in your last position at FDA are you most proud of?

I was fortunate to train and lead a wonderful group of dedicated physicians and scientists to evaluate drug development programs, some of which became the first pharmacological therapies to be FDA-approved for treatment of rare diseases. As part of a team, nothing I accomplished during my tenure at FDA was due to my effort alone.

I’m proud to have co-developed a visiting fellowship program with the American College of Gastroenterology for GI fellows, to help them learn first-hand how the FDA works. It took a few years of preparation, but it was very rewarding to see the fellows come through and enjoy their experience. hope they will help demystify the FDA for the GI community.

What led you to join NIH, and do you have a specific research goal you’d like to achieve here?

Much of the work I did at FDA involved assessing clinical trials prior to marketing approval. While some programs were successful, many weren’t. In the absence of strong groundwork in basic and translational sciences and well-planned early phase clinical trials, there were too many uncertainties to inform clinical trials that could support marketing approval. Working at NIDDK enables me to help facilitate and support the foundational work being done by NIDDK-supported investigators and consortiums, and to help enhance rigor to clinical trials.

What advice would you give to students interested in a research career?

It is a challenging road, but an incredibly rewarding career. Biomedical advances can improve the lives of so many people. As a young scientist, don’t be discouraged by peer review comments during grant and manuscript reviews. Focus instead on how those comments can help improve your application or manuscript. Follow your passion and don’t give up!

NIDDK hosts Facebook Live event about disaster preparedness

By January Payne

Shortly after Hurricane Harvey hit and with reports of Hurricane Irma on the horizon, NIDDK staff began mobilizing to help people with chronic diseases who were affected—or about to be affected—by natural disasters. In a Facebook Live event, Dr. Jeffrey Kopp discussed disaster preparedness with the NIDDK Office of Communications and Public Liaison.

Kopp, an intramural investigator and kidney disease expert, is no stranger to helping out during disasters. A member of the U.S. Public Health Service, he was on the ground during Hurricane Katrina, coordinating and providing medical care to patients with kidney disease and other conditions. He has researched how best to care for people during natural disasters, culminating in publications such as, "Hurricane Sandy as a Kidney Failure Disaster," and "Kidney Patient Care in Disasters: Lessons Learned from the Hurricanes and Earthquake of 2005."

During the Facebook event, Kopp discussed how people with chronic diseases can prepare for natural disasters before they strike and what they should do if they are affected.

"Ideally, every patient would put together a kit—left by the front door for easy access—that would enable them to get through a disaster safely, including a list of their medications and medical problems, as well as the medications themselves," Kopp said. "If they’ve recently been hospitalized, the hospital discharge summary should be kept in the kit. It can be very useful to help get through the disaster period and return back to regular life as soon as possible."

The event became the most-watched NIDDK video on Facebook of 2017, with 3,300 views and counting.

A few weeks after the Facebook Live event, Kopp was on the ground again, this time in Puerto Rico.

"Dr. Kopp’s commitment to helping the most vulnerable of our nation’s residents, even at times putting his own safety on the line, is admirable and appreciated," said Dr. Griffin P. Rodgers, Director, NIDDK. "The Facebook Live video interview shares valuable insights and practical tips and advice Dr. Kopp has learned through his on-the-ground efforts."

Watch NIDDK’s video about disaster preparedness for people with chronic health conditions.

NIDDK highlights type 1 diabetes research opportunities

The NIDDK seeks to continue scientific progress and develop new technologies in type 1 diabetes and its complications through collaboration with its federal partners and the scientific community. Two recent developments in NIDDK’s research planning process highlight efforts to encourage creative approaches to difficult research problems in type 1 diabetes and its complications.

• The NIDDK has published a summary (PDF, 193 KB) of an April 2017 workshop on research opportunities in type 1 diabetes. Under the auspices of the statutory Diabetes Mellitus Interagency Coordinating Committee, the NIDDK convened a panel of non-federal scientific experts and a lay representative to provide input on potential new and ongoing efforts of the NIH and the Centers for Disease Control and Prevention in type 1 diabetes and its complications. The panelists also identified additional opportunities, including attracting and developing the next generation of type 1 diabetes researchers.
• A list of anticipated initiative concepts (PDF, 41.41 KB)   that could be pursued through the Special Statutory Funding Program for Type 1 Diabetes Research, should it be renewed for Fiscal Year (FY) 2018, has been developed. Since 1998, the NIDDK has administered the Program to support a diverse portfolio of cutting-edge type 1 diabetes research that may not have been possible otherwise.

Become an NIH peer reviewer

The NIH’s Center for Scientific Review (CSR) welcomes researchers who volunteer to serve on our peer review groups. Reviewers have noted many benefits to the role, including a chance to better understand good grant writing, stay up-to-date in their field, and give back to the scientific community, among many other advantages (here’s a list of them).

There are several paths to review service:

• Learn about our Early Career Reviewer Program: If you are an emerging researcher with an active, independent program of research and you don’t have a major grant, consider applying for our Early Career Reviewer Program. This program may help jumpstart your career and prepare you to become a NIH reviewer.
• Contact a CSR Scientific Review Officer: If you are an established investigator, send your CV to a CSR Scientific Review Officer you know from having your applications reviewed or from having served as a reviewer in the past.
• Let us try to find a good review group for you: Send your CV here, and we explore options for pairing you with an appropriate review group.

Get more information on the benefits of peer reviewing for the NIH with the Reviewer Resources.