Clinical Trial News for NIH Grantees: Myriad Changes for 2018 Applications

Clinical trial applications must now be submitted to FOAs that specifically state that they allow clinical trials. Be certain you understand how NIH defines a clinical trial, and that you choose the appropriate FOA. Those FOAs that allow clinical trials will be reissued at least 60 days before the first due dates in 2018. Make certain you are looking at the most recent FOA. To read two of Mike Lauer’s recent blog posts on the topic, click here and here. For NIH definition of a clinical trial, click here.

Requirement for single IRB in multi-site research goes into effect for applications due on/after Jan 25, 2018. For non-exempt human subjects research, NIH will require a singe IRB for all multi-site trials. For details and a list of resources provided by NIH, click here

Are you doing a clinical trial in a program project or center grant? Guess what? New forms and guidance for that as well, depending on whether the clinical trial is restricted to one component or spans multiple components. Oy. The good news is that moving this info to these new forms will free up precious real estate in the Research Plan. Click here for details.

And what the heck is Delayed Onset, you ask? It means you know there will be a clinical trial, but cannot describe it yet. It is not when a clinical trial is planned and can be described, but will have a delayed start. Click here for more info and links.

Most clinical trial-related material is no longer allowed in the Appendix. For deadlines on or after Jan 25 2018, NIH has whittled the list of allowable appendix materials to the following:

  • Blank data collection forms, blank survey forms and blank questionnaire forms — or screenshots.
  • Simple lists of interview questions. (For clarification, these blank forms and lists are not and do not include items such as:  data, data compilations, lists of variables or acronyms, data analyses, publications, manuals, instructions, descriptions or drawings/figures/diagrams of data collection methods or machines/devices.)
  • Blank informed consent/assent forms
  • Other items only if they are specified in the FOA as allowable Appendix material

The notice, NOT-OD-17-098, states that “Some FOAs further restrict allowable appendix materials and/or may specify that some materials listed above must be provided in another part of the application.”

Tough grant cycle for clinical trial applicants! Stay calm and focused, and get your draft to your pre-award support people early! They are there to help.

Reminder: Use FORMS-E for due dates on/after Jan 25, 2018. Please use the new FORMS-E grant application package for due dates on or after Jan 25. See NOT-OD-17-119 for details. The reminder notice NOT-HS-18-003 has a handy list of related resources. Here is a summary of the changes in the new forms package:

  • Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms
  • Expansion and use of discrete form fields for clinical trial information to
    • provide the level of information needed for peer review;
    • lead applicants through clinical trial information collection requirements;
    • present key information to reviewers and agency staff in a consistent format; and
    • align with (where possible) and position us for future data exchange with
  • Incorporation of recent changes to R&R Budget and SBIR/STTR Information forms

Chronic Traumatic Encephalopathy Seen In Almost All Brains of Former NFL Players in Largest Study To Date

In by far the largest study to date of chronic traumatic encephalopathy (CTE), a study now shows that 110 of 111 former NFL players suffered from the degenerative brain disease. Results were published in the July 25 issue of the Journal of the American Medical Association (JAMA). The disease is linked to repeat blows to the head and can only be diagnosed after death. CTE and its link to football were recently highlighted in the film Concussion.

The study was conducted by Dr. Ann McKee of the VA Boston Healthcare System and the Boston University School of Medicine. Click here to read the JAMA publication, and here to read an NPR article about the research.

New Webinar Short Course To Help You Write Your NIH Submission

In the past few years, I have noticed an uptick in the number of grantees who pay for my grant support services out of pocket. I find this truly dismaying. Grantwriting is an essential skill for a biomedical researcher to master. Writing grant submissions to NIH is an iterative process, it takes time and multiple submissions to titrate your approach to a given IC and study section before you are successful. That means these grantees may be paying for grantsmanship support on multiple submissions from their own pocket, which is thousands of dollars.

In order to provide cost-effective support to the largest group possible, I developed a short course for grantees writing an NIH submission. I named the course NIH Launch, because I hope it will help people launch their funding relationship with NIH.

To develop the course, I thought carefully about the kinds of services my clients seem to find most helpful. I then translated that information into four 90-minute webinars.

The first will be offered in early Feb to help you take key steps before you write, such as mocking up different specific aims and shopping them around to different program officers at NIH to gauge enthusiasm. The second course, given later in Feb, will assist you in writing the most important page of your submission: The Specific Aims. In March, a webinar will discuss ways to “sell” the Significance of your submission, and concisely convey your competitive advantages in the Innovation section. Another will walk you through writing the Approach, the section whose score most closely correlates with your overall impact score.

I offer the courses live in February and March so that you will have a quality draft by early April, which gives you plenty of time to obtain feedback from trusted colleagues and mentors before the June-July deadlines.

Don’t worry if you have a schedule conflict—you can take the courses on demand at your convenience.

I have given versions of these talks for years in my in-person trainings; I am excited to be able to expand the number of grantees I can teach by offering these courses in a webinar format.

Another exciting new offering—we offer unlimited access to ALL our webinars for one year for a flat fee. Many of our clients have already signed up for the Annual Subscription-Individual for $1,000. We are also excited to offer Annual Subscription to Institutions for $30,000; this would enable hundreds of grantees to access our full complement of webinars throughout the year. This may be our most cost-effective strategy yet for training a large group of grantees in order to increase an institution’s NIH funding portfolio.

We hope you will take advantage of our new offerings and welcome your feedback!