Getting NIH funding and launch a clinical trial with Dr. Manish Shah

In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants. 

In other words, the success rate was 21%.

And the total funding amount was $8,827,444,624.

The question I had was, “What does it take to get grant approval and launch an NIH funded research project?”

To answer this question, I invited Dr. Manish Shah,  Professor of Pediatrics at Baylor College of Medicine and Attending Physician in the Texas Children’s Hospital Emergency Center in Houston. 

Dr. Shah has served on several national committees to advocate for improvements in pediatric and prehospital emergency care. 

His research has focused on developing, implementing, and studying outcomes related to evidence-based protocols for various clinical conditions, including seizures. 

Dr. Shah is currently the Principal Investigator for the Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study, which has been funded by the National Institute of Neurological Disorders and Stroke (NINDS) and is being conducted in the Pediatric Emergency Care Applied Research Network (PECARN).

Please join me in welcoming Dr. Shah on the Clinical Trial Podcast.

Sponsor:

This podcast is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/

Update: At the time of publishing this podcast episode, I am no longer part of Ceribell Inc. 

Show Notes:

[4:13] Dr. Shah is the lead investigator for the PediDOSE study 

[5:46] National Institute of Health has many institutes and each institute focuses on specific diseases

[6:27] Being part of the PECARN network is how Dr. Shah learned how to frame a grant and be successful in applying for a grant through the feedback that he received from the network itself

[9:04] Iterative process within the PECARN network to help improve the research idea that an investigator has 

  1. Pitch a research idea that we have we call it a concept
  2. If concept gets voted on and approved, then it goes through a rigorous process of developing into a more detailed research proposal
  3. Through that research proposal development process, investigators get feedback from other subcommittees and steering committee of the network itself 

[10:00] Future Investigators Meeting with NIH project officers and experienced researchers who’ve had federal funding for extramural research grants in the network. Researchers can pitch their idea in small groups and get feedback

[10:32] Unique research concepts can land a researcher with their own Special Session where NIH project officers come and give feedback on research ideas and develop these ideas into more succinct concepts with specific aims 

[11:45] Networking with your colleagues in order to learn about research networks in your medical specialty 

[12:04] Four-step process for identifying grant opportunities within the NIH:

  1. Focus on specific disease, diseases or disease categories. Every disease has a home at the NIH 
  2. Identify the correct institute that would fund research on that topic
  3. Look for appropriate grant mechanisms that would fall in line with the project that you want to do 
  4. Talk to a project officer at that point where you’re thinking about the idea just to get feedback on things to consider as you’re developing your idea and preparing to submit a grant

[13:27] It can take several years to secure grant approval and start your research project 

Dr. Shah started thinking about his idea in December 2017, it took him close to a year to get approval from the network, then he submitted the grant to the NIH in early 2020, received grant approval in 2021 after multiple iterations, and will begin enrollment in the PediDOSE study in 2022

[14:34] It is possible to secure NIH grant approval and conduct research without a network. The network not only provides valuable feedback on the research idea but also helps identify potential collaborators who are interested in similar types of research 

[16:45] Funding sources

  1. Federal Grants, such as NIH, CDC 
  2. State Grants, usually from Department of Health
  3. Private Foundations 

[20:29] Dealing with the possibility that the grant may never get approved and the project may not take off 

[21:40] How Dr. Shah addressed the feedback from panel of experts (i.e. study section) who review a grant application

[24:07] Dr. Shah is spending his professional time on research, teaching (journal club, helping fellows develop research ideas), clinical (patient care), and administrative responsibilities in the Division of Emergency Medicine 

[25:14] Journal club

  • Pick an article in the last year or two
  • Fellow presentation with preparation guided by faculty preceptor
  • Guided discussion using a literature appraiser tool 

[26:31] Similarities and differences in the role and responsibilities of the NIH and FDA 

  • FDA  
    • Exception from Informed Consent Requirements (EFIC) for Emergency Research including plan to notify parents and guardians of children that have been enrolled in study at the earliest possible opportunity
    • Investigational New Drug (IND) Application
    • Research Protocol and other study documents
    • Trial Registration on clinicaltrials.gov
  • NIH
    • Grant review and approval

[31:35] NIH Grant Criteria 

  1. Significance → Aims
  2. Approach → Methods 
  3. Innovation 
  4. Environment
  5. Investigators 

[36:40] Core study team 

  1. Expert in studying pediatric seizures
  2. Emergency Medical Services researcher with clinical trial experience
  3. Emergency Medical Services researcher with EFIC experience
  4. Neurologists
  5. Expert in statistics and clinical trial design 

[38:11] Industry Sponsored vs. NIH Funded Research (Federal) 

[39:39] Data collection using Redcap

[40:25] Single IRB requirement and gaining alignment with the IRB members and investigators (ex: training requirements) 

[44:17] Solving problems encountered during grant review process 

[48:49] Clinical Design Workshop

  • Coming up with a research question
  • Brainstorm approaches to address the research question
  • Well thought out research idea 

[51:37] Thinking about data collection from outset, structure of electronic record, collaboration with peers

Resources Mentioned:

Learn more about Dr. Manish Shah and PediDOSE study at Texas Medical Center 

Pediatric Dose Optimization for Seizures in EMS (PediDOSE)

National Institute of Neurological Disorders and Stroke

NINDS Grant Mechanisms

Health Resources and Services Administration (HRSA)

Maternal and Child Health Bureau (MCHB)

Emergency Medical Services for Children (EMSC)

Pediatric Emergency Care Applied Research Network: PECARN

Agency for Healthcare Research and Quality

Patient Centered Outcomes Research Institute (PCORI)

Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) Network

Neurological Emergencies Treatment Trials (NETT) Network

Grants.gov 

Centers for Disease Control

CASP tool 

Consolidated Standards of Reporting Trials (CONSORT) diagram tool

Exception from Informed Consent Requirements for Emergency Research

Investigational New Drug (IND) Application

NIH Review Criteria at a Glance

Collaborative Institutional Training Initiative (CITI) Training Program 

Interview with Hugh Levaux on Integrating EHR and EDC Systems

Books:

Think Again: The Power of Knowing What You Don’t Know by Adam Grant (Amazon, B&N))

Redcap data collection software 

Designing Clinical Research Fourth Edition by Dr. Stephen B Hulley MD MPH et al. (Amazon, B&N)

Designing Clinical Research Fifth Edition by Warren S Browner MD, MPH, Thomas B Newman MD, MPH, Steven R Cummings MD, Deborah G Grady MD, MPH, Alison J Huang (Amazon, B&N

Randomized Controlled Trials: Questions, Answers, and Musings, Second Edition by Alejandro R. Jadad MD, DPhil, FRCPC, Murray W. Enkin MD, FRCSC, FACOG, DSc (hon), LLD (hon) (Amazon, Wiley)

References:

NIH Funding Report

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