Request for Information (RFI): Seeking Input from Industry on Enhancing the Data Yield from Clinical Studies of Peripheral Neuromodulation Devices

Notice Number: NOT-RM-17-015

Key Dates
Release Date:   October 6, 2017

Related Announcements
NOT-RM-17-023

Issued by
Office of Strategic Coordination (Common Fund)

Purpose

Peripheral nerve stimulation to modulate organ function is rapidly developing as a therapeutic approach to a wide range of conditions. Clinical studies to date have yielded both promising successes and puzzling failures, highlighting an urgent need for clearer anatomical and physiological understanding of the neural control of organ function in humans. This understanding could be accelerated by increasing the data yield from clinical device studies. The purpose of this RFI is to request strategic input from industry stakeholders on how to work together on this objective. The input received will be used by the NIH SPARC (Stimulating Peripheral Activity to Relieve Conditions) program and shared with related programs across NIH Institutes and Centers.

Background

This RFI seeks to gather input from industry scientists and engineers on potential joint efforts in neuromodulation research areas of mutual strategic interest, specifically in applications involving peripheral or spinal neuromodulation of organ function. The NIH SPARC program seeks to catalyze the discoveries that will support the next generation of peripheral neuromodulation devices and protocols. Currently, SPARC supports a wide array of anatomical and physiological studies, including some that are intended as proofs of concept for eventual clinical applications. These studies make use of neuromodulation technologies at varying levels of maturity, from those that have FDA clearance or approval for certain uses, to others that are studied only nonclinically. For example, pre-clinical efforts are exploring the use of vagal neuromodulation approaches (IPGs and cuff electrodes) to treat the symptoms of asthma (cervical and pulmonary branch of the vagus) and diabetes (sub-diaphragmatic vagal trunk), spinal cord stimulation for gastroparesis and subcutaneous nerve stimulation for arrhythmia control. Other intervention points, that may be identified by SPARC's anatomical and physiological projects, include sensory and autonomic innervation of the lower urinary tract, colon and adipose tissue. In some cases, neuromodulation devices will be part of a closed-loop platform that includes sensing technologies for measuring organ function, such as gastric EMG recording to inform neuro-electric control of gastric motility and bladder pressure/volume monitoring for neuromodulation therapies targeting the lower urinary tract. SPARC’s technology development projects are also exploring the potential for using non-electrical neuromodulation approaches, such as optical and ultrasonic modulation.

Information Requested

To improve our public-private partnerships, the SPARC team is seeking perspectives on any and all of the following topics, or any other topic relevant to the above statement of purpose:

Partnering:

  • Challenges in establishing successful public-private collaborations around device-based clinical studies.
  • Sufficiency of existing incentives for industry participation in and co-funding of translational studies.
  • New therapeutic opportunities that can be explored using existing clinical neuromodulation technology.
  • The training needs of existing and emerging medical specialties in the field of peripheral neuromodulation.

Scientific data collection during clinical studies:

  • Availability, effectiveness, and shortcomings of clinical devices with expanded data acquisition and stimulus customization capabilities for research to improve specificity and mechanistic understanding.
  • Privacy, strategic, and intellectual property considerations regarding the sharing of human data with the scientific community.
  • Opportunities and challenges related to the collection of human peripheral nerve recordings in acute clinical settings to (e.g. during implantation surgeries or replacement of pulse generators).
  • The potential use of clinical settings to collect human physiology data to enhance our understanding of the functional relationship between neural signals and organ responses at points of intervention. The potential of such data to help translate and optimize the functional maps derived from animal models for prediction of clinical efficacy.

Research rigor, reproducibility, and safety:

  • Methods for improving the rigor and reproducibility of small, device-centered clinical studies (e.g. sample sizes, shams, controls, efficacy metrics and how to assess go/no-go criteria in small study populations with idiosyncratic conditions).
  • Special considerations in neuromodulation device-based studies with respect to study design and safety monitoring.
  • Evidentiary requirements for new therapeutic applications of existing clinical neuromodulation technology
  • Common pitfalls encountered in clinical research involving current neuromodulation devices (implantable or non-invasive; e.g. vagal nerve stimulators).
  • Regulatory and patient recruitment challenges involved when translating basic research into clinical device studies.
  • Ethical challenges and implications (e.g. liability, long-term patient care considerations extending beyond the study period, vulnerable populations, sham control).
  • Cost, time to market and/or return on investment considerations for devices and the associated studies (manufacturing, testing, target population, etc).

How to Submit a Response

We encourage submissions by any method convenient to the respondent. Written comments may be emailed to SPARC_TPNI@mail.nih.gov and will be tabulated by the NIH SPARC team. Audio files such as smartphone or dictaphone voice memos may be emailed to the same address. Voice mail messages may be left to Dr. Siavash Vaziri at 301-594-8921. Teleconferences with the SPARC team to convey information may be requested at http://nihsparc.setmore.com.

Responses to this RFI are voluntary. To ensure consideration, responses must be communicated by December 1st, 2017. NIH will confirm written response submission, but respondents will not receive individualized feedback.

Use of Information Submitted

This RFI is for informational and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States (US) Government or the NIH to provide support for any ideas submitted in response to it. The NIH may use the information gathered by this RFI to inform the development of future funding opportunity announcements. Please note that the US Government will not pay for the preparation of any information submitted, or for its use of that information.

Use of Non-confidential Information
The Government reserves the right to use any non-confidential information at its discretion, for example in summaries of the state of the science, or in any resultant solicitation(s). Any information shared publicly will be de-identified and will not be attributed to any individual or entity.

Protection of Privileged or Confidential Commercial or Financial Information
The Freedom of Information Act (FOIA), 5 USC 552, provides individuals with a right to access certain records in the possession of the Federal government, subject to certain exemptions. Exemption 4 protects "trade secrets and commercial or financial information obtained from a person [that is] privileged or confidential." The term "person" refers to a wide range of entities, including corporations, banks, state governments, agencies of foreign governments, and Native American tribes or nations, who provide information to the government. Also, see the DOJ Web site https://www.justice.gov/oip/foia-guide-2004-edition-exemption-4.

Information that is marked as containing confidential commercial information may be protected from public disclosure pursuant to the Exemption 4 of the FOIA and will be handled in accordance with 45 CFR 5.41 and 5.42. Pursuant to our regulations, final determinations on the applicability of Exemption 4 of the FOIA are made on a case-by-case basis by the NIH FOIA Officer. 

The complete language of the exemptions can be found in the FOIA. Additional information on the exemptions and how they apply to certain documents can be found in the HHS regulations implementing the FOIA (45 CFR part 5). Also, see the HHS Web site http://www.hhs.gov/foia/.

Inquiries

Please direct all inquiries to:

Siavash Vaziri, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8921
Email: SPARC_TPNI@mail.nih.gov