[Ip-health] KEI comments on DRAFT NIH Policy for Data Management and Sharing and Supplemental DRAFT Guidance

Claire Cassedy claire.cassedy at keionline.org
Mon Jan 13 10:42:34 PST 2020


https://www.keionline.org/32112

KEI comments on DRAFT NIH Policy for Data Management and Sharing and
Supplemental DRAFT Guidance
Posted on January 13, 2020 by James Love

KEI filed these comments on the NIH Draft Policy for Data Management and
Sharing and Supplemental DRAFT Guidance

------------------------------------------------------

Knowledge Ecology International
1621 Connecticut Avenue NW
Suite 500
Washington, DC 20009
www.keionline.org
<http://www.keionline.org>
January 10, 2020

Office of Science Policy
National Institutes of Health
6705 Rockledge Drive
Suite 750
Bethesda, MD 20892
Via Online Submission

Re:  Request for Public Comments on a DRAFT NIH Policy for Data Management
and Sharing and Supplemental DRAFT Guidance


Knowledge Ecology International (KEI) welcomes the opportunity to comment
on the DRAFT National Institutes of Health (NIH) Policy for Data Management
and Sharing.

KEI is a nonprofit non-governmental organization with offices in
Washington, DC and Geneva, Switzerland that focuses on improving the
management of knowledge resources in search of better outcomes in the
public interest. KEI’s primary areas of work are policies concerning
equitable access to knowledge and medicines in the US and globally. Through
these efforts, KEI has sought to promote open source data and the sharing
of information to promote increased innovation and improved outcomes for
patients and consumers. As a part of our work in increasing affordable,
sustainable access to medicines, KEI has advocated for increased
transparency of data in the area of medical R&D costs, in order to better
inform future research and policies to ensure the public has access to the
life-saving treatments they need.

While primarily concerning the data management and sharing of scientific
data generated from NIH-funded research, KEI would like to offer comments
regarding improved reporting and sharing of economic and cost data
associated with US taxpayer-funded research.

As noted in section I. Purpose of the DRAFT NIH Policy for Data Management
and Sharing (“Draft Policy”), the NIH has a “longstanding commitment to
making the results and outputs of the research that it funds and conducts
available to the public.” One such output is data concerning the costs of
conducting research, including human subject clinical trials, and the costs
of manufacturing of medical technologies.

As a part of the submission of the required Data Management and Sharing
Plan as outlined in the Draft Policy, researchers with NIH-funded or
conducted research projects should explain the expected costs to be
incurred in the course of their project, including in particular, the
expected costs of clinical trials, and the sharing of that cost among
various sources of funding, including the NIH grants or contracts, funds
from other federal and other government agencies, private charities,
industry and reimbursements from government or private health insurance
plans.

In the Supplemental DRAFT Guidance: Elements of a NIH Data Management and
Sharing Plan section, KEI would recommend that the Elements of a Plan
should include (in addition to those already proposed in the DRAFT
Guidance) data related to the costs of the research project such as:
1. Expected/Actual Total Cost of the Research Project;
2. NIH Grant Numbers associated with the Research Project (if applicable);
and
3. Any Clinical Trials conducted in connection with the research.

If there are clinical trials associated with research for which the Data
Management and Sharing Plan is submitted, KEI recommends the following data
regarding the trial be included in the Plan:
1. NCT Number
2. Trial Sponsor
3. Phase
4. Enrollment
5. Trial Start/End Dates
6. Expected/Actual Cost of the Clinical Trial
7. Expected/Actual Per Patient Cost of the Clinical Trial
8. The expected contribution to the trial cost by:
   a. the NIH grant or contract,
   b. any other federal agency,
   c. any other non-federal government agency,
   d. any charities,
   e. Industry,
   f. And health plans that provide reimbursements of trial related
expenses, including those required to do so under PHS Act section
2709(a).[1]

It will also be helpful to have the collection and sharing of data on
manufacturing costs for medical technologies.

The information will contribute directly to policy researchers exploring
how to design or reform incentives for biomedical research and development,
in the evaluation of the reasonableness of prices or incentives, and also
give researchers, academic, non-profit and industry, useful information on
the budgets required to bring inventions to practical application.

We would be happy to further discuss the suggestions and answer any
questions related to these issues. Thank you for the opportunity to offer
comments on the NIH Policy for Data Management and Sharing.

James Love
Knowledge Ecology International
1621 Connecticut Avenue, Suite 500
Washington, DC 20009
https://keionline.org
james.love at keionline.org


Footnote:

[1].  “PHS Act section 2709(a), as added by the Affordable Care Act, states
that if a group health plan or health insurance issuer in the group and
individual health insurance market provides coverage to a qualified
individual (as defined under PHS Act section 2709(b)), then such plan or
issuer: (1) may not deny the qualified individual participation in an
approved clinical trial with respect to the treatment of cancer or another
life-threatening disease or condition; (2) may not deny (or limit or impose
additional conditions on) the coverage of routine patient costs for items
and services furnished in connection with participation in the trial; and
(3) may not discriminate against the individual on the basis of the
individual’s participation in the trial.
A qualified individual under PHS Act section 2709(b) is generally a
participant or beneficiary who is eligible to participate in an approved
clinical trial according to the trial protocol with respect to the
treatment of cancer or another life-threatening disease or condition; and
either: (1) the referring health care professional is a participating
provider and has concluded that the individual’s participation in such
trial would be appropriate; or (2) the participant or beneficiary provides
medical and scientific information establishing that the individual’s
participation in such trial would be appropriate.”
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs15
; see also: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876354/


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