Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity in Access Planning

NIH is proposing to develop and implement a new policy within the NIH’s Intramural Research Program, the internal research arm of the agency. The policy would require organizations partnering with NIH through a patent licensing agreement that succeed in bringing certain products to market to submit a plan outlining steps they intend to take to promote patient access to any resulting drug, biologic, vaccine, or device. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.

NIH will use the responses to this request for information to develop a final policy. Comments on the proposed policy must be submitted at: https://osp.od.nih.gov/comment-form-draft-nih-intramural-research-program-policy-promoting-equity-through-access-planning.  Comments must be received by July 22, 2024.

In addition, NIH will be hosting an informational webinar on the proposed policy on June 11, 2024.  More information on the agenda and how to register will be provided shortly.

For additional context on the benefits of access planning, please see NIH’s 2023 Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.

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OSP Celebrates Clinical Trials Day; Releases New Resource Related to Consent Language for Studies Using Digital Health Technologies

Today, May 20th, is Clinical Trials Day; a day to reflect, recognize, and celebrate all that has been achieved through clinical trials and the participants, communities, researchers, clinical staff, and others who make these accomplishments possible.  Clinical trials are at the heart of all medical advances.  On behalf of OSP, thanks to all those who make clinical research possible.

As we look to the future of clinical research, advances in digital health technologies are providing new opportunities to bring trials to participants.  To assist in the responsible deployment of these technologies,  OSP, through an NIH-wide collaboration, has developed and released Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample LanguageThis resource presents general points to consider, instructions for use, and optional sample language for the research community. This resource will best be used to inform research teams and Institutional Review Board (IRB) members who are planning, reviewing, or conducting research that studies or uses digital health technologies.

Questions about this resource can be sent to SciencePolicy@od.nih.gov

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NIH and FDA Seek Comment on Draft Glossary of Clinical Research Terms Related to Innovative Clinical Trial Design

The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) have released for public comment a draft glossary of clinical research terms related to innovative clinical trial design, including studies using real world data to generate real world evidence. The draft glossary is intended to facilitate communication within the clinical research community by helping establish a common vocabulary to characterize clinical research more uniformly.

The draft glossary and information on how to provide comments can be viewed here. NIH and FDA will accept comments on the draft glossary until June 24, 2024.

For additional context on this NIH-FDA collaboration, please see the latest Under the Poliscope blog by Dr. Lyric Jorgenson.

Questions about this draft glossary can be sent to SciencePolicy@od.nih.gov

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FDA-NIH Want Your Input on a New Resource for Terminology in Clinical Research

Consider the tomato. Or as some would call it, the “tomahto.” The whole tomato-tomahto debate has entered the language as an example of a difference so small, it doesn’t change anything.  For example, people will generally know what you are referring to no matter how you pronounce it.  But what if one group of people thought a tomato was a red plant suitable for making delicious curries and burger toppings, while other thought a tomahto was a green fruit only found in the southern Australia?  This misunderstanding would certainly cause some considerable confusion at the family barbeque.

I choose the example above since it provides a good analogy for a problem that NIH and FDA have identified in the clinical research space: critical terms are not being used consistently across the clinical research landscape.  This is specifically problematic when discussing innovative clinical trial designs and certain studies using real world data to generate real world evidence. What are some of the perils of having a modern-day Tower of Babel when it comes to clinical research? For starters, if different words mean different things to people, and are operationalized differently in different trials, how can we compare results from or pool data from different trials?   Inconsistent usage of terms can also pose specific challenges in understanding the intended meaning and impact of terms.  Problems from inconsistently terms can also cause major headaches when trying to describe a study design, communicating the goals of a planned study, or interpreting and describing research results.

To avoid the pitfalls that inconsistent use of terms can lead to, NIH and FDA created an inter-agency team of experts to study the issue and develop a resource that could be used to assist the research community in effectively communicating about clinical trials.  As a result of the team’s efforts, NIH and FDA have released a glossary of terms related to clinical research for public comment.  Right off the bat, we should make clear that this glossary is not intended to cover the entire landscape of clinical research.  The glossary contains 37 terms the team identified as being inconsistently used within the scientific community. 

The NIH and FDA are most interested in hearing community feedback on the utility of the glossary in its goal of promoting effective communications.  In addition, we want to hear from you about how we did.  Did we leave any words out that we should have included? Did we include any words that aren’t necessary?  Comments on the draft glossary will be accepted until June 24, 2024.  For more information, including how to view the glossary and how to provide comments, please visit: https://osp.od.nih.gov/comment-form-fda-nih-resource-on-terminology-for-clinical-research/

The NIH and the FDA encourage all interested parties to review the glossary and provide feedback to ensure the glossary meets its directed effect. Having a resource that defines these often inconsistently used terms will help ensure that valuable clinical research is not lost in translation.

Lyric Jorgenson, PhD
NIH Associate Director for Science Policy
About Lyric