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A Sampling of Recent Literature on the Scientific Workforce

Wed, 10/18/2017 - 11:28

As NIH continues its work to better understand the many factors that influence the stability of the biomedical workforce, we wanted to take a moment to discuss some recent papers that highlight the need to take new measures to support early and mid-career researchers.

Earlier this year, we discussed a paper by our NIH colleagues who looked at data on the shifting demographics of lead principal investigators (PIs) on NIH and National Heart Lung and Blood Institute (NHLBI) research project grants. One of their findings is a decline in the representation of PIs aged 41-55. A recent paper by Michael Levitt (Stanford University) and Jonathan Levitt (Statistical Cybermetrics Research Groups) published in the Proceedings of the National Academy of Science supports these observations. The authors combined NIH data on R01-funded PIs and Association of American Medical Colleges (AAMC) data on U.S. medical school faculty to examine trends among three age groups: over 55, between 46-55, and under age 46. The number of medical school faculty and NIH R01 grantees over age 55 has increased steadily since 1980. Focusing on faculty in basic science departments, the authors see a similar trend to NIH R01 grantee data, where the representation of younger and middle aged PIs has remained stagnant, or declined, since 2000.

Looking at inflation-adjusted funding data, the authors see further evidence that NIH-supported PIs under age 55 are feeling greater pressure. Funding markedly increased for PIs aged 46-55 and over 55 at the time of the NIH doubling, but for PIs under 46 funding remained comparatively flat.

Levitt and Levitt, Proceedings of the National Academy of Sciences of the United States of America, 2017 Jun 20;114(25):6498-6503. doi: 10.1073/pnas.1609996114.

From 2004 to present, we see that funding to PIs under 46 and 46-55 is declining, while funding to PIs over 55 remains relatively flat. In Panel C the authors present the data in a way that seems to show a large net transfer of funding to R01 grantees over 55.

Levitt and Levitt, PNAS USA, 2017 Jun 20;114(25):6498-6503. doi: 10.1073/pnas.1609996114.

In 2008, NIH implemented the early stage investigator (ESI) policy, and data shown in this paper shows a modest effect of the ESI policy, with younger basic science PIs seeing more success in achieving funding, beginning in 2010. The authors argue that NIH should provide younger investigators with greater support, enough additional support to restore the age distribution of basic science PIs closer to that seen in 1980. Their model proposes that by adding 2,255 basic science PIs in the younger cohort (45 and younger) the enterprise would achieve a steadier distribution of scientists across all ages, now and in the future.

David Blau and Bruce Weinberg (both from Ohio State University) describe in PNAS other factors that influence the age distribution of the scientific workforce. They used National Science Foundation and US Census Data to show that the aging of the scientific research workforce cannot be solely attributed to wider demographic changes; in other words, it’s not just that the population as a whole is aging. In 1993, there was relatively little association between age and the proportion of the general workforce made up by scientists. In 2010, the situation is decidedly different – with scientists over age 55 making up a greater proportion of the general workforce. The authors’ models suggest that the elimination of mandatory retirement in 1994 played a substantive role in these changes.

Blau and Weinberg, Proc Natl Acad Sci U S A., 2017 Apr 11;114(15):3879-3884. doi: 10.1073/pnas.1611748114.

The authors examined other factors – including rate of PhD completion, changes in mortality, and representation of foreign-born PhDs in the US workforce – and found that these factors have little impact on the steady state distribution of the scientific workforce. By determining the rate at which individuals transition from scientific employment to non-employment, and modelling the implications of these rates on the future workforce, they predict an even further, and substantial, increase in the aging of the scientific workforce over the coming years.

Besides stabilizing in the scientific research enterprise, why else might we be interested in the data presented in the Charette, et al., Levitt & Levitt, and Blau & Weinberg papers? There are data that show the benefits of funding investigators of all ages. In a November 2016 Science paper, and February 2017 Science essay, Sinatra et al. present data on the careers and pattern of major discoveries of a broad group of scientists. Among computer science faculty, the most highly productive years – as measured by published papers – occurs within 8 years of starting their laboratory. However, among most scientists, including those in the life sciences, highest impact discoveries are not concentrated in the early-career stage, but rather are randomly distributed across early, mid, and late stage researchers. The authors argue that they “offer empirical evidence that impact is randomly distributed within the sequence of papers published by a scientist, implying that temporal changes in impact during a scientific career can be explained by temporal changes in productivity, luck, and the heavy-tailed nature of a scientist’s individual impact distribution.” This evidence suggests value for policies that offer funding support for scientists across all career stages.

Categories: NIH-Funding

Implementing a New Human Subject and Clinical Trial Information Form

Wed, 10/11/2017 - 15:21

We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.

The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms. It allows us to capture structured and semi-structured descriptive information for each study included in a grant application or contract proposal, which will allow us to clearly identify which funded studies will require registration and timely reporting of results.

Each study record requires a minimum number of requested data elements. This starts with leading the applicant through the four questions that determine whether the study is considered by NIH to be a clinical trial. (See our August 11 post, 4 Questions for Researchers and Institutions Involved in Human Subjects Research for more on the NIH definition of a clinical trial.) The answers to those questions will determine whether or not the applicant will need to complete Section 4 of the form, the “Protocol Synopsis.” The form will help in peer review and will enable NIH to answer important questions, like how many clinical trial studies we are funding, the phase of those trials, and how many have as their primary purpose treatment evaluation or fundamental discovery.

Some information collected in this form is information that you likely would have included in the application elsewhere, either in the protection of human subjects attachment or in the research strategy. Now we are capturing that information in a structured format, which supports better monitoring of the studies by NIH staff after award. It also serves the purpose of leading the applicant or contractor through each of the elements we expect them to consider as they are planning for their grant application or contract proposal, which we expect will make for stronger applications. Collecting the protocol synopsis, study population characteristics, recruitments plans, and plans for statistical design and power in one place will also allow reviewers to more easily locate and evaluate these critical elements. For delayed onset studies, those studies for which the details are not known at the time of application, grantees will submit this information to NIH through the eRA Commons once it is known.

One question we are often asked is whether the information collected in the new form will be duplicative of the information provided in the research strategy. That is not our intent. The form allows you to spell out methodological details in the study record, allowing more space in the research strategy for higher-level descriptions and justifications of your experimental design(s) and methods.

A key element in the design of the form is that we were careful to be consistent with the data elements required for Clinicaltrials.gov reporting, which will help with data reuse and exchange between systems.

If you haven’t seen the new form, we have a 9 minute video  that will guide you through and give you a good idea of how it works. The form will be included as part of the Forms-E application packages, which you will be required to use for all grant applications submitted for due dates on or after January 25, 2018. You will see the form associated with funding opportunity announcements as early as the very end of October/early November.  We expect to make the PHS Human Subjects and Clinical Trial Information form available for Requests for Proposals for contracts posted as of January 25, 2018 as well. We recently published the instructions for FORMS-E (HTML/PDF) if you want to take an early look.

Categories: NIH-Funding

Patents and the Relative Citation Ratio: Correlations to Assess NIH Impact

Mon, 09/18/2017 - 14:52

We previously referenced Ioannidis’ and Khoury’s “PQRST” mnemonic for describing research impact: “P” is productivity, “Q” is quality, “R” is reproducibility, “S” is sharing, and “T” is translation.  We wrote several blogs about “P,” productivity, focusing on publications, citations, and more recently the Relative Citation Ratio.  Now we’ll focus on a different kind of “P” for productivity, namely patents (which arguably are also related to “T” for translation).  We’ll also take a brief look at “S” for sharing.

In the April 7, 2017 issue of Science, Danielle Li [now with the Massachusetts Institute of Technology (MIT)], Pierre Azoulay (MIT), and Bhaven Sampat (Columbia University) published an investigation on the patent productivity of NIH grants. They identified over 365,000 grants NIH funded between 1980 and 2007, and linked them to patents. Two kinds of links were identified: “direct” links in which a patent cited an NIH grant, and “indirect” links, in which a patent cited a paper which in turn acknowledged support from an NIH grant.

The authors found that close to 10% of grants directly generate a patent. That’s remarkable!  But perhaps even more so, nearly 30% of grants generate a paper that is later cited by at least one patent. Even more remarkable, grants directly and indirectly generated patents whether they were “disease-targeted” or not, “patient-oriented” or not, or linked to a Request For Application or not. And, large proportions of grants assigned to different models directly and indirectly generated patents – models including humans, primates, rodents, invertebrates, multicellular eukaryotes, unicellular eukaryotes, prokaryotes, and viruses.

Another noteworthy feature of this paper is that the authors freely shared their data and statistical code. We took advantage of this to ask a question: do NIH-supported papers that are cited by patents have a higher Relative Citation Ratio than those that are not cited by patents? As a refresher, the Relative Citation Ratio uses citation rates to measure the influence of a publication at the article level

We identified 119,674 unique NIH grants that were funded between 1995 and 2007 and that generated at least one publication. Of these grants, 46,002 (38%) generated at least one publication that was later cited by at least one patent. The grants generated 1,241,307 publications that appeared between 1995 and 2015; of these, 103,421 (8%) were cited by at least one patent.

Figure 1 shows a box plot of the Relative Citation Ratio of papers that were or were not cited by at least one patent.  The Y-axis (Relative Citation Ratio) is log-transformed to reflect the log-normal distribution. Papers cited by a patent had a higher Relative Citation Ratio (median 1.75, IQR 0.85-3.62 compared to papers not cited by a patent median 0.97, IQR 0.46-1.91). For convenience, we drew a dotted line through the median value of RCR among the papers cited by a patent. The large dots represent the mean RCR values.

Figure 1

Figure 2 shows the Relative Citation Ratio of papers according to the number of patents citing them.  There is a gradient, with Relative Citation Ratio increasing as papers are cited by zero, one, two, three, or more than three patents (median values of 0.97, 1.46, 1.66, 1.87, and 2.40).  For convenience, a dotted line goes through the median RCR (1.46) for papers citing one patent.

Figure 2

Taken together, the data presented here suggest that the number of publications cited by a patent positively correlates with a higher relative citation ratio. In other words, when patents cite a publication, that article is also likely to be highly influential in its field.

These preliminary findings show one way we are continuing to explore research impact beyond bibliometrics. Though helpful, focusing on bibliometrics alone does not completely capture productivity and impact of our funded research programs. The analysis we present here attempts to build upon prior work by adding yet another instrument to our toolbox.

We recognize that this correlation between patent citation and relative citation ratio may be correlative, not causal. With that noted, both measures do still provide us with a glimpse into the influence of the NIH research portfolio. Our findings are consistent with prior findings showing that the relative citation ratio also correlated with post-publication peer review.

And finally, the “S,” sharing that is…

We are pleased to hear about ways researchers use our data to empirically analyze the productivity of NIH-supported research. We congratulate the authors of the Science article, and commend their willingness to share their data. We progress towards our goal of enhanced transparency and stewardship when researchers share data with each other and when funding agencies share administrative data. Ultimately, sharing information this way is how we, together, improve human health and reduce illness and disability.

Categories: NIH-Funding

Continuing to Clarify the NIH Definition of a Clinical Trial

Fri, 09/08/2017 - 14:47

A few weeks ago we released some case studies and FAQs to help clarify for our research community whether their human subjects research study meets the NIH definition of a clinical trial. These resources prompted a number of follow-on questions and thoughtful suggestions from the community that have helped us refine both the FAQs and the case studies. We are grateful for your thoughtful and constructive comments and suggestions, many of which we have incorporated into our revised documents and communications.

In addition to providing additional rationale for our conclusions in the case studies, we made a number of changes, to include clarifying: what it means to be “prospectively assigned”; what we consider to be a “health-related biomedical and behavioral outcome”; how to classify “ancillary studies”; in what circumstances we would consider a mechanistic study to be a clinical trial; the use of surveys, questionnaires and user preferences; and more.

One of the key clarifications is the distinction between an observational study and an interventional study. There was a lot of very productive discussion around case study 18, which resulted in our breaking the one case study into 6 variations on a theme. The new case studies 18 a-f should help the community understand the nuances of when a measurement is a measurement, and when a measurement tool or task is considered an intervention.

The case studies and FAQs are living documents. We fully expect them to evolve as we work together to think through various scenarios. Unsure whether your human subjects study meets the NIH definition of a clinical trial? Ask the NIH program official (scientific contact) listed in the funding opportunity announcement or on NIH’s website who is responsible for your area of research.

It is important that we get this right. We have an ethical mandate to assure the public that the results of all NIH-funded trials will be made available in a timely manner. We know that under the current state of affairs, over half of all completed NIH-funded trials are not reported out within 2.5 years of completion; the problem is widespread and pervasive. This is an unacceptable state of affairs; it should not be optional to report results. We look forward to continuing to work with you as we move towards higher levels of trust and transparency.

Categories: NIH-Funding

NIH’s Certificates of Confidentiality Policy Enhances Confidentiality of Participants Enrolled in Clinical Research Studies

Thu, 09/07/2017 - 17:59

A few months ago we blogged about our plan to release an updated Certificate of Confidentiality (CoC) policy. Today, we are pleased to announce that we have published the new policy (NOT-OD-17-109), which will go into effect on October 1, 2017. The new policy both enhances the privacy protections of individuals participating in NIH funded research studies and eliminates the need for NIH funded investigators to apply for a CoC.

To help protect the privacy of research participants, NIH has for many years issued CoCs, upon request, to researchers collecting sensitive information about research participants. The CoCs protect researchers and institutions from being compelled to disclose information in response to legal demands that would identify their research subjects.  Section 2012 of the 21st Century Cures Act authorized new provisions governing the authority of HHS to protect the privacy of research subjects.  The new policy implements the new CoC statutory requirements.

Under the new policy, as of October 1, 2017, NIH funded researchers will no longer have to request a CoC, nor will they receive an actual certificate. The CoC will be issued automatically to NIH funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that collects or uses identifiable, sensitive information. Compliance with the requirements of the law will become a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is issued a Certificate through this policy.

The CoC protects the privacy of subjects by limiting the disclosure of identifiable, sensitive information. Under the new policy, disclosure is not up to the discretion of the investigator. Disclosure is only permitted in the following circumstances:

  • if required by other Federal, State, or local laws, such as for reporting of communicable diseases
  • if the subject consents; or
  • for the purposes of scientific research that is compliant with human subjects regulations.

The restrictions on disclosures apply to all researchers or research institutions previously issued a CoC who are engaged in research.

A point that is important to understand is that if your research is covered by a CoC, you are required to ensure that any investigator or institution with whom you share a copy of the identifiable sensitive information that is protected by the policy understands that they are they are also subject to the disclosure restrictions, even if they are not funded by NIH.

If you have non-Federal funding,  NIH will continue to consider applications for CoCs for applicable non-federally funded research submitted to our institutes and centers through our existing online CoC application system.

We have noted the changing policy on our CoC website and will be overhauling the page to align with the new policy for the October 1, 2017 policy implementation date.

Categories: NIH-Funding

Have You Seen the Loan Repayment Program Recently? Here’s What You Missed

Tue, 09/05/2017 - 16:43

As I reflect on the research training I received during and after medical school, I recall how lucky I was that I did not have much resulting debt and severe financial constraints that could interfere with my research career. Unfortunately, today’s aspiring physician scientists are often mired in debt. The Association of American Medical Colleges estimates that two-thirds of medical students graduate with debt, with 80% of those students owing at least $100,000.

How can we alleviate the rising debt accrued during biomedical training for those investigators seeking a foothold in the lab? The NIH loan repayment programs (LRPs), managed inside the Office of Extramural Research, is one approach the NIH is utilizing to stabilize career trajectories for talented investigators. My predecessor, Dr. Sally Rockey, understood and also championed the impact of the LRPs, and I share her enthusiasm.

Congress established the first NIH LRPs nearly a quarter century ago to recruit and retain highly qualified health professionals into biomedical or behavioral research careers. If a researcher is awarded this opportunity and commits to studying diseases and conditions important to the NIH mission, the agency will repay up to $35,000 annually, over a two-year contract, towards their qualified educational debt. Individuals can also reapply for and receive LRP support if they continue conducting qualifying research and making significant strides in their career.

As you can imagine, we are motivated to share the successes and impact of these opportunities. NIH recently assessed career outcomes, as an example, of recipients of LRPs in 2003-2009. Preliminary results suggest that many awardees, for example, apply for and receive more peer-reviewed research grants as well as publish in scholarly journals, when compared to those who did not receive an LRP. These data suggest that individuals are remaining in active research careers and contributing to the advancement of biomedical knowledge and discovery long-term – just as the programs intended.

I’d like to highlight a few other recent updates that will help further promote this program with researchers and supportive stakeholders across the country.

First, to further support increased transparency and reporting of NIH data, we recently launched a new feature to provide access to a wealth of data regarding the NIH LRPs. The LRP dashboard allows users to easily access, visualize, and export trend data about the programs via a bold, new interface.

Figure 1 – LRP Dashboard widget showing the number of LRP applications and awards by degree category for FY 2013-2016. Data can be filtered by year and by LRP or award type within the dashboard by utilizing the pulldown and slide features.

The dashboard provides information regarding program funding (total and by IC), program success rates, the number of annual program applications and awards (by program and degree status, e.g. M.D., Ph.D., M.D./Ph.D., etc., as shown in Figure 1), and an interactive map highlighting the number of awardees by state (Figure 2).

Figure 2 – LRP dashboard widget showing distribution of LRP awardees by state FY 2013-2016. Data can be filtered by year and by LRP or award type within the dashboard by utilizing the pulldown and slide features.

Second, just like when diplomats foster relationships between the United States and other countries, LRP ambassadors serve as a personalized link between the NIH LRPs and investigators in the extramural community. Consisting of a nationwide network of current and former LRP recipients, these talented individuals share their personal experiences, provide advice on the application process, and support the perspective within their local scientific community. We invite you to search the directory to locate a nearby LRP ambassador if you are interested in applying.

Already an awardee and wish to serve your community further as an Ambassador? Feel free to visit the Directory as well for more information on the process and resources. There are currently already over 500 individuals like you across the country energized and committed to extolling the benefits of these invaluable NIH programs.

The LRP online application is open each year from September 1 to November 15. We recommend potential applicants begin by first engaging with LRP program officers within the NIH institutes and centers (ICs) before submitting their application. These individuals can help you understand the potential benefits of these programs to your career, explain eligibility criteria, as well as discuss the research and funding priorities for LRPs at their IC. These staff regularly attend scientific conferences as well to interact directly with the community and address any questions you may have.

We continue to spotlight these important programs facilitating career stability for investigators struggling with high levels of educational debt. Instead, our awardees can spend their time building a stable research career and making important biomedical contributions to improve public health – ultimately benefiting us all in the long run.

Categories: NIH-Funding

NIH’s Next Generation Researchers Policy Now Posted

Thu, 08/31/2017 - 15:23

Today we posted a policy (NIH Guide Notice NOT-OD-17-101) describing current plans for the Next Generation Researchers Initiative.  Since I first blogged about it in June, NIH leadership have reviewed data (see accompanying blog) and deliberated about how best to proceed.  Our goal is to increase the number of NIH-funded early-stage investigators and assure, as best we can, that funded early-stage investigators have a reasonable chance to secure stable funding during the earliest stages of their independent research careers. This new policy will supersede previous notices on new and early stage investigators (NOT-OD-08-121, NOT-OD-09-013 and NOT-OD-09-134).

The Initiative comes against a backdrop of worsening hyper competition that has led to severe challenges for biomedical scientists early in their career. We understand that these researchers worry  about “desperate pursuit of grants,” reduced time for research, dependence on senior scientists, taking on ambitious avenues, and administrative reporting burdens.

The Next Generation Researchers Initiative represents in part implementation of the Section 2021 of the 21st Century Cures Act. The Act states, “The Director of the National Institutes of Health shall … develop, modify, or prioritize policies, as needed … to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity.” The Initiative is also consonant with our responsibility to be proper stewards of public funds in alignment with goals set forth in NIH’s Strategic Plan for Fiscal Years 2016-2020.

As described in the policy, NIH institutes and centers (ICs) will prioritize meritorious applications that request funding for Early Stage Investigators (ESIs) and for Early Established Investigators (EEIs) who are at risk for losing all NIH funding or who have only one active NIH award. Here are some key definitions:

  • Early Stage Investigator (ESI): A Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years. Furthermore, these applicants would not have competed successfully as a PD/PI previously for a substantial NIH independent research award. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm.
  • Early Established Investigator (EEI): a PD/PI within 10 years of receiving their first substantial, independent competing NIH R01 equivalent research award as an ESI.

As we implement and monitor the Initiative, the NIH Office of the Director and the ICs will, in consultation with a Working Group of the Advisory Committee to the Director, consider evidence-based strategies to identify, grow, and retain ESIs and EEIs. Effective strategies will likely consider factors such as emerging areas of scientific inquiry, needs of the IC portfolios, and projected needs of the scientific workforce.

We have heard many questions about investigators who are new to NIH, but who are at stages in their career that make them ineligible for ESI or EEI status. In keeping with the 21st Century Cures Act’s call for “earlier research independence,” our focus in this Initiative will be to enhance funding opportunities for ESI’s and EEI’s.  We anticipate that individual ICs will seek to fund other more senior investigators who are new to the NIH system through specific programs as well as select pay.

We recommend that you confirm your dates of terminal degree and post-graduate clinical training is correct in eRA Commons. This will help ensure we can apply your eligibility appropriately to receive funding consideration under the policy. On a case by case basis, NIH will consider requests to extend the ESI or EEI period if you experienced a lapse in your research or research training (e.g. medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, or active duty military service).

We invite you to visit the Next Generation Researchers Initiative web page for more information. We appreciate hearing your ongoing feedback as we implement and develop this mission-critical Initiative.

Categories: NIH-Funding

Data On Trends According to Career Stage

Thu, 08/31/2017 - 15:12

By the 21st Century Cures Act, the Next Generation Researchers’ Initiative calls on the NIH to develop policies to increase funding opportunities for new researchers seeking to secure early independence. To put the Initiative in perspective and to extend on previous blogs we’ve posted on changing demographics in NIH-funded researchers, we thought it would be useful to explore trends according to career stage.

First, some definitions.  We define “Early Stage Investigators” (ESI) as those who are within 10 years of completing their terminal degree or post-graduate clinical training and who have not yet secured independence as a PI of a substantial NIH research award.  We define “New Investigators (Not ESI)” as those who have not yet secured independence as a PI of a substantial NIH research award but are more than 10 years from completing their terminal degree or clinical training.  We define “Early Established Investigators” as those who are within 10 years of receiving their first substantial NIH award and who received their first substantial NIH award as an ESI.  Finally, we define “Established Investigators” as all others.

Second, for the most part we will focus on competing R01-equivalent applications and awards – these include R01, R23, R29, R37 and RF1 activity codes.

In 2016, NIH received competing R01-equivalent applications from 24,498 unique applicants: these included 3,729 Early Stage Investigators (15%), 4,813 New Investigators who were not ESIs (20%), 3,461 Early Established Investigators (14%), and 12,495 Established Investigators (51%). Figure 1 shows box plots for age distribution by career stage. Age increases as we move from Early Stage Investigators to Early Established Investigators to New Investigators (Not ESI) to Established Investigators. The age distributions are not particularly skewed, as the means approximate medians in all groups.

Figure 1

Figure 2 shows the number of unique R01-equivalent applicants each year by career stage for each fiscal year since 1995; Figure 3 shows the same data by proportions.  Over time, the proportions of older investigators (New Investigators who were not ESIs and Established Investigators) increased, while the proportions of younger investigators (ESIs and Early Established Investigators) declined. (Note: in 2007, NIH introduced the “New Innovator” DP2 awards, and DP2s were not considered part of the R01-equivalent definition for considering ESI status until 2008. For this reason, there is a notable spike in the number and percent of ESI applicants in 2007, and a proportional decrease in the percentage of established investigators applying for R01-equivalents in 2007.)

Figure 2

Figure 3

Figures 4 and 5 show analogous data for awardees. The proportion of awardees who were Established Investigators climbed, while there was a marked decrease in the proportion of awardees who were Early Established Investigators.

Figure 4

Figure 5

Figure 6 shows funding rates by career stage. The funding rate in any given fiscal year is the ratio of unique awardees to unique applicants. Funding rates increased substantially during the doubling (1998-2003) for all career stages, but less so for Early Stage Investigators. Funding rates for all career stages decreased dramatically after the NIH doubling ended in 2003. There were declines in 2013 – the year of sequestration – which were particularly severe for Early Stage Investigators.

Figure 6

One reason why investigators may leave the NIH grant system is that they are unable to withstand a failed application if they don’t have other active awards to fall back on.  Figure 7 shows the average number of active substantial awards, according to career stage. As expected, Early Stage Investigators and New Investigators who are not ESIs do not have many active awards. Established Investigators have more active awards and this has increased somewhat over time. Thus, Established Investigators may have an easier time staying in the system.

Figure 7

Established Investigators not only make up a greater proportion of awardees (Figure 5), they also secure, to an even greater extent, a larger proportion of competing award dollars (Figure 8).

Figure 8

Finally, Figure 9 shows the percent of all first-time R01-equivalent awardees who go on to receive at least one more second substantial award within 5 years. For those he received their first award in 1996, over 55% went received at least one substantial award. For first-time awardees in 2011 that value fell to only 38% (and this even accounts for ARRA and the multi-PI policy).

Figure 9

In summary, consistent with changes in demographics, we have seen substantial changes in the career stage composition of R01-equivalent applicants and awardees.  As the Next Generation Researchers’ Initiative will focus on increasing funding for Early Stage Investigators and Early Established Investigators, we may see some turning of the curves.

Many thanks to the Statistical Analysis and Reporting Branch of the NIH Office of Extramural Research for their work on this analysis.

Categories: NIH-Funding

Monitoring the Impact of Hurricane Harvey on Research

Thu, 08/31/2017 - 10:09

The devastating effects of Hurricane Harvey cause deep concern about the health and safety of people and animals, and about the health of the biomedical enterprise in the affected areas. While everyone’s immediate efforts need to be focused on getting through this immediate crisis, we want to assure our applicant and grantee community that NIH will be doing our part to help you ensure your research continues. We issued a Guide notice reminding the community about our natural disaster policy, Reminder: NIH Natural Disaster Policy – Hurricane Harvey. To give you an idea of the ways NIH can help in these situations, our website on Extramural Response to Natural Disasters has a list of available resources, including guidance on animal welfare issues.

A recent National Academies study, supported in part by NIH, highlighted the importance of the research community working together to build resilience in the face of natural disasters. These recent events underscore their recommendations to work together to continue this dialog.

Following Hurricane Katrina and Hurricane Sandy, we issued supplemental funding due to the severity and devastating effect of these storms. For major disasters such as these impacting many institutions, NIH coordinates with other Federal agencies (such as HHS, FEMA and OMB), as well as with state, local, and institutional representatives, to develop any additional response.  We consider issues as whether a Federal Disaster is declared; the severity of damage inflicted; the length of time needed for the institutions to recover; the impact on investigators, human research participants, and animal subjects, and the overall impact on the community. We will be continuing to monitor the situation closely, identifying ways we can help as outlined on this page and we will publish additional information in the NIH Guide.

Our thoughts are with all of you affected by this crisis.

Categories: NIH-Funding

4 Questions For Researchers and Institutions Involved In Human Subjects Research

Fri, 08/11/2017 - 13:01

Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on ClinicalTrials.gov, and required use of single IRBs for multi-site studies. We are now entering the final phases of implementation of these initiatives – so, if you are contemplating research involving human subjects, please read on.

We’ve received queries from members of the research community seeking clarity on whether their human subjects research will be affected by these new policies, and if so, how. So, we want to call your attention to four questions researchers involved in human  studies need to ask, and answer. These questions are:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then we consider your research a clinical trial.

The NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. The definition was published in 2014, after extensive public input, and affirmed, after even more public input, in our policy published in September 2016. The clinical trial definition encompasses a wide variety of study types, as shown in figure 1. These range from mechanistic studies to behavioral studies, to pilot/feasibility studies, all the way to large-scale efficacy and effectiveness trials.

Figure 1

The breadth of the NIH definition is intentional, given the nature of the NIH portfolio and imperatives for maximal transparency. Transparency shows respect for the participants who put their trust in us, in the face of unknown outcomes, to help advance science. Our concerns about transparency stem in part from the issues surrounding the reporting of clinical trials data. For both NIH-funded and non-NIH funded trials, unreported data and untimely dissemination of results has been documented over and over again.  Others have expressed concern that the NIH has not collected needed trans-NIH data to enable it to function as proper stewards of clinical trials.

Some have argued that we should not expect trial registration and reporting for small or exploratory trials, for trials that focus on safety, or for trials that fail to meet enrollment targets. As we stated last September, NIH chose to emphasize the value of transparency for these kinds of trials as well, as “the benefits of transparency and the need to fulfill the ethical obligation to participants is as relevant to these types of trials as to any other type.”  We have an ethical obligation to report results, and this is especially true when volunteers contribute their time as study participants in prospective experiments, whether large or small. And, to be effective stewards of precious and constrained taxpayer monies, we need to collect a minimum of standardized data.

This transparency complements existing efforts to promote data sharing, public access to NIH-funded research results, and scientifically rigorous research design, all of which ultimately benefit the research community directly, as well. By developing and sharing robust data, we maximize the value of NIH’s investment in research by allowing scientists to build upon solid results. The definition, and our clinical trial policies, are an integral part of our efforts to enhance scientific stewardship, dissemination of information, transparency, and to excel as a federal science agency that manages for results.

Why is it important to know whether you are proposing to conduct a clinical trial? Correctly identifying whether your study is a clinical trial is crucial to complying with NIH policies, many of which are now in effect,  such as registering and reporting all NIH supported clinical trials in ClinicalTrials.gov and good clinical practice training. Very soon, your answer will be crucial to picking the appropriate NIH funding opportunity for your application, writing your research plan correctly (since some information will be captured in the new human subjects and clinical trials form), and ensuring that your application includes all the information required for peer review.

If you are having difficulty answering the four questions that determine whether a study meets the NIH definition of a clinical trial, we encourage you to consult the case studies and FAQs that are available on our webpage on clinical trial requirements for grants and contracts. We’ll be following up with additional blogs and NIH Extramural Nexus articles that provide more depth on the various initiatives. We strongly encourage you to look at these materials, and share them with your colleagues, to ensure that as an awardee conducting clinical trial research, you are aware of the need to register your trial and report its results.

Categories: NIH-Funding