FundScience Blog

According to a news release today, CSR is sending invitations to about 2,500 members of the scientific community to become members of their new “College of CSR Reviewers,” which will review NIH applications in a process similar to journal reviews. College reviewers will review up to 12 applications a year for a 2-year period and may be eligible for the continuous submission policy. College reviewers typically will be asked to review one grant application in their area of expertise within 2 weeks, mainly as “mail-in” reviews as part of a 2-stage review process (as occurred with the Challenge Grants – mail-in reviews and editorial board review).

Stay tuned for more details and watch for that special invitation from CSR in your own in-box.

AHRQ Announces Changes to Peer Review Processes, Evaluation Review Criteria, and New Application Forms for Grant Applications

AHRQ will be adopting many, but not all, of the procedures currently being implemented by NIH under the NIH Enhancing Peer Review initiative. This includes implementation of enhancing review criteria for evaluating the scientific and technical merit of research grant applications submitted to AHRQ through the peer review system.

AHRQ will also use the new, restructured versions of the paper PHS 398 and electronic SF 424 application packages, including changes to the Research Plan (i.e., Research Strategy with sections for Significance, Innovation, and Approach), Resources (environment), and Biographical Sketch.

Original new and competing renewal applications that were submitted prior to January 25, 2010 will be permitted two amendments (A1 and A2). For these “grandfathered” applications, AHRQ expects that any A2 will be submitted no later than January 7, 2011, and AHRQ will not accept A2 applications after that date.

BUT …

AHRQ will not be using the new, significantly shorter page limits announced but will instead maintain the page limits it currently uses. However, each AHRQ FOA will specify the page limit requirements for the Research Strategy section of the grant application.

Also, AHRQ will not be using the designation of Early Stage Investigator (ESI) on grant applications.

Recovery Act 2009 Limited Competition: Expansion of Research Capability to Study Comparative Effectiveness in Complex Patients (R24)

No LOI
Application Receipt Date: January 20, 2010

The total costs cannot exceed $1M per award. Funding may be sought for up to 2 years. The anticipated number of awards is 12.

AHRQ is soliciting grant applications from applicant organizations that propose to build or enhance partnerships, datasets and methodologies that will increase the capacity of high quality epidemiologic and comparative effectiveness research to be done that will inform the health system of the future in its ability to care for people of all backgrounds with multiple chronic illnesses (referred to as Complex Patients). The Research Plan component of the application may not exceed 35 pages, including up to 25 pages to describe the infrastructure and up to 10 pages to describe the small research project.

Mary Barton, M.D.
Center for Primary Care, Prevention and Clinical Partnerships, AHRQ
Agency for Healthcare Research and Quality
Telephone: (301) 427-1638
Mary.Barton@ahrq.hhs.gov

from Edward Ross (Division of Nephrology, Hypertension & Transplantation, UFla) in The Lancet today …

To die while awaiting the review… alone.
Ernest Hemingway

It is the nature of reviews to be late.
Aristotle

I invented slow manuscript reviews.
Al Gore

There is more to life than simply increasing the speed of manuscript reviews.
Gandhi

I deny reviewing any author. What is your definition of reviewing?
Bill Clinton

Am I late, did I miss the date? It is so sad, this work is bad.
Dr Seuss

Imagine all the reviews in the world being returned, on time, in peace.
John Lennon

Hasten the review slowly.
Augustus Caesar

All things come round to the author who will but wait.
Henry Wadsworth Longfellow

The review isn’t over until it’s over.
Yogi Berra

Never in the field of manuscript conflicts was so much owed by so many authors to so few tardy reviewers.
Winston Churchill

Is the review really late, or is the rest of the world moving faster?
Albert Einstein

Based on widely-circulated web humour, “Why the chicken crossed the road” (anon).

Conflict of interest statement: ‘Tis better to have published a letter in The Lancet than never to have published there at all.

Recovery Act 2009 Limited Competition OS ARRA: Comparative Effectiveness Research to Optimize Prevention and Healthcare Management for the Complex Patient (R21)

Letters of Intent Receipt Date: January 8, 2010
Application Due Date: January 20, 2010

Research Plan component of the application may not exceed 15 pages

12-18 awards anticipated – AHRQ will fund three types of projects:

Epidemiologic descriptions based on secondary analysis of large data sets of specific chronic illnesses for which there are no recently assembled data which describe the natural history, impact on quality of life over time, and life expectancy. In addition to describing the natural course of the disease, applications must describe the cumulative burden of therapies for the conditions over time, such as the number and types of medications, other recommended treatments, and services for tertiary prevention. Applications should describe at least 2 chronic illnesses, and applications will be greatly strengthened if they include descriptions of the epidemiology of the conditions for individuals, both with and without co-morbid chronic conditions. At least one of the chronic conditions must be one of the priority conditions identified above. Applications must clearly document either the lack of published information describing the epidemiology of the condition, or the need to update information due to developments in treatment that have altered the condition’s epidemiology. AHRQ expects a focus on priority population groups, including racial and ethnic minority populations. Studies that focus on this type of secondary data analysis are expected to be proposed with project period total cost budgets in the range of $250K to $375K and take 12-18 months to complete. Applications in this category that exceed $375,000, or 18 months, will not undergo peer review.

Analytic epidemiologic studies, e.g., using a retrospective cohort design, that assess the benefits and harms of preventive or therapeutic interventions in “real world” settings for patients who have multiple chronic co-morbid conditions. These studies would need to use cohorts with sufficient clinical data, and to use innovative statistical techniques in order to determine the relative positive and negative impacts of prevention/therapy in a population with comorbid illness compared to an otherwise healthy population. Studies of this type are expected to have project period total costs in the range of $400K to $500K, and take up to 2 years to complete.

Modeling studies that use accepted techniques to project the impact of recommended chronic disease interventions and preventive services on patients with two or more co-morbid chronic conditions. Both decision models and cost-effectiveness analysis models are acceptable. Expected findings would be expressed in terms of life years gained, quality adjusted life years, or costs per quality adjusted life years. Studies of this type must describe the chronic conditions of interest, treatment guidelines that will be utilized for selecting therapeutic interventions to be modeled, and preventive service(s) to be modeled. At least one of the chronic conditions to be modeled must be one of the priority conditions identified above. The use of nationally-recognized and evidence-based guidelines and preventive service recommendations such as those of the U.S. Preventive Services Task Force are encouraged wherever possible within projects. Models used in these studies should be sufficiently comprehensive to model the impact of the co-morbid condition on issues of competing morbidity and/or mortality, and on benefits and harms of the intervention if appropriate. Modeling projects may use existing data sets or propose conducting an epidemiologic study as foundational to the model. Modeling projects are expected to be proposed with budgets for the project period in the $300K to $500K total costs range and may take between 1.5-2 years.

The objectives of this FOA are to:

-Support comparative effectiveness research to allow prioritization of evidence-based services (testing and treatment) for patients with multiple co-morbidities (including physical and mental conditions), and suggest appropriate adaptations (in timing and frequency) of recommended preventive and care management guidelines for these patients.

-Provide evidence to clarify how co-existing chronic conditions modify the safety or comparative value of proven treatments for chronic diseases and recommended preventive interventions.

-Provide evidence to refine chronic disease quality measures for complex and frail patients.

To achieve these objectives, expected research approaches include mathematical modeling, statistical modeling, or epidemiologic studies that may be based on data from population surveys, medical databases from electronic health records, and possibly insurance claims data. Of interest are modeling projects that use newly developed or existing population-based datasets to estimate how the application and timing of specific, recommended therapeutic and preventive services will affect overall outcomes for the complex patient, especially as the patient ages. Modeling studies must consider how to optimize the management of patients with at least 2 chronic co-morbid conditions and the provision of at least one preventive service or chronic disease intervention. Studies focusing on AHRQ priority populations, including racial and ethnic groups, are encouraged (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). All types of studies are welcome to include a mental health co-morbidity.

Mary Barton, MD, MPP
Center for Primary Care, Prevention & Clinical Partnerships, AHRQ
Telephone: (301) 427-1638
Mary.Barton@ahrq.hhs.gov

Therese Miller, DrPH
Center for Primary Care, Prevention & Clinical Partnerships, AHRQ
Telephone: (301) 427-1585
Therese.Miller@ahrq.hhs.gov

AHRQ Institutional NRSA Postdoctoral Comparative Effectiveness Development Training Award (T32)

Letter of Intent Receipt Date: December 15, 2009
Application Receipt Date: January 20, 2010

The purpose of this program is to support the postdoctoral training of health services and clinical researchers who have made a commitment to focus their research on the generation, translation, and dissemination of new scientific evidence and analytical tools in comparative effectiveness. The award will provide two years of supervised study and research for two cohorts of clinical and research doctorates, with one cohort initiating training in the first year of the grant and the second initiating training in the second year of the grant.

Total project period costs cannot exceed $900,000; 3-year project period; 5-7 awards anticipated; 20-page Research Training Program Plan

AHRQ Mentored Clinical Scientists Comparative Effectiveness Development Award (K12)

Letters of Intent Receipt Date: December 24, 2009
Application Receipt Date: January 20, 2010

The purpose of this program is to support the career development of health services and clinical researchers who have made a commitment to focus their research on the generation, translation, and dissemination of new scientific evidence and analytical tools in comparative effectiveness. The award will provide 3 years of supervised study and research for one cohort of clinical and research doctorates.

Annual total costs cannot exceed $850,000; 3-year project period; Total project period costs cannot exceed $2.55 million; 5-7 awards anticipated; 25-page research plan

Program Officer (for both RFAs):

Shelley Benjamin
Office of Extramural Research, Education and Priority Populations
Division of Research Education, AHRQTelephone: (301) 427-1528
E-mail: shelley.benjamin@ahrq.hhs.gov

My standard advice is always to apply when the application is ready – strong, competitive, and not submitted just to get feedback (especially now with just one resubmission). I always give caveats on the various standard receipt dates and review cycles, such as Cycle 1 carrying the highest risk of delayed or deferred funding. Now, NIAID (who else) has a nice table summarizing all this for me.

Other great articles in this week’s issue of the NIAID Funding News cover the roles and responsibilities of the Advisory Council , whether securing an R21 helps new investigators receive an R01 later (yes, by a 2:1 ratio), and conducting your own “peer review” prior to submitting an application to the NIH.

Take a gander at the budget levels, particularly on the U13 … that will be one heck of a comparative effectiveness shindig.

ARRA-AHRQ Recovery Act 2009 Limited Competition: PROSPECT Studies: Building New Clinical Infrastructure for Comparative Effectiveness Research (R01)

The total costs for a grant awarded under this FOA are expected to range from $1.5 million to $3 million total costs per year. Total costs may not exceed $3 million annually. The duration of the project may not exceed 3 years. The grantee is required to accelerate the work where and when feasible. A maximum of 5 awards will be made. 25-page narrative.

The primary purpose of the PROSPECT (Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies) Studies will be to advance the quality, depth and scale of the electronic data collection infrastructure as a basis for comparative effectiveness research. The projects will substantially enhance the nation’s ability and capacity to systematically collect prospective data that will inform comparative effectiveness research on diagnostics, therapeutics, devices, behavioral interventions, and procedures used in clinical care, especially in populations typically under-represented in randomized control clinical trials or that have limited access to healthcare, or both, such as patients with multiple co-morbidities, extremes of age, and minorities.

ARRA-AHRQ Recovery Act 2009 Limited Competition: Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (U13)

The total costs are $4 million over a maximum of 3 years; AHRQ anticipates making one award. 20-page narrative.

The Electronic Data Methods (EDM) forum will convene investigators who are conducting PROSPECT studies on comparative effectiveness of clinical interventions used in priority conditions and populations, other experts in clinical registries, distributed research methods, health information technology and outcomes research, practicing clinicians, representatives from relevant organizations, and other stakeholders as needed. The EDM forum, through a series of meetings and workshops, will identify the challenges to conducting comparative effectiveness research using electronic data, including but not limited to scientific, technical, organizational, clinical, legal, and ethical issues, and challenges related to compliance with HIPAA. The EDM forum will propose realistic solutions to such challenges, or outline a research agenda and/or discussion that will advance resolution of the issues identified by the forum.

For both FOAs:

LOI receipt date: December 18, 2009
Application receipt date: January 20, 2010

Scientific/Research Contact:
Amy Lindinha
Center for Outcomes and Evidence, AHRQ
Telephone: (301) 427-1600
E-mail address: PROSPECTgrants@ahrq.hhs.gov

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application (includes the preliminary application and letter of intent phases of the program), by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:

• the communication is purely logistical;
• the communication is made at a widely attended gathering;
• the communication is to or from a Federal agency official and another Federal Government employee;
• the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or
• the communication is initiated by the Federal agency official.

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Rashanda Robertson, former Research Coordinator, Department of General Medicine, Emory University, engaged in research misconduct in research supported by grant K23HL077597. Specifically, the Respondent admitted that she fabricated enrollment forms to create enrollees who did not exist and falsified the data of some enrollees who did not exist to cover up the data fabrication. To create the fabricated enrollment forms, the Respondent:

• Identified patients who were eligible for the study based on their charge screens but who were considered ineligible after a face-to-face screen;
• Obtained patients’ names from the screening records and used the names to obtain the personal information (address and telephone numbers) on these patients from the site hospital’s pharmacy online system;
• Created a fabricated enrollment form for each of the non-existent enrollees; specifically, Respondent fabricated a participant’s name by using the name of a patient who had failed screening and then fabricated the date of enrollment by using the date of the patient’s screening failure; using this method, Respondent fabricated the participant names, personal information, and enrollment dates on twenty-eight (28) enrollment forms;
• Dispersed the fabricated enrollment forms among those enrollment forms, beginning around participant number 136 through 212;
• Falsified the numbering of the enrollment forms for some individuals who had actually been enrolled to disperse the fabricated enrollment forms among the authentic enrollment forms; Respondent falsified the status of some actual participants to include them in the intervention group, even though they had not actually received the intervention; Respondent falsified the data on both the enrollment form and the follow-up form for 16 participants between numbers 137 and 198;
• Respondent falsified data on the enrollment forms and follow-up forms for participant numbers 153 and 154 by changing their enrollment numbers.

ORI acknowledges that the Respondent was remorseful.

Fortunately, the K23 PI has been quite productive in terms of publications (per RePORTER Results tab) and has taken a new position with promotion … but no R01 or other mechanism funding as yet (though K23 was suspended/extended from Sept 2007 to June 2010, probably due to change in institution and misconduct investigation).

The Annals of Internal Medicine has a report entitled Sex Differences in Attainment of Independent Funding by Career Development Awardees … but I found the overall attainment statistics quite telling. The authors measured the rates at which recipients of K08 and K23 awards (2,784 awardees from 1997-2003 were studied) subsequently secured R01 awards. The bottom line:

Overall, 31.4% of the 1919 K08 awardees and 43.7% of the 865 K23 awardees were female (P < 0.001). Women were less likely than men to receive an R01 award (P < 0.001). The actuarial rate of R01 award attainment at 5 years was 22.7% overall, 18.8% among women, and 24.8% among men. At 10 years, the rate was 42.5% overall, 36.2% among women, and 45.6% among men. Sex persisted as an independent significant predictor of R01 award attainment (hazard ratio, 0.79 [95% CI, 0.68 to 0.92]; P = 0.002) in multivariate analysis controlling for K award type, year of award, funding institute, institution, and specialty.

This is through the 2007 cycle. Imagine the stats in a couple of years.

The authors were looking at a potential blockage in the pipeline to increase the number women faculty and chairs, noting that “in 2007, women constituted 49% of the medical student body but only 33% of medical faculty, 17% of full professors, and 12% of department chairs at U.S. medical schools.” A couple of their discussion point apply to any K awardee though:

K awards are designed to provide both protected time and mentoring to support the research career development of recipients. However, qualitative evidence collected by the NIH (18) suggests that the financial support offered by K awards may sometimes be insufficient to protect three quarters of the recipient’s working time, as these awards are generally intended to do. Some recipients may face pressure to allocate substantial time to clinical activities. To the extent that women receive smaller awards, protecting time for research may be particularly problematic for them.

The quality of the mentoring relationships of K award recipients also merits further investigation and targeted support. Mentoring is essential to the success of junior investigators in general and may be particularly important for female junior investigators (21–24). Mentoring has long been heralded as a mechanism by which to combat sex disparities in the professions. Some studies have suggested that the quality of mentoring received by women may be inferior to that received by men (15, 25), but others have found no differences (26, 27). K awards require recipients to receive designated mentorship. The low rate of R01 award attainment demonstrated in our study raises important concerns about the quality of mentoring within the K award program and whether mentors are prepared to deal with the special challenges female award recipients face.

The authors acknowledged their time frame may have been too short … but, aside from career breaks for family reasons, I don’t know of too many tenure clocks that extend beyond 10 years, even for clinicians, and the idea is for K awardees to secure their R01 during the K support period. It only gets harder once the K runs out.

Success of career development award recipients, who have a demonstrated aptitude and commitment to research and in whom considerable societal resources have been invested, is critical evidence of whether the physician-scientist pipeline is functioning adequately.

Indeed.