Monday, October 16, 2017

New NIH criteria for review of clinical trial applications

Beginning with the January 25, 2018 deadline, NIH will instruct reviewers to use additional criteria in the evaluation of grant applications that propose clinical trials.  The full policy change notice is located here.

The additional review criteria are as follows:

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Does the application adequately address the following, if applicable?
Study Design 
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis 
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

Study Timeline
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?  Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Saturday, October 14, 2017

Another video to help you through the new human subjects process

This 9-minute video guides viewers through the various components of the new human subjects form.  Some of this content may also be relevant to research administration personnel.  There is a lot to learn in order to comply with the new policy.

Friday, October 13, 2017

New NIH video to help with human subjects policy changes

NIH recently released a new video tutorial to help applicants understand and comply with the new human subjects research procedures.  These new guidelines will take effect in late January, so if you are planning a proposal submission for the February R01 or other spring and summer deadlines, you must comply with the new policy.  You can view the video here.

Wednesday, June 21, 2017

National Institute for General Medical Sciences (NIGMS) provides grant tips for new applicants

NIGMS has provided a handy page titled Tips for New NIH Grant Applicants.  This list was compiled by soliciting advice from NIGMS staff members.  This is a very introductory list designed for novices who are just learning about the proposal development process.  I highly recommend this list in particular for trainees who are writing career development awards.  The advice may also be helpful to individuals who are writing their first R-series proposals who have had limited training in the area of grant development.

Monday, June 19, 2017

Proposed NIH Cap on Indirect Costs (F&A) is a Research EMERGENCY

There is a strong likelihood that NIH will soon be imposing a cap of 10% indirect costs on all research awards.  This decision will happen soon, and it may take effect by the end of the year.  We need to get the word out and mobilize the scientific community! This is not about politics.  It doesn't matter whether you voted for Hillary, Trump, or Mickey Mouse in the 2016 election.  This is about the future of scientific research in this country.

Why are indirect costs important?  These costs are typically used to fund support staff and resources that help to make research happen.  This includes research administrators, research development personnel, laboratory and animal facilities, and other key research support resources.  In this blog post from approximately 2 years ago, Dr. Sally Rockey, the former Deputy Director for Extramural Research at NIH, included a detailed presentation describing how indirect costs are used.  The formal NIH definition of Indirect Costs is located here.  Here is a great article from AAMC that provides an in-depth explanation of indirect costs and their role in supporting research.

This recent article in Science also helps to better explain the current situation.  Currently, many of the leading academic research institutions have negotiated indirect cost rates with the government that range from roughly 50% to 100%.  This means that, for every $1 spent to conduct a research project, another $0.50-$1 is spent on resources to support high quality research.  A reduction of this magnitude to indirect costs would decimate the infrastructure and ultimately could impact the quality of the science.

Please make your voice heard!  Politicians, NIH decision makers, and the general public need to be informed.  It is hard for many outside of the research world to understand the potential negative impact of this cap, and it is up to us to come together as a scientific community and educate the country as to the vital need for adequate research infrastructure to enable groundbreaking scientific discoveries.

How will we cure cancer if we can't afford to keep the lights on?

Basic scientists: for your viewing pleasure

This video created by the Center for Scientific Review describes the grant submission and review process as it relates to basic sciences.

Friday, June 16, 2017

Helpful video from the Center for Scientific Review with tips for R01 funding success

This video provides some helpful tips for investigators who are trying to get their first R01 funded.  It is easy to forget that your proposal will be reviewed by actual people, who may or may not have scientific expertise specific to your area.  Watch this video for ideas regarding how to make the proposal review process work for you.

Thursday, June 15, 2017

GSI Haters Rejoice! NIH Launches Next Generation Researchers Initiative

Thank you to all members of the research community who made your voices heard in response to the proposed NIH Grant Support Index (GSI).  The GSI would have created a system by which different types of grants were assigned varying numbers of points.  Principal Investigators holding multiple significant grant awards would have been capped based on the point total equivalents of their awards.  The GSI proposal created much concern that team science would be discouraged and that experienced investigators would be penalized.

NIH has listened to our concerns!  Instead of the GSI cap, they have launched the Next Generation Researchers Initiative.  More details surrounding the background and the goals of the new policy are also provided in a recent blog posting from NIH Director Dr. Collins.