We have been busy over the past several months and are happy to announce you can now find helpful resources for stepped wedge group-or cluster-randomized trials (SWGRTs) and more than 15 other study designs and methodological issues on the RMR website.
We have embarked on a series of initiatives at NIH in recent years to enhance the quality, efficiency, accountability, and transparency of our supported clinical research. While we are all making great progress, our concerns about clinical trials that are overly complex, have small sample sizes, or rely on surrogate end points that lack clinical relevance remain. One resource to help address these concerns is the NIH Research Methods Resources website that NIH’s Office of Disease Prevention (ODP) launched in 2017. Since the site was recently revamped, we wanted to spotlight the new available tools and resources that can help you better plan the design, conduct, and analysis of rigorous NIH-defined clinical trials.
Last fall, we launched our newly revamped RePORTER site which made it easy to find information about specific NIH supported grants, investigators, and institutions. Today, we are adding to RePORTER’s functionality with a modernized version of MyRePORTER so you can stay on top of the research you care the most about.
With MyRePORTER, you can save searches and set customized weekly email alerts that are sent when new projects are funded or new publications are linked to projects in your search. Email alerts will provide a summary listing of the new items, with hyperlinks to bring you back to MyRePORTER to get more information about the projects and publications.
A few weeks ago, we touted the value of the NIH’s Research, Condition, and Disease Classification (RCDC) system to give us consistent annual reporting on official research budget categories and the ability to see trends in spending over time. RCDC’s robust scientific validation process, which allows for such consistency, provides public transparency into over 280 different NIH budget categories.
RCDC categories do not encompass all types of biomedical research. So, how can we get this type of data for other research areas that are not encompassed in RCDC categories, especially those which are newly emerging fields? Are we able to use the same thesaurus-based classification system to explore other research trends?
The NCATS Trial Innovation Network – A Resource Supporting High Quality and Cost Effective Clinical Trials Available to You
Well-conducted randomized trials are considered the best method of providing evidence about the safety and efficacy of treatments to improve health. Each year, NIH Institutes and Centers spend an estimated $3-4 billion supporting clinical trial activities. These activities require high-level understanding of human biology, of manufacturing and pre-clinical research, and of regulatory requirements. The process of translating a new therapeutic from discovery to practice can be robust, but … at the same time is long and expensive – and despite the challenges inherent in complex, multi-disciplinary research sometimes too long and too expensive.
Over two years ago, NIH rolled out a policy to enhance reproducibility of its supported research through rigor and transparency. Applicants and reviewers were required to devote more attention to four areas: the rigor of the prior research (scientific premise), the rigor of the proposed research (scientific rigor), consideration of biological variables including sex, and the authentication of key biological and/or chemical resources.
When the 21st Century Cures Act was passed later that same year, we were required, amongst other things, to assemble a working group of the Advisory Council to the NIH Director (ACD). These experts were charged with recommending ways to further enhance reproducibility of the research we fund, while being informed by the current policy.
As you know, our NIH Strategic Plan articulated an objective to “excel as a federal science agency by managing for results,” and to manage by results we must harness the power of data to drive evidence-based policies. Sometimes, however, our world can be complicated by requirements to enter the same types of data over and over again in one system after another. These situations do have an upside: they provide us the opportunity to look for opportunities to simplify.
Working with NIH applicants and awardees as an extramural program division director, I often shared the NIH RePORTER resource as a tool for exploring the research topics NIH supports. Learning what projects we support, using a robust database of historical and newly-funded projects (updated weekly), provides researchers valuable insight as they consider developing their own research programs and applications for funding.
Another valuable tool which you might be familiar with is Federal RePORTER, which expands the RePORTER concept to support searching over 800,000 projects across 17 Federal research agencies, with trans-agency data updated annually. As Federal RePORTER recently received an update to introduce some new functions and additional agency data we’d like to highlight some of the ways it helps both the public and scientific researchers alike ….
Do you remember walking into the person’s office down the hall from you when you needed to ask a question, instead of “popping” them an email, instant message, or text? There’s no disputing that the digital age definitely has its advantages – making information sharing faster, cheaper, and more convenient, and allowing us to communicate locally and abroad in seconds. But in this fast paced world of instant communication – the internet, email, and all of our social media choices – sometimes we forget how valuable face-to-face interactions can be. That is exactly one of the reasons I love the NIH Regional Seminars on Grant Funding and Program Administration. The seminars give me the opportunity to join over 60 of my fellow NIH and HHS faculty in sharing our knowledge and perspectives to ….
In the spring, I attended my first NIH Regional Seminar on Program Funding and Grants Administration. I greatly enjoyed meeting with a diverse group of scientists and science administrators. During two “Open Mike” sessions, I had the opportunity to engage in rich conversations with attendees on topics I frequently include on this blog. The conversations were enjoyable and insightful – there’s nothing like discussing such important issues like funding trends, research accountability, and grants policy face-to-face with new and early career scientists. …. Why am I writing about a seminar that took place in May? Because I have some good news for those of you who didn’t get a chance to come to Baltimore! NIH is hosting a second Regional Seminar this year, from October 26-28 …..