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One Year (or so) of “Open Mike”

As the year 2016 ends, my first full year in my new role here at NIH, I’d like to reflect on some of the topics covered here on Open Mike. Thanks to our NIH Regional Seminars, I have had the pleasure of hearing feedback from some of you in person, and I am also greatly appreciative of our virtual interactions, through the thoughtful comments posted by blog readers in this space. Our blog opened on October 19, 2015, when I noted that NIH is an extraordinary success story; even skeptics identify NIH as a government program that works. But at the same time, I also noted that all is not well with the biomedical research enterprise. In many respects, the 50+ blogs that followed have dug deeper into our anxieties and challenges. The sidebar highlights five major themes arising over the past year or so, and blogs related to those categories. To get a sense of community interest, we have also compiled some reader statistics. Further below, Table 1 shows which blogs, as of December 27, received the most page views, and Table 2 shows which blogs received the most comments. These themes, your viewership, and your comments ….

New Application Instructions and Important Reminders for Appendix Sections and Post-submission Materials

As you’re preparing your application for due dates on or after January 25, 2017, be sure to consult the recently updated NIH application guide, which reflects two important changes in our submission guidelines.
As announced earlier this year, you may only include certain materials as an appendix to your application. The only materials that will be accepted in the appendix section are: ….

Improving Visibility of NIH-supported Clinical Trial Activities and Results

In a separate post today, we provide an overview of the various reforms the NIH is leading to enhance our stewardship of clinical trials. In this post we’d like to focus a bit more on our efforts to broadly disseminate clinical trial availability and results information.

Timely dissemination of clinical trial results information has been a problem, one that has been documented more than once, and that appears to apply to NIH- as well as non-NIH funded trials. To realize the benefits of a clinical trial, the findings must be available to the public as soon as possible after the trial has concluded. This is not only responsible use of taxpayer dollars for publicly funded trials, but also fulfills our responsibility to the individuals who volunteered in these studies with an understanding that their participation would contribute to advancing medical knowledge. Today, NIH announced a new policy that will complement a new federal regulation, referred to here as the Final Rule, also released today, to improve the accessibility of information on clinical trial availability and on the outcomes and results of completed trials.

As you likely know, to carry out the laws passed by Congress, federal agencies issue regulations that govern the activities of the agency and the applicable community. The “Final Rule” announced today by the U.S. Department of Health and Human Services is …

Reminder for Fellowship Applicants using FORMS-D

If you are planning to submit a fellowship application for the August 8th due date, be sure to note the following changes that come with the FORMS-D application packages, and the advice highlighted in July’s NIH eSubmission Items of Interest: Among the changes are the addition of several new attachments: …..

NIH and FDA Seek Feedback on Clinical Trial Protocol Template

I’d like to call your attention to an opportunity to provide comments on a proposed clinical trial protocol template, developed by the FDA and NIH, and informed by the guidance set forth by the International Conference on Harmonisation (ICH) E6 Good Clinical Practice. The template provides a standard format, and corresponding instructions and sample text, for…

Bolstering Trust in Science Through Rigorous Standards

Scientists have long considered the research process to be self-correcting; we trust that, even if scientists may sometimes make errors in the lab, those errors will eventually be discovered and corrected as others try to substantiate and extend original research findings. However, as stated in a commentary by NIH Director Francis Collins and NIH Deputy Director Larry Tabak, “A growing chorus of concern, from scientists and laypeople, contends that the complex system for ensuring the reproducibility of biomedical research is failing and is in need of restructuring.”
There are examples that indicate that our processes have room for improvement. For example, a 2008 study ….

Proposed Changes to Human Subjects Regulations Are Open for Comment

As many in the research community know, the “Common Rule” refers to current regulations to protect individuals who participate in research as human subjects. The regulations, which have been in place since 1991, are followed by 18 federal agencies that support research – hence the name. Today I’d like to give you some background on how these regulations – and the conversation around these regulations – have evolved since 1991, and let you know about an opportunity to provide feedback on the modernization of these important rules. ….

Welcoming the Inaugural Director of the NIH Division of Biomedical Research Workforce Programs

I am pleased and excited to announce that in August, Dr. Kay Lund will join NIH as the inaugural director of the NIH Division of Biomedical Research Workforce Programs. As you might recall, the NIH Advisory Committee to the Director‘s Biomedical Workforce Working Group recommended that NIH recruit a leader and establish a dedicated office to guide NIH’s training and development of a well-prepared biomedical workforce….

Tune in to the ACD Meeting Today and Friday

I’m at the December Advisory Council to the Director (ACD) meeting today and tomorrow. Several updates and reports from ACD working groups are on the agenda.

Today, we’ll discuss the whirlwind of activities that NIH and HHS have been involved in related to the 2014 Ebola crisis, and we’ll hear updates on peer review evaluation and workforce diversity efforts. I’ll also be co-presenting with Dr. Sherry Mills, director of the Office of Extramural Programs within OER, and co-chair of the ACD’s Physician-Scientist Workforce working group. ….

Updates to Our World Research Reporting Tool – World RePORT

An article published in Science last week discusses the value of creating a global map of health R&D activity to improve coordination of research and create a “global observatory” for health research. I encourage you to check it out, and I also thought it was a timely reminder for discussing updates to the world research reporting tool I blogged about in March last year. The World Research Portfolio Online Reporting Tool (World RePORT) located at http://WorldRePORT.NIH.gov is an online database and map of research funded by NIH and other members of the Heads of International Research Organizations (HIROs). ….