Does NIH Expect Completion of GCP Training by the January 1, 2017 Effective Date?

Institutions need not regard the NIH Good Clinical Practice (GCP) policy’s effective date as a deadline by which we expect NIH-funded investigators and clinical trial staff involved in the design, conduct, oversight, or management of clinical trials to complete GCP training. Rather, as long as steps are being taken to meet the expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be completed after the effective date. For more information, …. Continue reading

Do I Have to Take a Particular Good Clinical Practice (GCP) Training Program to Meet NIH Policy Expectations?

The GCP policy does not specify that a particular GCP course or program be taken. The policy includes links to GCP training courses sponsored by NIAID and NIDA. In addition, NCATS has developed a GCP training program geared to behavioral clinical trial investigators. These courses are free of charge. Other free courses as well as fee-based courses are available.

For more information read the NIH Guide notice announcing the policy and other related FAQs. Continue reading

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 …. Continue reading

Characteristics and Outcomes of R01 Competing Renewal Applications (“Type 2s”)

An investigator’s long-term success depends not only on securing funding, but on maintaining a stable funding stream. One way to assure continued funding is to submit a competing renewal application. However, as we noted earlier this year, while new investigators were almost as successful as experienced investigators in obtaining new (type 1) R01s, the difference between new investigator and experienced investigator success rates widens when looking at competing renewals (type 2s), and success rates of new investigators’ first renewals were lower than those of experienced investigators. In addition, we know that since the end of NIH’s budget doubling in 2003, success rates for competing renewals of research project grants overall have decreased. To further understand trends in success rate for R01 competing renewals (“type 2s”) I’d like to share some additional analyses where we look at characteristics of type 2 R01 applications, and the association of their criterion scores with overall impact score and funding outcomes. Continue reading

The 21st Century Cures Act, and Perspectives from NIH

You may have been following news of the 21st Century Cures Act, a landmark piece of legislation with provisions for healthcare, medicine, and research. Republican and Democratic lawmakers supported this bill through its development and eventual passage, and yesterday, President Obama signed the bill into law. The Act establishes a multitude of important changes to our nation’s approach to supporting and funding health care, medical interventions, and research. Readers of this blog may be particularly interested in the many changes directly relevant to NIH’s mission. A New England Journal of Medicine Perspective essay …. Continue reading