0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Research Letter |

Trends in National Institutes of Health Funding for Clinical Trials Registered in ClinicalTrials.gov FREE

Stephan Ehrhardt, MD, MPH1; Lawrence J. Appel, MD, MPH2; Curtis L. Meinert, PhD1
[+] Author Affiliations
1Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
2Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, Maryland
JAMA. 2015;314(23):2566-2567. doi:10.1001/jama.2015.12206.
Text Size: A A A
Published online

Clinical trials inform evidence-based prevention and treatment recommendations. The National Institutes of Health (NIH) and the pharmaceutical industry have been major funders of trials. In general, the pharmaceutical industry funds trials that test their own products, whereas the NIH’s funding strategies are not commercially motivated.

In 2005, registration of trials became required for publication in major journals. Registration is also required for trials that meet the definition of an “applicable clinical trial” from the US Food and Drug Administration Amendments Act 801 and that were either initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. There are legal repercussions if sponsors or principal investigators do not register accurately.

We hypothesized that the number of NIH-funded trials has decreased. We investigated trends in funding of trials using the NIH-built database, ClinicalTrials.gov, with a focus on NIH and industry funding.

We downloaded data from ClinicalTrials.gov, searched for “interventional study” and obtained counts of newly registered trials by funder type: “NIH,” “industry,” “other US federal agency,” or “all others (individuals, universities, organizations).” Funder type “NIH,” for example, retrieves records for which at least 1 NIH institute or center has been listed as the sponsor (generally indicating NIH intramural research) or collaborator (suggesting extramural NIH funding).

We searched for date “first received” and the self-reported “study start.” Counts are by year (“first received” and “study start” dates between 2006 and 2014), as of June 26, 2015.

We calculated differences, 95% confidence intervals, and P values (2-sided χ2 test, α level <.05) using Stata version 12.1 (StataCorp).

Examining data according to the first received date, the number of newly registered trials doubled from 9321 in 2006 to 18 400 in 2014 (Table 1). The number of industry-funded trials increased by 1965 (43%). Concurrently, the number of NIH-funded trials decreased by 328 (24%).

Table Graphic Jump LocationTable 1.  Trials Registered in ClinicalTrials.gov From 2006 Through 2014 by Year First Receiveda

During this period of relatively few trials being funded by other US federal agencies, funding from the all others category increased by 7357 (227%). In a random sample of 500 trials in this category, a majority (353; 71%) did not have US-based funders.

Using the study start date instead of the first received date led to differences in counts per year but similar patterns (Table 2). From 2006 through 2014, the total number of newly registered trials increased by 5410 (59%) and that of industry-funded trials increased by 758 (17%). The number of NIH-funded trials declined by 316 (27%).

Table Graphic Jump LocationTable 2.  Trials Registered in ClinicalTrials.gov From 2006 Through 2014 by Year of Trial Starta

From 2006 through 2014, there has been a decrease in newly registered NIH-funded trials, whereas industry-funded trials increased substantially. The decrease in NIH-funded trials may have resulted from a decline in discretionary spending by the US federal government.

The 2014 NIH budget is 14% less than the 2006 budget (when adjusted for inflation).1 An expanding portfolio of NIH research with a flat budget may also have contributed to the decline in NIH-funded trials.

Tracking patterns in trial funding using ClinicalTrials.gov has limitations. First, available data by registration date and study start date differ. A registration date is assigned for all trials, whereas the study start date may have missing values.

In addition, investigators may define study start differently. Registration of ongoing or finished trials during the earlier years may account for larger numbers of NIH-funded trials by registration date relative to study start date. However, trends did not differ.

Second, trend data are valid indicators only to the extent that registration behavior by funding sources is not differential over time. Because of federal regulations, registration of NIH-funded trials on ClinicalTrials.gov is likely to be relatively comprehensive.

If registration behavior has improved over time, we may have underestimated the observed reduction in NIH-funded trials. Also, we do not know if there have been changes in how other trials were registered.

Third, the all others funder category is heterogeneous. It comprises non–US governmental agencies, organizations, universities, and other funders, mainly from outside the United States.

Section Editor: Jody W. Zylke, MD, Deputy Editor.

Corresponding Author: Stephan Ehrhardt, MD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD 21205 (sehrhard@jhsph.edu).

Author Contributions: Drs Ehrhardt and Meinert had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: All authors.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Ehrhardt, Meinert.

Administrative, technical, or material support: Appel.

Study supervision: Ehrhardt.

Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Appel reported receiving grants from the National Institutes of Health to conduct clinical trials. Dr Meinert reported receiving grants from the National Institutes of Health and industry funding to conduct clinical trials. No other disclosures were reported.

Additional Contributions: We are indebted to Jill Meinert (Johns Hopkins Bloomberg School of Public Health) for technical assistance for which she was not compensated.

National Institutes of Health, Office of Budget. Appropriations history by institute/center (1938 to present). http://officeofbudget.od.nih.gov/approp_hist.html. Accessed on June 6, 2015.

Figures

Tables

Table Graphic Jump LocationTable 1.  Trials Registered in ClinicalTrials.gov From 2006 Through 2014 by Year First Receiveda
Table Graphic Jump LocationTable 2.  Trials Registered in ClinicalTrials.gov From 2006 Through 2014 by Year of Trial Starta

References

National Institutes of Health, Office of Budget. Appropriations history by institute/center (1938 to present). http://officeofbudget.od.nih.gov/approp_hist.html. Accessed on June 6, 2015.
CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

6,303 Views
1 Citations
×

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles
Jobs