New FDA Tools for Investigators and Clinicians
June 4, 2021
The FDA recently released two new tools that were developed for investigators and clinicians: 1) Research IND Pilot Portal and 2) Expanded Access eRequest.
Tag: clinical trial
Is My Ancillary Study Considered a Clinical Trial?
January 8, 2019
It depends. Yes; if the ancillary study adds an additional prospectively assigned intervention to patients or a sub-population of patients within the larger clinical trial and all elements of the NIH clinical trial definition are met. No; if the ancillary study is only adding additional measures to an existing clinical trial.
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You Had Clinical Trial K Application Questions, We Have Answers
August 7, 2018
Are you submitting a K application? Check out some new frequently asked questions (FAQs).
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Are Studies Ancillary to Clinical Trials Considered to be Clinical Trials As Well?
August 7, 2018
It depends. Yes; if the ancillary study adds an additional prospectively assigned intervention to patients or a sub-population of patients within the larger clinical trial and all elements of the NIH clinical trial definition are met. No; if the ancillary study is only adding additional measures to an existing clinical trial.
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Looking for the Latest Definition for Terms Relating to Human Subjects and Clinical Trials?
August 7, 2018
The Glossary of NIH terms now contains definitions for Ancillary Study, Child, Clinical Trial Research Experience, Independent Clinical Trial, and Older Adult.
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Implementing a New Human Subject and Clinical Trial Information Form
October 11, 2017
We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.
The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms ….
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