Medical Device CRO Blog

Conducting International and U.S. Clinical Research

Posted by Kelly Jasko on Thu, Feb 11, 2016

On a recent monitoring visit a Research Coordinator was inquiring about a Sponsor’s international research sites and if there were any specific policies on accepting clinical data from foreign/non-U.S. clinical sites.  For this particular study the Research Coordinator expressed interest on how these sites support a premarket submission study conducted in the United States.

Section 569B of the Federal Food, Drug, and Cosmetic Act states that “In determining whether to approve, license, or clear a drug or device pursuant to an application submitted under this chapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug or device in the United States.” In other words, any data obtained from outside of the United States for a clinical study will be held to the same standards as that data obtained within the U.S. 

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Topics: FDA, U.S. Clinical Research, International Clinical Research

Planned Protocol Deviations- Should Sponsors Notify FDA?

Posted by Jaime Wynbrandt on Tue, Feb 09, 2016

During a routine monitoring visit of a physician-sponsored IDE study, it was noted that the site was receiving “waivers” from the Sponsor to enroll subjects who did not meet one of the anatomical exclusion criteria. A rational was provided on why the subjects were being enrolled in the study. The site submitted the planned protocol deviations to the IRB and received IRB approval prior to enrolling the subjects. The Sponsor did not seek prior approval from the FDA, but did notify them of the deviations via the Annual Progress Report (APR).

From the FDA’s perspective, did the Sponsor do enough?

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Topics: Protocol Deviations, FDA, Sponsor, Physician-Sponsored IDE Study, Monitoring

Sharing of Clinical Trial Data – Considerations for Researchers to Show Their Work...

Posted by Emily Haglund on Fri, Feb 05, 2016

The sharing of clinical trial data has become an increasingly discussed topic in the scientific community and could soon create impacts beyond that of scientists that include the public and those that participate in clinical research. The concept focuses on the sharing of clinical trial data that led to conclusions presented in scientific publications. It is a way for researchers and scientists to “show their work” and support how conclusions were reached.

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Topics: Institute of Medicine, International Committe of Medical Journal Editors, Clinical Trial Data

Study Closure and Final Sponsor Report

Posted by Jaime Wynbrandt on Mon, Feb 01, 2016

We have all had sites that close prior to the study actually being completed. It is always asked if the site’s IRB allows them to close the study and submit the Sponsor’s final report when the study is completed or if the study needs to remain open at the site to allow the final report to be received by the IRB.

If the study needs to remain open with the IRB, this can become time consuming and costly if the study completion is several years away.  The site would need to submit for Continuing Review each year until the Sponsor’s final report is received.

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Topics: FDA, IRB, Sponsor Report, Study Closure

FDA Hits User-Fee ERA Record

Posted by John Lehmann on Fri, Jan 29, 2016

The number of original PMAs for completely high-risk devices and panel track supplements for major new updates approved by the FDA, was at its highest level since 2001.  Approvals increased to 56% in 2015 compared to the previous year and almost double the 2013 total.

So is this the new normal or just a one-year spike? 

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Topics: FDA, CDRH, William Maisel, User Fee, Paul LaViolette

21 CR 812.100: A Medical Auditor's Favorite Regulation

Posted by Mary Lewis on Wed, Jan 27, 2016

I am often asked by industry colleagues that if I had to pick just one “favorite” federal regulation what would it be?  The answer is easily 21 CFR 812.100, as this regulation embodies 95% of the investigational site non-compliances  I observe as I conduct clinical investigator audits. Let me elaborate.

21 CFR 812.100 falls under Subpart E- Responsibilities of Investigators of the IDE Regulations.  This regulation succinctly details investigator responsibilities in just two sentences.

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Topics: Investigator Responsibilities, Clinical Reearch, FDA, 21 CR 812.100

A Question of Disclosure: FDA Findings and Publications

Posted by John Lehmann on Fri, Jan 22, 2016

When the Food and Drug Administration (FDA) identifies significant findings with the conduct of a clinical trial during an inspection, what happens to those findings? According to a article published online by JAMA Internal Medicine, those findings remain hidden in plain sight.

Charles Seife, MS, a professor at the Arthur L. Carter Institute of Journalism at New York University, conducted a research study that sought to “identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.”

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Topics: Charles Selfe, FDA Warning Letters, FDA Inspection

What to do When New information is Presented?

Posted by Michael Marotta on Fri, Jan 15, 2016

On the eve of the day we welcomed 2016 the FDA issued a draft guidance regarding notification of the public on “emerging signals” regarding medical devices that are already used in clinical practice.  The FDA defined an emerging signal as “new information about a medical device” that:

  1. The Agency is monitoring or analyzing
  2. Has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device
  3. Has not been fully validated or confirmed
  4. For which the Agency does not yet have specific recommendations
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Topics: Draft Guidance, FDA, Emerging Signals

Hear Ye, Hear Ye, This Meeting is Called to Order

Posted by Michael Marotta on Wed, Jan 13, 2016

This is the second of a two blog series on the Draft Guidance for Institutions and IRBs.  The first blog was published on January 7, 2016.

In November 2015, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) jointly issued a draft guidance to assist both institutions and institutional review boards (IRBs) in preparing and maintaining minutes of IRB meetings. The requirement for an institution or IRB to prepare and maintain adequate documentation of IRB activities can be found in the regulations (45 CFR 46.115; 21 CFR 56.115) and inadequate meeting minutes has shown up as a common deficiency in 2014 IRB inspections and Warning Letters. As a result, the draft guidance was prepared to provide recommendations on the type and amount of information to include in the minutes.

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Topics: Draft Guidance, IRBs, FDA, Institutions

Minutes of Institutional Review Board (IRB) Meetings: Draft Guidance for Institutions and IRBs

Posted by Emily Haglund on Thu, Jan 07, 2016

The draft guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs” was released jointly by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in November 2015. This draft guidance document is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings, describe requirements for minutes, and provide recommendations for meeting the regulatory requirements for minutes.

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Topics: Draft Guidance, IRBs, FDA, Office for Human Research Protections, Meetings