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FDA Endorses ICH E9 Addendum on Clinical Trials Analyses

The U.S. Food and Drug Administration (FDA) has issued a draft guidance that proposes the agency adopt, and in some cases, expand, an International Council for Harmonization (ICH) addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for trial estimation and measurement. The new draft guidance, “E9(R1) […]

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The Importance of Differentiating Between Registry Study and Interventional Trial

Well-designed research protocols that clearly differentiate between a registry study and interventional trial can cut down on review time, minimize questions from an institutional review board (IRB), and better ensure compliance and subject protection. Differentiating registry studies and interventional trials is required to protect research participants, and is essential to ensure proper regulatory compliance. To […]

Guest Blogger Anne Smallwood, MS, CCRA

Can You Reinvent Your Job Without Too Much Disruption?

We still face a lot of situations where we can't really change the clinical research job that we hold—participants in (or sponsors of) ongoing studies are counting on us, and often there is not an opportunity for us to move, or we have other constraints. However, we want to be more interested in our work, and […]

Dr. Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm

Can Sites ‘Guide’ FDA Inspections?

Most clinical study sites have never been through a significant inspection by the U.S. Food and Drug Administration (FDA). So when the agency informs site leaders that one is coming, they can sometimes act like passive victims or a deer in the headlights. It doesn’t have to be that way, says Dr. Darshan Kulkarni, principal […]

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FDA Seeks Comments on Guidance Designed to Speed Medical Device Approvals

The U.S. Food and Drug Administration (FDA) is asking for comment on a new guidance designed to streamline and otherwise accelerate the approval process for certain medical devices. The Breakthrough Devices Program (BDP) is a voluntary program for some medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases […]