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CDER Unveils Center for Clinical Trial ...

04/30/2024

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On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.

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Improving Clinical Trial Patient’s ...

04/09/2024

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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.

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FDA Issues Updated Draft Guidance on Use of ...

04/02/2024

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The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006.  The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.

Amanda Dzengeleski
FDA Issues Warning Letter for Clinical ...

01/03/2024

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On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.

Amanda Dzengeleski
FDA Releases New Draft Guidance on Confirmatory ...

09/27/2023

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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.

Patient Centricity

CTTI Releases Recommendations for Real-World Data in Study Planning and Recruitment

10/22/2019

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Clinical Trials Transformation Initiative (CTTI) released recommendations and tools related to using real-world data (RWD) to inform selecting eligibility criteria and recruitment of subjects for clinical trials. RWD are data related to patient health and health care delivery. Data are commonly collected from Electronic Heath Records (EHR) or other sources related to patient health, such as insurance claims. RWD has been available, but there has been a lack of research or consensus on how to use the information beneficially for clinical trials. These recommendations were developed through research and collaboration with stakeholders, including patients and caregivers, to provide the first steps for how sponsors may best use the RWD to plan for clinical trial eligibility requirements and recruitment.

Final Device Guidance Released!

9/24/2019

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The U.S. Food and Drug Administration (FDA) released a final guidance, “Humanitarian Device Exemption (HDE) Program.” The guidance is in alignment with requirements from the 21st Century Cures Act and amendments to the Federal Food, Drug, and Cosmetic Act by the FDA Reauthorization Act of 2017 (FDARA).

Optimizing eConsent for Patient Centricity: Recording Now Available

1/11/2019

Do you understand the difference between consent and centricity? Perhaps you already know that patient centricity is the process where the patient has control over information and are free to make choices they are comfortable with. Learn from subject matter experts about challenges to integrating patient centricity into clinical trials and how eConsent supports subject comprehension and decision making. Our own Sandra “SAM” Sather and an expert panel present information to help you support patient centricity with eConsent.

Optimizing eConsent for Patient Centricity Webinar December 13, 2018

11/28/2018

Do you understand the difference between consent and centricity? Perhaps you already know that patient centricity is the process where the patient has control over information and are free to make choices they are comfortable with. Learn from subject matter experts about challenges to integrating patient centricity into clinical trials and how eConsent supports subject comprehension and decision making. Our own Sandra “SAM” Sather and an expert panel present information to help you support patient centricity with eConsent.