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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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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.
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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.
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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to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.
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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.
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The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on what to do with unused investigational product (IP) shipped to study participants’ homes, a more common occurrence during stay at home orders and quarantines during the pandemic. The new question with answer makes it clear that regulations for IP accountability still need to be followed, but that alternative methods to traditional disposition can be considered.
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Why Take a Course in The General Data Protection Regulation (GDPR) and Clinical Trials?
Clinical trials are increasingly global by nature. The GDPR may apply to your clinical trial if conducted in a country within the European Economic Area (EEA) or the United Kingdom (UK). The GDPR data protections are broad in nature but it makes it clear that protection of personal data includes data created during the course of a clinical trial. Understanding the role your organization plays, which data are personal, and what constitutes a valid consent under GDPR requirements is key to compliance. This course highlights how HIPAA differs from GDPR, including reporting of data breach and notice requirements.
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Diversity in clinical research is imperative to ensure the safety and effectiveness of drugs and medical devices for all people. Participants in clinical trials should reflect the consumers that will be using the medical product once it is approved. This is a concern because the product may react differently in different age groups, races, and ethnicities. The National Institutes of Health (NIH) confronted a lack of diversity in clinical trial participants in 1993 by supporting a policy requiring federally funded clinical research to include women and minorities called the NIH Revitalization Act of 1993. Clinical trials today still lack ethnic diversity, and the question remains as to how stakeholders can build equity into clinical trial design.
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On October 1, a man from Richland, Washington was pronounced guilty of 47 counts of fraud and drug-related charges. Sami Anwar faces more than 28 years in federal prison according to the U.S. Justice Department’s Eastern District of Washington.
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The Food and Drug Administration (FDA) released a final guidance in November 2020, “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs.” Certain populations are underrepresented in clinical trials, even though they are part of the target audience for the investigational product once approved. The guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).