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In October 2024, The Food and Drug Administration (FDA) released a final guidance: “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”. It is intended for sponsors, principal investigators, institutional review boards (IRB), contracted research organizations (CRO) (all of which are considered regulated entities) and other interested clinical trial stakeholders that use electronic records and systems.
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In September 2024, the Food and Drug Administration (FDA) released another draft guidance titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” for sponsors intending to conduct global clinical development programs (CDP) for new cancer treatments. The guidance provides advice on using evidence obtained from multi-regional clinical trials (MRCT) to support marketing applications.
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In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s Real-World Evidence program. This guidance was released the day before their final guidance on Conducting Clinical Trials With Decentralized Elements, both guidance discuss the FDA’s current position on collecting health information from sources outside of the clinical research site in order to improve enrollment and protocol adherence to scheduled visits
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On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT).
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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.
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On June 21, 2024, The U.S. Food and Drug Administration (FDA) sent a warning letter to Massachusetts Institute of Technology (MIT) outlining several violations observed during a remote regulatory assessment (RRA) of MIT’s Institutional Review Board (IRB). The remote regulatory assessment was conducted as part of the FDA Bioresearch Monitoring Program (BIMO), which includes RRAs and inspections.
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On July 25, 2024 the US Food and Drug Agency (FDA) published a final guidance for industry “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” This guidance is intended to help sponsors and other interested parties determine whether or not to use electronic health records (EHR) or medical claims data (information submitted to insurers to receive payments for treatments and other interventions) when making regulatory decisions on the effectiveness or safety of a drug.
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The US Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI) announced an upcoming hybrid public workshop titled “Artificial Intelligence (AI) in Drug & Biological Product Development” on August 6th, 2024 at 10:00am-5:30pm EST. AI refers the area of computer science that creates intelligent machines intended to mirror human cognitive functions such as learning, recognizing patterns and relationships within datasets, adapting, and problem solving. AI is already being put to use in the field of clinical research.
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On June 26, 2024, the US Food and Drug Administration (FDA) released a new draft guidance “Diversity Action Plan to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” The underrepresented populations in clinical trials can be disaggregated by sex, age, and racial and ethnic demographics. If a subset of a population is not present during the clinical studies, potential differences in safety information may not be fully understood.
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In April 2024, the US Food and Drug Administration (FDA) released a draft guidance for industry titled: Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. The draft guidance explains the difference between data quality and data integrity. While both are necessary to maintain in a clinical study in order to obtain reputable data, they each have important differences.
