Blog — Clinical Pathways

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New Draft Guidance on Protocol Deviation Management Part 2/2

New Draft Guidance on Protocol Deviation Management Part 2/2

01/21/2025

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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.

ICH E6(R3) Progresses into Step Four

ICH E6(R3) Progresses into Step Four

01/15/2025

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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).

Bye Bye to Five Whys?!

08/16/2022

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Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the Five Whys. But if you have used the Five Whys before, have you noticed that you are not confident in the results?

EMA Complex Clinical Trials Guidance Released

06/14/2022

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The European Medicines Agency (EMA) released a Complex Clinical Trials Questions and Answers guidance document in May 2022. Complex clinical trials (CCT) are defined as “being non-conventional in the sense that they have elements, features, methods or combination thereof, including novel approaches, that confer complexity of their designs, conduct, analyses or reporting.”

New Patient-Centered Drug Development Guidance – Collecting Input

03/01/2022

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The US Food and Drug Administration (FDA) released a final guidance “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients” in February 2022. This is second in a series of guidance related to a patient centered approach to drug development. The first guidance in the series, “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input”, was finalized June 2020. These guidance documents are aligned with the 21st Century Cures Act (Cures Act) of 2016 requirement for patient-focused drug development (PFDD). The guidance documents clarify how patient experience data collected from patients can best be used for drug development and regulatory applications. The June 2020 guidance discusses best practices for the methods of data collection that ensure accurate and representative experience data and goes further into patient experience data, which includes their experiences, perspectives, needs, and priorities.