• Regulatory NewsRegulatory News

    Amended ICH GCP Guideline Addresses Evolution of Trials Landscape

    The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline with the aim of helping industry address the increasing scale, complexity and cost of clinical trials. The evolving use of technology and new risk management processes offer opportunities to increase efficiency, ICH says. The updated guideline is intended to provide a unified standard for the regulatory authorities in the EU, Japan, US, Canada and Switzerland to fa...
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    WHO: 'Critical' Data Integrity Issues Found at Indian CRO

    Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October. Background As part of its Prequalification of Medicines Programme , WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy." The program focuses on prod...
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    FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

    New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. Background The draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States , is closely related to a rule proposed by FDA in February 2013. That rule, Hum...
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    Good Clinical Practice: Where Ethics and Quality Meet

    What Is Good Clinical Practice (GCP)? When clinical research professionals are asked why they do things the way they do, they often reply, "because it's GCP!" Good Clinical Practice, or GCP, should form the foundation for all activities that take place within clinical research.  The US Food and Drug Administration (FDA) defines GCP as: "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials th...
  • New Data Show Clinical Trials Conducted Outside of US, EU Have Nearly Doubled since 2005

    A new "comprehensive analysis" conducted by the European Medicines Agency (EMA) has found that more than 60% of patients enrolled in pivotal trials submitted in support of drug applications-that is, Phase III clinical trials meant to assess a drug's efficacy and safety in a large patient population-were recruited from outside of the European Economic Area (EEA), calling attention to the difficulties regulators face in policing global clinical trials. Background The repo...
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    Seeing the Bigger Audit Picture with an Enterprise Quality Management System

    If you ever want to watch a lively debate, bring together three groups-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) auditors-and tell them to find common ground for their processes so they can coexist in the same system. They will look at one another's processes and find things that are totally foreign, and conclude that they cannot do it. You know what? They are right. GLP auditors are responsible for assuring the qu...
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    GCP Convergence Improves Transportability of Medical Device Clinical Data

    • 10 January 2013
    The safety, performance and effectiveness of medical devices are often evaluated by well-controlled clinical investigations before marketing authorization. The integrity of these clinical studies is ensured by compliance with voluntary standards or government regulations known as Good Clinical Practices (GCPs). Four GCPs are most applicable to US and Japanese marketing approvals: US Food and Drug Administration (FDA) regulations and guidance, Japanese GCP ordinances and n...
  • Brazil Clarifies Informed Consent Requirements

    Brazil's National Health Surveillance Agency, Anvisa, has released a notice clarifying the rights of individuals who participate as clinical research subjects in the country. The notice specifies that clinical trial subjects must be informed that Brazilian law prohibits compensation for participating in a trial with the exception of being reimbursed for the cost of transportation and meals. The notice also states that a clinical trial subject has the right to lea...
  • MHRA Consolidates Clinical Practice Guidelines, Regulations in New Guide

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guide on Good Clinical Practices (GCPs) for regulatory professionals, calling it the "authoritative guide" for understanding the legislative and regulatory framework surrounding GCPs. MHRA's Good Clinical Practice Guide , released 24 September 2012, is the result of UK regulators receiving frequent feedback that its GCP framework was too disparate and was in need of a single docum...
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    Pitfalls in Good Clinical Practice

    A pitfall can be defined as a potential and usually unanticipated disaster or difficulty. 1 When we perform clinical studies we try to anticipate unforeseen pitfalls before they arise. However, other occurrences are clearly foreseeable, yet we permit them-or cause them-to happen. Good Clinical Practice (GCP) refers to international standards of quality for the performance of clinical studies with human subjects. These standards aim to ensure the data generated are h...