Your Complete Guide to Global Clinical Research and GCP Compliance
IRB/IEC Review of Payment Plans and Advertising Language IRB/IEC Review of Payment Plans and Advertising Language Introduction to IRB/IEC Review Process The review process conducted by Institutional Review Boards (IRBs) in the US and Independent Ethics Committees (IECs) in the EU and UK is critical to ensuring the ethical conduct of clinical trials. This process…
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Assessing Undue Influence When Setting Payment Levels and Schedules In the ever-evolving landscape of clinical trials, understanding the nuances of compensation structures is critical for clinical research organizations (CROs) and associated professionals. This comprehensive guide aims to address the ethical considerations surrounding undue influence in the context of payment levels and schedules in clinical studies….
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Sponsor and CRO Governance for Equity in Recruitment Across Portfolios Sponsor and CRO Governance for Equity in Recruitment Across Portfolios The governance of clinical trial operations by sponsors and Contract Research Organizations (CROs) plays a critical role in ensuring equity in participant recruitment, especially across diverse portfolios of studies. This article will provide a step-by-step…
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Compensation Approaches for Vulnerable and Economically Disadvantaged Populations Clinical trials are an essential aspect of medical research, and ensuring access to these trials for vulnerable and economically disadvantaged populations is of paramount importance. This comprehensive guide details compensation approaches tailored for such groups, highlighting best practices, ethical considerations, and compliance with regulatory requirements in the…
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Using Real-World Data to Inform Equitable Recruitment Targets Using Real-World Data to Inform Equitable Recruitment Targets In the evolving landscape of clinical research, the use of real-world data (RWD) has become a pivotal aspect in ensuring equitable recruitment targets across diverse populations. This tutorial will provide a comprehensive step-by-step guide tailored for clinical operations, regulatory…
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Communications That Support Trust in Historically Underserved Communities Despite advancements in science and medicine, historically underserved communities remain underrepresented in clinical trials. This article provides a step-by-step guide on enhancing equity in recruitment and ensuring fair participant selection in clinical trials, particularly in the context of the lecanemab clinical trial. The guidance provided herein is…
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Case Studies: Successes and Failures in Diverse Participant Enrollment Case Studies: Successes and Failures in Diverse Participant Enrollment Understanding the Importance of Diverse Participant Enrollment in Clinical Trials Diverse participant enrollment in clinical trials is crucial for ensuring that the findings are applicable to a broad population. The inclusion of varied demographics—such as age, ethnicity,…
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Community Partnerships to Improve Representation in Clinical Trials Community Partnerships to Improve Representation in Clinical Trials The landscape of clinical trials is shaped by the imperative to ensure equitable representation of diverse populations. This necessity is not merely an ethical obligation; it is instrumental to the scientific validity and generalizability of research outcomes. Poor representation…
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Linking Equity in Recruitment to Benefit Sharing and Post-Trial Access Linking Equity in Recruitment to Benefit Sharing and Post-Trial Access The landscape of clinical research is constantly evolving, necessitating rigorous ethical considerations in recruitment practices, especially concerning equity and fair access to trial benefits. This tutorial provides a comprehensive guide to integrating equity into recruitment…
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Regulatory Expectations for Diversity Plans in Global Trials Regulatory Expectations for Diversity Plans in Global Trials In the ever-evolving landscape of clinical research, the integration of diversity plans within global trials has become a focal point of regulatory guidance and ethical considerations. As clinical operations, regulatory affairs, and medical affairs professionals engage in international projects,…
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