GUEST COLUMNISTS

  • How — And Why — To Embrace Intersectionality In Clinical Trials

    Intersectionality is the framework for how a person’s relationships, identities, interactions, and interdependencies can create different advantages and disadvantages. In order to fully embrace intersectionality and make meaningful impacts in clinical trial recruitment of diverse populations, the entire journey of the patient must be realized — every step of the way.

  • Survey Reveals High Levels Of CTIS Adoption In Europe

    Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.

  • India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022

    To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?

  • Key Learnings To Optimize Clinical Trials During COVID-19

    Designing and conducting trials during the COVID-19 global pandemic forced clinical teams to be creative, to explore the use of technology, and to design a trial that meets the participants where they are — without compromising outcomes. 

  • Key Insights From The 2022 PDA/FDA Joint Regulatory Conference

    Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.

  • How To Implement Patient-Focused COAs

    Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.

  • How To Optimize Returns On Plain Language Summaries

    The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.

  • RWE & Advanced Diagnostics Propel Better Patient Outcomes

    Notable diagnostic advancements in data science and the scientific community’s ability to use analytic tools are playing an essential role in improving patient outcomes.

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CLINICAL LEADER CONTENT COLLECTIONS

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The articles in this e-book all relate to the challenge of CRO selection. We hope you enjoy them and learn from the insights contained in them.

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FOCUS ON PATIENTS

  • Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.

  • The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.

  • Between 2000 and 2020, nearly 80% of clinical trial participants were white. The underrepresentation of diverse racial and ethnic groups is not new, but we must do more to address disparities. Here are five strategies for action.

EMBRACING DIVERSITY & INCLUSION

  • Except for South Africa, sub-Saharan African countries are still largely underrepresented in the global clinical study map. Hesitation to conduct clinical studies in Africa may be partly a result of assumed poor infrastructure, missing regulations, and inexperienced researchers. But is it truly so? Or is our thinking stuck somewhere in the past?

  • Whether in the world of employment or clinical trials recruitment, if recruits can’t find what they’re looking for from you, they will find it from someone else or fail to engage entirely. Explore five trends crucial to successful employee and trial participant recruitment.

  • Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America.