GUEST COLUMNISTS

  • The Evolution Of Biomarker-driven Approaches To Clinical Trials

    Greater understanding of the specific and varying genetic bases for cancers has provided greater opportunities for clinical trials to take advantage of patient genetic variability for recruitment and segmentation purposes. In this article, historic data provide insights into the evolution and future of biomarker use in precision medicine.

  • Starting A Career In Clinical Research: 7 Things We Wish We Knew

    The clinical research industry is facing a talent shortage that could become acute in the next decade. A main contributor to this shortage is a lack of focused intervention at every level to identify the skills, behaviors, and knowledge that will enable motivated candidates to begin and mature their careers in the industry. 

  • New Approaches In Patient Tracking For The Rare Disease Sector

    While we have seen exponential growth in the effort to develop drugs to treat rare diseases in the 30 years since the Orphan Drug Act was introduced, unique challenges remain. Awareness of rare diseases is often low among stakeholders including physicians, healthcare providers, payers, and even patients themselves; trial protocols and regulatory pathways may be unclear, especially for investigational rare disease drugs that are first-in-class; and data on disease incidence, onset, progression, and burden are often limited.

  • Janssen’s Patient-centric Approach To Psychiatric Disease Management

    Diseases as complex as those of the brain require an equally complex approach, centered on the unique needs, goals, and circumstances of the individual patients, as well as the loved ones who support them. Listening, empathizing, understanding — these basic human interactions will have a critical role in our ability to reach our goal and deliver transformational medical innovations.

  • Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions

    By forcing the FDA to become comfortable with the use of real-world data in order to authorize COVID-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of real-world evidence (RWE) it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE.

  • How EMD Serono Is Bringing Diverse Patient Voices Together

    The pandemic has created an opportunity to address some of the causes underlying clinical care inequities. And while combatting these issues will take time, much can be done by first addressing the gap for minorities in clinical trials. This is a topic I am passionate about both personally and professionally as a female Hispanic chief medical officer.

  • Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?

    The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.

  • Ensuring Patient-Friendly Clinical Trials For Complex Disorders — A Small Biopharma’s Playbook

    Rezolute, a small company working in the rare pediatric disease space, is developing a new therapeutic option specifically for patients with congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. Connecting and partnering with advocacy groups and physicians is paramount in the company's clinical trial execution. 

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When the pandemic hit, many hospitals, clinics, and sponsor companies were caught by surprise. The effort to protect patients and keep them away from clinics put many trials in jeopardy. Amidst the chaos, sponsors and regulators were able to scramble and keep many trials going while considering the safety and needs of participants. In this collection of articles from Clinical Leader, learn how companies not only survived, but created new policies that will be tomorrow’s best practices.

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FOCUS ON PATIENTS

  • Janssen’s Patient-centric Approach To Psychiatric Disease Management

    Diseases as complex as those of the brain require an equally complex approach, centered on the unique needs, goals, and circumstances of the individual patients, as well as the loved ones who support them. Listening, empathizing, understanding — these basic human interactions will have a critical role in our ability to reach our goal and deliver transformational medical innovations.

  • Ensuring Patient-Friendly Clinical Trials For Complex Disorders — A Small Biopharma’s Playbook

    Rezolute, a small company working in the rare pediatric disease space, is developing a new therapeutic option specifically for patients with congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. Connecting and partnering with advocacy groups and physicians is paramount in the company's clinical trial execution. 

  • 4 Practical Ways To Improve The Patient Experience In Clinical Trials

    Stakeholders have recognized the need for patients and advocates to have a seat at the table and be the central focus in enterprise approaches, commercialization, and research and development. How can we gather as much data in as few studies as possible? And in doing this, how can we acknowledge the impact that taking part in a trial has on the patients we are working to help?

EMBRACING DIVERSITY & INCLUSION