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Clinical Leader - Helping clinical research professionals connect and collaborateClinical Leader offers the latest expert insights, trends, and thought leadership in clinical research that enables pharmaceutical companies, contract research organizations, and supporting providers to build strong, collaborative relationships.Clinical Leader - Helping clinical research professionals connect and collaborate Get more clinical research insight with our FREE newsletter sign me up Log In or Subscribe Trial Design Partnering Clinical Technologies Regulatory Find A Partner CRO Services (Phase I-III) Clinical Trial Software and Services Consulting & Regulatory Partners Patient & Site Solutions Events Clinical Leader Live Clinical Leader Solutions Expo 2024 Clinical Leader CRO Leadership Awards FDA Finalizes Guidance On Dose Optimization For Oncology Therapies The FDA recently finalized its guidance on "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases" — with a few notable updates since its draft. Why Are We Still Excluding Persons With Disabilities (PWDs) In Clinical Trials? Not What I Expected From A Vendor Conference Clinical Development Negotiation: How Can A Notebook, Chronodex, And Compendium Help Enhance Partnerships? Dedicated Trialist, Nurse Navigators Help Advance Cancer Therapy Into Accelerated Approval 4 Steps To Help Sponsors Return Individual Patient Data Returning Individual Trial Data To Patients: How And Why It Needs To Happen Which Top HEOR Trends Will Have The Biggest Impact On Clinical Research? Pelage Embraces Diverse Patient Recruitment For Non-Hormonal Hair Loss Therapy More Diverse Enrollment Means More Attention To I/E Language GUEST COLUMNISTS Pelage Embraces Diverse Patient Recruitment For Non-Hormonal Hair Loss Therapy Pelage Pharmaceuticals’ CMO Qing Yu Christina Weng, MD discusses how the company expanded criteria to include patients of all skin and hair types and incorporate decentralized elements in their trial design for a novel hair loss treatment. More Diverse Enrollment Means More Attention To I/E Language Clinical research nurse Teri Crumb, MSN, RN, CCRC picks out a few potentially problematic inclusion/exclusion (I/E) criteria and details ways to address them. 3 Surefire Ways To Design Trials That Patients Want And Need   Alpha Tau Medical CMO Robert Den, MD details three ways sponsors can more effectively design clinical trials with patients in mind.   A 5-Step Approach To Strengthen Clinical Trial Partnerships In Low- And Middle-Income Countries To find suppliers and partners for our clinical trial programs, we need to go beyond just selecting the best offer and then managing them. For virtual organizations in particular, we must strive to be the partner of choice.  A Vision For Inclusion: Designing Trials That Benefit Visually Impaired Patients Ocugen CMO Huma Qamar, MD, MPH, CMI contends that whether targeting vision-related conditions or other medical needs, sponsors must design trials that ensure vision-impaired patients are included. These 3 Areas Need Risk Management Attention Now Consultant Jessica Cordes and medical affairs expert Oscar Segurado team up to discuss the three key areas of risk in clinical trials. The DEI Dilemma: Separate Teams Or Embedded Methods? Denise Bronner, PH.D. examines the advantages and drawbacks of separate, dedicated DEI teams and diversity roles embedded across functional areas. The Small Biotech's Checklist For FIH Trials Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps. More From Our Guest Columnists CLINICAL TRIAL WHITE PAPERS RNA Therapies – Global Clinical Trial Landscape - Focus On Asia Pacific Learn about the global clinical trial landscape of RNA therapy, with emphasis on trends in the Asia Pacific, and recent advancements in the field. Prioritizing Safety In CAR-T Therapy 8/8/2024 Patient safety is paramount in the promising field of CAR-T therapy. Let's examine a comprehensive monitoring approach using advanced flow cytometry and genomics. Closing The Gap In Our Understanding Of Sleep Health With DHTs 4/26/2024 This article delves into the current state of sleep assessments in clinical trials, advocates for a broader understanding of sleep, explores opportunities presented by wearable digital health technologies and examines regulatory expectations. Accelerate Precise Medical Coding In Clinical Trials 2/16/2024 Learn how the algorithm behind Rave Coder+, a next-generation medical coding solution, revolutionizes medical coding in clinical trials, offering unparalleled efficiency and precision. Antibody-Drug Conjugates Clinical Trials 2024 6/3/2024 Gain comprehensive insights into Antibody-Drug Conjugates (ADCs) with our 2024 clinical trial report, offering a deep dive into new drug developments and market trends shaping cancer treatment. The Annual Clinical Trials Round-up 2021 10/19/2022 This year’s Roundup focuses on Phase I–III clinical trials initiated in 2021 across all therapeutic areas. The significant growth in 2021 trials results from approaches used in response to the pandemic, such as decentralized trials, innovative recruitment strategies, and greater patient engagement. More Clinical Trial White Papers CLINICAL TRIAL APP NOTES & CASE STUDIES Addressing The Data Integrity Challenge 6/3/2024 Learn how ProPharma streamlined operations and enhanced data integrity for a leading pharmaceutical company through expert process harmonization and strategic guidance. Digitizing And Standardizing Participant Pain Body Maps 6/13/2024 Explore how digitizing clinical trial processes, such as paperless "body map" assessments, can enhance efficiency and standardization in pharmaceutical trials. Examining A Phase 1 COVID-19 Clinical Trial 5/10/2024 Uncover how we were able to efficiently activate the site and enroll 130 participants within six months, demonstrating our expertise in clinical trial management. Preparing Data Packages For Regulatory Submission 7/23/2024 Gain insight into how a dermatology-specialized European CRO joined forces to carry out interim statistical analysis in its study on seven subjects and prepared necessary data packages for regulatory submission. Case Study: Global Oncology 2/1/2024 Scout's transportation, expense reimbursement, and time and wage loss compensation helped an oncology study recruit and retain hard-to-reach patients. How Advocacy Groups Motivate, Mobilize Participants In Trials 8/29/2023 Patient advocacy groups can play a key role in educating patients about ― and ultimately enrolling them in ― clinical trials. Learn why these groups are trusted sources among community members. More Clinical Trial App Notes & Case Studies NEWSLETTER ARCHIVE 09.16.24 -- The Future Of MDMA-Assisted Therapy After FDA Rejection — Where Do We Go Now? 09.16.24 -- Enhancing Global Trials: Case Studies And Solutions Inside 09.14.24 -- Clinical Leader Best Of August 09.13.24 -- Which Top HEOR Trends Will Have The Biggest Impact On Clinical Research? 09.13.24 -- Partners Serving Solutions For Patients And Sites More Newsletters Not What I Expected From A Vendor Conference FDA Under Pressure To Respond To China-Related Clinical Trials Questions Are You Afraid Of Adopting New Outsourcing Models? Why We Need Technology Consolidation In Clinical Trials Government Contract Advances Walgreens In Clinical Space More Dan Schell articles Newsletter Signup Get the latest articles from Clinical Leader delivered to your inbox. I agree to the Terms. I agree to the Privacy Statement. SIGN ME UP CONTENT COLLECTIONS Realizing The Value Of RWD Perspectives On DEI You Haven't Heard Before Clinical Data Collection: Best Practices And Latest Trends More Clinical Leader E-Books 2024 CRO LEADERSHIP AWARDS See who the winners are of the 2024 CRO Leadership Awards. FOCUS ON PATIENTS Why Are We Still Excluding Persons With Disabilities (PWDs) In Clinical Trials? Canary Advisors Cofounder and COO Richie Kahn details the National Council on Disability's call for the inclusion of people with disabilities in clinical trials. 4 Steps To Help Sponsors Return Individual Patient Data In part two of this series on individual patient data return (iPDR), Legacy Health Strategies experts offer four steps to help sponsors make iPDR a reality. Returning Individual Trial Data To Patients: How And Why It Needs To Happen Returning individual data to clinical trial participants is seen by many as "the right thing to do." Yet, its uptake is lacking. Legacy Health Strategies experts discuss why it's so important and how it can be achieved in part one of this two-part series. More From Our Focus on Patients Series RECRUITMENT AND DIVERSITY Why Are We Still Excluding Persons With Disabilities (PWDs) In Clinical Trials? Canary Advisors Cofounder and COO Richie Kahn details the National Council on Disability's call for the inclusion of people with disabilities in clinical trials. Dedicated Trialist, Nurse Navigators Help Advance Cancer Therapy Into Accelerated Approval Thoracic medical oncologist Sally Lau, MD Lau discusses her role as a principal investigator, from the benefits of the FDA’s accelerated approval pathway to best practices for retaining a challenging patient population. Pelage Embraces Diverse Patient Recruitment For Non-Hormonal Hair Loss Therapy Pelage Pharmaceuticals’ CMO Qing Yu Christina Weng, MD discusses how the company expanded criteria to include patients of all skin and hair types and incorporate decentralized elements in their trial design for a novel hair loss treatment. More From Our Recruitment And Diversity Series CLINICAL TRIAL PRODUCTS AND SERVICES Pharmacovigilance Solutions Clinical Study Assessments And Rescues Revvity Signals Software Signals™ Medical Review EHR-To-EDC Integration High Speed Blistering, Cartoning, And Serialization Capabilities GMO Solutions Qualified Person For Pharmacovigilance (QPPV) Patient Engagement More Products and Services This website uses cookies to ensure you get the best experience on our website. Learn more Got it! 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