Patient Advocacy Strategies’ Post

FDORA calls for greater diversity of patients in research. What do you see as the root causes preventing diverse populations currently and how can we reduce these? I think about how often I go to the doctor (which is not enough), but I would be much more inclined to complete a telehealth call and save a few hours in the commute time alone. We need this same thought process in clinical trials using modern technology and practices to go direct to the patients. If we can do this, we can start to attract a wider population.

Discover the art of fast-tracking drug development with Miami Clinical Research! In our newest blog, we unveil the tactics and tools driving our success in expediting clinical trials. Join us as we navigate the complex landscape of medical research, delivering efficient and impactful solutions that shape the future of healthcare. Don't miss out—click the link below to uncover the science behind our strategies: https://lnkd.in/gm6mHD7D #medicalresearch #clinicaltrials #medicalstudies #miamiclinicalresearch #drugdevelopment #clinicalresearch #pharmaceuticalresearch #healthcare #drugtrials

The FDA recently issued draft guidance on clinical trial diversity, emphasizing the importance of representative participant populations. The agency aims to improve data about patients who will use medical products if approved. Key points from the guidance include: 1.Diversity Action Plans: Companies should create comprehensive diversity action plans that consider the entire clinical development process. These plans are required for phase 3 trials and investigational device exemption (IDE) applications for devices. 2.Recruitment Goals: Companies are expected to set recruitment goals for different racial groups, stratified by age and gender. These goals should align with the prevalence of the condition the product treats. 3.Recommended Strategies: Strategies to meet diversity goals include community engagement, patient advocacy groups, transportation assistance, reviewing study exclusion criteria, choosing diverse trial sites, and decentralizing trials when necessary. 4.Transparency: Sponsors should publicize their recruitment strategies transparently. The public has until September 26 to comment on the FDA guidance, and once the final draft is published, companies beginning enrollment 180 days later will be required to submit diversity action plans. What do you think about the new proposed requirements? https://lnkd.in/eFn5jgns #FDA #Research #Lifescience #Bio #FierceBio #Biotech

Top 5 Challenges of Managing Clinical Trials As a practice in the life sciences industry, clinical trials are essential for developing new drugs and treatment methods. https://lnkd.in/d87WMMYZ

With their extensive knowledge across various drug classes, formulations, and therapeutic areas, Medical Monitors are invaluable to CROs and Sponsors. Read how their strategic guidance and oversight help navigate the complexities of modern clinical trials. https://hubs.ly/Q02fdFBt0 Al Blunt #clinicaltrials #clinicalresearch #drugdevelopment

Excellent article written by Heather Granato on #clinicaltrials, specifically the influence of #pharma clinical research design on #nutra trials. Along with other experts in the clinical #research space, Joshua Baisley weighs in with some key drivers behind FDA's guidance and what we still need to consider in the nutra industry including potential impact on study planning, costs, and operations. Explore these and more: https://lnkd.in/guKeJ5EZ

Only 12% of new drug candidates that enter phase 1 #ClinicalDevelopment ultimately receive FDA approval. This dismal success rate leaves millions of patients with unmet medical needs and drives up the costs for the small number of #drugs that make it to market. Here, Dr. Joseph Geraci, Ph.D. CSO/CTO and co-founder of NetraMark, explains how #AI-based patient characterization can improve #ClinicalTrial performance without large data sets: https://lnkd.in/exPg46Be #clinical #ALS #BigData #ArtificialIntelligence

𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗿𝗲𝘃𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 #𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 #𝘁𝗿𝗶𝗮𝗹𝘀: Carelane, a life sciences technology start-up, has announced the successful closure of its pre-seed funding round, raising €800,000. The investment, led by HTGF | High-Tech Gründerfonds (HTGF), will fuel the expansion of its unified platform designed to streamline clinical trials, significantly reducing the operational burdens faced by pharmaceutical companies, contract research organizations, and academic researchers. Clinical trials today face inefficiencies and high costs because they are reliant on multiple disjointed software systems for essential tasks such as data management, eConsent, tokenization, sample tracking, drug supply, and patient follow-up. The time required for integration and the challenges of process orchestration, along with regulatory compliance demands for unified audit trails, further complicate the situation. 𝗥𝗲𝗮𝗱 𝗺𝗼𝗿𝗲: https://lnkd.in/dzWuBz6V Gustav V., Yannick Boerner, Dr. Baltrukovich Natalya, MBA, PhD, Tobias Jacob

Exploring the vital role of quality assurance and control in #ClinicalTrials 🧪 Discover the key to precision and reliability in clinical research. Read more at: https://lnkd.in/degAv8Hr #QualityAssurance #Octalsoft #Innovation #Efficiency #EclinicalSoftware #CRO #PharmaTech #HealthcareIndustry #ClinicalResearch #LifeSciences #HealthcareSector #Pharma #PharmaceuticalIndustry #Healthcare #Blogs #ClinicalTrial #Blog #HealthcareInnovation

In the latest collaboration from ACRO and TransCelerate BioPharma Inc., Nicole Stansbury of Premier Research and Madeleine Whitehead of Roche discuss the impact that ICH E6(R3) will have on Good Clinical Practice and implications for innovation. Read the feature in pharmaphorum: https://bit.ly/3UIQAvm