Diversity Now, the first protocol to achieve diversity in clinical trials according to the FDA guidelines for Race and Ethnicity Diversity Plans This plan provides a pharmacist-centered approach for compliance with Section V Categories 4 and 5 of the US Food and Drug Administration’s industry guidance (hereinafter “FDA Guidance”) for developing the required Race and…
Diversity in Clinical Trials – Background The Federal Drug Administration (FDA) issued non-compulsory guidance on clinical trial diversity to encourage diverse populations in clinical trials and improve the applicability of clinical trial results. The guidance recommends diverse clinical trial populations to better understand the safety and effectiveness of medical products across race, ethnicity, and gender.…
Pharmacists demonstrate tremendous expertise in drug counseling and dispensation, so it seems undeniable that they should play a prominent role in clinical research. After all, clinical trials are designed to establish the safety and efficacy of drugs: a pharmacist’s specialty. However, pharmacists are rarely consulted in clinical trials. To remedy this issue, Founder and CEO…
Welcome to our E2 Dispensing Webinar series. Over the next few weeks, we will release 8 episodes, introducing the E2 dispensing methodology and ecosystem to all. These webinars are aimed at everyone involved in clinical research and clinical trials. We will go into RxE2’s innovative and disruptive way of simplifying decentralized clinical trials and more specifically introducing…
New drugs and treatments have to undergo a slew of studies and tests to help patients who need cures for their conditions. Clinical trials lay the foundation of efficacy and safety for new therapies and drugs. However, the process could be herculean for trial coordinators and pharmaceutical companies that dedicate a great deal of time,…
I want to make clinical trials available to everyone, everywhere by bringing the practice of pharmacy into clinical research. Believe it or not, this has never been done before. It will improve healthcare by giving people worldwide clear access to more lifesaving medicines and access to the medication experts — the pharmacist. In an interview…
By: Gerald E. Finken Technology changes healthcare. From the earliest vaccines and antibiotics to using artificial intelligence to predict the antibacterial function of a molecular structure and the development of CRISPR gene editing, there can be no doubt that technology has always, and will continue to always play a pivotal role in the healthcare fields…