Global trials are critical for developing orphan drugs because they provide the necessary platform to evaluate the safety, efficacy, and overall impact of these therapies on rare disease populations worldwide. Orphan drugs are specifically designed to treat rare diseases and face unique challenges during development, particularly due to the limited number of patients available for […]
Read More →Project management in clinical trials involves the systematic planning, execution, and oversight of clinical studies to ensure their success. From initial planning stages to final execution and reporting, understanding the complexities and best practices of project management is crucial for achieving reliable and impactful results in clinical research. As clinical trials are essential for advancing […]
Read More →In clinical research, understanding the distinctions between rare and standard disease trials is crucial for optimizing study design and execution. Rare disease trials focus on conditions that affect a small percentage of the population, while standard disease trials target more prevalent conditions. However, both types of trials are equally important in advancing medical science and […]
Read More →Clinical trials in rare diseases present more significant challenges compared to trials in more common diseases. These challenges arise due to various factors, including trial design, the limited patient population for recruitment, regulatory support, and more. However, implementing a well-defined strategy for clinical development in rare diseases can help overcome these challenges. Such a strategy […]
Read More →Clinical supply chain teams manage some typical challenges almost every day of their work in handling clinical trial logistics for local or global clinical trials. These include those related to regulatory compliance, temperature control (or, excursions), labeling, actual shipment, or last-mile delivery. These challenges are often compounded multi-fold when clinical trials are related to a […]
Read More →Patient recruitment in rare disease clinical trials presents several difficulties. These challenges include limited eligible patients, dispersed geographic distribution, low disease awareness, site and investigator identification difficulties, and ethical considerations. They hinder participant enrollment and cause trial completion delays. Over the past few years, the rate of drug development in rare diseases has been increasing. […]
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