Stepping into a first-in-human (FIH) clinical trial is a defining moment in drug development. It’s when a new drug that’s been years in the making finally transitions from lab bench to bedside. This isn’t about proving efficacy—that comes later. FIH clinical trials are all about safety, tolerability, and understanding how the drug behaves in the […]
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 →Aside from being one of the most preferred regions to conduct clinical trials, North America is also the location of 45% of global clinical trials, which is why researchers prefer this region. The increasing prevalence of cancer, heart disease, infectious diseases, and tropical diseases has generated multiple unmet requirements for the research of new drugs. […]
Read More →The number of clinical trials in rare diseases is growing drastically from the last ten years to more than 500 compared to a few hundred clinical trials. Currently, more than 400 orphan designated drugs are commercially available, and around 1000 drugs are undergoing clinical trials. But still, the clinical trials in rare diseases present many […]
Read More →For the approximately 7,000 known rare diseases, less than 10% of diseases have an FDA-approved treatment available. Due to a small number of patients, limited understanding of the variability and progression of the diseases, developing a drug or treatment for rare diseases is often challenging. As the disease is rare, finding sites to conduct clinical […]
Read More →Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions makes it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]
Read More →Many regulatory agencies across the world are offering incentives for the development of orphan drugs for rare diseases. These incentives include financial benefits, faster approvals, less stringent clinical data requirements, and many more. The countries that are offering the regulatory incentives for orphan drugs include the US, Europe, Japan, Australia, South Korea, Brazil, and most […]
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. […]
Read More →The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages of drug development. Commercially rare diseases drug development differs from traditional diseases, as there are considerably few patients to take the drug, therefore pharmaceutical companies should consider […]
Read More →