The conduct of clinical trials is a critical process. Along with resource hiring, it also requires materials for different activities. Some of these materials can be investigational products. But, a vast number of products could be non-investigational products necessary for the conduct of clinical trials. It becomes critical to plan for procurement or import of […]
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The use of dietary supplements and nutraceutical to lower risks for illness and enhance health has gained popularity in Japan over the past few decades. The shipment value of health foods in Japan reached about 888 billion Japanese yen in the fiscal year 2021, continuing the upward trend from previous years. The market was expected […]
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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 […]
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Oncology trials are more complex than trials in any other therapeutic area. Research in oncology differs in terms of trial design, trial types, the role of a comparator, treatment outcomes, adverse event reporting, interpreting the results, and more. Developing a well-defined clinical development strategy for oncology clinical trials is crucial due to the significant costs, […]
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Do you know, according to clinicaltrials.gov, a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing clinical trials as recorded on Oct-2020? The number of clinical trials is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the USA, more than 2.3+ million people participate in approximately 80,000+ clinical […]
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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 […]
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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 […]
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The US FDA recommends efficient clinical trial design strategies such as basket designs, and umbrella designs to expedite the development of oncology drugs and biologics. FDA also provides guidance and advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials. In contrast […]
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To make a clinical trial faster, cost-efficient, and more successful, it all starts with a strategic design of a clinical trial, and the sturdy trial design is essential to ensure a successful clinical outcome. A proper study design determines the fate of the clinical trial and its likeliness to be successful. A study design involves […]
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Drug development is a lengthy, complex, and costly process entrenched with a high uncertainty that a drug will successfully reach the market. So for this, you need a proper drug development strategy to avoid uncertainties and complete clinical trials in time with quality data. Drug development is the process to bring a new pharmaceutical drug […]
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