After huge changes in the regulatory system, Japan has become the largest market for clinical trials in the Asia-Pacific region for both local and global studies and is now a country of choice in clinical development maps. Previously regulatory lag was a huge hurdle for global drug developers. One good example of such lags is […]

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Most errors and technical failures in clinical trials arise due to the improper selection of clinical trial designs. The clinical trial design selection will have a strong impact on the cost and time associated with clinical trials. The expected outcomes shall be thought and carefully addressed while designing a clinical trial. The selection of clinical […]

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The number of clinical trials for rare diseases is increasing drastically from the last ten years to more than 500 as 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. Drug development in rare diseases is often challenging and […]

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Oncology trials are more complicated than trials in any other therapeutic area. The research in oncology differs in the trial design, type of trial, the role of a comparator, treatment outcomes, adverse events reporting, interpreting the results, etc. Developing a perfect clinical development strategy for clinical trials in oncology is crucial as the research involves […]

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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 are more challenging than clinical trials in more frequent diseases for many factors such as the trial design, the number of patient populations available for recruitment, require regulatory support, etc. Applying a perfect clinical development strategy may help in overcoming these challenges and accelerate the drug development process in Orphan […]

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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 process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. The drug development process starts from drug discovery to getting market approval and post-marketing studies. This entire process of medical device/drug development takes years and completely depends on […]

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