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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Small and Mid-Sized CROs for clinical trials occupy about 44% of the market share of outsourced development works approximately. These CROs are gaining interest and becoming the choice for startups, small and mid-sized pharmaceutical and biological companies. While in the first part of this article series on “Contract Research Organizations For Your Clinical Trials” the […]

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Do you have scientifically proven evidence that the country you have chosen is a perfect destination to conduct your clinical trial? Does the country you have chosen provide all the resources for conducting your clinical trials?  Have you compared it with other eligible regions? The US and most Western European countries remain the important centers […]

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The global contract research organization market value reached $39 billion in 2018 and is expected to exceed $51 billion by 2024. The market is becoming competitive, with large CROs going for acquisitions and mergers to increase the portfolio and reach, whereas small and medium CROs are becoming more prominent with their personalized approach, contact flexibility, […]

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