Accelerating Drug Development, Health News, ET HealthWorld

through Sanjay Vyas

It is no longer news that the COVID19 pandemic has taken the world by surprise. As deadlocks ensued in different countries, scientists and the healthcare community had to keep up with this sudden change and find effective preventive and curative treatments. Given the rigorous and process-oriented requirements of drug development, immediate efforts were focused on identifying existing drugs that could help control the disease. Drugs like Favipiravir, Remdesivir, Tocilizumab and recently 2-DG have been seen as breakthroughs in reuse for use against COVID19 infection. The pandemic has highlighted the importance and potential of repositioning or reorienting drugs as alternative therapies.

The development of new therapies is a tedious, long and expensive process. Even with the best resources, the risk of failure is high. In comparison, reuse costs 50-60% less than new drug development, and drugs are typically approved earlier due to their existing evidence in multiple geographies. In addition, reused drugs have gone through the process of preclinical and clinical development for the treatment of other diseases and have therefore already been tested for their toxicity. This allows them to move directly to Phase II clinical trials, dramatically reducing the time to deployment compared to the regulatory and approval processes required to launch a new drug.

While reused drugs are one of the positive outcomes of adaptive therapy, adaptive trial designs are another important factor being explored to revolutionize trials. Defined as designs for making changes to tests or procedures once a test is underway, adaptive designs preserve the overall validity and integrity of tests. When carefully designed and executed, these trials can provide multiple results, such as increasing the likelihood of success of a new therapy, shortening development times, and reducing overall development costs and risks associated with volunteers. and the study sponsors.

One of these successful and important adaptations observed in the field of adaptive assay design is the development of core protocols. In 2018, the Food and Drug Administration (FDA) announced draft guidelines for core protocols to accelerate the development of drugs and biologics in oncology. This guide aims to provide sponsors with a manual for conducting clinical trials intended to evaluate multiple drugs (oncology) and / or multiple types of cancer in adult and pediatric populations within the same main protocols.

Core protocols designed using a unique infrastructure, trial design and protocol allow multiple drug and disease populations to be evaluated simultaneously. Compared to a traditional trial where a single infrastructure is used to evaluate a single drug in a single disease population, this can help improve efficacy and speed up drug development. To better understand the main protocols, it is important to know the different methods such as umbrella, cover and platform test designs. A primary protocol designed to examine multiple treatment options or drug combinations for a single disease population is called a general trial design. On the other hand, basket trial designs assess a single drug or combination of drugs at multiple stages of disease from different populations based on the number of prior therapies, genetics, or demographics. The platform’s trial designs assess multiple drugs or drug combinations in multiple disease populations and help add or remove regimens based on decision algorithms.

The industry is witnessing how newer and repurposed test designs are paving the way for building a well-organized testing infrastructure that will continue to help reduce time to market and decrease the cost of time to market. overall drug cost, thereby allowing therapies to reach needy patients more quickly.

Sanjay Vyas, Executive Vice President and General Manager, Parexel India

(DISCLAIMER: Opinions expressed are solely those of the author and does not necessarily endorse them. will not be liable for any damages caused to any person / organization directly or indirectly.)

Source link

Comments are closed.