New guideline compounds complexity to clinical trials

Adding to the existing uncertain clinical trial woes in India, in September 2014, the CDSCO (Central Drugs Standard Control Organization) came up with new order for pharma and clinical research organizations who want to carry out clinical trials in India


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According to the new order, organizations wanting to carry out clinical trials in India need to justify how the country would benefit from the trial.

The companies are expected to provide details on the following three parameters:

  • Risks vs Benefits to the patients
  • Innovation vis-à-vis existing therapeutic options
  • Unmet medical needs in the country

"Obviously drug innovation is about addressing unmet medical needs and improving medical outcomes. However, it is not possible to guarantee or predict therapeutic benefits of a molecule before the clinical development process is completed. For example, we got a ‘placebo effect' when we conducted trials on our oral insulin molecule IN105, but the therapeutic intent was powerful," expressed Dr Kiran Mazumdar-Shaw, CMD, Biocon.

Clinical trials are an indispensable part of drug discovery and development research, and it is at the heart of all medical advances, offering hope for millions of patients, and an opportunity to help researchers find better treatments for future generations.

Moreover, companies can also learn a great deal from the trial data, instilling confidence to pursue a particular molecule.


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