Clinical trials are research studies involving human volunteers. The clinical trials are undertaken in a series of steps called ‘phases’. If a new treatment is successful in one phase, the trial moves onto the next phase. There are three main phases of clinical trials: Phase 1, Phase 2, Phase 3 to test safety, efficacy, and clinical benefit at each respective clinical trial phase. The number of volunteers increases by 10X in each phase. The median cost of phase III trials in the United States is $19 million. Clinical drug development is sometimes outsourced to contract manufacturing companies. The CDMO company develops and manufactures clinical supply for the innovator company. Quite often, we see companies also complement their offerings by providing clinical trial packaging services to the innovator.
Some of the major spending in the clinical trial procedure includes Clinical procedures (20%), Staff and Admin (20%), Site monitoring (14%), Site retention (12%), Lab cost (8%). Conducting a trial across the world at various sites and recruiting patients further increase the cost
With multiple cost heads, clinical trials are expensive to run. However, once the drug is launched the breakeven is reached in 2-3 years.
For more information https://www.piramalpharmasolutions.com/development/clinical-trial-services/clinical-trial-packaging
Answer ( 1 )
Clinical trials are research studies involving human volunteers. The clinical trials are undertaken in a series of steps called ‘phases’. If a new treatment is successful in one phase, the trial moves onto the next phase. There are three main phases of clinical trials: Phase 1, Phase 2, Phase 3 to test safety, efficacy, and clinical benefit at each respective clinical trial phase. The number of volunteers increases by 10X in each phase. The median cost of phase III trials in the United States is $19 million. Clinical drug development is sometimes outsourced to contract manufacturing companies. The CDMO company develops and manufactures clinical supply for the innovator company. Quite often, we see companies also complement their offerings by providing clinical trial packaging services to the innovator.
Some of the major spending in the clinical trial procedure includes Clinical procedures (20%), Staff and Admin (20%), Site monitoring (14%), Site retention (12%), Lab cost (8%). Conducting a trial across the world at various sites and recruiting patients further increase the cost
With multiple cost heads, clinical trials are expensive to run. However, once the drug is launched the breakeven is reached in 2-3 years.
For more information https://www.piramalpharmasolutions.com/development/clinical-trial-services/clinical-trial-packaging