An innovative design utilizing a more adaptive approach in clinical trials had been discussed by FDA under CPI in 2006.
Since then, different innovative and adaptive designs in Clinical studies have been proposed and implemented.
These designs provide more flexibility as they allow adaption in a trial according to the accumulated results.
Some of these designs are:
Continual reassessment method: This design is used to identify maximum tolerated dose by combining all collected trial data with the data from the past trials.
Sample size re-estimation design: This design allows the reassessing the sample size of an ongoing clinical trial to get the required statistical power.
Food and Drug Administration (FDA) has provided a new type of study design for conducting Phase I first-in-human oncology studies.
This design, known as a multiple expansion cohort (MEC) design, allows the sponsor to have multiple experimental groups in a single study simultaneously.
The FDA guidelines explain that objective of these specially designed trials can be the assessment of anti-tumor activity in a setting specific to the disease, finding safe dose in special populations, evaluating alternative schedules or doses etc.
Each group has a different objective as explained above, therefore, multiple objectives can be achieved in a single phase.
This helps in better resource management as a sponsor can decide whether to proceed or to discontinue the drug development based on the Phase I study.
Multiple expansion cohort designs enable the investigator to know early that in which population the drug is working effectively.
Learn the first news about what the controversy on the FDA approved marketing of the Contraception App “Natural Cycles” is all about.
Traditional generic drugs, on the other hand, are versions of a drug that are equivalent to a brand-name drug in active ingredients and effects but may have slight variations, such as in inactive ingredients like fillers and flavors.
EpiPen maker Mylan reveals generic—it’s only triple the price
High-profile examples of authorized generics include Mylan’s cheaper form of its EpiPen, a life-saving epinephrine autoinjector that curbs deadly allergic reactions.
But it’s still a staggering hike from EpiPen’s original cost of around $50 per injector in 2007.
That year, Mylan bought the rights to EpiPen and then raised the price more than 400% in the years that followed.
Moreover, because brand-name drugs’ list prices are often subject to rebates and discounts by middlemen, the authorized generics’ lower prices sometimes have no impact on how much drug companies net for their drugs.
