What are the Steps to Ensure an Unbiased Comparator Arm?

The desire to lower the #DrugDevelopment costs and speed up trials, together with higher availability of real-world data, has forced the regulators to embrace the use of SCAs in #ClinicalDevelopment.

In oncological studies, the use of SCA (synthetic control arms) has successfully lead to the expedited approval of multiple innovative therapies.

For example, the EFGR modulator Tagrisso by AstraZeneca received approval from the FDA in only three years from the first patient receiving the dose due to the use of SCAs.

In non-oncological fields, SCA trials are commonly used in combination with natural history studies, for example, the trial performed for approval for Zolgensma, a gene therapy indicated for spinal muscular atrophy.

In order to choose the right approach for designing SCAs, different factors come into play such as the types of data available, the anticipated length of a trial, the desired sample size, and the potential biases.

The possibility of sampling bias while using real-world data is higher but can be quantified and minimized by adjusting the use of propensity scores.

Deciding the best SCA approach is important to make sure that the findings are robust and necessary transparency is maintained.


3 Key Points

  1. The use of SCAs in clinical trials has been positively embraced by most regulators due to its ability to reduce the total costs and increase the speed of drug development.
  2. In order to choose an appropriate approach to designing SCAs, it is important to take into account factors like the different types of data available, the desired sample size, and the anticipated duration of the trial.
  3. In order to eliminate biases, propensity score (the probability of enrollment into a given arm of a trial) must be used.

Source: http://bit.ly/2Q1t7Uz

#ClinicalData, #DataManagement, #ClinicalDataManagement, #MedidataSolutions, #ClinicalTrials, #SCA, #SyntheticControlArms, #Comparator

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