It can take up to 15 years to get a new drug through the regulatory-approval process before it becomes available to patients. One of the reasons is the time it takes to analyze the mountains of data generated by clinical trials about the efficacy and safety of the product. Drug companies perform quality-assurance tasks to verify that the steps carried out during clinical trials comply with government regulations. Regulatory agencies then check the data from the trials, as well as from the trial sponsors, to ensure that the safety of patients wasn’t compromised.
The way in which quality is assured hasn’t changed much in about 25 years, says Timothé Ménard, head of quality data science at pharmaceutical company Roche in Basel, Switzerland. Meanwhile, the number of clinical trials has increased, and their designs have become more complex, Ménard notes.