Understanding Biopharmaceutical Clinical Trials
Before delving into how biopharmaceuticals are leveraging the power of analytics in clinical trials, let us first understand what constitutes them. These trials are rigorous and systematic processes to analyze the efficacy and safety of new drugs, therapies, or medical interventions before they can be approved for widespread use. These trials typically progress through three main phases:
Phase I trials primarily focus on evaluating the safety and establishing the appropriate dosage range of a new drug in a relatively small group of healthy volunteers. During this phase, researchers examine the drug's pharmacokinetics, including its absorption, distribution, metabolism, and excretion within the human body. This crucial information is obtained through the collection of blood samples, typically conducted in an inpatient setting, to monitor the drug's concentration in the bloodstream.
Phase II trials involve a more significant number of volunteers, which is used to assess the effectiveness of an experimental drug on a specific disease. These trials are typically randomized, where participants are assigned randomly to receive the experimental drug, a standard treatment, or a placebo. In double-blind studies, participants and KOLs (engaged in drug trial development) are unaware of the treatment to prevent bias, while in single-blind studies, only participants remain unaware.
Phase II trials offer a larger pool of patients, enabling better side effect observation, and around 33 percent of drugs progressing through Phases I and II move on to Phase III.
Phase III trials involve hundreds to even thousands of patients across multiple centers to assess a drug's safety and efficacy. Phase III studies can span several years, and upon completing a
Phase III study, a life science company can file a drug application with the appropriate regulatory authorities to seek approval to market the drug.
However, traditional trials, despite their significance in advancing medical knowledge, frequently encounter a set of distinctive challenges, which necessitate innovative solutions to ensure the efficacy and efficiency of drug development.
