“If you ask too many questions in a clinical trial, you are likely not to get the optimum answer. The objective has to be very clear,” – Dr Stephen Wright, Limber Strategic.
In a recent interview with Technology Networks, Dr Stephen Wright, Independent Consultant in medicines development, talks us through the various phases of clinical drug development. He explains what is meant by an IND application, discusses how clinical trials are designed and how the data generated in these trials is processed.
The clinical stage of drug development typically consists of four key steps – Phases 1–4. At each of these phases there will be a specific objective, or primary endpoint. Occasionally that endpoint can be a composite of different measurements, but you must succeed in that primary endpoint to progress to the next phase of development.
“By the time you get to approval you should understand, you hope, quite a lot about how the drug behaves in the body, and how the body responds to the drug, what the optimum dose is, and what the efficacy is,” explains Wright.
“What you don’t really understand fully, is the safety, and the safety long term. For those reasons, most companies will take on a commitment to continue studying the safety in long-term use.”
“The attrition rate – the rate at which drugs fail in development – is very high. Less than one in ten drugs that get to human studies in the first place will make it through to the drug approval process.”Wright explains that the high failure rate observed in the clinical stage of drug development is typically caused by an issue with one of three key elements – quality, safety or efficacy. To produce a successful drug you must ensure it can be produced to an adequate standard that is reproducible (quality), it must be safe to administer to patients (safety) and it must be able to treat the condition it was designed for (efficacy).
“… there are a lot more failures in drug development than there are successes,” – Dr Stephen Wright, Limber Strategic.
“Even when you get into the drug approval process there’s at least a 25% chance you will fail,” Wright adds.
Watch our interview with Stephen Wright below to discover the finer details of clinical drug development.
Watch some of the other “Exploring Drug Discovery” episodes to learn more about the drug development process more broadly.
Visit our drug development hub page for a comprehensive overview of the steps involved when taking a drug from bench to bedside.