Alex Telford
The Pharma Industry From Paul Janssen to Today: Why Drugs Got Harder to Develop and What We Can Do About It
Drug development in the pharmaceutical industry has become increasingly challenging and expensive over the years. The probability of a drug entering clinical trials and reaching the market has not improved significantly. Factors contributing to this include the industry's historical focus on natural products, the layering of regulations, and the long, inefficient, and expensive drug discovery and development process. Clinical trials, in particular, have become complex, bureaucratic, and costly. The industry is also facing barriers to entry, such as stiffer competition, regulation, and expensive manufacturing. Despite these challenges, there is a belief that the industry can do more to improve productivity and develop drugs that benefit patients.
Observational data collected outside of the context of a clinical trial, by contrast, are often hopelessly confounded, which is why we see results like vitamin D supplementation failing to improve health outcomes for most patient groups across many randomised controlled trials, despite seemingly strong associations between vitamin D levels and morbidity or mortality in retrospective observational data. The value of randomised clinical trials is their ability to separate the true effect of a drug from chance effects, which include the regression to the mean that is often observed in episodic or cyclical conditions as patients are most likely to enrol in a trial when symptoms are near their zenith. (View Highlight)