Xconomy insight whitepapers
The existing framework around modern clinical trials is antiquated and inefficient. The foundations for clinical development date back to the 1938 US Food, Drug, and Cosmetic Act which gave the FDA authority to ensure drug safety. It was later amended by congress—The Kefauver-Harris “Drug Efficacy” Amendment of 1962—which required that drugs be proven efficacious and safe before being sold, and that it was the FDA’s authority to oversee safety and effectiveness was that of the FDA. Now, 40 years later, we’re running clinical trials almost the same way we did when we started.
The world and technology, on the other hand, are passing our industry by. Digital tools continue to advance while clinical research remains slow to embrace efficient platforms and offerings. The result is a market where a new drug costs in excess of $2 billion and takes over 10 years to get to market – if it even makes it to market.
Fixing the current paradigm and ensuring that every patient gets access to the best possible care is a moral imperative. This white paper considers how incorporating more virtual/hybrid trials and decentralized research into clinical development can better integrate healthcare into patients’ real lives and accelerate approval of new medications