Expert Insights

Expert Insights

Advancing Drug Development Decisions Through PK/PD & Clinical Trial Simulation

Advancing Drug Development Decisions Through PK/PD & Clinical Trial Simulation
18 September 2019

A recent article from the MIT Sloan School of Management published in the Journal Biostatistics estimates the success rate of a product entering clinical development to be about 14%. Rates vary depending on the therapeutic class, with vaccines and infectious diseases having a high of 33.4% and investigational cancer drugs being on the lower end at 3.4%.

Why do many promising drugs fail in clinical development?

The cost of such failure can be enormous and potentially catastrophic for small/mid-size companies that are highly dependent upon new drug registrations to remain viable. So what are the causes of this dismal record? Analysis of the principle causes of drug failure in the clinic reveals several weak spots including:

  • Incorrect selection of the drug dose and schedule
  • Poor target validation and/or lack of biological activity
  • Inappropriate choice of disease

Inappropriate dosing and scheduling can have dire consequences on both drug safety and efficacy resulting in late stage failure or registration delays while problems are investigated. However, new technologies are aiding the choice and dose schedule before a clinical trial ever begins.

Advanced PK modeling tools and computer assisted trial simulation strategies can have a tremendous impact on how clinical trials are designed by providing a rational scientific basis for dose regimen selection and mitigating these risks. Generally, drug action can be described by the union of pharmacokinetics (PK), such as drug absorption, distribution, metabolism, elimination) with pharmacodynamics (PD), or the safety or efficacy characteristics of a given drug. PK/PD modeling unites these two processes to mathematically describe the link between drug exposure and drug response. A unique strength of this approach is the ability to run "what-if' scenarios on previously untested dosing regimens to predict clinical outcome.

Improving Critical Drug Development Decision Making Through Clinical Trial Simulation. Contact us for more information.

Learn more about innovations in PK/PD to help perform "virtual clinical testing" of a new drug. Download our white paper on Improving Critical Drug Development Decision Making Through Clinical Trial Simulation. Contact us for more information.

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