Media Room

22.06.2020

Key Сost Drivers in Сlinical Trials Development

Pharmaceutical clinical trials are expensive — and even with these expected and elevated costs, they can easily run over budget. According to to multiple analytical sources the cost of clinical trials development increased by around 100% from 2008 to 2019. In 2003 the estimated average cost of a clinical study was 802 million dollars. This is in sharp contrast to the estimated cost of 2.6 billion dollars for bringing a drug to market in 2016.

At the same time, the budget for a clinical trial may range from 2.1 million dollars (a trial with 4 patients to test uridine triacetate for a rare hereditary metabolic disorder) to 346.8 million dollars (a noninferiority study that assessed the impact of a new combination cardiovascular drug for chronic heart failure on hospitalization and cardiovascular mortality). This is obvious, since costs of studies vary a lot depending on the type of drug, indication and clinical program. Clinical trials costs vary depending on the therapeutic area as well. Let’s look at the key cost drivers that form the budget of any study.

The major cost drivers are:

Study Design:

  • Sample size;
  • Duration of treatment;
  • Complexity of study procedures;
  • Expensive concomitant or comparator medications or equipment;
  • Need for specific vendors — ePRO, Central Labs, IDMC, etc).

Study organization:

  • Geography (choice of countries);
  • Enrollment challenges (no of sites and average enrollment rate);
  • Risks and critical paths;
  • Overall study timelines (incl. IMP manufacturing and logistics timelines).

But how to determine which costs for clinical trial services can be optimized without sacrificing quality? And in which ways has the current health crisis shifted the financial obligations of clinical trials? Amongst hidden costs, unexpected study adjustments and missed planning opportunities, maintaining a budget can be a challenging task. 

OCT Clinical experts bring together all their expertise and experience in planning budgets and explain how to navigate shifting study needs while staying on track. A special checklist of hidden costs and expert guidance on seeking out weak points will be provided at the webinar hosted by CenterWatch and OCT Clinical on June 25. Make time for this 40-minute session by Irina Petrova, OCT's Director of Clinical Operations, and gain a better understanding of the cost drivers and the intricacies of a clinical trial's finances. Register to the event through the link.