Faster, smoother and more approvable clinical trials start with you.
Ben Locwin, Contributing Editor
Original link: https://www.contractpharma.com/issues/2021-09-01/view_columns/planning-for-better-clinical-trials/
Clinical trials can only occur with a very delicate and complex balance of supply chain logistics, documentation and execution.
When did Noah build the Ark? Before the rain.
Thinking about the necessary parameters and elements for your trials is only a benefit if you do it ‘ante hoc.’ Wishing you had something in place that you never planned for is ‘post hoc’ project management, meaning ‘after the fact,’ which is not project management at all. It’s more like ‘failure planning’.
Why trials fail
The factors associated most often for why clinical trials fail include:
Failing to demonstrate safety or efficacy of an investigational drug;
Lack of funding, which then leads to a host of cost-related logistical effects;
Recruitment and eligibility issues, which could be partly platformic; and
Issues regarding improper conduct.
It’s been estimated to cost about $42,000 per patient enrolled in a clinical trial in the U.S. Though that number varies wildly based on the trial and drug complexity, it provides a relevant marker. Phase 2 and 3 trials take a lot of patients and cost progressively more money. Make your approaches to ensuring success commensurate with the dollar-value-risk.
Not every factor is controllable, but as Galileo Galilei once said, “measure what is measurable, and make measurable what is not so.” In your case, in your trial, it means measuring and understanding where the risks exist and shoring-up those areas.
Clinical trial platforms and supply outsourcing
Various clinical trial platforms (software and system packages) have systematized and standardized many required inputs, leaving less to chance. This is always a good thing. Also, clinical trial supply outsourcing has provided Sponsor companies with a much-needed analog of the risk-sharing offered by CROs and CDMOs, whereby the supply chain can be outsourced to provide much needed logistical support where it matters most.
One thing is certain: None of these approaches happens spontaneously without intervention by the clinical team. To get better means acting better and availing yourself of the various technologies and service offerings to increase your chances of success.
Don’t neglect the benefits clinical trial technology and supplies outsourcing can provide as well as finding experts to consult with your organization to help facilitate your trial’s success. Winning beats losing every time.
Roulette wheels, games of chance and clinical trials
Sometimes it seems like each individual disparate element of the trial process costs too much, but think of it this way:
Running clinical trials is the ultimate medicinal gamble. If you were to approach the blackjack table with odds of about 9-in-10 not in your favor, and an average buy-in (development cost) of $1 billion, wouldn’t you do everything you could within the boundaries of the game to stack the deck in your favor?
Remember: Chance favors the prepared.
