The True, Very Large, Insane Costs of a Delayed Clinical Trial

Biopharmaceutical companies developing novel medicines begin clinical trials with the best of intentions, a multi-colored timeline in Microsoft Project and a feasible budget.

And, then reality comes to greet us. Clinical study sites tell us they enrolled ALL the subjects they know; but we still need another 150! The shiny blue flyers in the doctor’s waiting room aren’t moving the patient enrollment needle. The radio ad the CRO suggested...well, only two people called that 800 number.

With a downcast gaze, the project manager opens up the Microsoft Powerpoint timeline and moves the diamond-shaped milestone of Last Patient Out (LPO) to next year. “Whew!” he says under his breath. That seemed easy.

But it will not be easy, because the True, Insane, Very Large Costs of a Delayed Clinical Trial have just taken over your company. And these are: 

  • Increase in Operational Costs – For most companies each additional month of clinical trial operations for a multi-site study translates into $1 million/month or more! A trial that is delayed by 3 months can then be costing an additional $3 million to run.
  • Decrease in Net Present Value of the Product - A delayed trial decreases the product’s Net Present Value (NPV) to the company by shifting revenue generation to a later time while consuming more resources than planned.
  • Risk to First Mover Advantage - A delayed trial may prevent the product from entering the market first, ahead of competitors, and realizing the first-entrant advantages, such as increased adoption.
  • Decrease in Company’s Valuation – Since company’s valuations depend on the achievement of certain milestones, the delay of the milestone will likely decrease, and certainly delay a rise in valuation.
  • Delay in Innovation – Innovation tends to feed on itself. The longer it takes us to develop Medicine A, the longer it will take us to get to the improved version.
  • FINALLY, the TRUEST and LARGEST cost: The Loss of Health - Assuming the treatment we are developing is safe and effective, every day that we delay its filing for approval is a day that a patient loses health. And health is a horrible thing to lose.

 

So, How Do We Avoid a Delayed Clinical Trial?

Generally, the treatment duration is fixed, so one of our best levers is to accelerate patient enrollment. The old ideas (clinical sites, field medical personnel, print, radio, banner ads, static websites) are now old and few of them seem to do that much anyway.

What helps instead is to design and deploy an online patient lead generation system. What’s that, you say? It is the use of social media advertising, combined with a carefully designed web-screening tool that results in qualified patient leads to formally screen into your trial today.

And why? Because, patients have fully transitioned online to search for disease education and treatment options, and because people, like you and me, are spending lots of time online. We know that patients spend more time on Facebook than they will ever spend with their healthcare professionals. Our best chance to intersect them with education about a clinical trial is online, not at the doctor’s office.

If compliance alarms are going off, then let the IRB-approved Facebook Ads for a clinical trial running on Facebook today quell those significantly. Methods exist to protect patient privacy and set up appropriate controls to minimize risks.

Patients are on Facebook waiting to be found for your clinical trial. Let’s find them, yes?

Learn more at www.seekerhealth.com or contact me: Sandra@seekerhealth.com