With more clinical trials being outsourced every day it should come as no surprise that increases in outsourcing applies constraints on CROs' resources and infrastructure. But how do you know when your study is going wrong and when is it necessary to "call time" on your CRO?
For every day your product is not on the market it could cost your company in excess of $1m per day in revenue, and that's without considering the impact delays can have on your share price. What's more, the impact could be even greater if another compound gets ahead of you in the race to market. In the world of drug development, time is a precious commodity, so hanging onto a poorly performing CRO isn't a wise option.
Things to look out for:
For your study to be effective you need an experienced and capable team supporting your trial. Beware of high turnover rates as this can quickly lead to damage on the ground. When building your team, positive characteristics to look for include: being proactive, taking ownership, accountability, honesty and trustworthiness.
Boil down your metrics and KPIs into the essentials. Don't "major on the minors". Be clear what you are looking for and measure against it.
Excessive delays in quality site enrolment, poor patient enrolment and issues with drug supply are all warning signs that your study could be heading for the rocks. But first engage with your CRO to air your concerns and review their plan before hitting the "eject" button.
The importance of the contract cannot be underestimated, so ensure all eventualities are covered before signing on the dotted line. Red flags include: not following through on the contract and minor improvements being highlighted as a change in scope.
Although you are outsourcing you cannot outsource accountability for the trial. Great surveillance and governance of your study can prevent issues before they occur, however not always foreseen.
Issues within a trial are not always performance failures. As with any project where science is involved things don't always go according to plan. The first line of defence should be free and open communication with your supplier to see if the problem can be resolved quickly and without damage to the study. Hallmarks that issues may be irreparable include:
- Escalation of issues doesn't result in resolution
- Violating terms of contract
- Jeopardising patient safety
- Dishonesty and breakdown of trust
- Poor data quality
- Surprise fees
If you reach the point when the CRO needs to be replaced, it is important to ensure your rescue CRO is lined up ahead of time with the contract prepared in advance. Avoid the temptation to panic buy and check the experience of your new CRO along with references from your personal network. As soon as the decision to pull the plug is made, start building a transition plan to ensure that all paperwork is handed over and communication is tight.
Lastly, manage the exit without blame - like all relationships sometimes it just doesn't work - it's a small industry and you never know when you might see these people again.