In my last blog on expanding your global grasp, we explored the prospect of expanding clinical trials to regions beyond North America and Western Europe. However, even the best plans can encounter unforeseen obstacles. Today, we’d like to relay some advice that may help you circumvent variables that could delay progress.
Firstly, it’s essential to formulate a team of experts, who can make the necessary adjustments when an unforeseen situation arises in the design, development and/or distribution phases. Planning is an essential element of any clinical trial, but you don’t want progress to be impeded by unanticipated factors. Some examples might be enrollment pace, milestones, extensions, material availability and distribution.
According to a Forbes Contributor, David Grainger, Contributor in “Why Too Many Clinical Trials Fail – And A Simple Solution That Could Increase Returns on Pharma R+D,1“…Late-stage trial success is around 50% and the track record for novel, first-in-class agents is considerably lower. Whatever the precise figure, the current failure rate is unexpectedly, and unwelcomely, high.” He notes that failures may occur when the indication is expanded, new primary endpoints are set, the patient population is deemed too homogeneous or, most commonly, there is a false discovery rate. None of these can be forecasted in the initial planning process, but it takes professional guidance to mitigate them.
Here are six best practice tips to support your planning process:
1. Start discussing supply logistics while the protocol is being developed
2. Anticipate regulatory and logistical challenges by brainstorming potentials with your team and trusted partners
3. Plan a course of action for the challenges you’re able to anticipate
4. Choose a supply chain partner with knowledge, experience, breadth of services and a global footprint
5. Estimate materials with “more is better than less” as a guideline
6. Conduct a trial that focuses on your commitment to health and safety of your patients
Sometimes the unique nuances of clinical trials require the team to add experts with familiarity across many therapeutic areas. These resources can recommend alternatives based on experience as well as provide bandwidth to meet your deadlines.
For additional practical advice about planning clinical trials, click here to access other blog articles on this topic