3 Ways to Outsmart the Big Dogs as You Move into the Clinic

by Dan McDonald

You’ve done all the background work. You’ve navigated the complex U.S. regulatory environment and achieved investigational new drug approval. You’ve secured investors and assembled your core team. You are now preparing for the next big milestone for your burgeoning biopharmaceutical company – entering the clinic. It’s an exciting step, filled with potential, excitement and a lot of peril. Many companies don’t make it past phase 1, let alone into proof of concept and pivotal studies. You’re going to be different.

Hey, the fact is that you’re small and you’re now swimming in a large ocean of big-time companies, all vying to enroll their studies—possibly competing directly with yours, or at least creating a lot of waves to navigate. Your size can be a tremendous advantage, especially when it relates to overcoming one of the largest pitfalls of ANY size company running clinical trials; enrolling study subjects on time. Delayed enrollment represents one of the biggest risks in the successful completion of a trial. The good news is there are things you can do.

If you’re in the greater Toronto area on March 20, you can learn more by joining us at JLABS @ Toronto for a special session. Click here for information about this event.

Until then, here are three key considerations to keep in mind when taking your drug to trial:

Proactive Planning: In a 2017 survey of 400 clinical operations executives from mostly large biopharmaceutical companies, it was revealed that 45 percent of those companies didn’t develop their own proactive recruitment plans. Yet more than 85 percent of trials are delayed due to slow or no enrollment. By putting a proactive plan in place, you are immediately taking a critical step that others have missed because of a variety of reasons; not one of them being that it’s not smart. In fact, if you attend the event in Toronto, you’ll see a case study demonstrating the significant cost savings that can be achieved by developing a proactive recruitment plan vs. waiting and facing a rescue situation. It’s tens of thousands of dollars.

Treat Sites Like Your Best Clients: Your study sites are on the very front lines of clinical research and patient enrollment. There is no recruitment program in existence that can overcome sites that don’t enroll patients. Study sites are filled with hard working people. Guess what? People like attention, support and to feel like they are heard and respected. Many large trial sponsors have lost sight of this fact and their studies suffer for it. You can immediately differentiate your study by engaging your sites and getting their feedback and opinions before, during and after the trial. Regular communication, on-time payments and low/no-cost acts of recognition all go a long way towards keeping sites focused on your study and enthusiastically enrolling subjects into YOUR study.

Treat Study Volunteers Like a Critical Partner in the Trial: Quite simply, without individuals consenting to participate in your trial and remaining engaged and compliant with study requirements, you’re dead in the water. Like sites, study volunteers are a critical partner in the success of your study. Treat them as such. There are a lot of things you can do to make sure that they are educated properly about your study, consented correctly, communicated with frequently and supported consistently.

We hope you can join us at the JLABS @ Toronto event on March 20, where we will present more specifics on keeping study subjects engaged.

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