Boutique biotech agency guarantees recruitment to drug sponsors
- Boutique biotech agency Clinical Enrollment is offering a guarantee to drug sponsors that CE’s patient enrollment goals will be met
- The unprecedented move also includes a first-ever equity position recruitment option for cash-strapped drug sponsors, ensuring that sponsors are able to retain much-needed capital to increase drug development probabilities of success
- Clinical Enrollment’s unique recruitment efforts are outperforming traditional methods by more than 200%
- They place a strong focus on making diversity action planning more straightforward, resulting in more diverse patient cohorts, which are difficult to achieve with traditional methods
Clinical trials are unpredictable based on the numerous variables that can’t be controlled, like safety issues or drug efficacy. However, with a groundbreaking move, a boutique biotech agency has removed one uncertain variable by providing a guarantee to drug sponsors that Clinical Enrollment will hit their patient recruitment milestones.
You read that right — a guarantee. Full stop.
In a first-ever move of its kind, Charlottesville-based patient recruitment agency Clinical Enrollment, helmed by digital marketing veteran Bryan Manning, has taken screen fail rates and under-enrollment off the table as reasons why a drug therapy wouldn’t make it to market. So confident is Manning and his team at CE at the efficacy of their carefully-honed recruitment approach that they are currently offering drug sponsor clients assurances that no payments will be due until CE hits their guaranteed number of patients.
And in a landscape where roughly 1 in 4 Phase III clinical trials fail due to lack of funding, that type of safety net means sponsors have nothing to lose, including much-needed capital.
“Is it a bit of an audacious move? Yes, but only for us. From a sponsor standpoint, it’s as much of a ‘sure thing’ as exists in biotech,” says Manning. “Ultimately, this incentive could be a game-changer for helping ensure that potentially life-altering therapies get into the hands of patients who need them, so we’re comfortable making these assurances.” And by “these,” he’s including Clinical Enrollment’s other maverick move: being the first-ever agency to offer equity position recruitment for cash-strapped sponsors. The never-been-done-before “discount” of sorts proposes that sponsors can maintain enough capital to get their drug to market by bartering a nominal equity position which would only be triggered upon certain milestones like drug approval or takeover.
So, how does Clinical Enrollment plan on pulling off this one-two punch? For starters, the structure is built into their business model. “We’ve always offered a 5-patient randomization evaluation period for clients, where we don’t get paid until we’ve hit that benchmark. So this guarantee is just upping the ante a bit more,” says Manning. “Also, clinical trial recruitment includes a binary metric for success: Informed Consent forms and enrollments. We don’t get paid until we send patients — the right patients — down the funnel, get them to the sites, and provide these trial teams the resources they need to keep humming.”
How can CE be so confident they’ll find these patients? Their approach works. The proof is in the numbers. Currently, CE is able to boast between 30% and 50% of overall patient recruitment attributed to their team’s efforts, which outperforms the industry norm by more than 200%. And with the FDA’s diversity guidance emerging in 2023, CE has made diversity action planning more straightforward and optimized right along with it. Their team of world-class content creators marry their backgrounds in ecommerce, lifestyle marketing and digital storytelling with their expertise in clinical trials, patient psychology, and disease states to achieve a more comprehensive overview of the recruitment landscape.
Their meticulously targeted approach doesn’t just ensure that potential patients become aware of these trials, but that they connect with them emotionally and are spurred to action.
According to Manning, “It’s not enough to just have our clinical trials be seen. You need to let patients feel seen in the messaging they encounter.”
Manning has knowledge of that nuance on a personal level, which is why his recruitment offer is driven by a larger sense of purpose. “Anyone who knows our origin story knows that, as a patient myself with a degenerative retinal disease, I understand the importance of not only getting visibility for these clinical trials, but also seeing potentially life-changing treatments actually earn FDA approval. Finding patients is the first hurdle. But the drugs need to actually make it to market, and for a lot of sponsors, that determining factor is having enough participants — and enough money — to get it over the finish line.” For now, at least, while the Clinical Enrollment guarantee is being offered, it appears that for drug sponsors, the gauntlet has been thrown.
Learn more about Clinical Enrollment and their recruitment practices here.