Cancer is the therapeutic target of more than half of all clinical trials now, and yet, said Accelovance President and CEO Steve Trevisan, small companies trying to launch early phase trials on their promising young compounds in oncology have no good place to turn for quality handholding.

That’s why the CRO Accelovance has launched HERO (Helping Early Research in Oncology), an initiative that Trevisan said is tightly tailored to the needs of small pharma companies and biotech firms working on the very early stages of cancer trials.

Why do they need their own carved-out initiative? Trevisan said small companies have traditionally sought help from large CROs that have a high profile, but found that those CROs are ultimately unable to devote much time to them at a critical juncture when they need a lot of assistance.

“We reached out to several companies of various sizes in early phase oncology to get a feel for their level of satisfaction with their CRO, and what we heard was overwhelming disappointment in the level of service and the outcome seen for their investment,” said Trevisan. “That drove us to launch HERO.”

Said Trevisan, small trials like these may only mean direct fees of $1 to $2 million for the CROs working with them, which often results in very little attention afforded to the client. “When you’re doing billions of dollars worth of business a year, one to two million doesn’t move the needle for you,” he said.

And it’s not just about the money. The infrastructure of large CROs—think massive late-stage trials in multiple countries—isn’t designed to help with small trials, he said.

“They have built big battleships when small cruisers are better for navigating the environment,” Trevisan said of the early stage space.

In addition, big CROs often mold their early phase oncology programs as “feeders” to late-phase research, which can result in a lack of attention to budding research.

Bharat Patel, senior director of Operations for US Oncology Research, said it makes sense for those in the early phase space to work with an initiative like HERO, and for medium-sized and small CROs to begin launching such initiatives.

“As they understand the importance of these trials and the challenges associated with them—lack of appropriate trials, lack of time for research, screening and enrolling patients—it makes sense for them to support phase I operationally, finding execution models that best position and differentiate the CROs in the marketplace,” he said.

Begun in 2005, Rockville, Maryland-based, Accelovance initially focused on vaccines, running trials via the small site network it acquired (NTouch Research) when the company began.
In 2009, Trevisan said the company’s executives decided to build on the CRO’s background in immunology and add oncology as a therapeutic area, as many cancer compounds now embrace immunology as a central thrust. Accelovance began a focus on early phase work, and soon had the goal of becoming best in class in this space, he said.

Since then, Accelovance has developed electronic data capture (EDC) systems tailored to small cancer trials, established master service agreements with several sites that focus on oncology, leading to fast start-up times—eight weeks using HERO when it normally takes 12, according to the company—and has recently added staff with robust oncology backgrounds to the HERO initiative.

Eight weeks? Is that possible? Yes, if you know what you’re doing, it is, said Patel.

“It takes many moving pieces to bring such timelines together,” he said. “It requires diligent preparation up front to ensure preliminary efforts are in place and sponsors have the required pieces to the programs.”

As part of the launch of HERO, Accelovance is inviting early phase oncology therapy developers to request complimentary reviews of their protocol or concept documents, and they’ll offer operational, therapeutic and strategic comments.

Speed at startup for these trials is essential, and if HERO makes a real impact, that will be helpful for the entire field. Patel said, “Reducing start-up timelines is essential to survival in the future, and if an organization doesn’t evolve to this demand, their livelihood will be quickly challenged.”

Trevisan said response to the launch has been very positive thus far. He expects HERO to grow to become 30 to 50% of Accelovance’s business. After all, cancer remains a big conundrum in medicine.

“This is a therapeutic area in which we haven’t solved the puzzle,” he said. “It isn’t like hypertension, where the market is somewhat full. There’s still a huge need for cures. Cancer is where most of the investment in the industry is going.” 

This article was reprinted from Volume 21, Issue 16, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »