Interest BioPharma and Other Sponsors in YOUR Investigator Initiated Trials

79
Genetic Research Scientists Work with Medical Equipment in a High Tech Research Laboratory. Female Scientist is using a Micro Pipette While Working with Colleagues.

By Jeanie Magdalena Gatewood

How can community cancer centers win support or simply participation from BioPharma and other collaborators for Investigator Initiated Trials in regional settings? It’s not easy, and it’s not common. But new avenues are opening up that can change this.

Only academic centers?

Investigator Initiated Trials and Investigator Initiated Studies, or IITs and IISs are typically associated with large research centers. These centers often have separate funding streams, dedicated to research, rather than relying solely on operating revenue and reimbursement from payers. They have built up sizable and sustained teams that understand the inner workings of physician-led studies.

Life sciences companies are highly likely to take note of trials in these settings. The KOL’s, financial infrastructure and resources are already there. These corporations enter into collaboration agreements, make investigational product available, or even financially support these IITs.

Community cancer centers, on the other hand, typically don’t have a  dedicated funding stream to get them started, or to sustain a research program. They often struggle to resource a large enough team to support trials. As such, it’s understandable that BioPharma companies are not likely to invest as much attention to IITs in this setting. An investment in time, resources and capital here bears greater risk in seeing a fruitful outcome.

This sets a challenging stage for the conduct of clinical trials outside the confines of academic research centers. It also means we are missing out on the insights that can come from frontline community cancer care. This is true in the U.S. It is true globally.

“The benefits of doing IISs are often offset by the myriad challenges posed by an IIS,” wrote Indian physicians in Perspectives in Clinical Research. “These include finances, regulatory submissions, continuous oversight, training of study personnel, lack of expertise in statistics, data management, and medical writing.”

The weight of these challenges is intimidating. But it is not insurmountable. We could look to sponsors to lend more support, but cancer centers can get the ball rolling themselves, with the help of newer technologies.

Knowing your patient population at the molecular level

Let’s start with recruiting and enrolling patients. Even with sponsor-led trials, about 20 percent of oncology clinical trials cannot reach their endpoints due to insufficient enrollment. Regional cancer centers can’t afford the sunk cost of time and resources if the success rate is that low. Keep in mind many IITs may actually have gotten underway by individual physicians out of their own pocket.

They need a higher chance of success, and they need to have greater certainty before launching the trial. Knowing the size of the potential patient pool and what enrollment numbers might look like, informs the decision-making process when contemplating pursuit of an IIT. 

Finding patients is intense work. Traditionally it requires medical staff to review medical records, largely by hand, pull up additional sources of patient data and screen potential participants carefully. Modern information technology can make a difference, and is designed to fit into the operational workflow while demanding less from medical staff. 

Until recently, making progress with technology on this front might include installing software, slowly learning how to use it, learning about the “edge cases” the software developers didn’t think of that can derail it, and incurring costly implementation overall. Newer software has evolved and is worth a second look from cancer center teams.

Advanced technologies like artificial intelligence, machine learning and natural language parsers provide practical support, smooth out the edges in user interface and provide precision insights to clinicians about their patient population. Those insights help signal what studies have the potential to be conducted successfully in a given setting. Essentially, intelligence software has become highly fluent in the extraction and transformation of the details of clinical records, in organized them, and in presenting them in a more user-friendly format.

Compounding investments

Up until today, a community cancer center might view investment in novel technology, simply to reduce its own internal barriers to IIT success, as out of reach. But let’s stop a moment and look at those investments.

Today, that “investment” is actually more on the side of staff time than the actual budget. Newer patient matching clinical trial platforms can be onboarded at no cost to the institution, given the importance of the data to advancing research.

Sponsors and CROs have an interest in expanding the number of centers and patients available for trials. As such, they have invested in high performance platforms and making them accessible. Healthcare organizations can and should take advantage of this.

Another benefit, as technology has evolved, is that the investment of staff time is actually reducing for certain activities. Specifically, study feasibility and patient matching is significantly more efficient and less time consuming than traditional methods.

Healthcare teams can go from spending 24 to 48 hours on average in evaluating feasibility of a trial to spending 30 minutes with software platforms designed and proven to facilitate that workflow.

The final result is that a cancer center can demonstrate an ability to more predictably understand what trials can be successfully recruited, and which cannot. The center can do this with fewer resources, thus supporting the overall health of an entire research program, freeing up staff to sufficiently undertake IITs.

Making this possible can, in turn, open up greater participation in clinical trials – available to more patients, bring more care options within reach, and deliver faster progress to new and better cures.

Jeanie Magdalena Gatewood is Vice President of Cancer Center Support Services at Inteliquet