“The pharmaceutical industry has a couple of really big challenges in its clinical development model,” Martin Giblin, VP, Data Science, Safety and Regulatory Operations, Quintiles told Outsourcing-Pharma.com earlier this month at CROWN Congress in Philadelphia.
“Right now it’s costing too much and it’s taking too long to bring new drugs to market,” he added, explaining that it can take up to ten years and cost up to $2.5bn to develop a new drug.
Additionally, the industry is seeing issues in productivity. “We’re still not getting enough drug approvals from the effort that we’re putting in collectively,” added Giblin.
One reason for this, which many have cited, is late stage trial failures.
“Those drug approvals we are getting, which are great and clearly bring new therapies on the market, often are starting to be in quite targeted and in stratified patient populations,” added Giblin. “So rather than them being broadly applicable to a huge patient population they are quite narrow.”
Consequently, the return on investment for a company is quite challenging.
For a company like Quintiles, Giblin explained that it’s up to them to bring new ideas and innovations to the marketplace to their customers in order to “square that circle of too long, too expense, and not enough productivity.”
Risk based monitoring
According to Giblin, risk based monitoring (RBM) is becoming a well understood term in the industry – and it is also one proposed solution to overcoming challenges in clinical development.
In RBM companies are using data to evaluate the value of site visits and when the optimal time for a visit is, instead of visiting on a regular basis. Giblin explained it could be more often than in the past for some sites that need more support, or it could be less often for sites that are doing better.
“The way that that manifests itself is in the data that we’re collecting from those sites,” he added.
“What we’re doing on a regular basis in RBM is pulling together all of the operational data from a site and then making an assessment of the necessity to do an onsite visit, maybe a remote visit, or not visit at all because the performance of the site is solid.”
For Quintiles, part of this model is Centralized Monitoring: “We don’t just see RBM as that idea of going to site on a different cadence,” said Giblin, “We see it as a completely different way of planning and executing clinical trials.” And data, in conjunction with the proper technologies, is at the heart of this.
“Technology is really helping us to get much greater value out of our data assets and allowing us to select sites, investigators, and patients more effectively,” added Giblin, and as such, is bringing a much needed improved productivity to the industry.
New Guidelines
Original guidelines from regulators gave the basic framework in which clinical trials could be executed. Today, these terms are being refined.
New guidelines, which will be released in November, will specifically describe the risk strategies that will become necessary in clinical trials moving forward.
“So your ability to access risk, measure tolerances for that risk, and execute your trial and show the regulator at the end of the trial that you’ve stayed within those tolerances you decided on at the start, or if you varied beyond them, that you had a good strategy to manage them,” will be become not just important, but necessary, explained Giblin.
“All of the organizations that are going to be playing in this space need to be comfortable with data,” said Giblin. “They need to be able to aggregate data, be custodians of data, interpret data, and be able to stand over the decisions they’re making based on data…And to do all that you need technology.”
Quintiles believes the new requirements will play to the company’s strengths; however, others may struggle if they don’t have “strong technology underpinning their processes,” added Giblin. “It’s very had to do this without strong technology.”