|Fabio Thiers, founder and CEO, ViS Research||Otis Johnson, executive director, Clinical Informatics & Feasibility at iCTRS|
With the cost of a single clinical trial costing upwards of $100 million, it’s not surprising the cost of developing a new drug has risen to more than $1 billion. The rising costs of drug development have personnel at every level of the process seeking ways to cut expenses. A recent collaboration between ViS Research and inVentiv Clinical Trial Recruitment Solutions (iCTRS) seeks to cut the cost of trials by speeding up the process of evaluating and selecting a clinical trial site.
“Pharma and CROs don’t have all of the information they need to properly select the right sites,” says Fabio Thiers, ViS founder and CEO. “As a result, pharma firms and CROs may well end up with centers that don’t recruit any patients, and trials that take twice as long as they should. This lack of available information on trial sites will therefore drive up the cost of trials.”
To help solve the problem, ViS spent a decade creating a map of over 400,000 sites that exist around the world. The company’s online feasibility platform makes information on those sites, such as patient populations, investigators, and disease-specific specialties, accessible to sponsors and CROs.
“One of our goals was to eliminate a lot of the repetitive work that is unnecessarily being performed by trial sites,” says Thiers. “When a pharma firm or CRO contacts a center, one of the first things they will do is send a feasibility questionnaire. The sites fill out these forms over and over again, usually answering the same questions. The whole process is laborious, time consuming, and costly. Our platform has an online profile for each site that they can keep updated with answers to the questions most often asked. It also facilitates direct contact between the trial planners and the centers. If there are questions that are not answered in the profiles, they can be addressed quickly and accurately. Nobody wants to put up with these repetitive feasibility questionnaires anymore.”
“Patient recruitment is the area where most of the delays in clinical trials occurs,” says Otis Johnson, Executive Director, Clinical Informatics & Feasibility at iCTRS. “It is estimated that up to 30% of the clinical product development lifecycle resides in that space. A typical Phase III clinical trial takes nine months to complete enrollment and can cost up to $86 million. That means there is a lot of opportunity to optimize and reduce the amount of delays that occur in that space. The industry is paying a lot of attention to this because of the huge cost that delays will impose on drug sponsors, which includes lost patent time.”
Otis notes there is another aspect that must be considered when evaluating costs: the cost of initiating sites that do not perform. He cites the Center for the Study of Disease at Duke University that publishes metrics on clinical trial performance. Based on past data published, 11% of sites in a given trial will not enroll a single patient. That can get expensive, especially when you consider the cost of initiating a site is anywhere from $20,000 to $30,000. Then there is the cost of maintaining sites, which is estimated to be about $1,500 per month.
Don’t Set Unrealistic Expectations
Otis and Thiers both believe one of the biggest contributors to unfulfilled expectations, and a key reason why trials are being delayed, is not setting the right expectations up front. Trial planners will tend to be overly optimistic with their planning and as a result set unrealistic timelines that cannot be met.
When planning a large Phase III trial, many planners mistakenly assume that all sites participating in the trial will contribute patients. That is obviously not true based on the numbers from the Duke study. Many planners will also assume that all sites in all countries will start enrolling patients at the same time and at the same rate. That could not be further from the truth. Otis notes large Phase III trials are normally global trials subject to different regulatory agencies and timelines, which cause considerable variation in enrollment rates and start dates.
“The industry has evolved quite a bit,” notes Otis. “Just 12 to 15 years ago companies would write a clinical protocol, find sites that are able to run the trial, and hand the protocol over to the site. Then it was just a matter of waiting for the trial to be completed. More recently there are a lot more drugs on the market being excluded from protocols. There is more competition and more regulation over what is even allowed. As a result, recruiting for trials is more difficult and firms need to plan proactively for recruitment and ensure proper strategies are in place.”
It’s no secret that recruiting patients has become more difficult. Otis believes one of the reasons is more exclusionary medicines on the market. He notes a typical asthma study from 15 years ago did not have to deal with dual mechanism medicines such as Advair. These more sophisticated medicines are making it more difficult to find the specific patient that would be best suited to a particular trial. The growth of personalized medicines also has companies looking for a specific patient population to use in trials. The end result is more patients needing to be screened and a heightened need for targeted recruitment campaigns.
A Better Way To Evaluate Sites
Otis believes when preparing for a clinical trial, the ability to find sites that have a demonstrated track record of good performance in certain trials can immediately improve the probability of running a successful trial and make patient recruitment less of an issue. Access to patients, higher performance in similar trials in that particular disease area, and credentials of site personnel will all be key components in the site selection process.
Another benefit ICTRS hopes to get from the agreement with ViS is efficiencies and streamlined processes. “Our goal is to make it easier for sites to participate in trials,” says Otis. “One of the problems the industry is contending with, aside from patient recruitment, is investigator recruitment. Many investigators will choose to not participate because it has become so difficult to do so. Others are losing money because of the time consuming and laborious processes they have to go through. By streamlining the process required to get a confidential disclosure agreement (CDA) in place, we are simplifying the process for investigators to hopefully retain and attract more.”
Another cog in the process of evaluating investigators is verifying they are a good fit for trials. Simplifying the process by which investigators provide information about their sites is a benefit for everyone involved. “We don’t want someone to have to answer those basic questions time after time,” adds Otis. “With this system, that information can be stored once and updated on a regular basis. So instead of answering those questions multiple times, investigators can focus on answering protocol specific questions that will help differentiate their site from another site being considered. It saves time and makes the site selection process more valuable.”