October 16, 2017
CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Sony Salzman spoke with Shree Kalluri, founder, president, CEO & chief customer officer of Forte Research Systems.
Q: What are some common pitfalls in clinical research operations, and how do you work with clients to resolve them?
A: One of the biggest challenges for research organizations, no matter their size, is financial viability. It’s very uncommon for sites to appropriately gauge the feasibility of doing a study. Equally challenging, for sites of all sizes, is patient recruitment. Sites sometimes overestimate their ability to recruit patients on clinical trials leading to unrealistic commitments to CROs. Both of these challenges are on the business side of research. Researchers are really good at just that—research. But smaller organizations may not have enough operations experience, and large organizations tend to have silos between departments that challenge communication and prevent effective operations.
We help our customers by alleviating those administrative and operational burdens, so that they can focus on the research. First and foremost, because clinical research has become so complex, researchers should be using technology to improve their processes. In order to estimate current capacity and trial feasibility, researchers need to track past trial performance. They should ask themselves these questions:
- How many patients were we able to put on a clinical trial?
- How much did we budget versus how much did we make?
- Technology can provide clinical researchers with the right data to make informed decisions on future trials.
Q: How is modern technology influencing and improving clinical trial operations?
A: An enterprise software solution provides more opportunity to streamline operations. At an academic center, the centralized repository provides staff the ability to be on the same page. Everything is tracked in one system, so that the work of the person developing the contract is visible to the person developing the budget. This ultimately creates a tool similar to Google Maps, in which leaders can visualize the traffic patterns, and see where things are stuck. It’s all about having good visualization so the organization operates like a well-oiled machine. Without technology, there is no way to become a center of excellence.
In addition, there is a need for collaborative technology that is accessible by multiple stakeholders. In any clinical trial, there’s something called a schedule of events or protocol calendar, which is usually a PDF document shared with every site. The problem with this method is that sites can make a lot of mistakes when trying to interpret the document, which leads to deviations from the protocol. How can that problem be solved? At Forte, we’ve created technology enabled services in which the protocol is interpreted once, creating a detailed guideline document that is then approved and gets distributed to all of the sites. Almost immediately, the number of deviations goes down with this service. This is an example of how to connect different organizations responsible for a clinical trial. The industry is ready for standardized solutions that can span across stakeholders.
Q: Can you describe how clinical trial operations can use performance metrics to inform decision-making?
A: There are two aspects of performance metrics. One is the internal view, where an organization looks at past performance and then creates goals and targets moving forward based on those insights. As the saying goes, if you do not measure you cannot improve. This strategy leads to incremental enhancements in overall performance.
Ultimately, for dramatic changes in operations, sites need comparative analytics that benchmark their performance against peer organizations. Unfortunately, IRBs had determined that this would create artificial pressure on sites, so sponsors were prohibited from sharing their data. However, I truly believe the way to solve this problem is to aggregate data across multiple sites and multiple trials, at which point you start seeing patterns.
Seven years ago, Forte started such an initiative. The first step was collecting metrics that were worthwhile to measure. Next, we asked several institutions to share their metrics, and brought them together to compare apples to apples. Organizations were able to see where there was opportunity for improvement, and the really interesting thing was the pride participants had in seeing the places in which they excelled. Participants were asked to present webinars in those areas where they excelled to share best practices with other sites, which they did happily. This initiative has really grown; in fact, there were over 1,300 people registered for our latest webinar. People are really hungry for information and like learning how to improve from others who have had success. These types of initiatives bring the community together, without creating the hurdle of confidentially, to advance clinical research.