Everyone would like to have a quicker study start-up process. In many companies the process and the paperwork have not changed for decades, and the process is always time-consuming.
At the 2018 Veeva R&D Summit, Jennifer Heckman, Senior Director, Clinical Trial Logistics at Incyte, discussed the company’s approach to selecting a study start-up solution. Incyte is a mid-sized company that has been growing very quickly. The company is primarily focused in oncology treatments, with two commercial products and 18 compounds currently in development. More than 80 percent of the company’s drug candidates are discovered and developed in-house, and Heckman leads the study start-up team.
“In recent years there have been some significant advancements made in how companies conduct clinical study start-up activities,” says Heckman. “Sponsors used to plan a study, get sites onboard, and start recruiting patients. The processes required to do so were much simpler than they are today. Today there are frequently changing laws, new regulations, and different practices in place at each of the individual sites that create complexity. There are many different moving parts that sponsors need to keep track of, which contributes to the lengthy study start-up process. Incyte has spent the last few years focused on speeding up this process.”
Three Main Goals
Part of Heckman’s job entails tracking the planned upcoming clinical activities and ensuring the start-up team will be prepared to begin work to assure timely start-up of the clinical studies. She works with project teams to track development but is sometimes still surprised by sudden changes in the schedule.
“Our scientists surprise me all the time,” states Heckman. “A study that wasn’t on the clinical study schedule last week may suddenly pop up and the team wants to start the study this month. As a result, my team must constantly adjust and prepare to do things with more urgency than we had expected just days before. Therefore, having agility and flexibility within the organization is really important.”
Getting sites up and running quickly was something Heckman needed to improve upon. While her team has had success with getting some sites up and running within a week after the final protocol; there were other sites with more challenging processes. Heckman knew that technology would help her better understand where improvements could be made. “When the study team begins selecting sites to participate in the studies, they need a good estimate of how long it will take for each site to be ready for site initiation,” says Heckman.
Second, she wanted to reduce the burden placed on sites. She believes minimizing that burden will lead to faster start-up timelines. One way to reduce the burden was for Incyte to use information that had already been provided to them from prior trials. Any solution she implemented should have a way to harness that information and customize the approach with each site. Heckman’s goal was help Incyte become the company trial sites wanted to work with on clinical trials.
“Finally, we wanted to make sure we are using that information to hold ourselves accountable,” says Heckman. “For example, if we provide estimates for how long it's going to take us to green light each of these sites, we certainly want to achieve those timelines. We also want to make sure we are looking at opportunities to continue to exceed expectations in that area. Additionally, we want to make sure there's consistency in our approach so that quality is the underpinning factor in everything we do. That means making sure we have the right tools in place to enable that to happen.”
A Tedious and Manual Process
In 2015, Incyte began a pilot program that it hoped would lead to faster start-ups. At that time the company did not have a technology platform to facilitate the process. The process in place was manual and time consuming, and there was no way to review the metrics from these processes.
“When I joined the organization, we knew we needed to put together a business case and a rationale for bringing in a technology solution to support this work,” says Heckman. “The manual method we had in place can work for a period of time, but eventually we knew we would need a systematic approach.” Additionally, Incyte was becoming increasingly more global, requiring more robust systems for managing requirements in multiple countries and enabling the team to work efficiently.
Incyte is an innovative company and therefore, Heckman states, her strategy for a study start-up technology solution was not a hard sell. In fact, the number of executives within the company who were supportive of the platform meant the request moved forward rather quickly.
Develop a List of Requirements
Heckman then had to decide on the right study start-up tool. The company had already selected its eTMF solution which was implemented in 2017, so simply sticking with the same company would have made the selection process easy. But, she opted to perform a methodical search of the products that existed.
“We first developed our list of requirements,” explains Heckman. “We wanted to make sure that there was accessibility and intelligence built into the tool. My team sought cross-functional input to identify the requirements. We also wanted to make sure the workflows were easy to follow. There would be a lot of documents and information being sent back and forth through the sites and being reviewed by internal teams. It’s important that we not miss any steps along the way. Those workflows, in my opinion, are the opportunity for us to build quality into the work we're doing.”
Next, the new platform would have to be able to integrate with other systems. Regardless of what solution was selected, Heckman wanted to make sure her teams would not be working in silos. She also wanted to have control over documents and be able to see the various versions of them. Flexibility was also a concern. Some sites would welcome the opportunity to work within a site portal, but some would not. For sites that opted out of using the portal, the Incyte team should be able to work seamlessly within the tool, entering documents received back from the sites.
Heckman had a few final requirements. She wanted to be able to generate start-up status reports quickly and easily. She wanted those reports to be clean and easy for management to see the activities underway and be able to identify challenges. Finally, she wanted to ensure the teams would be able to leverage historical data as applicable in order to avoid collecting forms that were already collected from sites on previous trials. That information would also allow Incyte to customize and expedite its welcome package sent to sites.
Making the Selection
To make the selection, considerable product research was performed. Individuals from Incyte also attended conferences to see what products were available and could meet the company’s requirements. A cross-functional team was formed consisting of individuals from across development operations that would be using the tool. Individuals from legal and regulatory were also consulted. Initially the tool would be used by the study start-up team, but Heckman knew it could eventually be used by other departments.
RFPs were sent out and Incyte received a response from five companies. After review of the requirement, the team was able to narrow down to a few vendors and have them perform live demonstrations of their solution. She had the demos performed at the end of the summer, when employees were returning from break. Her hope was to get the work done prior to the end of year. She also scheduled the demos to be performed within a short period of time.
“That is very important,” she says. “If you are going to view several product demonstrations, you want to keep them close together. That makes it easier to make comparisons between them and decide which one is the best fit for you. Also, people are busy. They must find the time to do this while also performing their day jobs. Therefore, you want to streamline that process as much as possible.”
Once she narrowed the selection to two products, it was time to take them for a test drive. The tool was set up in a sandbox environment where employees could test it at their leisure. Employees were asked to complete a survey and rank the two tools on various parameters that were set prior to the evaluation. The group then landed on the final product, which Incyte opted to license and implement earlier this year.
Today, Incyte has completed the build and implementation of the study start-up application and is in the process of expanding its usage within the study start-up team.
“For anyone who has not been through this, I would first say that it has been a lot of work,” she says. “The implementation involves taking processes that exist outside of any kind of workflow or tool and translating it into a tool that will be user friendly. We were basically getting sites up-and-running while at the same time developing our new processes. Our processes were well-established, but you still must think about how they might change as a result of using a tool. We were also looking for places where we would become more efficient. That can be difficult when you are working on an implementation and have technology people talking in one language and business people talking in another.”
A final step for Heckman involved making sure training materials connected Incyte’s processes to the technology, which was necessary to ensure there would be no ambiguity for end users. She also made sure enough time was dedicated to training, which would be necessary to make the installation a success.
Heckman knew it would not be possible to pull an entire group of team members from their day jobs and have them sit through training. Still, a lot of resources were invested in the project. Without the training, it would not be successful. In the end, the key word for Heckman is “patience.”
“That is one thing you can never have enough of,” she says with a laugh. “I have worked on other technology implementations and having the patience to see them through is always very important. Implementations take time, and you must plan for that. Along the way, you also need to keep reinforcing your purpose. There will be struggles. When they occur, that’s when you need to remind the team why you’re adopting a new technology. Occasionally, someone will question the project. When they do, I remind them of the challenges we had in the way we worked before with traditional spreadsheets and other basic tools. Change can be painful. But in the end, we will be better able to collaborate with one another and outside of our organization. And, the information on our site activation timelines will be visible with the push of a button. That ability is worth the pain.”