The clinical research industry is falling behind the innovation curve, says Ken Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD), taking years — and sometimes decades — to evaluate, adopt and fully implement new technologies and methods.

Clinical research sees some of the longest adoption timelines of any industry, Getz told attendees at the 2023 MAGI East Clinical Research Conference in Philadelphia last week.

“There are many constraints that limit our ability to embrace a new innovation and start to implement it. We also are typically not given the right incentives to even take the risk as an enterprise in piloting an innovation and moving quickly once a decision has been made to embrace that adoption across the organization,” he said. “I want to elevate the notion of the necessity to innovate in a more efficient way. It is so critical at this time.”

Getz presented data that show some major technology innovations introduced in the 1990s still aren’t fully implemented more than 20 years later. For example, electronic data capture, first introduced in the early 1990s, took approximately 22 years to become accepted practice in the industry (defined as adoption by two-thirds of companies). And electronic patient-reported outcomes and clinical outcome assessment technologies introduced in the mid-1990s still have not hit the two-thirds adoption mark.

On the individual company level, CSDD data show sponsors take an average of nearly six years to adopt new ideas, while CROs take three years.

Getz offered ideas for making the process more efficient and timely across the four stages of initiation, evaluation, decision and implementation.

Initiation

A number of things can help optimize the initiation phase, Getz said. Regulatory agencies can help by provide greater guidance and clarity, which many companies have named a critical need in the early stages. Regulators are currently trying to deliver greater direction, issuing guidance in such areas as participant engagement and diversity, and virtual/remote solutions.

In addition, clear and visible buy-in from a company’s senior leadership is essential to optimizing innovation uptake, Getz says.

More companies are also recognizing that gathering site and patient feedback at the beginning of innovation adoption can help determine which specific innovations might have greater relevance and “might actually provide greater benefit to our sites and patients,” he added.

Evaluation

Here, too, site and patient feedback can help determine the criteria that will be used to measure the success of pilot programs, Getz said.

Crossfunctional alignment is also key to optimizing the innovation adoption process, both at the evaluation stage and elsewhere, he said, noting that misalignment in companies has led to a “tremendous amount of poor pilot design” and poor execution amongst stakeholders today.

“We often see measurement or pilot design success factors that relate specifically to one department or function but cannot be translated across the others,” he said. “We also often see multiple vendors being piloted simultaneously, often for projects that can’t be generalized to the most common projects in our portfolio. As a result, we’re getting information and data from a variety of different approaches that can’t be compared and are not representative of the projects in our portfolio.”

“There isn’t a lot of shared understanding of the highest areas of perceived risk at the C-suite level,” he continued. “Often, we’re focusing on totally different areas that are challenging our willingness or comfort level moving forward. We don’t have insight into other parts of the organization, what they ultimately want to see us support and deliver. There’s a lot of disconnects that exist within the organizations.”

Decision

Creating change management plans earlier in the process can help keep things moving when the decision to adopt is made. Currently, companies typically get started on this close to the time full implementation begins, he said.

Focus on areas where you anticipate needing to engage with the entire organization when developing change management plans for an innovation, he advises.

“Most organizations do not take the time to think through a change management plan until it’s too late, until they have to move far faster to implement it,” Getz said.

Implementation

Full implementation, which is both the longest stage on average and the one rated most challenging by industry, can greatly benefit from a focus on training, which helps support and push more rapid, complete implementation across an organization. It’s common to see a limited amount of resources put toward this stage, making it take even longer, Getz said.

Although sponsors usually steer clear of innovations recommended by external parties in the current landscape, the COVID-19 pandemic serves as proof that industry can successfully achieve accelerated research timelines and allow greater collaboration to occur when stakeholders want to, he said. More collaborative, open models have translated to great success in other industries and, in Getz’s view, these models are something the clinical research industry needs.