Sponsors and CROs say the industry is still moving too slowly when companies adopt trial innovations because they’re not using unified, enterprisewide approaches when they implement new systems and new trial approaches.

Electronic data capture, for example, took approximately 22 years to implement on a large scale, while clinical trial management systems took 18 years, and other technologies still haven’t reached a two-thirds point of adoption, according to research by the Tufts Center for the Study of Drug Development (CSDD).

A host of innovations — decentralized trial components, artificial intelligence solutions, wearable sensors and novel endpoints, among others — could see similarly slow adoption times if sponsors and CROs don’t improve the ways they select, evaluate and implement new approaches.

Nearly nine out of 10 respondents from approximately 340 organizations revealed that their innovation processes are strewn across individual functional areas that may be influential in different parts of the company but are largely isolated from each other when new technologies are identified, assessed, test-driven and adopted. That’s according to preliminary insights from an ongoing 2021 survey by Tufts CSDD and WCG Avoca.

Just a small fraction (13 percent) of respondents said they have moved to form organizationwide innovation teams that spearhead efforts to bring on new systems and approaches across their companies.

“For the research that we conducted, centralized innovation groups were mainly involved in organizationwide change vs. protocol-by-protocol solutions,” Caryn Laermer, head of member engagement at Avoca, told the 2021 WCG Avoca Quality and Innovation Summit last week.

Many also felt that their organizations were moving moderately to very sluggishly in bringing on new innovation compared to their peers, and a lesser amount felt their companies’ efforts were ineffective. A majority (83 percent) ranked their firms as taking “somewhat” or “much longer” to adopt a new innovation compared to other companies, while nearly a third (34 percent) ranked their organizations as being “poor” or “very poor” at implementing new solutions. More than half (58 percent) felt that their organizations were late or last to adopt.

Respondents also shared their own concerns about innovation: 57 percent said that innovation adoptions “greatly” or “somewhat” complicate their ability to meet or exceed their current work and project expectations.

And according to Denise Calaprice, a senior consultant for Avoca, certain innovations are more palatable than others. In general, companies are most hesitant on innovations that involve AI because they aren’t as knowledgeable on how it functions, although they do recognize its potential value.

The process for adopting new innovations is straightforward and involves four key steps: initiation, evaluation, adoption decision and full implementation, Ken Getz, director of Tufts CSDD, explained during the summit.

The initiation phase is the identification of a need within the company, gauging interest on a specific technology and doing the initial planning steps. The next stage, evaluation, is where the technology being considered is assessed and put through a pilot program. Third, the adoption decision, is where the company determines if it will actually move ahead with enterprisewide implementation. And the final step, full implementation, is where the chosen solution is broadly rolled out, communicated and taught through training.

“We know that there are a number of very, very common challenges that are experienced in the early stages. A lot of it has to do with cross-functional alignment and senior leadership buy-in and support,” Getz said. “In the evaluation stage, we often hear that the pilot studies that are conducted have been poorly designed, they’ve been poorly executed and ultimately downstream, it makes it difficult to really determine based on the pilot whether there is sufficient evidence to move forward and if there really is a measurable return on investment that can help inform full implementation.”

Companies also complain that they find it a struggle to compare different solutions, making the evaluation and adoption decision processes even harder to do, Getz said.

Full implementation, which spans broad rollout, communication and training, is viewed as the most difficult part of the process among respondents, the preliminary survey results showed. Specifically, 47 percent ranked it the most challenging area, identifying major hurdles in cross-functional buy-in and support, poor commitment and lack of senior management backing. The findings also revealed areas where the problematic process could be made better.

“In the full implementation phase … we see a number of key themes that are raised in terms of process optimization: better change management planning, more effective communication and promotion of an innovation, as well as creating greater alignment of incentives,” he said.

Respondents cited adoption decision as the second most challenging part of the process, with 32 percent naming it the most difficult stage. Only a handful of respondents said that initiation (10 percent) and evaluation (11 percent) were the most difficult steps for them.

The largest pharma companies took the longest to get through the four-step process and were the least consistent in their times, according to the survey. They took about 5.5 years to get through the process of bringing on a new innovation with high variability in their times, while small and mid-sized pharma firms had an approximately 6- to 8-month advantage in terms of speed. They were also less variable in their times, particularly in the later steps. CROs were the fastest of all, moving about 24 months faster than the largest companies, perhaps because of the priority they place on setting themselves apart by adopting new technologies, Getz said.

Notably, one insight from the preliminary findings revealed that the 54 percent of respondents who ranked their company as “excellent” at handling innovation adoption also noted they were rewarded for their efforts to drive innovation, suggesting that incentivizing innovation may be a strategy worth adopting.

The survey also questioned representatives on the ways they were initially exposed to new innovations. Nearly half (49 percent) said that they learned of new innovations from industry collaborations and consortia, while 33 percent and 31 percent of respondents named regulatory agency recommendations and industry conferences as their sources, respectively. Fewer named independent consultants (23 percent), CROs or vendor partners (17 percent) and publications (11 percent) as their initial introductions to new innovations.

“Sponsors and CROs are passionate about the importance of innovations to help optimize drug development performance and economics. The intent to innovate is stronger than ever,” Getz said. “But the innovation process is fraught with difficulties and inefficiencies that add to protracted cycle times. [Our] study has identified numerous opportunities to streamline and improve the innovation process.”

Tufts CSDD and Avoca intend to finish gathering responses and analyzing them late this year and will profile the innovation practices of five similar industries. The results and analysis will be disseminated this year and throughout 2022.