Change Management Confounds Clinical Trial Professionals

Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, Chief Integration Officer, Centricity Research

Change management continues to bedevil clinical trial practitioners even as industry expectations, best practices, and technologies appear to be evolving with increasing speed.

The good news, as it were, is that if you are overwhelmed, you definitely aren’t alone, according to a new survey from the Tufts Center for the Study of Drug Development (CSDD).

Two-thirds (67.8%) of respondents rate their company’s ability to adopt innovations as “excellent” or “good.” However, 60% say their company is slower to adopt these innovations than its peers.

While he was not particularly surprised by most of the survey findings, Kenneth Getz, MBA, research professor and executive director at Tufts CSDD, found it revealing how many organizations still “don’t know how to [handle] change management. It’s not an overnight process, and I think many organizations find it daunting.”

Noting regulatory and legal voices within organizations may be “dragging their heels” in part because of vagueness in current laws and regulations, Getz said organizations would be better served to press ahead and embrace change, in part by adapting valuable operational lessons learned during the COVID-19 pandemic pivot from onsite to remote trials. Broadly speaking, “we saw it was possible to compress time” without sacrificing quality in trials, he notes.

“I see obstacles [to better handling change management] on several fronts,” says Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, chief integration officer at Centricity Research and vice chair of the Association of Clinical Research Professionals (ACRP) Board of Trustees.

“All companies have a certain tolerance for change baked into their culture,” Senn says. “I have worked at clinical research sites where change sometimes feels impossible—contracts are negotiated at a snail’s pace; departments work separately rather than collaboratively; the bureaucracy and processes make the most tenacious people quit, and the people who stay decide it’s not worth the effort to aim for change.”

But its not just those averse to change who struggle, Senn says.

“We were early adopters of electronic source documents (eSource),” she notes. “Despite everyone in the industry seeming to recognize that eSource gives sites the opportunity to have quality assurance people on staff reviewing quality in real time and gives monitors the opportunity to review data without traveling and to review data more often, we couldn’t get any sponsor or [contract research organization (CRO)] to help us mitigate the cost through the budget. It would cost far less than paying a person to fly to us, rent a car, and get lodging, but they saw the old way as the acceptable way for several years, despite its drawbacks. We see that still with any innovation we try.”

She does offer suggestions for those who want to champion change. “First, I’d like to speak to the amazing leaders at sponsors and CROs who I hear speak at ACRP conferences and elsewhere: You are on track. When I hear you speak about the changes that can be made to budgets, recruitment, and site selection process, I wholeheartedly agree. But [why am I] just now starting to see changes that I heard you discuss six years ago? Your organizations are massive, but where can you tear down the burdens that keep your departments in silos and get your innovations and ideas implemented?” Senn’s suggestion here: hire Six Sigma Black Belt and Agile project managers.

She has proactive ideas for sites, too. While noting leadership at the very top is vital, she adds, “a great information technology vendor can take you from good to great. To adapt to change, you need technology that supports seamless communication to ensure cross-departmental knowledge and improvements, serves as a repository for company information so you don’t lose institutional knowledge when an employee leaves, sets you up for repeated quality through checklists and automated process, and enables you to conduct remote monitoring or decentralized clinical trials (DCTs) without jeopardizing patient data security. Great technology is not necessarily expensive, but it’s a game-changer for being a highly adaptable site.”

In addition to insights on the industry’s struggle with change management, other Tufts CSDD survey findings include:

  • Except for DCT adoption during the COVID-19 pandemic, innovations supporting clinical trial execution take on average 69 months from planning to portfolio-wide implementation.
  • Overall, companies spend almost 14 months planning/initiating an innovation, close to 16 months evaluating the viability and impact of an innovation, more than 16 months deciding whether to move forward with full adoption, and 23 months to implement an innovation across the portfolio.
  • The timeframe to go through each stage of the process varies by company size, but overall, respondents report the later stages of the process—deciding to adopt the change and implementing it—are the most difficult.

The results are based on an online global survey developed by Tufts in collaboration with a working group of 18 pharmaceutical and biotechnology companies. In total, 612 respondents employed by pharmaceutical companies completed the survey. More than half (52%) of the respondents were based in North America, 37% in Europe, and 11% elsewhere.

Author: Michael Causey