By Deborah Borfitz 

February 17, 2026 | A top scientific leader at Merck issued a call to action to stakeholders in the clinical research enterprise at last week’s SCOPE event, inviting them to focus on what’s important to the real-world people they’re looking to treat and clearly answering the questions being asked by people holding anti-science views. Patients as well as physicians and policymakers have “completely cocooned versions of the truth” and need to be met where they are in pursuit of common ground, according to Eliav Barr, the company’s chief medical officer and head of clinical development.  

Barr was engaged in a fireside chat with interviewer Ken Getz, executive director of the Tufts Center for the Study of Drug Development and a research professor at the Tufts University School of Medicine. The pair have often dialogued about clinical trial complexity and customization, and on this occasion talked about emerging technologies and AI-enabled approaches to address simplification and drive efficiencies.   

The backdrop to the conversation is remarkable growth in Merck’s pipeline over the last several years. The company is currently working through the industry’s largest loss-of-exclusivity event (Keytruda goes off patent in 2028), accentuating the importance of introducing new medicines and vaccines across therapeutic areas, says Barr. This has required increasing medical monitoring and clinical expertise in those different disease states, while enjoying the economies of scale from large networks and database structures.  

Simplifying clinical trials is a prioritized task and a challenging one in the face of an “enormous desire to collect every last bit of data ... in a manner that enables you to answer any and all questions that you might ever consider,” he adds. “The problem is the majority of data that we collect is not actually used ... [and] patients suffer for it.” 

Filling out questionnaires and being poked and prodded, even if done electronically or passively, can be difficult for patients and creates an enormous amount of data management work, says Barr. Merck is consequently trying hard to stay focused on “the critical questions that the relevant constituents want from us and how often ... to measure that piece of data.” 

The goal here is to moderately reduce protocol complexity, he continues. Automation and AI can handle standardized work processes while human experts manage the unique elements of a study that represent the “unavoidable complexity.”  

It is widely recognized that trial sponsors collect much more data than needed and, from Barr’s experience, the reason boils down to “a false thinking that just in case is very important.” Study teams worry about what happens if the FDA asks for data they didn’t collect, or a large payer wants to see data in a particular way so they can run an economic analysis. 

While their concerns are understandable, Barr says, the cost of answering every conceivable question exceeds the value gained. “In general, there are things that clinical trials simply cannot answer and that’s something we have to address through real-world data or large trials after the end of phase 3.” 

Barr says he is frustrated by remarks like “we’ve always done it this way” or “that’s the form we use.” The good news is that a new database system “kind of cut that at the knees” at Merck. 

Data Deluge 

Years ago, Getz points out, organizations would sometimes set aggressive reduction goals for data collection or trial-related procedures, endeavoring to simplify protocols, and “it never worked.” He and Barr agree that optimization may be a better goal. 

Anything achievable is “something you can put on a slide,” says Barr. His first ask of study teams is “not to use the old protocol to start another protocol” but instead begin with key goals of the study and then build the flowchart. 

Another important element is to understand who the customer is, and the person determining whether a drug is or isn’t meaningful to patients, he adds. “At the end of the day that kind of clarifies the kinds of questions that we need.” 

It is eye-opening for scientists on the team to be shown the high percentage of data normally collected that never ends up getting used, Barr says. But since “everyone can find a reason” for their favored question or procedure, it also helps to tie study funding to meeting a reduction target (e.g., 7% or 10%) on protocol complexity.

Enrollment Challenges 

On the topic of patient enrollment, one of the most widely recognized problems facing clinical research, the biggest obstacles are somewhat geography-specific, says Barr. Merck is primarily an oncology company and places more than 60% of its trials in the United States, where the issue is “congestion” related to the systemic problems many patients have accessing healthcare at a designated cancer center. 

Given the large number of community oncology practices, the company is concentrating on how to empower those sites to participate in clinical trials, Barr says. “They’re busy, and it needs to be part of their workflow.” That means thinking about how well a clinical trial mimics the standard of care or if it interferes with the work being done there to an impossible degree. 

“Entrainment into the usual practice is very important,” stresses Barr. Patients are also sick, so the more trial activity that can happen at home, the better. 

Barr frequently reminds his oncology team that “we’re not evaluating sites as much as the sites are evaluating us ... they want something that makes sense for them.” Secondly, patients in the U.S. have good care options relative to their counterparts elsewhere and therefore “you cannot make them do things that a young athlete would have to be able to do because they’ve got cancer.” 

Merck takes a “walk the protocol” approach where discussions center on what a regular visit looks like, he says. “The next step is I want my folks to go out and visit the sites and remind themselves about what is actually happening [there].” 

Focus on Patient-Centricity 

During the pandemic, awareness about clinical research was at much higher levels and, within select communities, trust in the clinical research process also increased, reports Getz. “It has actually fallen since then; in the last year in particular, there has been even more question about the value of science.” 

When it comes to public awareness, public trust and clinical research literacy, Barr says a good starting place is to accept the reality of other people and never speak down to them. “The biggest challenge is when people are completely anti-science; at that point a disaster has to happen to help them remember why science is important.” 

Overall, says Barr, “we’ve done a pretty bad job with the idea of ‘trust us, we know what we’re doing’ ... [rather than] explaining why trial and error is an important element of things.” Beyond addressing fallibility in science, he recommends “being open to hearing and clearly answering questions that you might think are not reasonable.” These include questions coming from new groups of educated, if resistant, people whose concerns need to be addressed in a new way, he adds.  

At Merck, keeping the attention on patient-centric activities under the pressure of tight timelines and budgets is a matter of putting a lot of emphasis on the patient journey and patient experience within both clinical operations teams and in medical affairs, Barr says. “It’s not about symbolism for us; it’s really important for us to be competitive.” 

Many people early in their career are highly focused on “getting the absolute best protocol to address all the questions,” versus Barr’s preference to examine why patients might want to come into a study and what they are being uniquely offered. One of his big learnings during Merck’s vaccine trials for Gardasil was that women who came into the clinical trial, particularly those living in middle income countries, simply needed someone to watch their children during study visits. 

Opportunities exist to open daycare centers and offer meal vouchers in sites doing a lot of trials enrolling young women, he says, working with ethics review committees and institutional review boards to ensure they don’t constitute undue influence or coercion. 

When it comes to cancer patients, the big concern is not wanting to go to the oncology center for fear of getting an infection, as well as not wanting to see people who are dying. “That’s why we’re so focused on subcutaneous and oral medicines and why we try to limit the amount of time that people spend in the cancer center to the absolute minimum,” says Barr. 

It would be better yet to establish health system satellite centers, so patients don’t have to go to the big mothership hospital, he continues. “That’s very intimidating ... [it] takes all day.”