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Engaging with ineligible participants can transform a potentially negative experience into a positive one.

The Art of Saying No: Navigating Ineligibility Conversations with Clinical Trial Patients

Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.

Study Finds Many Randomized Clinical Trials Have Poorly Justified Exclusion Criteria

Study finds that addressing racial disparities in lupus clinical trials requires targeted education, increased diversity among trial staff, culturally sensitive recruitment strategies, and addressing social determinants of health to improve Black patient participation.

Addressing Racial Disparities in Lupus Clinical Trials

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, address the challenge of patients not being informed of clinical trials by their primary doctors. 

Accelerating Drug Development with Faster Patient Enrollment

, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discussed results from the Barriers in Clinical Trials survey conducted by StuffThatWorks. Key challenges identified by the survey include lack of physician communication, patient education, and the complex recruitment process. Elish and Ross highlighted how the findings can be used to streamline processes and leverage patient data to improve clinical trial recruitment.

ACT: Considering the findings from the Barriers in Clinical Trials 

, what are some new opportunities for medical research to accelerate drug development?

think that when you think about the number one challenge that we still face—and we've been facing it for decades—is enrollment into clinical trials. What will accelerate drug development is faster enrollment and then when you put these survey results that say physicians are not discussing the options of clinical trial with their patients, you now need to ask, how do we solve for that? You've got many patients across the world who are very, very interested in clinical trials. Many of them have—and the survey data called it out—exhausted their clinical recourse in today's standard of care, so you've got this whole patient pool that is seeing their private practice physicians and yet struggling to get to clinical trials and we have to solve for that as an industry.

Clearly, patients are also stating in the survey, and I think it's very natural that they rely on their doctor, and that the doctor's opinion of the clinical trial—we're talking to them—will be very influential in their decision to actually participate, or to try and take part in the clinical trial, also education in general, education by physicians, and general education, information and communities, so it seems it's very clear that on the onset of things, patients have exhausted treatment options. They know what clinical trials are, 82% say that they know what clinical trials are. The vast majority have never been spoken to about participating in the clinical trial, and they want to get any education on top of that. In numbers, it's all about funnels at the end of the day, right? You have the number of patients that are getting in the gate towards participating, and then the screening process, and then the locations of the sites that are limited, it's not everywhere, and every such step of the way, especially if you start off with the fact that 80% of patients will not be exposed to the clinical trial because of their doctor and not supported, you will see where the funnel is going, and you will see why at the end of the day, pharma is struggling with recruitment.

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