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Articles

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

Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses:

Industry’s greatest challenges in reaching diverse patient populations

Podcasts

Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more. 

Reaching Diverse Patient Populations With Personalized Treatment Methods

Improving access while maintaining a high level of research.

Advancing Patient Engagement in Community-Based Oncology Research

The clinical trial industry has a rare opportunity to redefine its role in public health conversations. 

The Gatekeepers Are Gone: What’s Next for Digital Patient Engagement?

Progress made in measuring decentralized clinical trial use in patient recruitment and retention.

Replacing Anecdotal With Empirical Evidence On Impact of DCTs

Clinical trial liaisons rather serve as experts in their therapeutic areas and as clinical trial specialists to provide a suite of strategic advantages to benefit a study.

The Value of Clinical Trial Liaisons in the Drug Development Lifecycle

Use of decentralized approach in a Phase 1 pharmacokinetic trial shows the ability to enable remote data collection and monitoring, which could improve patient access and enhance the efficiency of clinical research.

Decentralized Phase I Trial Highlights Promise of Remote Data Collection to Improve Clinical Research

In this video interview, Krinx Kong, chief commercial officer, Cognivia, highlights how patients’ perspectives on vaccine trials may shift if a policy change was to take place.

Public Perception of Clinical Research Amidst Policy Changes

, Krinx Kong, chief commercial officer, Cognivia, discussed the potential impacts of policy shifts on vaccine trial design and patient perceptions. Stricter regulations could increase trial complexity, affecting recruitment and retention. Kong emphasized behavioral insights as crucial to understanding patient motivation and mitigating dropouts. Looking forward with the potential for policy changes in vaccine trials, clinical operations professionals must focus on flexibility, behavioral visibility, and effective communication to ensure success.

ACT: There are already challenges with how patients perceive clinical research. From their point of view, how could a potential policy shift with vaccine trials further affect perception and trust?

Vaccine trials are already subject to intense public scrutiny and often misunderstanding. Therefore, when political or policy discussions suggest a new use of placebo controls, even though they've been long been the gold standard, it can create confusion. From the patient's perspective, this can sound like researchers are just now deciding to withhold treatment, which naturally triggers concern or mistrust. The truth is, placebo use is well governed and deeply rooted in evidence-based medicine. However, perception is everything nowadays. If patients or the public believe vaccine trials are less transparent or less ethical, that perception alone can damage trust, and we're seeing that today. That's why it's imperative to consider behavioral insights as a core aspect of trial success. Sponsors need to understand how participants interpret trial protocols, not just whether they follow them. This understanding helps trial teams communicate more clearly, empathetically, and persuasively, so patients feel safe, informed, and valued, even in a complex or high-profile trial in the era of misinformation, perception is no longer a side issue. It's central to both enrollment and impact.

Videos

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how newly emerging data from patients can help the industry improve its recruitment strategies. 

Leading with the Patient Voice

, 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: What implications will the Barriers in Clinical Trials 

 results have on the clinical research industry?

We've known for decades that patient recruitment is the number one challenge with clinical trials. We talk about the data, we see the data. We now have data directly from patients through the StuffThatWorks platform where you can engage with patients directly that are saying, “I, no matter where I live, want to participate in clinical trials. I have a need. I've exhausted other avenues. My physicians are not bringing these opportunities to me. When I raise it, physicians will impact the way that I view the clinical trial.” We have enough data now and enough direct patient insights that it is time for us to change how we're running clinical trials. It is time for us to lead with the patient's voice and restructure the way we conduct clinical trials. Looking at it through the lens of the patient, I want, and I believe and trust in my primary I want opportunities, no matter where I live, to clinical participate in clinical trials. It's upon the industry to solve for that, and the time is now.

: I second that very much, and I think that one of the biggest problems is the disconnect between access to patients and access to patient data. There is a total lack of access to patients. Every time you have to recruit patients from scratch, there's no way to really identify or advertise to patients online, because Google, Facebook, they self-regulate, and then you have to screen patients all over again because you don't really have their data. They're coming without data, so they have to be screened, and then their medical records have to be downloaded, and the information and screeners and the whole process. If you have access to patients at scale, and together with their data, this is a kind of game over, because you now know already who is eligible, you know where, and you just need to reach out to them and as we said before, I think, be in a respectful, ongoing conversation with patients and be involved. Have the primary care physician, the doctor, the immediate doctor be on board with the process, because that's probably the key issue here.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, talk technology and how it can save time in the recruitment process. 

Streamlining Patient Recruitment with Technology

ACT: How can key stakeholders in clinical research better educate and engage their patients?

You have to also remember that for a very significant number of patients, the severity level that is reported and the level to which it interferes with their personal lives is very significant, so they can be treated as ordinary people. If it's difficult for a person that doesn't suffer from a chronic condition, to change the their daily lives and accommodate something, then it's even way more difficult for someone who is suffering from a chronic condition to do that, let alone the process itself, the hurdles that you have to go through, the number of people that you have to talk to during the screening and after the screening, and this whole hand holding thing, which is, again, not ideal, and is causing a significant percentage of people that could have participated and are eligible to participate to end up not participating because they haven't been hand held properly throughout the process. There needs to be a much smoother process in which someone is identified, communicated to onboarded, their data is onboarded, the whole thing needs to be brought to the next level in terms of both technology and optimizations. I always think it's very funny that, when I started StuffThatWorks also, that in every other aspect of our lives, other than health, everything is so optimized to be convenient for us, so that we end up buying something or whatever you have, you have all this data about us, everything is data driven, everything is optimized, every piece of the funnel is polished to maximum, and when it comes to health, and it's along everything, along the way in every little aspect of fragmentation is huge, and clinical trials is also just one of these reflections, but it's interesting, because in clinical trials, this is where the interest would be aligned, because financially, the amount of money that is being lost every day of delay, which is usually caused because of recruitment is enormous, so here, at least financially, you're supposed to have alignment of interest, and it's, it's not actually happening.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how industry can improve on truly understanding the unique circumstances of patients. 

Strategies to Improve Patient Engagement

I'm sure there is, and it starts with leveling with having an ongoing conversation, ongoing education, and ongoing relationship with patients. You don't arrive out of nowhere. We're just throwing a little ad that says not much, very, very limited, and expecting people to be all over you, in participation into clinical trials. There are financial aspects. There are many opportunities to educate—not educate, I really don't like this word—but to expose, to talk about, to explain to in a way that is really leveled, patients understand. We know from StuffThatWorks, that patients are extremely educated. They know everything about their condition. They know everything about the treatments. They know in many senses, much more than the industry and the doctors gives them credit and I we're happy at StuffThatWorks to also transform their experiences into data that can arm them to become even more educated patients, but at the end of the day, the industry has to be more respectful to patients in how it approaches and how it communicates, and be more modest in expectations from patients.

I would just add that, I think we have to engage the patient with where they're at, so often we want to bring a patient into a trial, and we're trying to meet the inclusion/exclusion criteria and find the cookie cutter, but that may indeed be one of the biggest challenges with patient recruitment is we're asking them to create a whole new way of behaving to get into the clinical trial. I have to go to a different doctor. I have to behave differently. I have to, go to different places, a different place to get my blood drawn, my CT scan, my whatever it might be, we put all this burden on the patient. Then secondly, as a patient is interested in a clinical trial, do we not only ask them to behave differently, we ask their primary physician to behave differently, to say, “Yes, I support you. Go do that.” Almost like, “I can't help you with anything, therefore, go and do the trial.” Part of me says if we can solve for those two factors, how do we allow that patient to stay in their normal community while participating in the clinical trial? How they can still maintain their relationship with their primary even though they're in the clinical trial. Those are different engagement parameters that we have to solve for as we go forward, if we're going to solve for this patient recruitment challenge.

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

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.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, highlight the results and how patients are interested in learning more about clinical trials relevant to their condition. 

Findings from StuffThatWorks’ Barriers in Clinical Trials Survey

ACT: Could you tell our audience a bit about the Barriers in Clinical Trials 

 and highlight some of its most noteworthy findings?

I would just love to take just a few minutes to give context on the platform on which this was done and why we got into doing that. The survey was conducted by StuffThatWorks and StuffThatWorks is the company that I founded and I'm the CEO of and StuffThatWorks is a crowd sourcing platform that allows collection of crowd sourced data from patients with chronic conditions at scale and in organized numbers. The reason I started this company was from personal experience, where I was taking care of my daughter and my dad, and I realized that there is not enough information about what happens in the real world with patients. While you have a lot of clinical trial information about treatment outcomes, or generally medical information about conditions, it's very different from what actually happens in the real world. It's very different in terms of how treatments really work and impact people and different people and all that. Because I came from Waze, prior to that, I was in the founding team of Waze, I thought that crowdsourcing is really ideal for collecting data at scale, and the point being not discussion data, like in groups and discussion boards, but transforming that into real, organized, structured data that you can analyze and do stuff with. In essence, it's almost like transforming survey data at the base of it into structured data consistent across all conditions. We now have about 3 million patients across 1,250 conditions, chronic conditions. At some point, since pharma is our target market as a business model, we decided to dive into this issue of, why is it that clinical trials are constantly facing a major problem with recruiting patients by asking patients what are the barriers for participation? We conducted this survey where we have basically questioned patients across all 1,250 conditions with about 35 questions, and received a really, really amazing, interesting data that I think highlights a lot of what on what needs to be done in the industry.

Just to build on what Yael is saying, as the data came in on the survey, some of the most noteworthy things that come out are that the majority of patients, their individual doctors do not discuss clinical trials with them. The survey had 6,000 respondents, and 97% of them said their doctor is not discussing clinical trials with them. The majority of those individuals knew what clinical trials are all about, and they're extremely interested, like 93% of them are very interested in hearing about clinical trials, and yet it's not happening. I think we have to start to ask ourselves, why not?

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