Webinar Recap: Enabling Site Success – Key Insights to Reducing Burden and Increasing Access

Investigator sites are essential for successful execution of clinical trials – ensuring studies are conducted ethically, safely, and in compliance with regulatory standards. Being an investigator and supporting clinical research, though, is not easy.

In addition to bringing new and innovative treatment options to patients, the business of conducting research can be an administrative burden and workload for sites and staff. Sites need partners dedicated to understanding a site’s distinct challenges and driving solutions to ease burden, create a better experience for sites and patients, and expand access and representation in research.

In a webinar sponsored by Syneos Health, Atlas Clinical Research’s chief executive officer Mark Scullion and Batisha Anson, global head of patient diversity and health equity at Syneos Health, shared their expert insights on ensuring clinical research site success – including the important need for a partner who understands the challenges and drives solutions that can ease burden, create a better experience, and expand access and representation in clinical research for patients.

Medical foundations: Becoming an investigator

Fundamentally, what motivates a physician to become an investigator, according to Anson, is inspired by the healthcare industry’s shared passion to seek and find medical advancements and ensure patients have access to new therapies. Such a passion requires support, however.

“Ensuring that we are by their side, offering training around compliance, ethics, patient safety, but not just giving training for training's sake,” Anson explained. “I think it's really important to understand where they are interested in focusing, the environment in which they're operating, and actively listen to help fulfil their needs and this amazing decision to become an investigator to support clinical research globally.”

“Before they're investigators, they're doctors,” added Scullion. “What makes a person become a doctor is the place where we start. Fundamentally, when someone becomes a doctor, yes, they're choosing a career, but they're choosing a career in which they want to help. They want to help the most number of people that they can in the way that they're best equipped to do.”

Challenges and burdens

It is, at the end of the day, about partnership – ensuring that the infrastructure is right and the training is there. After all, successful sites mean successful clinical trials. But success comes by first addressing challenges.

“The challenges are many; there are as many as the opportunities,” noted Scullion. “In the end, [it’s] recruiting patients to try and answer scientific questions […] We try and bring a patient into a study. For an investigator, let's use the investigator as a representative of the site here. The site [firstly] has to find a patient.”

“Second, is making that a good experience for the patient, scheduling them, bringing them in, making sure they understand what they're being asked to do, that they're informed, and they give their consent to the procedure,” he continued. “Then, there's the data collection. How does one get the data? What systems does one have to use? After you've been doing this a while, if you're a doctor and you become an investigator, if you're really good at it, you might end up working with multiple different pharmaceutical sponsors and multiple different CROs, which means you might have multiple different ways of doing the same thing, and that can get confusing.”

“We know in the traditional medical environment that doctors are already feeling overburdened, and that is amplified, certainly, within clinical research in terms of the fact that sites are responsible for holding to such high, rigorous standards,” agreed Anson. “Clinical Trial Site Networks [have highlighted] that 60% of sites are using more than 20 overlapping software technologies. You can just imagine having different passwords, usernames – all of the different training requirements just to figure that out. Two-thirds of sites indicated set-up and training on sponsored tech are more burdensome than five years ago. That's something that we certainly need to address, and quickly.”

“Certainly, we learned during the pandemic that access to data became critical. Particularly if you're trying to monitor subjects remotely, how does one get access to data?” said Scullion. “There was then almost an increase in technology and tools to try and close the gap because there was a genuine and correct nervousness […] It's all born out of really good intentions to try and give sites more to help them, and to make sure that they can oversee their patients correctly, so that finally we get clean and efficient data.”

Nonetheless, when working with multiple companies, or if the same company is doing different things on multiple therapeutic areas and multiple studies, it can get a little “overwhelming,” says Scullion. “The intention is right, the goal is correct; the only way through all of this is going to be with improved tools and technology.”

Partnerships vs competing systems

However, tools are ineffective without relationships; technology does not work if used without partnership. CROs must actively listen to the sites they partner with, and develop and design technologies according to that fostered relationship.

“We talk about a site like it's a monolith, like they're all the same,” cautioned Scullion. “They're not; they're very different. It's not just four walls and a bunch of people with medical equipment. Each one has its own quirks.”

It is, in short, about trust – person to person, before technology even comes into play.

“It's people first,” asserted Scullion. “If you get people that are able to talk to each other – ‘Who is my partner?’, ‘What is their name?’, ‘How do I reach them?’, ‘What do we talk about?’ – if we have people that can interact together, after that is having some shared understanding of what success looks like and being transparent with each other […] If we can give each other first the name of a person with whom we work, that can be someone that's consistent, that understands us as a site, that we understand our partner's motivations – that's gold.”

Diversity of patients and sites

Nonetheless, the world we live in is immense, with different cultures, different communities, different engagement practices, and different regulations.

“Now, there's even more pressure that we're all feeling in healthcare, but certainly is really headstrong on clinical trial sites in terms of how we are determining representation within our clinical trials [and] ensuring that we're pivoting to different regulatory changes and health technology assessment needs,” said Anson.

“You can't have sustainable partnerships if we're only working on a past study basis,” agreed Scullion. “You can't build that trust, can't build the longevity. It's the listening, it's the infrastructure, it's the support so that we can do what we're supposed to do best, which is represent in the communities where we're based to patients.”

“We've been really seeing amazing progress in terms of community engagement, something that the US FDA is asking for, by using AI to better understand distinct patient populations motivators, specialist behaviours to ensure that we're providing more relevant content that, of course, needs to be validated by direct sites,” explained Anson. “I think we've had a lot of great success with AI in terms of evolving our protocol practices, ensuring that we're thinking more broadly to be not just competitive to ensure that we have the right novel agents, but ensuring that we are thinking through the lens of patients.”

“Anything that improves patient optionality and lessens barriers to entry are great things,” added Scullion. “There are many of the modalities of DCTs [decentralised clinical trials] which fit into that box. We can then combine that with site and patient burden to make it easier, even if it's some parts of the visit or some parts of the protocol, where a patient might have a choice to do some of that remotely. It doesn't necessarily require them to travel.”

“The extent to which we can then integrate medical records into our feasibility, we can give better advice to a patient on studies for which they would fit,” explained Scullion. “For the patient's perspective, if their record then connects with us, if we can use AI then to better approach a patient, to screen those patients, and even when it gets to something so simple as scheduling a patient, if the outreach, the text messaging, and so forth can be done on the patient's schedule, sites are very flexible.”

“Everything has to come back to the human,” said Anson. “I certainly think sponsors are leading the charge. They want to also ensure that their research partners really share their values in terms of partnership. They don't want us just to be head-down, transactional data collectors. They really understand the power of human connection because, ultimately, it makes their studies better.”

“Let's be honest, sometimes we know there's going to be a second or third amendment after first patient,” admitted Scullion. “If we can avoid that, and when that is done well, then the site goes into it knowing how much work they need to do, how they're going to do it, and which platforms are consistent with the patient population. It's really about consistency in people again.”

“This is not just about social good, it's about advancing health equity globally, but also this allows us to understand how medicines work in different populations,” said Anson. “Patients have to be at the centre of everything that we're doing to really understand scientific integrity, scientific progress, innovation, and certainly back to patient safety.”

“We need to demonstrate that we have been intentional in our practices to ensure that we are providing equitable opportunities for diverse individuals to participate -- race, ethnicity, sexual identity, gender, sexual orientation, gender identity, age are all really critical,” insisted Anson.

“I have a mantra I've used for a long time,” shared Scullion. “Does it help? How much does it help? Whom does it help? If you can't answer those questions, then we're not going to deploy it at all. That would be the starting point.”

“The world is changing. Trials are becoming more complex. Regulations are asking for more. It's really critical that we ensure that our systems are readied, and that we're being socially responsible in terms of our decision-making,” Anson concluded.