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There can be many challenges associated with starting clinical trials. These can include, but are not limited to, ensuring diversity, site selection, regulatory barriers and patient retention. And, with rare diseases, finding enough people to participate in clinical trials can also be a big challenge. So how can companies overcome clinical trial issues? Sheila Rocchio is the chief marketing officer of eClinical Solutions. With more than 20 years of industry experience, Rocchio manages all aspects of marketing including branding, communications, lead generation, product marketing, and education. She told Labiotech that clinical trial recruitment has long been a challenge, and one of the biggest issues in terms of finding the right patients at the right time to really achieve a fast timeline for bringing a new drug to market. “When companies talk about their challenges, much of it is focused around identifying the right patients, keeping them engaged, and supporting them throughout their overall experience in the trial. It has been interesting to see how that conversation has evolved. Even simple awareness of research as an opportunity, and letting enough people know about the type of trial they might be eligible for has been a challenge. So, one of the issues is educating physicians and doing more primary education for researchers about communication to eligible patient populations.” Patient engagement in clinical trials Rocchio explained that there are pockets where potential trial patients are more engaged. “The rare disease community, for example, tends to be more engaged and actively searching for research opportunities. By contrast, in oncology, there are many opportunities, but it takes more effort on behalf of the patient. And then for more chronic diseases, patients often may not even know that drug research could be an option for them. Education and access are key issues - knowing what trials are available and the willingness to enroll. In many cases there is still a good amount of worry for patients, “Will I be taking a medicine that’s not approved? What are the risks?” “Educating about safety is important within the process of finding and reaching patients. Again, how these various factors may play out is a little bit dependent on the patient population. But education is probably the biggest opportunity for patients and their caregivers.” Ensuring clinical trial representation It has been a long-standing challenge in drug development to find appropriate representation of disease and the right set of clinical trial participants for a given study, Rocchio noted. “We have an existing difficulty with recruitment regardless of age, gender, and race, which makes reaching more parts of the population that are representative of the disease even more challenging. The problems are multi-faceted, but three key areas are representation and education, measurement, and access. Under-representation across life sciences, clinical development, and healthcare negatively impacts researchers’ ability to connect with and attract patients from different backgrounds.” Rocchio said studies have shown people are more likely to trust an individual who looks like them. It isn’t a quick or easy problem to solve, but the representation of physicians, clinicians, and investigators matters. When it comes to measurement, it’s about strategy and it’s also a technology problem, Rocchio explained, although she said this is one that has improved over time. “Identifying in a precise way where the target demographics are and taking a very concerted effort to reach out to them can’t be a guessing game. Recruiting strategies need to account for diversity and must utilize technology to identify gaps, find representative populations, measure, and improve. We’re seeing that now with the FDA’s requirement to submit diversity plans. “The FDA is looking to drive meaningful change for more diverse research, and if the industry intends to drive that as well, reaching those outcomes will be about more than drafting and submitting a plan. This is one of the areas where the adage, “You can only manage what you measure,” is true, and that’s where technology comes in - helping teams ensure their diversity plans achieve desired results.” Rocchio said the last piece is about accessing and meeting patients where they are, which decentralized clinical trials (DCTs) seek to address, from removing barriers to participation with remote data collection technologies, to direct-to-patient recruitment leveraging tech and data. In addition to the many opportunities where DCTs can help, it’s also about the diversity of sites, she stressed, so that research is not happening only at the big university hospitals. A lack of geographic diversity in sites is part of the problem in the lack of diversity across patients. Clinical trial geography challenges So what are the best ways to overcome these? Labiotech recently interviewed companies in Mauritius, which is promoting itself as a great place for trials because of the ethnic diversity, so is the way forward to diversify geographically? Rocchio said there’s no one solution to overcome these challenges, but many different approaches, and there is a need to be consistent about addressing it as a multifaceted problem. “Expanding the types of regional locations where clinical trials are conducted will help, and that also speaks to identifying, training, and educating the clinical teams that could recruit and participate in research - articulating the benefits of that approach. Mauritius may be great, but it might also be different in terms of the diseases that impact the region. It’s certainly not a one-size-fits-all situation,” Rocchio explained. “We did hear from the regulators the importance of understanding the impact of disease on the representative populations and how going forward, the FDA would like to see the same distribution in the trial population as is impacted by the disease. That requires analysis of real-world data: looking at the EMR, understanding incidence, natural history, and population studies, and applying that data in order to be able to act on it in real time. “So, there is a geography problem. There is a need for education and outreach, where partnering with local communities can help. And there is a technology strategy to know what to look for and how to achieve it. And finally on protocol design, having an agile and continuous feedback loop and not making it too difficult to meet inclusion/exclusion criteria or too difficult to update protocols based on what is seen in the population is another area to address.” Rocchio said all of those approaches, coupled with continuous partnerships with regulatory authorities, will help the industry move forward. “Perfect is probably not achievable, but making progress and evaluating each program to figure out practical strategies is going to be an ongoing component of achieving better representation.” Recruitment difficulties And Rocchio also explained why some trials are more difficult to recruit for than others. “Diseases where patient advocacy is very strong, such as specific rare disease communities, tend to have more awareness because they’re a very informed patient group,” Rocchio observed. “Oncology trials can be difficult because there are many oncology therapies, and the burden of disease is significant. Trials where there is a significant burden of disease already tend to be more difficult to recruit for than trials where the risk and severity are less significant. The motivation to participate and safely profile is also a factor. For some diseases, again oncology is an example, trials are competing for patients - which means patients must be willing to do the research to figure out which trial could have the best effect, and a lot of times people are really scared and worried about getting the initial diagnosis, so this additional work to research options feels like a burden. "The patient may have standard of care treatments that are already daunting on their own. In many cases, it will come down to the patients’ healthcare team and their knowledge of research and options available, which is why education and access are so important.” Tackling the different regulations around the world can also create hurdles, and Rocchio said there has been an effort to harmonize the conduct of clinical trials; over the last 20 years they have become increasingly global in nature. Rocchio predicts global trials will continue to be a trend as information access becomes easier and faster. “Negotiation of rules and regulations may not be the primary hindrance when it comes to diversity, although it is important. Logistics challenges are still significant in global clinical trials as well,” Rocchio noted. “And we need more stories about why a certain country might be a good location for research – Australia is one we hear about more than some others. If a country sees it as important, making sure that they are aligned with ICH guidelines is key. Certainly, there are countries that could work to make it a better option by potentially streamlining their rules and regulations, while some countries appear to have achieved better consensus than others in the way they approach it. That alignment is an important piece that can help encourage more global and thereby more representative trials.” Clinical trial costs We often hear about the high costs of research, recently estimated by the Tufts Center for the Study of Drug Development (CSDD) at $2.6 billion for a new approved compound. Rocchio said DCTs aim to reduce some of that cost through efficiency gains and decreased cycle times. Typically, she said, patients don’t have to pay to participate in a trial and are often reimbursed. For the patient, then, it’s more about the opportunity cost and time. Considerations include how difficult it is to get there, what are the procedures required, how often do they need to be there and how much waiting is involved. This is another area where decentralized trial models are trying to make it easier to participate in order to reduce at least some of the opportunity costs, Rocchio said. Future developments in clinical trials There’s a lot of attention of late on artificial intelligence (AI). Can technology such as AI make clinical trials easier? “There are AI use cases across the clinical development lifecycle, including those that can support greater diversity in clinical trials. In terms of making recruitment easier, analyzing data to help sponsors focus on where patients are is one area that AI can support by automating the analysis of EMR and other data,” Rocchio explained. “There have been many technological advances making it easier for patients to find trials or for that patient matching to occur and to enroll and screen patients in trials. AI could also be used to improve trial designs. Bringing AI/ML (machine learning) into the fold offers great potential to increase the accuracy and speed of efforts to recruit diverse trial participants.” Rocchio said that technology infrastructure and clinical data platforms are making trials easier and faster for clinical development by connecting digital data and making it easier to make informed decisions throughout trials. She said centralized data enable measurement of trial diversity plans to ensure goals are achieved. “Advances like these can help us improve representation in trials when combined with patient-centered strategies. We have seen commitments to share more data with patients after a trial has been completed so they know the results, as well as the Patient-Centered Outcomes Research Institute (PCORI) and government patient-centered research, focusing on outcomes that are important to patients. The focus on DCT models strives to reduce patient burden by utilizing a combination of in-person and remote options, incorporating more patient choice.” Rocchio concluded that there’s no one-size-fits-all approach, and that multiple methods are needed. She said that making the patient’s role in research easier is at the core of a multi-pronged strategy to improve trial diversity, which includes leveraging technology, looking at protocols, improving access, deploying flexible models, and improving connectivity to sites in various ways.

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