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Understanding Cross-Border Enrollment for International Clinical Trials

International clinical trials offer a number of opportunities. Work on rare diseases becomes more feasible when patients can be drawn from a larger population. Clinical trial teams can collaborate internationally, providing more effective care and pursuing more complete results.

Yet enrolling patients in clinical trials across international borders is not easy. Cross-border trial enrollment comes with many of the same challenges as domestic enrollment, plus the added hurdles of navigating multiple countries’ regulations and the need to communicate effectively across cultures and languages. The right technology can help clinical trial teams boost cross-border enrollment effectively.

The Rise of the International Clinical Trial

Clinical trials have a long history. While international interest in clinical trials has existed for centuries, international guidance for clinical trials is newer. The Nuremberg Code, the first international guidance of the ethics of using human subjects in research, was created in 1947, emphasizing voluntary consent. Consent remains a significant issue in clinical trials performed worldwide, writes Arun Bhatt in an article on the evolution of clinical research.

As technology has connected once far-flung corners of the world, it has also expanded our ability to conduct clinical trials at greater distances. As cross-border enrollment becomes feasible for more clinical trials, challenges also arise. For instance, while international standards for clinical trial conduct exist, they offer only one source of guidance — various countries also have their own specific rules governing what constitutes informed consent, how trials are to be conducted, how information is secured, and other issues.

Enrollment has long posed challenges in clinical trials, and expanding these trials to international or multi-national populations has not always solved these problems. For example, trial participation criteria still bar many people from taking part in a clinical trial, or these criteria pose hurdles that discourage otherwise qualifiable participants, as a recent editorial in Nature notes. Because international effort will be required to clarify the best practices for trial criteria, addressing the issue will need to take place within international clinical trials as well as those performed entirely within the borders of one country.

As international clinical trials have become more popular, however, they’ve also raised a number of questions. As far back as 2007, for example, an article by James Cekola in the Northwestern Journal of International Law & Business noted that the trend of U.S. pharmaceutical companies outsourcing clinical trials to India raised issues such as whether clinical trial participants were adequately protected.

Such questions persist today. In the case of international trials with cross-border enrollment, regulations protecting the safety, health, and information privacy of participants pose only one of many challenges.

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Challenges in Cross-Border Enrollment for Clinical Trials

Because they span more than one country, international clinical trials pose unique challenges, including challenges in enrollment.

In a 2020 study published in Frontiers in Medicine, Teodora Lalova and fellow researchers found that participants in clinical trials named logistical and financial burdens as their top concerns with cross-border enrollment.

Both respondents who had participated in a cross-border trial and those who had not said that travel distance was a challenge, for example. Patients who had actually participated in an international clinical trial were more likely to say travel was a hurdle; in the study, 77 percent of past clinical trial participants named travel as a challenge, and 60 percent of non-participants said the same. Concerns about follow-up care at home were also high on the list.

Patients face challenges in participating in clinical trials that require them to cross borders. For trial managers, getting these trials off the ground can be a challenge as well.

Regulations in various countries create a complex web of demands for clinical trials. Many of these demands arise even before the enrollment stage, while others impact cross-border enrollment specifically.

Recent changes to China’s data security and privacy laws, for example, have pushed clinical trial managers to update contracts, change their records retention requirements, and take a second look at methods for obtaining consent from participants, writes Zhou Hanshuo, an attorney at Jingtian & Gongcheng in China. Other nations have similarly complex laws and regulations governing the security and privacy of health data.

Rare diseases pose another challenge for clinical trials. Because rare diseases appear in only a minute fraction of the human population, patients who have them are more broadly scattered around the world. An international trial may be essential in order to recruit sufficient patients for study, making cross-border enrollment a must.

Even when rare diseases are clustered within a specific population, reaching out to that population for study poses challenges.

“Clinical study managers often do not have the knowledge or expertise to anticipate the additional assistance involved in arranging the complex international and cross-border logistics required of many rare disease trials,” writes Scott Gray, CEO at logistics management services provider Clincierge. Choosing the right tools in these instances is vital to clinical trial success.

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Choosing Tools and Strategies for International Clinical Trial Enrollment

Strong communication is a must when pursuing cross-border enrollment activities. “There was a consensus among interviewees and survey participants on the need for reliable and accessible information and advice,” write Lalova, et al. Top information needs mentioned in the study included:

  • Information on best practices.
  • Considerations for cross-border access to clinical trials.
  • Information and instruction on risks associated with international trials.

The researchers recommend that best practices be developed collaboratively by experts and stakeholders with experience handling cross-border enrollment in international clinical trials.

Improved communication and information-sharing may help to build trust during the enrollment process. Trust is essential for improving patient participation in clinical trials, particularly among diverse or traditionally underserved populations, says Melissa Simon, founder and director of the Center for Health Equity Transformation and the Chicago Cancer Health Equity Collaborative at Northwestern University.

Technological tools offer ways to improve communication, identify and refine best practices, meet regulatory demands, and enhance cross-border enrollment in international clinical trials.

In a 2019 study published in the Journal of Thoracic Oncology, Matthew P. Smeltzer and fellow researchers found that enrollment in lung cancer-related clinical trials dropped by 14 percent globally during the COVID-19 pandemic, fueled by concerns about travel and lab access as well as fears about the virus itself.

Yet the researchers also found that certain digital tools helped to mitigate the decline in trial participants. For example, 89 percent of clinical trial site respondents said that remote consent options helped shore up participation, while 85 percent agreed that telehealth visits, off-site procedures, and remote patient-reported symptom documentation helped reduce patient loss in these trials.

These tools can also help clinical trial teams build and maintain enrollment in a cross-border setting, say doctors Bob T. Li and Sir Murray F. Brennan. Remote options help reduce the burdens associated with travel, encouraging patients to enroll and keeping them connected with the trial team.

The right data management platforms can help clinical trial teams organize collected information, meet various security and privacy requirements, and glean meaningful insights from patients’ participation — regardless of their location on the globe.

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