An increasingly connected world allows clinical researchers to expand their collaborations across borders and time zones. The ability to collaborate internationally on research and development has proven particularly useful in the search for a COVID-19 vaccine.
Although international R&D collaboration offers opportunities, it also poses significant challenges. Balancing the national regulations of multiple countries and remaining sensitive to changing industrial and cultural norms create additional hardships for transnational teams.
The pharmaceutical industry continues to embrace both the challenges and the benefits of collaboration across national borders. Digital tools can make such collaborations more productive.
International collaboration by pharmaceutical researchers often provides benefits for both research teams and clinical trial patients.
“A better understanding of disease pathology, improvements in relevant disease outcomes, better treatment strategies and the development of novel therapies all contribute to improving healthcare and treatment options,” write Patrick Durez and fellow researchers in Acta Clinica Belgica: International Journal of Clinical and Laboratory Medicine. International collaboration provides opportunities to foster this improved understanding.
Collaboration can help pharmaceutical companies move products through clinical trial phases more quickly, without sacrificing quality. For instance, pharmaceutical giants Scripps and AbbVie recently collaborated on a project to more quickly allow the companies to develop next-generation T-cell therapies.
The Scripps/AbbVie collaboration “represents a robust path forward for some of our programs, complementing a diverse ecosystem of innovation we’ve created over the past years at Scripps to advance life-changing therapies,” says Peter Schultz, Ph.D., CEO of Scripps Research.
Such collaborations, extended across national borders, can create greater opportunities for innovation. They can also help researchers reach more diverse clinical trial populations, united in their need for new, effective pharmaceutical treatments.
The myriad opportunities for success offered by international research collaboration make such collaboration inviting to many pharmaceutical R&D teams. Yet certain key challenges can make realizing these benefits challenging.
International research and development is more important than ever. In a 2019 Science|Business poll, 73.79 percent of respondents from universities and public and private research agencies said that global research collaboration was “vital for the future of the world.” In addition, 62.5% saw international collaboration as “vital for the future of my organization/region.”
Despite the growing sense of urgency surrounding international medical research collaboration, research organizations find themselves hesitating to build relationships due to difficulties in two areas: understanding applicable regulatory demands and funding.
About half of those surveyed said that funding remained a major hurdle. Nearly 90 percent of respondents said they needed more information about international R&D activities, including more information about applicable laws and regulations in collaborating nations.
A lack of historical participation in clinical trials can also make it difficult to extend trials into certain areas. In an article published in JCO Global Oncology, Olusola Solarin and fellow researchers point out that while Africa contains approximately 20 percent of the world’s population, less than one percent of all clinical trials are conducted there.
African nations may be particularly promising places to conduct clinical trials for conditions like sickle cell anemia and malaria, write Solarin and the research team. Yet a lack of empiric data, combined with the regulatory challenges of working with 54 separate national governments, can make clinical trials in Africa seem daunting.
“Collaboration and partnership among all stakeholders in the clinical trial ecosystem will reduce the burden on sponsors and make Africa competitive as a destination for clinical trials,” write Solarin and fellow researchers.
The digital era has made it easier than ever to share information. While legal and practical concerns may still create hurdles to international R&D collaboration, digital platforms and tools have improved our ability to share information.
For example, artificial intelligence is improving the ability of clinical trial managers and researchers to better collect and analyze data, reducing cycle times and improving productivity and outcomes, write Deloitte researchers Karen Taylor, Francesca Properzi and Maria Joao Cruz.
One particularly promising use for artificial intelligence in the international clinical trial field is in maximizing the value of real-world data. While RWD has become easier to collect in recent years, analyzing it has posed a challenge for research teams.
Using the right tools, however, can maximize the value of RWD when the AI is used within the right digital infrastructure. “Unlocking RWD using predictive AI models and analytics tools can accelerate the understanding of diseases, identify suitable patients and key investigators to inform site selection, and support novel clinical study designs,” write Taylor, Properzi and Cruz.
Because AI can be embedded within a digital platform or program, its ability to analyze data and spot patterns can be made available to all the partners in a pharmaceutical R&D collaboration, regardless of their physical location.
Building R&D partnerships across national borders is essential not only for pharmaceutical research, but also for populations who may otherwise struggle to obtain the medications they need to fight pressing local problems.
“Efforts to enhance research capacity, exchange know-how, standardize data collection, and share results rapidly are critical to developing and deploying the tools we need to protect health workers and communities in low- and middle-income countries,” says Professor Nicholas J. White, chair of the scientific research committee for the Drugs for Neglected Diseases Initiative.
Such initiatives are critical to transnational collaboration on pharmaceutical clinical trials worldwide. When the race for a COVID-19 vaccine began, the need for digital collaboration initiatives became urgent.
“With hundreds of clinical trials for potential coronavirus therapies in the works—and even more in development—concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts,” writes Jill Wechsler, the Washington editor at Applied Clinical Trials.
Partnerships that coordinate research and make information available through digital platforms can reduce certain risks by creating transparency. When researchers can examine one another’s work and data, regardless of their global location, they can better coordinate their efforts, understand conflicting data and avoid unnecessarily duplicating studies or results.
When digital tools are employed in the service of R&D partnerships, both pharmaceutical companies and patients benefit. Although COVID-19 has devastated lives worldwide, pressure from the pandemic has also created a new commitment within the research community to streamline international collaboration.
“We are working on an equal footing and shared basis with other interested bodies across the board to find solutions so that safe and effective treatments can be accessible for all those in need — wherever and whoever they might be,” says Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations, which has taken a key role in promoting international pharmaceutical R&D collaborations.
The need for a strong pandemic response has accelerated demands for international pharmaceutical research and development, but it has not eliminated key challenges. By embracing digital tools and techniques for gathering, analyzing and sharing data, pharmaceutical companies can facilitate cross-border R&D to fight COVID-19 and other diseases.
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