将临床试验扩展到新领域：探索成功的关键

Expanding Clinical Trialsinto New Territories:Exploring the Keys to Success Maximizing geographical reach by leveraging expertise,technology, and local experience IAN PEMBERTON, Vice President, Head Of Alliance Management, Mid-Size and Emerging Models, Clinical FSP, IQVIAGARY WHITE, Head of Go to Market – Clinical FSP, IQVIA Table of contents Introduction3Key drivers of country expansion3Patient recruitment and diversity4Regulatory flexibility4Cost efficiency4Access to untapped markets5Technological advancements5Regulatory harmonization5Matching countries to trials: the importance of scrutinizing every variable5Balancing FSO and FSP solutions in country expansion6Assessing country infrastructure7Enrollment modeling and scenario planning7Site intelligence and identification8Regulatory and startup8Navigating the logistics, trial supplies, and supply chain8Finances, contracting, and payments8Staying on course: patients, sites, and data management9Customizing—and optimizing—patient recruitment and retention9Consistency and excellence in data management and compliance10Conclusion10About the authors11 Introduction “With today’s increasingly innovativetools, data, capabilities, andtechnologies, the opportunity toachieve success conducting clinicalresearch overseas has neverbeen greater.” For as long as societies have existed, people from allwalks of life have been compelled to travel abroad —for leisure, commerce, education, or perhaps to start anew life in a foreign land. Venturing into new, unfamiliarregions introduces new sights, sounds, languages andcultures, ultimately rewarding us with an enrichedunderstanding of the world in which we live. Yet no matter what the motivating factor is forventuring overseas, one cardinal rule stands the test oftime: the more prepared and informed the traveler isabout the destination country, the greater the chancesof a successful journey. Therefore, whether utilized as a full-service offering(FSO) or functional service provision (FSP) partner, itis highly beneficial for sponsors to collaborate with aCRO that possesses a strong global footprint, has in-depth local experience and insights, and sufficientlyrobust capabilities. This combination helps to ensurethe successful design and delivery of quality clinicalstudies in an expansion country. The logic is simple: understanding local norms, lawsand attitudes helps ensure the traveler remains on theproper course and avoids precarious setbacks. Soundcontingency planning is also necessary as a safeguardin the event the journey doesn’t go as planned. Having conducted clinical trials in more than 67 countriesacross a broad range of therapeutic areas, we at IQVIAhave written this paper with the goal of sharing keyinsights, challenges, and best practices for successfullyexpanding clinical research into new markets. Nowhere are these principles more relevant thanin today’s clinical trials, as sponsors and theirCRO partners increasingly seek to expand theirgeographical reach to conduct medical research. But first, let’s delve into some of the key factorsdriving the trend of geographic expansion. Conducting clinical trials in less charted researchdestinations — for example, within Latin America,Asia, Africa, and Eastern Europe—provides significantopportunities to develop treatments for more diversepatient populations, achieve greater operationalefficiencies, maximize flexibility, accelerate overalldelivery, and achieve many other potential benefitsfor medical science. And with today’s increasinglyinnovative tools, data, capabilities, and technologies,the opportunity to achieve success conducting clinicalresearch overseas has never been greater. Key drivers of countryexpansion There are 6 main drivers fueling pharmaceuticalcompanies to conduct research into new territories(see Fig. 1), and are listed below: •Patient recruitment and diversity•Regulatory flexibility•Cost efficiency•Access to untapped markets•Technological advancements•Regulatory harmonization That being said, without robust experience,local expertise and planning, sponsors will likelyencounter unforeseen issues that can cause delays,added costs, compliance risks, and—in the worst-case scenario—compromise patient safety. country mix for these type of trials has the potential toengage a greater volume of participants, significantlyaccelerate enrollment, and reduce timelines withoutcompromising quality. Patient recruitment and diversity Expanding geographical reach can provide sponsorsnew avenues to access and recruit a greater volumeand broader range of key patient population groups. Additionally, since many diseases and treatmentsimpact patient populations differently—often due tovariations in genetics, lifestyle, and environments—increasing the diversity of trial participants throughgeographic expansion can help sponsors yieldmore robust, representative data that enhances thedevelopment of more precise, targeted treatments Keep in mind that the increasi