Many pharmaceutical companies and CROs are tapping Eastern Europe, Asia, Latin America, and other areas to meet their clinical-trial needs.
While there are challenges associated with conducting research in nontraditional geographic regions — such as nascent healthcare infrastructures, technology, and connectivity issues — these areas represent tremendous opportunities for pharma and for patients and investigators.
The need for a larger source of patients is great. Delays in clinical-trial enrollment are getting worse, according to CenterWatch data. Just 14% of U.S. trials enroll on time, and 57% have more than a one-month delay.
Continued globalization of drug development is moving clinical trials into places not traditionally considered. Many pharma companies and CROs are looking outside the United States — especially in Eastern Europe, Latin America, and Asia — as a way to meet their patient and physician recruitment needs.
But to be successful in conducting research outside the United States, companies first need to identify what their particular challenge or opportunity is and then select the countries that best meet their needs, says Hugo Stephenson, M.D., president of Quintiles Strategic Research Services…
Soundbites from the Field
CROs in China: Only the Beginning
European Patients Want to Participate in Trials
U.S. Clinical-Trial Delays
Experts on this Topic
Terri A. Cooper, Ph.D. Partner, Global Pharmaceutical/Life Sciences Practice, IBM Business Consulting Services, Toronto; IBM Business Consulting Services provides business process and industry expertise, and the ability to translate that expertise into integrated, adaptive, on demand business solutions. For more information, visit ibm.com/services/bcs.
Alan Davies, M.D. European Medical Director, Kendle International Inc., Cincinnati; Kendle is among the world’s leading global CROs, delivering clinical-development solutions to help the world’s biopharmaceutical companies maximize product life cycles and grow market share. For more information, visit kendle.com.
Mark Engel. President, Excel PharmaStudies Inc., Beijing, China; Excel is a full-service CRO founded in 1999 that provides monitoring and project management for Phase I to IV studies in China. For more information, visit excel-china.com.
Scott Freedman. President, Monitorforhire.com, Philadelphia; Monitorforhire.com is a Web-enabled resource management company, providing qualified, regional independent clinical monitors to the pharmaceutical, biotech, medical-device, and contract research industries. For more information, visit monitorforhire.com.
Ed Holdener, M.D. Head of Global Development, Roche, Basel, Switzerland; Roche is a leading innovation-driven healthcare company. For more information, visit roche.com.
Claes Jagensjö, M.Sc. Pharm. Business Development, Trial Form Support (TFS) International AB, Stockholm, Sweden; TFS is a full-service CRO, providing the pharmaceutical, biotech, and medical-device industries with a wide range of clinical-trial services from Phase I to IV within the Nordic region. For more information, visit trialformsupport.com.
Faiz Kermani, Ph.D. Budgets, Proposals, and Marketing Executive, Business Development, Chiltern International Ltd., London; Chiltern International has accumulated extensive experience running trials from Phase I to Phase IV across a broad therapeutic range. For more information, visit chiltern.com.
Jean Paty, Ph.D. Founder and Chief Quality Officer, invivodata Inc., Pittsburgh; invivodata combines behavioral science, information technology, and clinical expertise to capture clinical-trial data directly from patients. For more information, visit invivodata.com.
Lawrence Reiter, M.Sc. General manager, South Africa, Criterium Clinical Research Pty. Ltd., a division of Criterium Inc.; Criterium, with corporate headquarters in Saratoga Springs, N.Y., is a technology-based contract research organization that has been providing creative clinical-research solutions for 13 years. For more information, visit criteriumusa.com.
Hugo Stephenson, M.D. President, Quintiles Strategic Research Services, Research Triangle Park, N.C.; Quintiles Strategic Research Services, a unit of Quintiles Transnational Corp., focuses on nonregistration medical research that can help companies win over prescribers, patients, regulators, and payers. For more information, visit quintiles.com.
Brian Tiplady, Ph.D. Senior Clinical Scientist and Chair, European Scientific Advisory Board, invivodata Inc., Pittsburgh; invivodata combines behavioral science, information technology, and clinical expertise to capture clinical-trial data directly from patients. For more information, visit invivodata.com.
Alan Wood, Ph.D. General Manager, Global Clinical Development Services,Covance Inc., Princeton, N.J.; Covance is a comprehensive drug-development services company. For more information, visit covance.com.