spacer
home > white papers > Clinical Trials in Emerging Markets: Goldmines or Landmines? - Pharm-Olam, LLC
WHITE PAPERS
logo_Pharm-Olamo.jpg

Pharm-Olam, LLC

phone +1 (713) 559-7900
email info@pharm-olam.com
web http://www.pharm-olam.com
email 79 T.W. Alexander Drive Building 4401, Suite 240, Research Triangle Park, NC 27709

Clinical Trials in Emerging Markets: Goldmines or Landmines?

Over the past decade, biopharmaceutical companies have increasingly turned to emerging markets as a way to reduce clinical trial costs and timelines. Areas such as Eastern Europe, India, and Latin America—with their ready population of treatment naïve patients—can be an answer to the intense competition for patients seen in developed markets. Many of the countries within these regions may now be considered as “emerged” countries but yet, conducting trials in these regions does require some special attention and expertise. Before deciding to conduct studies in these areas, companies should have a full appreciation for the ethical, medical, regulatory, legal, and operational hurdles that must be surmounted for success. Here we highlight a number of those issues and offer our recommendations for how sponsor companies can deal with them effectively.

The Allure of Emerging Markets Sponsors’ interest in emerging markets as loci for clinical trials has been mounting for at least a decade. (See Figure 1A and 1B.) In 2011, this phenomenon reached a tipping point: for the first time, more data were submitted to the European Medicines Agency in marketing-authorization applications on patients from outside of Europe and North American than from within those areas. While the “Rest of the World” designation includes some mature markets such as Australia and Japan, there is, nonetheless, a clear takeaway: emerging markets have become a hot bed of trial activity.

Clinical Trials in Emerging Markets: Goldmines or Landmines?
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Medovate announces distribution agreement with LTR Medical for sales of SAFIRA® in Australia and New Zealand

08 September 2020: Medovate, the medical device development company, has concluded a distribution agreement with Brisbane-based LTR Medical which will provide exclusivity for SAFIRA® (SAFer Injection for Regional Anaesthesia) in Australia and New Zealand.
More info >>


White Papers

The Importance of ADCC in Assessing Clinically Relevant Differences

Sartorius Stedim BioOutsource Ltd

Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental to any biosimilar development project. The biosimilars pathway to approval is not always without difficulty, biosimilars are still relatively new, and as each new applicant is reviewed we are learning more and more about these molecules.
More info >>


Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement