Outsourcing
Trial organisers must be aware of certain limitations in APAC countries, like the inability to test for certain cancer biomarkers.
Yet, what countries in the Asia-Pacific lack in expertise, they doubtless make up for in population. With literally billions of eager subjects to choose from – many of whom have never been examined before, even as they increasingly suffer from the same ailments as their Western cousins – it’s no wonder that trial organisers the world over are flocking to the continent. That’s shadowed by serious investment in new labs and better test centres, which together could transform the region into a genuine competitor to Europe and America. Not that Asia’s ascent is by any means assured. A lack of doctors has traditionally left many countries off-limits to the biggest trial conveners – and that’s before you consider the looming and inescapable threat of political instability.
Raising their game $20bn CEPI 38
Together with schemes like Operation Warp Speed, CEPI has invested this amount into Covid research.
Sheraz Ali has crisscrossed the Asia-Pacific for years. Starting his career in his native Pakistan, he then spent four years in Saudi Arabia, working at the Ministry of Health, before ultimately settling down to become an academic tutor at the University of Tasmania. To phrase it differently, Ali is in an excellent position to reflect on the challenges and opportunities of Asian clinical trials – and indeed clarify what ‘Asia’ even means. This isn’t an idle point. From a geographical perspective, after all, the continent technically spans from Tel Aviv to Taipei. But for Ali, and indeed most experts in the field, ‘Asian clinical trials’ actually refers to the south and east of the continent, essentially a crescent of countries starting in Pakistan and ending in Japan. If you include the ‘APAC’ moniker, you also include Australia and New Zealand. Obviously, even these more limited definitions are pretty vague: China
and India account for over 35% of the world’s population. Yet, it’s in that very diversity that the region’s historical weaknesses can start to be understood. That begins with what Ali calls the “language barrier”. With India boasting 22 official tongues, it can often be hard to find staff to conduct trials effectively. That’s echoed by physical infrastructure. “If you’re transporting medicine from one city to a rural area,” Ali explains, “it can be a challenge to maintain the temperature of something like a vaccine.” That’s hardly a mere hypothetical: in July, thermometers can hit 38°C in Pakistan, while researchers habitually warn about a lack of cooling equipment across developing nations. Combine these practical limitations with forged results – a 2016 report in the British Medical Journal found that 80% of all Chinese trial results were fraudulent – and it’s unsurprising that major pharma giants have traditionally been reluctant to move to Karachi or Guangzhou. Yet in a striking way, it’s the very differences of East Asia that are turning the region into a trial hotspot. “There was a great impetus ten years ago or so because the costs were lower than in other regions,” says Adjunct Professor Victoria Elegant, vice-president, region head, medical affairs at Amgen Asia Pacific, as well as the firm’s Access to Healthcare global lead. On top of that, Elegant continues, many Asian countries, including India and China, have local regulations which require drugs sold locally to first undergo local registration trials. “Companies are understanding that this is a very attractive market,” Elegant notes. “We’ve got an ageing population, we’ve got a growing middle class that will be able to access drugs better.”
Clinical Trials Insight /
www.worldpharmaceuticals.net
angellodeco/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53
