WYETH FAST FACTS • Founded in 1926 under the name American Home Products Corporation • Headquartered in Madison, NJ • Operating in more than 100 countries • 47,500 employees worldwide
“Ethics committees in other countries sometimes also ask a lot of questions about placebo: why you want it and can you do it without it. Eastern European countries are stricter now about placebos as well. Originally countries like Poland were pretty open to clinical trials but now the psychiatric committee there has issues with some kind of consensus. “As long as there’s available treatment they do not suggest that we use placebo in the studies, so we had to withdraw our applications. We don’t know the trend but it looks like as a company we are moving towards more Asian and South American locations instead of Eastern European countries, although Russia is currently has a pretty good regulatory environment.”
Patient quality Patient recruitment methods also differ depending on the country in which the trial is being carried out. Shen says she is strongly opposed to the notion that patient recruitment should be conducted based on speed alone. “I want to recruit patients quickly, but I also want to emphasize the quality of the patient. We also face challenges with patient trust in some regions. “For example, in China and Taiwan the method of recruiting patients largely depends on the relationship with the site. In those countries patients need therapeutic alignment with the physicians, so if they trust the physician they come to the studies and stay with the treatment, but if they don’t it’s hard retain them or get them to come to clinical trials because it’s still a relatively new concept in those regions. “You have to have a very good relationship with the site. I cannot emphasise that enough because that’s one of the things our com-
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pany is doing. I’ve currently initiated this in China, to try to build long-term relationships with the key opinion leaders there, as well as the PIs. To better understand their needs we help to train them. We help them to obtain the disease knowledge to get the best quality from the clinical trials. “Those regions are looking for collaboration. They don’t want to be treated just as a site: give us patients and we’re done. They want to be treated with mutual respect and also have long-term collaborations. They also like to have a co-author on the publication.” In Shen’s view, it’s about building a long-term relationship. “Many big pharma companies have been operating in countries like China for a long time, so they already have good reputations there. This can mean that when they have four or five trials they prioritise ours, which can be significant factor in enrollment rates. As a big company, what you need to do is build up a relationship with local government. If you get their support, things are much easier. “We also have good relationships with India and many other countries, and this does make a huge difference. We as a study team go to visit the sites. We exchange scientific information and then make ourselves available if they have problems or questions. Once you start the trial, you can’t just throw that out and leave them on their own.
“We need a diversified patient population, which is very important for development if you are marketing all over the world” “In those regions they are still learning to ensure study quality. For this reason, I would strongly suggest providing a refresher or other visits to rejuvenate the study’s energy and to refresh the memory of what’s needed, otherwise quality could deteriorate throughout the study, especially if it’s long. That’s how I feel about the energies we need to put in to help get recruitment as we need it.” Another important aspect of building relationships with international sites is education. As Shen explains, training at sites is very important, as well as training the company site managers. It’s not a matter of setting up the trial and leaving them to get on with it. “You can’t just give it to the region and wait for results. That never works very well. “We need to educate people, to help them understand that if they want to have those medications available for the local population, they need to make sure patients understand that joining studies helps them and will help others in the future to get medicines early on. That’s also the selling point for the government when they say, ‘You’re trying to test our population.’ Then we’ll say, ‘This is the only way we can get this on the market early so everybody can have this available.’ Those are the things we want to see not just for clinical trials, but also for long-term patient benefit.”
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