Pharmerging markets appear to be a “dream come true” for contract research organisations (CROs) attracted by the idea of establishing clinical trials in countries where set-up costs are potentially lower and patient populations are high, said Shaylyn Pike, senior research analyst at Cutting Edge Information.
But to achieve positive results in clinical development, Pike argues CROs should make more of an effort to understand the intricacies of a country’s culture and regulation system to ensure trial success.
“Thoughtful, proactive planning could save the sponsor trouble and the CRO and site staff significant heartache,” Pike told Outsourcing-Pharma.
According to a report, cultural differences, language barriers and regulatory discrepancies among countries are but some of the major issues CROs need to consider when establishing trials in BRIC countries.
“Decision makers receive mixed intelligence about the feasibility of emerging markets for clinical development,” said Pike, who explained that overtly positive or negative interpretations of experiences from multinational companies can influence a trial's success.
As part of a study on clinical development in emerging markets, Pike and colleagues interviewed several CROs who told her that trial sponsor company representatives wanted the trials to be set up and carried out in exactly the same way as in the US.
They felt the trial sponsor companies refused to listen to suggestions of a different approach, instead demanding that as the sponsor they should determine how things are run.
Trials carried out by these means rarely succeed, explained Pike, but instead of realising the errors of their ways and making constructive alterations, sponsors tend to blame it on emerging markets.
However, Pike said: “Understanding the true opportunities and challenges inherent to each market will give decision makers the facts they need to select which countries to locate sites in and which countries to stay away from.
“Only when teams go in with an accurate understanding can trial success be ensured.”
Out of all of the BRIC countries, Pike said pharmaceutical companies rate China the highest for cultural concerns when establishing clinical trials. According to her studies, China offers the least friendly culture to multinational CROs, exacerbated by growing economic tension between China and the West.
Cultural points every CRO should know before entering an emerging market.
South American markets have their own set of unique considerations multinationals must abide by. Brazil, for example, is a largely Roman Catholic nation so companies should be aware of Holy days. Scheduling appointments on Good Friday or Easter Monday will only result in no-shows.
Similarly, companies must be aware when operating clinical trials in countries whose predominant religions prohibit the use of certain animal products.
Pike claims it is also imperative that CROs address language issues when working abroad. The lack of high-level medical understanding of trial subjects frequently causes trouble, so a trial sponsor must ensure patients comprehend the procedure they will be participating in.
“Companies need to learn to work with the culture” said Pike, quoting a Russian executive who pointed out the concern some CROs share that a different and “far removed” social structure means the countries have nothing in common. “What we do have in common is the desire to deliver good medical services to the population,” he said.