Problems With Emerging Markets Trial Data

Problems With Emerging Markets Trial Data

July 23rd, 2012 // 2:38 pm @


The ongoing debate over the growing use of clinical trials in so-called emerging markets has been the proverbial thorn in the side of clinical research organizations. The cost of running these trials in such countries can cost less than in the US, for instance, which appeals to drugmakers. But on-the-ground conditions vary from country to country, an issue that has regularly raised concerns over the quality of data obtained from trial sites.

To quell such worries, several CROs made available data from more than two dozen large Phase II and Phase III trials that were conducted in numerous countries. And a subsequent analysis of query rates – which measured discrepancies found between protocols or source data and case report forms – found no statistical differences among regions when compared with the US or Western Europe, according to a paper in Drug Information Journal.

“A comparative assessment of query rates suggests that the quality of clinical trials conducted in emerging countries is consistent with those conducted in developed regions,” the authors write. “Despite several limitations of our analyses and the multifaceted complexities of global clinical trials, our findings should alleviate some concerns regarding clinical studies conducted in emerging nations.”

How did they reach this conclusion? They received trial data from seven CROs – Covance, ICON, Kendle, PharmaNet, PPD, Quintiles and RPS – from more than 4,700 trial sites that had enrolled nearly 64,000 participants. Overall, the data included 1.39 million queries, 7.5 million case report forms and 95 million data parameters. From there, they looked for database changes and change rates.

They found that the baseline average global query rate was 0.19 percent, and the observed query rates for North America, Western Europe, Central and Eastern Europe, Africa, and Asia were 0.35 percent, 0.17 percent, 0.18 percent, 0.31 percent and 0.17 percent, respectively. The highest query rate was found in Sweden at 1.37 percent and the lowest was 0.09 percent in Thailand (here is the abstract and here is a link to the study).

The number of participants enrolled in various regions, by the way, ranged from 846 in Japan to more than 21,500 in Western Europe. On average, 53,462 queries were noted per study. And the trials represented various therapeutic areas: cardiovascular, central nervous system, oncology and hematology, women’s health, general medicine, arthritis, asthma, anti-infectives, gastrointestinal and overactive bladder.

There were some limitations. The authors, for instance, acknowledged that query rates can depend on the complexity of the therapeutic trial and study design and on the frequency of monitoring. They did not have details on the nature of the queries. And there was also an imbalance in the number of sites and participants from different regions. Among the emerging nations, data were available only for four studies conducted in China, with 485 participants and 28 sites.

The authors, however, attempted to explain the problem this way: “While additional data will help in reinforcing our initial findings, at the least, there are no major problems that are evident for studies done in this region. Moreover, the number of sites included in our study from different regions should be viewed with due consideration to the relative contribution of these regions to the global clinical trials activity.”

Maybe. Meanwhile, we should note that two of the three authors work for INC Research, a CRO that owns Kendle, which was one of the companies that supplied trial data. The third author, Pankaj Desai, a professor at the College of Pharmacy at the University of Cincinnati and a member of Shivani Enterprises, which is a consultant to the Association of Clinical Research Organizations. Not surprisingly, the trade group was tickled over the results. “We are very pleased, but not surprised, by the findings…,” says ACRO executive director Doug Peddicord.

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