Testing, testing

Editor's note: Cliff Echols is market intelligence director at SCORR Marketing, a Kearney, Neb., marketing and communications firm.

Interest in China has always been high, especially in biopharmaceuticals, but companies in a variety of market sectors aimed at drug and medical device development are drawn to China for the opportunities represented by its steady growth in international clinical trials. Because market research designed to help companies understand and profit from the Chinese clinical trial industry is in demand, it was a natural topic of interest for an ongoing research partnership between Applied Clinical Trials, a peer-reviewed magazine, and SCORR Marketing.

The China Clinical Trials Survey Report 2015 was undertaken to gather input regarding the size, strength and future of clinical trials conducted by non-Chinese companies in China. To address this question accurately, the first hurdle was to qualify a body of survey respondents who would be in a position to influence or at least to know their companies’ intentions regarding current and future participation in Chinese clinical studies.

By the nature of its content, it can be assumed that virtually every reader of Applied Clinical Trials holds some position of interest or authority in conducting clinical research. So solely by virtue of the distribution list – subscribers to the magazine  – the survey was able to take a significant step forward in data validation and integrity. By beginning the survey with questions to determine the respondents’ positions relative to decision-making regarding their companies’ participation in clinical trials in China, we were able to establish a respondent base well-qualified to provide valid answers. The final panel included respondents from international pharma companies; contract research organizations; academic institutions; service providers, consultancies and laboratories with positions in R&D; clinical operations; business development; corporate management; regulatory affairs; quality assurance; strategy; planning and medical affairs.

Asked the right questions

Once we were confident that we had a valid audience, the next step in designing this survey was to make sure we asked the right questions to support our thesis, in this case: “The number of clinical trials being conducted in China by non-Chinese companies is growing.” By testing the preferences and perceptions of those conducting or considering trials in China along-side the facts of their participation, we hoped to achieve an overall survey response with more depth and nuance than could be achieved by mere statistics.

In crafting the questions and the survey design, one key consideration was the length of interaction (LOI). With little or no incentive such as a gift or monetary reward, respondents will only tolerate a relatively short survey with a limited LOI. As no incentive was offered for this research, we created a survey with multiple-choice and ranking questions that could be answered relatively quickly without a lot of critical thinking. Once the survey questions were loaded into our online survey software, we asked a few people to take it blindly, just to make sure that the survey was not too long. Someone reading the questions for the first time was expected to respond like a true survey respondent. Using this information, the China Clinical Trials Survey was designed to be completed in about 10 minutes.

In the end, we narrowed the scope of the survey to address these key topics:

• how many companies conduct trials in China and why;
• therapeutic areas most likely to be the focus of trials in China;
• the impact of Chinese regulations to combat corruption and align procedures with good clinical practices;
• whether companies conducting trials in China prefer to partner with a Chinese company or establish their own presence; and
• regions that will see more clinical trials in five years.

Steadily migrating to Asia

Although North America and Western Europe remain the predominant regions for clinical trials, studies are steadily migrating to Asia at the expense of those areas. A total of 41 percent of the respondents reported they currently conduct clinical trials in China and 33 percent of all respondents say they have increased the number of trials enrolled in China in the past two years. The reasons cited for increasing their presence parallel those for working in China in the first place: the country’s large pool of patients (mentioned by 71 percent) and its sizable and growing pharmaceutical market (65 percent). Interestingly, only 6 percent attributed their decision to hold more trials in China to lower costs.

For the respondents whose companies increased the number of trials in China, some business and job segments were more likely to view China’s large patient pool as of primary importance: 88 percent who work at pharma companies and 86 percent in R&D see population as the major driver for the increase. Companies that conducted research in China were twice as likely to work with a Chinese partner as have their own infrastructure.

For companies that had not increased the number of trials conducted there in the past two years, the two most common reasons cited were concerns over quality (27 percent) and delays in study start (24 percent). Respondents from companies headquartered in the U.S. were more likely to name quality as a reason for not increasing clinical trials and less likely to blame study start delays. Language barriers, logistics and supply difficulties, as well as lack of sufficiently-trained clinicians, were other reasons making China less attractive for clinical trials.

Unavoidable decline

Global clinical trials will inevitably increase in China and other developing markets as 68 percent of respondents forecast growth in China, 51 percent in India and 49 percent in both Latin America and other Asian countries. This growth will cause an unavoidable decline in activity in traditional clinical trial sites, however: 51 percent forecast a drop in Western Europe, 43 percent in North America and 19 percent in Australia/New Zealand.

The migration of clinical research from developed to developing nations has been going on for some time, with the reasons most frequently cited being large native subject populations, low operating costs and increasingly stable testing infra-structures. As this survey shows, although the large pool of patients is a key motivation, nearly two-thirds of those planning to increase the number of trials they conduct in China are doing so also because of China’s large and growing market opportunities.

As companies working in China overcome language barriers, logistics and supply issues and as China itself addresses its lack of sufficiently-trained clinicians, the number of clinical trials, in China and other developing countries can be expected to keep rising.

Detail and nuance

An online blinded survey such as the China Clinical Trials Survey Report can yield valuable marketing in-formation but it’s only one tool in the market research toolbox. A survey with a larger number of qualified respondents made possible by an incentive program may yield more accurate results; a series of one-to-one interviews or multiple focus group sessions will almost certainly provide greater detail and nuance to the numbers.

However, both of these latter techniques are potentially quite expensive and time-consuming depending on the market and research being considered. By having an alliance with a respected media channel proving a qualified respondent base, researchers can fairly quickly craft a survey to yield accurate, actionable information on a wide variety of questions.