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Each Country, big or small within Asia has its own cultural and geographical challenges when considering patient recruitment for clinical trials. According to report, clinical trials submitted in Marketing Authorization application to the EMA on 8th April 2013 gives an overview of the number and geographical location of patients, investigator sites and pivotal clinical trials based on data gathered from Marketing Authorization application gives the figures indicative of regions contribution to patient contribution to global trials. Figures from the report shows that 27.8% of patient recruitment for clinical trials filed with EMA during 2005-2011 came from outside, with Asia pacific countries making up 9.3% of all patients recruited over entire five year period i.e. 83,599 patients in total. Figure 1 demonstrates increasing importance of the region as recruitment destination, patient recruitment numbers increased substantially year by year with Asia Pacific making up only 3.3% of global patients in 2005, but growing this figure more than four times by the end of reporting period to reach 12.2% of total in 2011.
India was the most important nation for recruitment in Asia making up 1.9% of total global patients. Australia with 2nd position 1.3%, Philippines in third place with 1.2%, China & Thailand were responsible for 0.9% each, South Korea and Japan 0.7% & 0.5% respectively.
There have been recent changes in state of patient recruitment in many Asian Countries; best strategies need to be identified for approaching recruitment in some key countries in the region.
According to recent changes in state of patient recruitment in many of the Asian Countries best strategies for approaching recruitment in some key countries in the region have seen most changes over last two years. It is important to say that there is difference in each country within the region as diseases like diabetes and autoimmune disorders manifest differently in different climates like infectious diseases. Ethnicity plays major role in determining suitability of region for recruitment in clinical trial
Recruitment & Retention Issues
Patient retention remains a problem in many countries in Asia and patient recruitment organization gives a number of strategies in dealing with this issue which varies depending on the particular factors driving patients wanting to participate in trial in each specific country. In countries where healthcare is largely self pay like India, one of the primary drivers for getting patients to participate in the trials and remain until end of the study should be emphasized that the care will be free. Travel is the factor for recruitment and retention in many Asian countries, the cost of the trial is significant factor in these countries. Odd recruitment issues could include localized factors such as lack of confidence or trust in medical professionals, in clinical trials as well as specific cultural barriers to recruitment in particular disease area such as psychiatry and pediatrics.
There have never been problems in recruiting patients in India and the region has found itself in recruitment location, most patients signed up for trials than any other Asian countries according to EMEA figures and coming seventh on global basis. This has however all begun to change over last couple of years as sponsors are pulling out of the market due to significant and growing challenges. As the market is now in decline, CRO’s, PRO’s and sponsor are engaged in talking to regulatory bodies in the country in order to improve matters as the present problem will be recovering sooner.
Japan as a patient recruitment destination can be seen in the fact that they are relying on specialist site management organization and patient recruitment organization (a full third of BBK’s multinational project involved Japan). Japanese regulatory body PMDA after to identifying the reasons for lag in clinical trials is attracting PRO’s for shortening the time needed for clinical trials in creating Japan as a destination for global clinical trials. Sponsors and CRO’s in this country are now much amenable to wider variety of patient outreach to traditional solutions such as posters, newspaper adverts, to more up to date technology and enhanced efforts such as use of medical databases.
Patient recruitment in china is developing as fast as might be expected from a surging global economy with an expanding middle class and the largest population of any country in the world. With such a large concentration of potential patients it has never been a significant problem for recruitment organizations in China to get the required number of patients in time for clinical trials when the country is becoming increasingly important for clinical trials. There are very high levels of staff from PRO’s in China with various recruitment methods involving traditional methods, outreach with doctors and clinics.
The recent guidelines are streamlined for quality data and it would not have impact on patient recruitment
This is interesting, thank you, Sreedhar. Do you think the recent regulatory alterations made in India will make it harder to recruit patients?