W 32: Geo-Political Analysis of Phase 3 Clinical Trial Recruitment: Changes in 2015
Colin G. Miller
BrackenData United States
This study evaluates the changes in geographical locations of sites recruiting subjects in Phase 3 (Ph3) study sites in 2015 compared to the previous 5 years.
The information housed at the web site www.clinicaltrials.gov (CT.g) was downloaded and “cleaned”, using filtering and logic processes. This data was evaluated in an analytics software to evaluate the annual number of Ph3 studies conducted and the number of countries recruiting subjects.
The dataset from CT.g was filtered to identify only Ph3 studies sponsored by industry and then filtered for the years from 2010 to 2015. The numbers were 1089, 1089, 1035, 959, 982, 944, in 2010, 2011, 2012, 2013, 2014 and 2015 respectively. The mean number of subjects per trial was 601, 517, 593, 639, 549, 529 respectively per year. It was anticipated that the number of countries used for recruiting subjects per year would remain consistent whereas it decreased significantly in 2015.
Taking the mean (and median) number of countries used in phase III studies where there are sites in >1 country, there was a decrease in 2015 compared to previous years. The mean (median) number of countries in 2015 was 10.19 (8) compared with 11.23 (9) for the five previous years.
A geographical “heat map” was generated to evaluate if there were obvious changes or if this was a random event. It was apparent that there were three distinct geographies that were not used in 2015; The middle east centered on Syria, Africa and South America.
Middle Eastern studies: In the years 2010 to 2014 there were on average 114 studies conducted in this region. In 2015 this declined to 93 studies. It is presumed that due to the significant conflict of the area centered on Syria, that sponsors declined to initiate studies in this region.
African Continent: In the years 2010 to 2014 there were on average 94 studies conducted in this region. In 2015 this declined to 53 studies. It is presumed that due to the significant conflict of the area centered on the Northern countries of this continent, that sponsors declined to initiate studies in this region.
South America. In the years 2010 to 2014 there were on average 173 studies conducted in this region. In 2015 this declined to 101 studies. It is surmised that there maybe a number of factors: including some political instability, the cost of doing business and the rise in the zika virus and the perceived health risks associated with the area.
This study provides a number of useful insights into the geopolitical aspects of recruiting subjects into multi-center, multi-country Ph3 clinical trials. With careful use of analytics and the information from CT.g it was possible to ascertain the decrease in countries and locations where study subjects are being recruited. It is the first time in 6 years we have observed a decline in countries where clinical trials have been conducted. While it was not part of this study, the same effect was also noted in other phases of clinical trials from the same data set.
This suggests that the international political changes may have a profound effect on the recruitment of clinical trial subjects. More countries have been involved in subject recruitment to provide access to either unique, naive or just larger pools of subjects for Ph3 industry sponsored trials. This study does not provide information as to whether recruitment rates are decreasing or whether it is possible to recruit the same subjects in a smaller geographical spread with a stronger focus.
The authors have provided a reasonable hypothesis as to the reason for the decrease in the number of countries participating in PH3 studies, but further work will be required to confirm these findings. The other limitations are that it is assumed that all Ph3 studies are registered on CT.g to ensure publication rights are available for obtaining the NCT number.
In conclusion, data analysis and carefully curated analytics has provided clear insight into the decrease in investigator sties in 2015 on a global basis. It has allowed the geographical changes to be easily highlighted and it now needs to be evaluated if this is a change in a single year or a clear change in the country locations of clinical trials.