Using data collected from North America, Europe, China, and Japan, this article provides a consolidated analysis, highlighting regional differences and similarities to help clinical trial stakeholders make more informed decisions in the design and implementation of IMPs in global studies.
The Study’s Growing History
Seminal research on patient perceptions of IMPs was first conducted in 2012 by the Patient Survey Project Team at the ISPE’s Investigational Products Community of Practice (IP CoP). With survey results from 1,425 clinical trial participants (predominately in North America), the team analyzed respondents’ opinions about their experiences with IMPs and published suggestions for improvement.
Although these findings were intended to help improve the patient experience and better align medicine kit design with the needs of the patients, the study’s collaborators wanted to expand the survey to a globally diverse population. With an adapted survey run in 2015, they targeted a larger geographical scope. The team first expanded to Europe and China, publishing those consolidated results in 2016.
Around the time of that publication, a team in Japan started gathering data from current and past clinical trial participants. The research teams have now received and analyzed data from 1,473 participants in Japan to create new averages with previously collected data in 2017.
Given that clinical supply practices have not drastically changed since the original survey was completed in 2013 in North America, the study collaborators’ combined data can be compared and used as a benchmark across the four regions.
Objectives
With data collected from Japan and compared to data from North America, China, and Europe, the survey sponsors wanted to identify global themes and regional differences as they related to the use of IMPs. Other goals of the survey and its resulting publications included:
- Increasing the industry’s understanding of the patient experience with IMPs
- Determining if there are any noticeable differences in patient experiences
- Providing stakeholders with valuable data sets to support correct decision-making relating to the use of IMPs
- Fostering collaboration between global regulatory agencies, facilitator organizations, and stakeholders involved in the clinical trial process
Table A: Patient Demographics
|
North America
(2013) |
|
China
(2014/2015) |
|
Europe
(2014/2015) |
|
Japan
(2017) |
|
---|
Participating in a clinical trial |
Currently |
31% |
Currently |
68% |
Currently |
40% |
2016 |
45% |
|
< 6 months ago |
23% |
< 6 months ago |
16% |
< 6 months ago |
11% |
2015 |
23% |
|
< 6 months ago |
46% |
< 6 months ago |
16% |
< 6 months ago |
49% |
Before 2015 |
32% |
|
Female |
60% |
Female |
43% |
Female |
49% |
Female |
28% |
|
Male |
40% |
Male |
57% |
Male |
51% |
Male |
72% |
Top three therapeutic areas |
Diabetes |
12% |
Diabetes |
23% |
Neurological |
23% |
Heart disease* |
40% |
|
Respiratory |
9% |
Heart disease |
16% |
Cancer |
17% |
Diabetes |
18% |
|
Pain |
9% |
Cancer |
16% |
Heart disease |
14% |
Hyperlipidemia |
14% |
*(Hypertension, cardiac angina)
Methodology
In each region, the survey reused many of the same questions from the original North America study. However, some questions were eliminated from the surveys that followed in China, Europe, and Japan to focus on key themes recognized in the original survey. Some other questions were slightly reworded to account for cultural differences in translation. The methodology varied among geographic locations as described next. The teams relied on agencies, site management organizations, and patient advocacy groups that had access to patients mostly through clinical trials, pharmacies, and research nurses. Access to appropriate patient populations was instrumental to the survey’s success, with patient anonymity being strictly controlled. See Table A for details about patient demographics.
North America
For North America (N = 1,425), 48 questions in an electronic survey were given to patients that had taken part in a clinical trial in their lifetime and taken their medication home (to ensure a participant was not from an in-hospital study).
Europe
For Europe (N = 109), the study was conducted electronically and in English only, with 48 questions adapted from the original study in North America. The small sample size in Europe was attributed to several factors. First, the survey was delivered only in English, which may not be the primary language of potential participants. Second, as a generalization, Europeans tend to be a little more reserved and are more reluctant to either openly praise or criticize than in North American culture. Third, participants were excluded if they had not participated in a clinical trial that involved IMPs. In addition, not all patients responded to every question; thus, the figures show varying N for the European study population. The results were reanalyzed for this publication; therefore, they slightly differ from the referenced publications.
China
For China (N = 1,935), the survey contained 44 questions modified from the original study in North America, which were translated into Chinese. Data were collected via mobile or paper versions, depending on patients’ preferences. Surveys were conducted in person at study sites.
Japan
For Japan (N = 1,473), the survey focused on 18 key questions, which were designed based on the questions from the survey in Europe. Working with the University of Tokyo, an online survey was sent to 2,688 adult patients (> 20 years old) who enrolled in clinical trials conducted from 2013 to 2016 in Japan. Those patients were extracted from the survey panel of INTAGE, Inc. The data collection period was March 7–9, 2017. The response rate was 54.8%. The survey designers reduced the number of questions to increase the chances that the participants completed the entire survey. The data were collected in an online format.
Results
The following section discusses the results, outlining the range of criteria used throughout the surveys.
Table B: Top Three Forms of Medication Received*
|
North America (2013) |
China (2014/2015) |
Europe (2014/2015) |
Japan (2017) |
---|
Bottle |
42% |
47% |
29% |
14% |
Blister |
30% |
37% |
37% |
71% |
Syringe |
15% |
14% |
20% |
12% |
*Other medications included topical and inhaled forms.