Patient Perceptions of IMPs: An International Perspective was featured in the May/June 2016 issue of Pharmaceutical Engineering® magazine.
This three-part paper focuses on the final results from the EU and China Patient Perceptions of Investigational Medicinal Products surveys and compares some of these results with the original “ISPE Project Concerning Patient Experience with Clinical Trial Materials” published in 2013. Part one will focus on:
- Overview of the original study
- Revised and expanded parameters for the new study
- Objectives of the study
Contributions and opinions are based on the individuals’ knowledge and expertise; this presentation should not be construed as a statement or opinion by Catalent Pharma Solutions, or any other member of the task team.
Every clinical trial professional faces the same challenge: Get 1) the right product 2) to the right patient 3) at the right time 4) every time. This bar only gets higher when new products with inherent stability challenges (such as biologics or patient-tailored medicines), increasing globalization of clinical trials, and financial constraints are part of the picture. A sound appreciation for the role of clinical site personnel, a commitment to clear instructions for both the patient and the clinical site, and flexibility in IMP design may help address all these concerns.
Traditionally, preparation of investigational medicinal products (IMPs) had been focused on upstream activities compliant with current good manufacturing and distribution (cGMP and cGDP) practices, with little thought for the preferences of the end user—the patient or the clinical site. This may be changing, however, as patient centricity and global perspectives increasingly influence decision making to improve patient adherence and compliance to protocol.
In 2012, ISPE’s Investigational Products Community of Practice (IP CoP) formed a Patient Survey Project Team to conduct what they hoped would be the first industry-sponsored global survey to understand patient experiences with clinical study supplies.1
Published in 2013, the “ISPE Project Concerning Patient Experiences with Clinical Trial Materials” surveyed 1,425 clinical trial patients to learn about the suitability of clinical materials, collect patients’ opinions about their experiences, and gather suggestions for future improvements. While study findings indicated a good level of reported drug compliance and demonstrated that patients were generally satisfied with the IMPs they received, the results also revealed a number of areas for consideration in improving medicine kit design. A significant challenge, however, was that despite the project team’s considerable efforts to recruit a globally diverse study population, almost all (97%) of the respondents were from the United States.
Revised and expanded
To help identify possible geographic differences in patient preferences, regional ISPE Investigational Product (IP) teams decided to adapt and expand the original US-weighted survey to explore detailed feedback from three populations. The first spinoff study was conducted in the United Kingdom (UK) and European Union (EU). In a similar timeframe, the China IP CoP completed a study in China, a region that had never provided feedback on IMPs before. A third arm, conducted in Japan, is still ongoing.
Survey questions for each of the studies were adapted from the original 2013 study, and centered on whether IMP kit design, packaging, and labeling influenced patient compliance with the protocol and retention within the study. These are important cost drivers in clinical trials, where noncompliance can lead to patient failure and unevaluable data. Even a small percentage of failures can be detrimental, since each lost patient has been estimated to cost the study sponsor as much as $42,000 per patient, even if they’re not replaced.2
All studies went live in the fall of 2015; as before, all were conducted under ISPE auspices. Interim results for the EU and China studies were presented at the ISPE 2015 Annual Meeting, and were published in Pharmaceutical Engineering in 2016.3 Final results for the EU and China studies were presented at the ISPE 2016 European Conference, ISPE 2016 China Spring Conference, and ISPE 2016 Japan Annual Meeting.
This paper focuses on final results from the EU and China surveys and compares some of these results with the original 2013 survey, which for the purposes of this paper will be referred to as the “original US Study,” based on the location of most of the respondents.
The vast majority of patients in both studies found their medication easy to use; this is no reason for complacency, however
Objectives Patient Perceptions of IMPs Surveys
Research teams sought information that could help ensure patient compliance, adherence, and retention in clinical trials. If these new survey results revealed major geographic differences, they could affect how IMP kits are designed, labeled, and packaged for different regions. These are important concerns in clinical trials, which are frequently conducted in multiple countries, languages, and regions.
Goals were to:
- Gather patient feedback on the suitability of clinical materials provided
- Obtain patient suggestions for improvements
- Understand the effect of key patient differentiators
The team hoped to gather results that would support management decisions about IMPs, as well as increase collaboration between global regulatory bodies, sponsor companies engaged in the IMP sector, and facilitator organizations like ISPE so that enlightened global guidance could result.
Access to appropriate patient populations was instrumental to survey success, with patient anonymity being carefully controlled.
The EU team partnered with three agencies who had access to patient groups:
- UK National Health Service (NHS)
- UK National Institute for Health Research (NIHR)
- European Patients Academy on Therapeutic Innovation (EUPATI)
All had read the results of the original US study with interest and all were actively focused on public and patient involvement in clinical research.
The study was conducted electronically and in English only, with 48 questions adapted from the original US study. ISPE administered the survey and aggregated the responses; NHS, NIHR, and EUPATI disseminated the surveys to patients through clinical trials pharmacies, research nurses, or patient advocacy groups; the Robertson Centre for Biostatistics, University of Glasgow, analyzed and reported on the resulting data.
The final EU analysis contained data on 109 patients out of 543 collected responses. Not all patients responded to every question, thus, charts below show varying Ns for the EU study population.
In China, the ISPE China IP CoP partnered with Drug Information Association China to enlist five site management organizations to collect responses:
- Hangzhou Tigermed Consulting Co., Ltd.
- Medkey Med-Tech Development Co., Ltd.
- SMO ClinPlus
- WuXi Apptech
The patient survey was also sponsored by seven companies:
- Cardinal Health
- Fisher Clinical Services
- Merck & Co., Inc.
As in the EU, the China survey contained 46 questions modified from the original US study, which were translated into Chinese. Data were collected via mobile or paper versions, depending on the patients’ preferences. Surveys were conducted in person at study sites.
Total valid data for analysis was 1,935 out of 2,488 collected responses.
Unless indicated otherwise, N is always the total study population.
See Table A for study demographics, therapeutic area, and IMP statistics.
By: Esther Sadler-Williams, Lynn Wang, Samantha Carmichael, and Paula McSkimming
Receive part two of this three-part series delivered straight to your inbox by subscribing to ISPEAK. Part two of the Patient Perceptions of IMPs: An International Perspective will be published tomorrow and focus on the results from the surveys.
1. International Society for Pharmaceutical Engineering. “Report on the ISPE Project Concerning Patient Experiences with Clinical Trial Materials.” November 2013. www.ispe.org/patient-initiative/2013novreport.pdf.
2. Pharmaceutical Research and Manufacturers Association and Battelle Technology Partnership Practice. “Biopharmaceutical Industry-Sponsored Clinical Trials: Impact on State Economies.” March 2015. www.phrma.org/sites/default/files/pdf/biopharmaceuticalindustry-sponsored-clinical-trials-impact-on-state-economies.pdf.
3. Sadler-Williams, Esther. “Patient Perceptions of IMPs.” Pharmaceutical Engineering 36, no. 1 (January/February 2016): 22–23.