W-08: The Benefits of Knowing Patient Preferences in the Clinical Trial Continuum
Saumya Shankar Nayak
Associate Director, Patient Recruitment Programs, Asia Pacific
The objective of this study is to describe the benefits of patient preferences in the clinical trial planning.
A survey was conducted from August 14, 2016 to September 7, 2016 of members of patient advocacy groups (1 each) in China & India. Survey questions addressed patients’ interest to participate in a clinical trial outside their home country and other reimbursement expectations for participation.
The two patient advocacy groups liaised with their members to get a total of 12 surveys completed. The patient advocacy group from China returned seven completed surveys and that from India returned five. 83% i.e., 5 surveys each from China and India were completed by parents of patients aged <12 years and required at least one or both parents to accompany them for trial participation. Except one parent from China, all other parents expected reimbursement of daily wages for their time away from their home country. The expected imbursement varied from a salary equivalent to their current monthly salary or more (1.5 times, 2 times and more than 2 times) than current monthly salary. 80% of their salary ranged from 150 to 750 USD per month and 20% in the range of 750 to 1500 USD per month. The patients and their parents also expected to visit their home country at least 3 to 4 days every month or every 2 to 3 months. Based on their responses, per patient cost was calculated. For a patient from China, with both parents accompanying the patient, the expected expenses ranged from 108,000 to 172,000 USD and for a patient from India, it ranged from 130,000 to 243,000 USD for a duration of two years. The results and analysis provided the sponsor a clear indication of potential expenses if they plan to enroll patients from the neighboring countries.
Incorporating the voice of the patient is becoming a clear trend in clinical trials especially for rare diseases and conditions involving small and under-diagnosed patient populations
The survey results clearly demonstrated:
• The patients being young cannot travel alone and would require both or at least one parent accompanying them for the trial duration
• The parents expect reimbursement for all expenses including their daily wages, housing rentals, frequent visits to their home country during the trial duration
• For parents, relocation to another country for trial participation is very challenging and seemed less interesting especially when the benefits of participation was not clear
The sponsor clearly benefited from the current study results as the initial plan of enrolling patients from other neighboring countries seemed quite challenging after knowing what patients’ or their parents expect if they are to participate in a trial outside their home country. Certain requirements of patients were beyond consideration as it would compromise ethical conduct.
Exploring patient preferences helps in:
• choosing the right countries
• understanding realistic recruitment timelines and associated costs
• determining the level of efforts required in motivating and engaging patients based on the barriers that are identified
In summary, eliciting and translating patient preferences is a promising approach in clinical trial continuum.