Take a global approach to patient recruitment
Choosing to participate in a clinical trial is a big decision that should be weighed carefully. According to the Center for Information and Study on Clinical Research Participation (CISCRP), fewer than 4% of all U.S. physicians participate in clinical trials and only 7% of Americans say their doctors have ever suggested that they participate in a clinical study.
If you are one of the select few to hear that clinical trials may be an option, there are multiple things to consider, including the exploration of other possibilities to manage the condition. A potential participant will want to be as informed as possible about what is involved; factors such as the duration of the trial, the absence or presence of placebo, and the number of visits to the study doctor are all things that may determine whether participation is the right decision.
The location of the study site can be one of the most important factors to consider. Some may want a clinical trial location near their home or office; others may be willing to travel to a destination. In some research studies, participants are located so far away from study sites that they actually will need to travel by air to get to their appointments. This is where clinical trial opportunities can collide with what is called “medical tourism.”
Medical tourism is the process of traveling outside one’s country of residence for the purpose of receiving medical care. This is a growing trend and, according to Ian Youngman’s “Medical Tourism Facts and Figures 2015,” 6 million people now annually travel for medical treatment from one country to another; add those who travel a distance within a country and the number exceeds 10 million a year. There also are instances where people may go abroad specifically to participate in a clinical trial.
Medical tourism is happening more in particular clinical areas—such as cosmetic surgery, dentistry, cardiovascular and oncology—with certain countries, such as Costa Rica, India, Israel and Malaysia, serving as leading destinations. According to Patients Beyond Borders, the worldwide medical tourism market is growing at a rate of 15% to 25%, with rates highest in the North, Southeast and South Asia.
So, in which instances would a destination be a factor in a clinical trial? Years ago, I worked on a clinical trial that was for traveler’s diarrhea. In that study, patients were required to visit a U.S. travel clinic and be randomized to either a placebo or active study. They then would travel to one of several defined locations outside the U.S. and see a study doctor in their destination country. Upon arrival, participants were required to keep a patient diary and have some lab work done in their destination country. In that instance, the travel was free and was a major motivator for recruitment cases. In most cases, the sponsor of the trial covers the costs associated with the study, including the medicine and tests needed; coverage also may include other costs such as standard of care or travel.
What would motivate someone to consider a clinical trial in another country? According to a worldwide survey conducted in 2013 by CISCRP, the greatest motivator to join a clinical trial is to advance medicine and the least motivator is to receive medical care. If the trial location happens to be in a destination country, however, the motivations may look much different. There also is a new term for medical tourists who actively seek care situations that are unapproved in their country: They are called “circumvention tourists,” and they look for specific opportunities to try unproven and untested medical interventions that they cannot receive in their own country.
With the global proliferation of clinical studies and the growing trend of medical tourism, joining a clinical trial in another country may be an appealing option. Although expanded access programs are making experimental drugs available to some patients before they are approved in the U.S., however, it is only done under very limited circumstances.
Patient recruitment strategy largely has been focused on finding the patients. That approach typically includes messaging people within a defined geographic range of a specific study site location. As medical tourism trends continue, a more global approach to recruitment and trial awareness will be required.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email comments and suggestions to firstname.lastname@example.org.
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