Clinical trial volunteers play a crucial role in research. They agree to participate in studies for a variety of reasons, including medical, altruistic and financial incentives – with significant differences depending on the country in question.
Hundreds of thousands of people around the world volunteer every year to advance medicine. In India and the United States, where healthy subjects receive an actual salary in exchange for their participation, people tend to volunteer more for financial reasons than altruistic ones. According to the newspaper The Hindu, in the region around Bangalore, an Indian can receive 300 Swiss francs for participating in a therapeutic trial on melatonin. Also known as the sleep hormone, melatonin is an ingredient in a number of sleeping medications. This is almost three times the amount of the monthly minimum salary in this city. India is home to an increasing number of clinical trials according to the New Delhi Institute for Studies in Industrial Development. In 2008, 0.9% of trials took place in this south Asian country; this figure rose to 4.9% in 2013.
The meteoric rise in inexpensive drug testing can be explained by three factors according to the Indian institute, namely “cheap human resources, the low cost of recruiting volunteers and the low amount of compensation paid out in the event of injury or death.”
Around 40% of all clinical trials in the world occur in the United States. 75% take place in private practices or commercial research centres. American volunteers often participate in multiple trials. Jill Fisher from the Center for Bioethics at the University of North Carolina followed 180 participants in phase I trials (see inset p. 28) for three years as part of the HealthyVOICES project. “Only 25%
of the people included in the project were participating in a clinical trial for the first time, which is a very low percentage,” she explains. “Most were repeat volunteers. The trials represent their only source of income or act as a regular supplement when paired with part-time or seasonal work, for example.”
The associate professor goes on to explain that the profile of American volunteers varies. However, the stereotypical volunteer is an African-American or Hispanic man between the ages of 30 and 50 with only a high-school education. As in India, “serial volunteers” in the United States mostly participate in trials for financial reasons. “The volunteers are unsure at first. They are worried about their health and don’t want to get swindled. Once they see nothing bad happened to them and they do actually receive their $3,000 or $4,000 payment, the perceived risks for the second trial fall.”
In Switzerland, the phenomenon of “serial volunteers” isn’t very common. Firstly, healthy volunteers who participate in clinical trials aren’t paid to do so. They are only reimbursed for the costs incurred due to their participation, such as transportation fees and the time spent doing the study.
“Compensation varies between around 100 Swiss francs for a simple 30-minute meeting with a survey to 2,000 Swiss francs,” estimates Marc Froissart, director of the Clinical Research Clinic at CHUV.
At the upper end of the spectrum, the studies require participants to spend several days or nights at the hospital under surveillance and take blood pressure tests, give blood samples, etc.” For example, participants in the test for the Ebola vaccine conducted in 2015 received 800 Swiss francs. Some Swiss residents, such as students or low-income individuals, participate in trials to make ends meet. “We shouldn’t kid ourselves – receiving an additional source of revenue is the primary motivating factor in most healthy volunteers.”
Secondly, in Switzerland and in Europe in general, the number of trials authorised per subject is very low and more closely monitored than in the United States. “The regulatory framework in Switzerland was recently updated, especially with the law on human research that entered into force in 2014 and the 2002 law on therapeutic products. As a result, it is slightly more restrictive than in the rest of Europe,” says Marc Froissart.
In January 2018, out of the 850 clinical trials that were listed on the Swiss National Clinical Trials Portal (SNCTP) platform, which includes all the studies in Switzerland that had been approved by ethics committees and put online by researchers, most involved subjects who already had a disease. The primary motivation for this type of volunteer is to benefit from medical breakthroughs. The law does not provide for any kind of compensation when the potential health benefits help the subject directly.
At the Leenaards Memory Centre (CLM) at CHUV, researchers are pursuing a two-part goal focused on finding treatments that are effective against the lesions created by neurodegenerative diseases such as Alzheimer’s and stopping them before they lead to debilitating symptoms.
“We explain to our patients who might want to participate in a study, as well as to their families, that medicine has not yet invented a cure for these diseases, only measures to help ease symptoms. Nevertheless, the possibility of helping to identify a potential treatment motivates quite a few people to volunteer.”
Olivier Rouaud, a neurologist at CLM, has noted two other reasons why people participate in trials in addition to their altruism and their desire to help advance medicine. These individuals want to give themselves another chance at beating their disease or reducing the severity of their symptoms. Some volunteers also appreciate the regular hospital visits that are required by the research protocol. “They feel it helps improve their health because they’re monitored differently than in traditional healthcare environments.”
This begs the question – how can you convince healthy people to participate in these scientific studies without offering them a financial incentive or the hope of a cure? “The Swiss are much more altruistic than we think,” says Martin Preisig, director of the Psychiatric and Psychopathology Epidemiology Centre (CEPP)
and the psychological section of the CoLaus/PsyCoLaus study at the Lausanne University Hospital. This observational study was launched in Lausanne in 2003. Its primary goal is to gather information on the links between cardiovascular diseases and psychiatric diseases as well as the causes of these conditions.
“Unlike therapeutic tests, we simply observed a sample recruited from the general population of Lausanne, without affecting their daily lives,” Peter Vollenweider, acting director of the Lausanne University Hospital's Internal Medicine Service and manager of the physical section of the study. Some 6,734 people aged 35 to 75 were selected at random in 2003 and asked to participate in the CoLaus/PsyCoLaus study. Participants then completed an initial interview that included a survey on their general health, cardiac health and family risk factors, as well as a clinical exam during which their vital statistics and blood pressure were measured and a blood sample was taken. Then, they were called in for a second interview designed to detect the presence of psychological issues (depression, addiction, etc.).
The study has offered insights into the population of Lausanne. “The participants want to improve the state of medical research and help others,” explains Peter Vollenweider. The purpose of CoLaus/PsyCoLaus is to gather information that will help improve the treatment and prevention of cardiovascular diseases and psychiatric disorders in the medium term. “These diseases are common. All of the volunteers have a parent, friend or colleague who has already been affected.” Participants also want information about their own health and to be reassured. “The first interview is like a check-up, and the results of the analyses are transmitted to the volunteers.” The study participants were called in again in 2009 and 2014.
“We have to be able to see how the population’s health changes over the course of several decades,” says Martin Preisig.
“We’ve also added other types of testing over time, including eye, pulmonary, sleep, cognitive function, and MRI exams, to name just a few.” After coming so far, the team has no intention of stopping. “We will soon ask the children of the volunteers to participate. The goal is to determine the prevalence of risk factors for cardiovascular and psychiatric disorders in younger subjects between the ages of 15 and 35 and study the factors governing the transmission of these diseases in families. We are very thankful for the help provided by the Lausanne population.”
Women are traditionally under-represented in clinical trials. “The risk of pregnancy and the possibility of hormonal changes that could cloud the test results have long been used as justification for their exclusion,” explains Carole Clair, senior physician at Lausanne University Medical Polyclinic (PMU).
The impacts of male-focused medicine are significant. “For example, the recommended doses for chemotherapy have sometimes proven to be incorrect for women, who are more susceptible to side effects like nausea. Aspirin, which was initially touted as an effective component of primary prevention for heart disease, is actually only beneficial for men.”
Nevertheless, this imbalance is slowly correcting itself. “One of the requirements of the major European research project Horizon 2020 is to take women into account.”
Olivier Rouaud, a neurologist at CLM, has noted two other reasons why people participate in trials in addition to their altruism and their desire to help advance medicine. These individuals want to give themselves another chance at beating their disease or reducing the severity of their symptoms. Some volunteers also appreciate the regular hospital visits that are required by the research protocol. “They feel it helps improve their health because they’re monitored differently than in traditional healthcare environments.”
This begs the question – how can you convince healthy people to participate in these scientific studies without offering them a financial incentive or the hope of a cure? “The Swiss are much more altruistic than we think,” says Martin Preisig, director of the Psychiatric and Psychopathology Epidemiology Centre (CEPP)
and the psychological section of the CoLaus/PsyCoLaus study at the Lausanne University Hospital. This observational study was launched in Lausanne in 2003. Its primary goal is to gather information on the links between cardiovascular diseases and psychiatric diseases as well as the causes of these conditions.
“Unlike therapeutic tests, we simply observed a sample recruited from the general population of Lausanne, without affecting their daily lives,” Peter Vollenweider, acting director of the Lausanne University Hospital's Internal Medicine Service and manager of the physical section of the study. Some 6,734 people aged 35 to 75 were selected at random in 2003 and asked to participate in the CoLaus/PsyCoLaus study. Participants then completed an initial interview that included a survey on their general health, cardiac health and family risk factors, as well as a clinical exam during which their vital statistics and blood pressure were measured and a blood sample was taken. Then, they were called in for a second interview designed to detect the presence of psychological issues (depression, addiction, etc.).
The study has offered insights into the population of Lausanne. “The participants want to improve the state of medical research and help others,” explains Peter Vollenweider. The purpose of CoLaus/PsyCoLaus is to gather information that will help improve the treatment and prevention of cardiovascular diseases and psychiatric disorders in the medium term. “These diseases are common. All of the volunteers have a parent, friend or colleague who has already been affected.” Participants also want information about their own health and to be reassured. “The first interview is like a check-up, and the results of the analyses are transmitted to the volunteers.” The study participants were called in again in 2009 and 2014.
In observational studies, the volunteer is monitored by researchers without any kind of intervention. The purpose is to gather information on risk factors, lifestyles or the effects of exposure to a substance in the environment. The follow-up period can last several years.
Interventional clinical trialsare used to test treatments or procedures designed to prevent, identify or cure disease. The researchers “intervene” by asking the patient to undergo a diagnostic method or a surgical, radiation or medicinal treatment.
Drug trials include four phases:
1) Evaluate the medicine’s pharmacokinetic characteristics and safety, and identify side effects (10 to 80 people*).
2) Find evidence of a beneficial effect and assess safety (100 to 300*).
3) Determine if the treatment is clinically beneficial and/or better than previous treatments (500 to 20,000*).
4) After marketing, these studies are mainly focused on detecting rare adverse events (pharmacovigilance).
*Number of patients is provided for informational purposes only.
