Jamie is a 27-year-old designer, June is 61 and a homemaker, and Alison, a student, is 26. All three of them are vital in the development of new medicines working alongside doctors, nurses, medical researchers and product developers and without them new drugs, diagnostics and treatments would simply not see the light of day. June is the mother of a son with Type I diabetes. “When my son was diagnosed with diabetes I would have walked over broken glass, anything, to get him the right treatment and to improve his situation,” she said. “I saw a notice in the hospital seeking healthy volunteers for a Phase I clinical trial for a new diabetes drug and I immediately enrolled. It may or may not directly benefit my son, but I feel like I’m contributing and helping the medical researchers working so hard in the labs looking for new treatments.” Having a family member with a disease is a common reason that motivates healthy volunteers to participate in a clinical trial. Feelings of helplessness and distress can be reduced in some people by contributing to the research effort. Being closely involved with a friend or a family member suffering from a disease also highlights the deep desire to access new treatments and medicines, bringing clinical trials into the conversation and raising awareness of their existence for the first time with some people.
Jamie is a regular healthy clinical trial volunteer in Adelaide. He first decided to participate in a clinical trial when he recognised he had a family history of severe arthritis and started to consider how new drugs were developed. “It has always fascinated me as to the how and the why drugs are developed,” said Jamie.
“The first trial I participated in was for an avian flu vaccine”, he said. “It was raging overseas and thousands of people were dying. I wanted to be able to help and do something to protect us here in Australia. I saw an ad in the newspaper. They needed a lot of participants to go into the trial. I thought – I can do this and I’ll get paid for my time.” From development of a discovery in the lab to becoming a new drug or treatment frequently initially depends upon healthy people to volunteer to test the product through the three stages of clinical development. Healthy volunteers will usually get no personal benefit from the medicine they are testing, and neither will June’s son for example, but they do get paid for giving up their time.
Francis, another regular clinical trial volunteer expressed the same initial curiosity about how new medicines were discovered and developed. “New medicines are critical in being able to treat diseases, we look for them when we go to the doctor, yet few of us really consider how they are developed and even fewer of us consider how we can help”, she said.
“If there are no clinical trial volunteers – there are no new drugs. It’s as simple as that. If we want access to new medicines, we need to contribute as a society.” Clinical trial volunteers and the data their participation creates are the most important components of the development process between discovery and the market. Francis is exactly right in saying that without volunteers, no new medicines will reach the market, as the regulators that approve new drugs demand human clinical trial results and the number of human volunteers usually needs to be in the thousands. “Clinical trials are something I’d never considered, I was not even aware of, until my son was diagnosed with diabetes,” June said. “I can now see how important we are in helping to get new drugs into the hands of our doctors. I really feel like I’m making a difference.”