For most, clinical trials are a necessary evil.
Almost nobody will voluntarily be the first human guinea pig to test the adverse effects of new drugs, but the sad truth is: we need them...
|The results of insufficient thalidomide testing|
I don't have to remind you that things can go terribly wrong during a clinical trial, but like all accidents, lessons have been learned, protocols adapted.
If you would like to know more about phase 0 and I drug testing, visit the Ghent University's Drug Research Unit.
There are of course other clinical trials that don't involve new drugs, for example: developing new vaccines.
My first clinical trial: efficacy of an influenza vaccine against bird flu (H5N1).
In 2006 the pandemic panic was on a high: H5N1 bird flu was going to wipe us out! To test a new vaccine consisting of small parts from the virus (subunits) in low doses (antigen sparing), Ghent University's Center for Vaccinology set up a trial. As a student Biomedical Sciences, I was intrigued by this and joined.
- For the 300 euro's? Of course some extra pocket money isn't that bad...
- For science? Experiencing immunology in practice was a bit more interesting than learning all cytotoxins in class..
- To be safe from the H5N1 rapture? I must admit that I really don't like the flu and was happy to get access to a vaccine that was still unavailable to the rest of the population...
- To be able to cuddle birds in the future? No comment..
Was my "sacrifice" useful? Yes!
- The results from this clinical trial were published in one of the highest ranking journals: The Lancet
- I even got mentioned in the acknowledgments:
We thank the National Institute for Biological Standards and Control (Potters Bar, UK) for providing the vaccine virus strain and reference standards; the Centers for Disease Control and Prevention (CDC, Atlanta, USA) for supplying the A/Indonesia/5/2005 strain; the participating clinicians, nurses, and laboratory technicians at the study site and the sponsor’s project staff for their support and contributions throughout the study, in particular Laurence Baufays for study coordination; Catherine Vigano-Wolff for preparation of the study protocol and related study documentation; the study volunteers; Kati Zierenberg, Roger Bernhard, and Elisabeth Neumeier who did the immunological laboratory work; Emmanuel Hanon, W Ripley Ballou, and Roland Saenger for critical reading of the report and very helpful suggestions; Miriam Hynes (independent, UK) for her assistance in preparing the report; and Isabelle Camby (XPePharma SA, Belgium) for coordination. TV is supported by a PhD grant of the Research Foundation-Flanders. This study was supported by GlaxoSmithKline (GSK) Biologicals, Rixensart, Belgium.
- And for me personally: this trial and its results inspired me. Four years later I graduated and joined these researchers for a PhD in malaria vaccine development.
Back to the current trial
Why do people actually want to get infected with malaria? Even after receiving an informed consent from the study doctor and their own doctor?
For most of the volunteers, it is simple:
You do get a lot of money for this trial, but the trial also asks a lot of time and effort from you
"The amount has been determined before the study and is based on the burden of the clinical trial. Influencing factors of the burden of the clinical trial are e.g. number of blood samples taken, burden of disease, the amount of time the volunteer needs to expend for participation, number of overnight stays, ..."
In this trial, you have a blood sample drawn twice each day, you will probably have some symptoms of malaria, have to stay in town, ...
This is quite a burden, so you'll get a good compensation....
... but it won't make you rich.
So is it wrong to join clinical trials for the money?
No. People who occasionally join a trial will not have any negative effects on the long term. There are however people who you could call medical prostitutes, who try to make a living out of joining clinical trials. This is of course very bad: the volunteer can have a negative effect from combining different medications that could potentially interact, but more importantly: this is very bad for science! The results can be affected by using the same volunteers each time or that they don't resemble the population anymore (by taking significantly more medications, vaccinations, ... than the average person). In the worst case, development of a promising new therapy is stopped because of wrong results...
To prevent this, there are of course several safeguards: participants are screened in a national database to see if they are currently or very recently enrolled in another trial, the doctor at the trial screens them also to see if they are honest about habits, intentions, ...
The truth is: we need people who don't mind to make a bit of money by joining trials.
People should realize that to live in a healthier world, we need volunteers who lend their body to science. If you're a biomedical scientist, you probably know how difficult it is to find volunteers for trials... Of course, you can't join your own studies (ethics, blinding of study results, ...).
However, you can and should join the trials of your peers!
Don't count on others looking for some extra money, progress starts with you, not only as a scientist, but as a human.
If you would be interested in joining a clinical malaria challenge you can always check these websites:
Living in Belgium and considering joining a vaccine trial?