The framework for clinical trials has been strengthened by new legislation ragarding research on humans. But it’s not enough.
Last year, 205 clinical drug trials were authorised in Switzerland, each including hundreds or even thousands of participants. These tests are not without risk. Swissmedic, the Swiss authority responsible for the authorisation and supervision of therapeutic products, has reported 78 cases of “unexpected serious adverse events” (see glossary). The people who take part in studies are not adequately protected when they experience serious negative side effects, says the Swiss Patient Organisation (SPO).
Switzerland’s new Human Research Act passed on 1 January 2014 has improved the framework for clinical drug trials by setting up a national registry to record clinical trials and by improving the classification of research procedures according to the risk involved. However, the legislation did not introduce the SPO’s primary demand to reverse the burden of proof if the participant is harmed.
“The new law is not in favour of patients,” claims the SPO delegate for French-speaking Switzerland, Anne-Marie Bollier. “In the event of complications, it is the injured party who has to prove the relationship with the drug administered under the trials.” That is what is expli-citly written in the Explanatory Report on the Ordinances to the Human Research Act.
She criticises this requirement as “absurd”. “The balance is unfairly tipped in favour of industry and insurance companies. Patients don’t have 35 lawyers paid year round to defend them.” The SPO demands that it should be the responsibility of the research organisation and its insurance company to discredit any causal relationship, not for the participants to demonstrate it.
The SPO President Margrit Kessler does not provide any specific figures but mentions “several cases” where subjects in clinical trials were victims of complications and did not receive financial compensation or had to fight to receive any. In addition to the inflexibility of insurance companies and sponsors of clinical studies, the SPO criticises the denial of medical investigators.
The organisation provides concrete examples on its website, such as the case of a man suffering from advanced melanoma. He did not want to be treated using chemotherapy, so he participated in a research project based on an alternative treatment. Nine days after testing began, he experienced partial paralysis in the face, a side effect that had never been mentioned previously. The medical community first denied any relationship with the treatment. It was the patient’s wife, a nurse, who managed to prove it after a long battle. Now, after the intervention of the Ethics Committee, facial paresis is included in the initial analysis report.
“It seems absurd that in the event of complications, the injured party has to prove the relationship with the drug administered under the trials”
Health professionals, however, believe that patients benefit from adequate guarantees. “I don’t see how participants could be better protected, given the number of rules and clinical best practice guidelines that have to be followed,” says Bernard Waeber, director of the Clinical Research Centre at Lausanne University Hospital. “Before deciding on any changes to reverse the burden of proof, we should first
draw from the teachings of the Human Research Act’s first year of application,” says Maximiliano Wepfer, deputy head of communication at the Swiss Medical Association (FMH).
Tighter control over individual studies
The fate of subjects in clinical drug studies is not the SPO’s only concern. This umbrella organisation also demands greater protection for individual testing. The practice is legal, as long as patients provide their “informed consent” and are indeed properly informed. “But it doesn’t always work that way,” Anne-Marie Bollier of the SPO points out. “Patients with a life-threatening illness will try anything, and information is not always entirely clear,” she notes.
The SPO requested, in vain, that individual testing be covered in the Human Research Act. “We want the law to require a written record of what the patient knew at the time testing began,” says Anne-Marie Bollier. The organisation won a half-victory. Thanks to her efforts, the Swiss Academy of Medical Sciences began reviewing the directives on the distinction between a standard treatment and an experimental treatment, including specific rules governing the information that must be provided for patients. The SPO delegate applauds this progress but remains cautious: “At least it provides a legal reference in the event of a dispute in court.”
1. Clinical trial
A study conducted on human beings to test the safety, efficacy and other properties of a treatment (e.g. a drug).
Person or organisation
that initiates a clinical trial.
for conducting a clinical trial (e.g. a doctor).
4. Unexpected serious adverse effects
Any unexpected serious adverse effect (that causes death, is life-threatening
or requires extended
hospitalisation) related to the use of an experimental drug during a clinical trial.
Experimentation on a
non-standard treatment (e.g. an unauthorised
drug) as part of an