Dr Angela Orcurto is one of two physicians who meets with the patients scheduled for participation in the trial, to provide them with a detailed explanation of what they can expect. Over two consultations, she covers the protocol "from A to Z" and presents the consent form.
In a consultation cubicle on the 6th floor of the main building of the Lausanne University Hospital, the patient – often accompanied by his or her family – discovers the document for the first time. The title alone takes up three lines: Étude de phase I pour évaluer la faisabilité et la sécurité d’un transfert adoptif de lymphocytes T autologues infiltrant la tumeur en combinaison avec de l’IL-2 suivi d’un rattrapage avec nivolumab chez des patients atteints d’un mélanome métastatique avancé ("Phase I study to evaluate the feasibility and safety of an adoptive transfer of autologous T lymphocytes infiltrated into the tumour, combined with IL-2 followed by nivolumab treatment in patients suffering from an advanced metastatic melanoma").
This first step in the consent process, which sets the tone for all those to follow, takes place according to relatively strict criteria. The consultation generally lasts an hour, and Dr Orcurto does not have much leeway in how the interview takes place. Her role is to guarantee that the patient has understood "the nature, importance and scope of the study."
This particularly long consent form – no fewer than 27 pages – begins with a 16-point summary based on a standardised model. The objectives of the study and general information on the research project, how it will be performed, and the benefits and risks for the participants are all presented. "I start from zero repeating everything that they have probably already been told," states Angela Orcurto, "since no one can take it all in at once."
In the course of this interview, Dr Orcurto also discusses the available alternatives to the treatment proposed in the trial or, in the worst case, informs the patient that there are no other therapeutic options possible.
"The patient must know whether there are other choices available. He or she must also know that, it is possible to withdraw their consent and discontinue their participation in the trial at any time, without needing to provide any justification whatsoever."
The list of side effects alone takes up six pages; the list is classified according to frequency of occurrence. It is based on research and results from the United States, where the treatment has already been tested. "It is a very complete document," Angela Orcurto points out. "I am here to discuss in detail everything that might happen and thus lighten the impact of the form."
Patients often ask about hair loss, caused by the chemotherapy that precedes the re-injection of cells, but amongst others, Dr Orcurto also brings up the shivers and nausea that can occur while the cells are being reinfused.
She speaks openly and emphasises an important point:
"There may be reactions to the treatment that no one has yet predicted."
"The patients must be made aware that we cannot predict everything. Some people have no choice, and they instantly decide to go ahead. Most see the good side and agree to try a treatment that gives them an extra chance."
Another key message that is not always easy to convey: "We cannot provide any guarantee that the treatment will be of benefit to the patient," even if the principle of any clinical trial is that the expected benefit outweighs the risk.
Drafted by the Bureau of regulatory affairs of the Centre for experimental therapeutics, the consent form presents the protocol of the study based on a standard model. Ideally, the text should be written in clear language, avoiding "jargon" and overly specialised terms. It is reviewed by the physicians before being submitted to the ethical commission of the canton as part of the clinical trial authorisation procedure.
At the end of the first consultation, the patient takes the 27-page form home. He or she is then entitled to a reasonable amount of time in which to decide whether they wish to take part in the trial.
During a second consultation, he or she is free to ask any questions that might come up in order to be able to consent in an informed manner.
There then follows the somewhat solemn moment when the patient signs the form, in duplicate. Next, Dr Orcurto signs the forms herself. From there, she will follow the patient throughout the screening phase to ensure that his or her general condition remains sound and that each check-up provides positive results that enable him or her to participate in the trial.
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