Content - Trial participation

Participation in clinical studies

Clinical studies on the safety and efficacy of new treatments for cancer offer patients additional and, in most cases, new prospects. Clinical researchers focus their questions on the needs of patients. They thus act in the interest of the patient and are committed to reducing the suffering caused by cancer. Patients who are suitable for a study can benefit from the advantages of new treatments even before they may be approved as standard therapy. They are thus often provided with an additional treatment option that would otherwise not be available to them.

A cancer patient who takes part in a clinical study is a partner of the researcher - a person with rights and needs. Participation in a clinical study is always voluntary. You will be informed before and during a study about the objectives, procedures, benefits and possible risks and have the right to withdraw your decision to participate at any time. It is thanks to people who take part in clinical studies that chemotherapy and other methods of cancer treatment therapy are steadily being developed further, and they thus play a key role in the improvement of cancer therapy.

  • Costs

    Participation in a clinical study at the same time means treatment. This does not entail any extra or special costs to you or your health insurance for the examinations and treatment within a clinical study, even if the new treatment is more expensive than standard therapy. In the case of a new medicine that is not yet approved for the market, this will be provided to you free of charge. In a clinical study no special tests are usually carried out‘, but the methods that usually correspond to the disease situation are used. If additional measures are necessary (e.g. chromosome analysis, genetic tests or x-rays), the resulting costs are not charged to you, but are paid out of the research funds. However, the insurance franchise and deductible for the cost of tests and treatments that have to be carried out anyway have to be paid by you as with any other treatment.

  • Consent

    Every test and treatment within or outside the scope of a study requires your approval and your informed consent. If the tests and treatments are carried out in the framework of a study, you will be asked to sign this declaration of consent confirming that you are willing to take part voluntarily in the study concerned. But you may still refuse to take part in the study without suffering any disadvantage in terms of your further care. However, certain treatment options will only be provided or paid for in the framework of clinical studies. In the event of your refusal, your doctor will discuss the best-possible alternative treatment options with you. Regardless of participation in the study, you should know what short and long-term effects and side effects are to be expected and how likely it is that these effects will occur. You must also be informed about the objectives, methods, tests, risks and benefits of the study. You should also be informed about other treatment options, changes and entitlements to compensation in the event of study-related damage. You should only sign the document if you are in agreement with the content. As in the case of any test or treatment, so too in the case of the study, you can decide yourself whether to take part and whether to retract your consent at a later stage.

  • Conditions of participation

    Every study is aimed at patients with particular characteristics, such as the nature of the cancer, the extent of the cancer and general health. Before it is decided whether you can be treated in a clinical study or not, careful tests are needed in order to gain an accurate picture of these characteristics:

    • Diagnosis and extent of disease (staging)
    • General health
    • Function of organs (kidneys, liver, heart and lungs)
    • Other or previous diseases and treatments
    • Medication needed
  • Protection and safety

    Clinical studies are complex and involve an elaborate procedure and analysis. Our laws on clinical studies demand complete and comprehensible information, provide for the protection of trial subjects, ensure that the study is correctly carried out and guarantee the reliable analysis and publication of results.

    As a participant in a clinical study, you will be treated like all other patients in oncology centres, outpatient clinics, hospitals or in the practice of a specialist or your general practitioner. In many studies, however, the need for optimum monitoring means that treatment must take place at oncology centres which have the necessary know-how and facilities at their disposal.

  • Data protection

    All data collected during the clinical study is subject to the professional code of confidentiality. Personal data concerning you, your heath and your treatment must of course be recorded and archived during the study, so that it is available for evaluation. However, data is only forwarded for this purpose in encrypted (de-identified) form. This encryption means the data can only be traced back to you by your study doctor, which is necessary for your own safety. Neither in the analysis nor in the publication of the results are individual study participants specifically mentioned or identifiable. As a patient your privacy is protected during a clinical study.

  • Control

    The registration and management of all the data call for a highly developed computer solution. The data must be checked to ensure that it is correct. Health authorities or their representatives may inspect the data to check that it is correct. In the case of relatively large or prolonged studies, interim statistical analyses are carried out to monitor whether the treatment is producing the desired effects. The final results of a study are made accessible to other researchers in scientific journals or presented at conferences, but always in compliance with the data protection law.

  • Patient insurance

    If you take part in a clinical study, you are insured against damage through the implementing organization, e.g. the SAKK. The organization that carries out the study and is also legally designated as the sponsor must have adequate liability insurance, which covers not only damage during the study, but also subsequent damage where applicable.

  • Rights

    Your individual right to self-determination is always respected, regardless of whether you are treated in the framework of a study or not.

    As a participant in a clinical study you have the right to

    • particularly careful information, treatment and monitoring
    • personal data protection
    • ongoing information about alternative, new findings on the effects of the intervention being studied, the risks, benefits, your clinical condition and results of the study
    • comprehensible explanations
    • freedom to make up your own mind and self-determination
    • termination of participation in the study at any time
  • Obligations

    The conclusiveness and reliability of the results obtained from the study depend on your cooperation. Your cooperation plays a crucial part in the quality of a clinical study. The doctor responsible for treatment in the study will inform you in the run-up to the study what treatments and tests are necessary and whether certain comments are expected from you. If you decide to undergo a test or treatment within the framework of a study, you undertake to observe certain rules:

    • You reliably keep to agreed appointments.
    • You follow the directions of your doctor and the instructions for taking the medicines.
    • You answer the doctor’s questions on your health truthfully.
    • You enter your data and comments in detail, accurately and as fully as possible in the study diary, notebook or questionnaires if you are asked to do so.
    • You inform the study doctor immediately if you notice any health changes or abnormalities.
    • You inform your study doctor immediately if you are prescribed further medicines and additional treatments by other doctors.
    • You notify your study doctor if you are taking non-prescription medicines as self-medication.
    • If you move or change your treating family doctor, please tell the study doctor as well.
    • Cooperate faithfully with your doctor. Your doctor needs the information that only you can give to provide for your maximum safety.
    • If you are uncertain whether you want to continue the study, do not keep these thoughts to yourself. Talk to the treating physician, who may be able to dispel any anxieties or uncertainties.
  • Withdrawal from study

    Just as you can refuse to take part in the study, so too is it your right to retract your decision to take part at any time. Your declaration of consent to take part does not mean you have to participate to the end of the study. Remember to ask questions in order to eliminate any uncertainties. In the event of an early withdrawal from the study, it is possible that he expected results of therapy have not yet taken effect. In the event of a curtailed or underdosed treatment, a benefit is often questionable or completely absent. The decision with withdraw participation in a study will not have any impact on the quality of your further care, i.e. you will not be punished for your decision. Your doctor will discuss other possible treatments with you.