Clinical trials are scientific activities in which patients voluntarily participate to test new drugs or medical procedures, to compare different types of therapies or to evaluate the safety of their administration.
Communication with the investigating physician in the clinical trial in which you have been enrolled is essential so that side effects can be assessed, treated, and any general side effects of the oncology medication or specific to the study medication can be prevented. The study protocol contains sufficient information to guide the investigating physician in dealing with any side effects reported by you in a timely manner.
Participants in a clinical trial must meet certain clinical trial conditions before entering the trial. In general, patients in a study share some key features such as: type and stage of cancer, age, gender, previous treatments, results of certain laboratory tests. Enrolling participants with similar characteristics ensures that the results are due to the study treatment and not to other factors.
In order to check the inclusion and exclusion criteria for a possible clinical trial compatible with your clinical situation, please contact the clinical trials team at firstname.lastname@example.orgemail@example.com to arrange a consultation.
Please note that all medical data in your patient record is required for this consultation.
Finding answers to questions and making decisions are often difficult steps for the cancer patient to follow. Diagnosis, as well as making decisions about what to do about your illness, are moments that can cause confusion and even irritation.
It is very important to discuss therapeutic options with your doctor. Your specialist oncologist or radiotherapist can advise you on the choice of a standard treatment or enrolment in a possible clinical trial. Discuss with your specialist any problems you have in making your decision.
It is advisable to be accompanied to the doctor by a relative, a close acquaintance, to help you clarify certain questions you have. You can also draw up a set of questions before the doctor’s visit that make you anxious and that you want answered. There are no unnecessary questions to ask your doctor.
Every patient is different. Ask your doctor to customise treatment options according to risks and benefits.
And don’t forget! The Amethyst medical team is available to provide you with information so you can decide what is best for you.
Before participating in any clinical trial and signing the consent form in which you will find specific explanations related to that trial, it is good to ask your doctor the following questions:
– What kind of study do you propose? – what a phase: II, III, IV?
– What are the benefits of my participation in this study?
– If I do not wish to participate, what are the standard, usual treatment alternatives?
– How do you assess the risk-benefit balance, not in general, but strictly in the case of my participation in this study (taking into account the particularities of my case)?
– Is it possible to receive a placebo (inactive) medication in the study? If the answer is yes, keep asking if there are definitely no standard therapies that are more effective for you.
– Does my participation in the study mean coming to the hospital/office many more times; does it mean many more tests than usual?
– Are there other studies in other centres that I could have access to that might be more effective in my case?
– How can this study affect my daily life?
– How long does the study take?
– What kind of long-term follow-up is involved in this study?
– What additional costs does enrolling in the study involve for me?
Informed consent is, by definition, a decision to participate in a clinical trial that must be written, dated and signed, taken voluntarily and after all necessary information about the nature, significance, consequences and possible risks, as well as the necessary documentation, has been received by a person capable of giving consent or, in the case of a person who is not capable of giving consent, by his/her legal representative.
If you are enrolled in a clinical trial, you will be monitored rigorously at regular intervals. The data obtained will be reported anonymously to the study sponsors. You may be monitored more frequently than usual, and this may entail more frequent biological sampling. This can create a certain sense of discomfort, but at the same time, it also involves closer monitoring of side effects and response to treatment.
It is your right to withdraw from participation in a clinical trial at any time. Your rights as an individual are not influenced by the decision to participate in a clinical trial. It is advisable to have a discussion with the investigating doctor about the reasons for your decision to withdraw. The decision to withdraw from the study should not have any negative consequences for your relationship with the investigating physician.
If during the course of the study it becomes clear that the treatment you are taking is not beneficial to you, you will be withdrawn from the study and your doctor will provide you with information about the remaining treatment alternatives.
Phase 0 trials – Investigates whether and how a new drug works.
Phase I trials – These are designed to answer the question: “Is this treatment (drug, procedure) safe?”
Phase II trials – These answer the question: “Is the treatment active?”
If a drug is found to be reasonably administrable (in Phase I), i.e. free of major toxicities at a given established dose, it will be evaluated in a Phase II study for therapeutic action.
Phase III Trials (available in the Amethyst Clinic) – Answer the question: “Is the new treatment better, more effective than what we already have, what is used in current medical practice?”
Phase III studies thus investigate the efficacy and tolerability of new drugs compared to what is considered standard medication in current medical practice.
Unlike earlier phase trials, Phase III trials enrol large numbers of patients, at least several hundred, and are conducted in several medical centres in one country or even in countries on all continents. Studies can be carried out in various hospitals with oncology departments and specialist practices, not only in high-performance university centres.
Phase IV trials (available in the Amethyst Clinic) – Even when a drug has received approval (after Phase III trials) for widespread use in current medical practice, there is still the possibility of late adverse reactions occurring after longer periods of time than the follow-up time from Phase III trials. Also, when the drug starts to be used, by a much larger number of patients than in the Phase III trials, other side effects are likely to occur and need to be evaluated, as well as other possible degrees of therapeutic efficacy.
Phase IV studies, being carried out only with already studied drugs in daily practice, pose the least risk to patients.
The benefit to patients participating in such studies is that of more complex monitoring than in current practice.
These studies may be carried out at the initiative of the pharmaceutical industry. These studies are validated by rigorous scientific protocols and respect ethical principles and the interests of the individuals participating in these studies.
Patients wishing to participate in clinical trials can turn to a variety of sources:
– Doctors or cancer specialists;
– Cancer Associations or Societies – European Organisation for Research and Treatment of Cancer (EORTC) – go to http://www.eortc.org/clinical-trials/
– Patient groups;
– Pharmaceutical companies – Large pharmaceutical companies conduct or sponsor clinical trials. Information can be found on their websites.