Participation in a trial
Why are there clinical trials?
The search for new medicines starts with fundamental research in laboratories. Researchers attempt in laboratories to discover why a disease develops and how a certain disease progresses. This includes the development of a suitable treatment with medicines. What is developed in the laboratory must after all still prove its effectiveness in the clinic. This is achieved with trials in the clinics, also called clinical trials.
Next to newly developed medicine, we also have trials that provide a new combination of medicine that is not used together before. Lastly, it could also could be medication that is already on the market for a different disease might also be beneficial for hematologic diseases.
Why is it important to participate in a clinical trial?
Most people that are ill want to know the best treatment for their disease. The answer is mostly due to fellow sufferers who participated in a clinical trial. After all, a great deal can be improved in disease therapy and HOVON is therefore constantly searching for the best therapy for a disease.
Studies with cells on a petri dish, in a test tube or in mice, however, do not always correspond to what happens in reality with patients. Participation in clinical trials is the only way of obtaining more knowledge and improving the treatment of patients.
What are the benefits of a clinical trial?
Through clinical trials, the following can be achieved:
- Patients gain faster access to new, promising treatment methods or medication;
- It sometimes emerges from a trial that a specific treatment that appeared promising is either not effective or unnecessary;
- The study results can result in determination of a new treatment standard for a specific form of disease;
- A trial is a first step in making fundamental research (= research into the occurrence of a disease and possibilities for treatment) available for clinical practice;
- The results of a trial eventually lead to good practical medicine.
How does a clinical trial differ from ‘standard’ treatment?
If you participate in a clinical trial, you will receive more examinations and sometimes also more visits with the treating specialist than you would if you do not participate in a trial.
If you do take part in a trial, you will be informed in more detail than is normal for a ‘standard’ treatment. Another difference is that you must give explicit permission to participate in the treatment. You will follow a treatment timetable prescribed by your specialist. You will receive information about this timetable. If you consider this information understandable and sufficient, you give permission for participation. This is known as ‘informed consent’.
If you participate in a trial, it is possible that your treatment team will be larger than with ‘standard’ treatment. Doctors, nurses, social workers and other professionals in health care may make up the treatment team. They will closely monitor the progress of your treatment process.
What kind of trials are there?
There are different phases through which medication research is performed. This can be for new medicine, a new combination of medicine or medicine already on the market but now investigated for hematologic diseases. They are listed below.
These trials correspond with the first administration of the medicine in humans, following toxicological studies in animals. Phase 1-trials are aimed at identifying the behavior of the medicine in humans (absorption, distribution in the blood, excretion from the body). This research has therefore no immediate therapeutic interest. Tolerance and safety are looked at, usually through increasing doses. It also often involves an evaluation of pharmacodynamics and pharmacokinetics.
Phase 2 trials have the main objective of determining whether the medicine is indeed effective for the intended indication. The search is also implemented to find the optimum dosage for achieving this effectiveness with the minimum side effects.
Phase 3 consists of a series of trials aimed at better understanding the characteristics of the medicines and differentiating this medicine from other existing medicines. These trials differ from Phase 2 trials by the larger number of patients involved and by the longer duration of these trials. In these Phase 3 trials, more specific populations are also investigated. It is only at the end of Phase 3 trials that the health organizations evaluate the results and issue permission to prescribe the drug by doctors and to have it reimbursed by the healtcare insurance.
Phase 4 trials are carried out following approval of the product. The manufacturers decide to carry out extra research to obtain additional information about the product.
What information do I need to obtain before and during the trial?
Information about the new medicine:
- the possible complications
- the possible advantages
- the results of previous trials
Information about the study:
- Study/tests necessary
- The medicine you may receive instead of or in addition to the medicine to be studied
- Whether you are participating in a standard-controlled or placebo-controlled study
- The results during the current study that are important to you, for example serious, undesirable side effects that make it necessary to stop the trial
- The right during the current trial to cease further participation; you don’t have to specify a particular reason
- Information about after care and follow-up checks.
- It is possible you will have to keep a logbook on the medication and complete questionnaires about your health.
Your treating physician is able to tell you everything about the list of topics provided above.
Information about your privacy: information concerning your privacy is provided in the Patient Information Letter that you will receive before the beginning of the study. You can also find more information on our website page about Privacy.
If you've got any questions concerning our trials, you can best contact your own treating physician. He/she can best provide any advice or answer your trial related questions. Because HOVON is executing trials, we must remain independent and unbiast. Therefore we cannot directly be in contact with any patients treated within our trials. We are sorry for any caused inconvenience.