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Answers to basic questions
What are clinical trials and why are they important;
The term clinical trials refers to research studies that test new methods of screening, prevention, diagnosis, or treatment in humans.
Therapeutic clinical trials aim to test dosing, toxicity and effectiveness of new treatments or new ways of using current treatments in people. Combinations of different treatment types may also be tested in these trials. Clinical trials follow strict therapy and follow up protocols, are conducted in certified medical centers by certified medical personel and are registered in public registries of international organizations (FDA, EMA). People who take part in clinical trials have an opportunity to contribute to medical knowledge and to help in the development of improved treatments. They also receive state-of-the-art care from medical experts.
*Every new treatment and drug that has entered the market has emerged after several clinical trials.
Will I benefit from a clinical trial?
Taking part in a clinical trial is entirely your decision. A specialist doctor or a research nurse will first discuss with you your treatment options and go through a process called informed consent. The goal of this process is to make sure that you understand the clinical trial’s plan, purpose, risks and benefits. You will be given time to study the consent form and ask questions. If you decide to join the clinical trial, then you will be asked to sigh the informed consent form.
After your voluntary enrollment in a clinical trial
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- you will be monitored by the most specialized health professionals, in the field of your disease
- you will receive a promising treatment that is in a process of evaluation and in the same time a high quality health care.
- you will have examinations related to your disease and your treatment at no charge for as long as you will be treated and also for the follow up time period which is specified by the treatment protocol.
- your volunteer participation will contribute to a future optimal treatment for other patients with the same medical condition as you.
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How participant patients are protected;
Clinical trials are conducted according to rigorous scientific and ethical terms and conditions.
They have received appropriate approvals by health authorities and have as a prerequisite the fact that participants are covered by a liability insurance policy and the conduct of the trial is done by researchers provided with accredited qualifications who always conform to the Good Clinical Practice principles (ICH GCP – http://ichgcp.net ).
The work performed in every department is available for evaluation by International and National Health authorities at any time, while controls for the proper conduct are made by the sponsor or by independent authorized organizations at regular time periods.
Please note that no personal data of the participants will be disclosed in these reports and will be protected by the clinical team.
What is informed consent?
When the investigator/doctor identifies a patient that is eligible for a clinical trial, he will arrange a meeting in order to inform the patient regarding his/her treatment options and go through the informed consent process.
Informed consent is a document that includes information about the disease, the purpose of the clinical trial, the procedures that are going to be followed, the benefits and the possible known adverse effects/reactions. Furthermore, it is made clear that the process is voluntary, and that the patient may withdraw from the trial at any time without having to justify his decision and that this decision will not affect his future treatment. It is also been agreed that the investigator has the right to decide the discontinuation of the trial treatment if he judges that this is medically necessary, or for compliance reasons. The patient, the investigator/doctor who informed and the witness, if there was any present, sign the informed consent form. The document is then filed to the trial’s folder. The patient/participant has the right to receive a copy.
How long does a clinical trial last?
The actual time of participation lasts as long as the patient receives trial treatment. However, the patient’s health status will concern the investigators for a longer duration than it is defined by the protocol so that all the required information is collected in order to draw safe conclusions.
It may be needed depending on the nature of your disease to provide information about your health to the investigators for a lifetime (If you are willing, otherwise you have always the right to withdraw).
Who designs the clinical trials?
The design of a clinical trial is a collective work of biomedical specialized researchers, working in academic and research centers, and relies on very strong pre-existing data.
Which is the legal framework in Greece?
The relative European and harmonized National Legislation (ΔΥΓ3/89292,ΦΕΚ Β1973/31-12-2003 and the Directive 2005/28/ΕΚ) sets that that the clinical trials are active only after the approval of the National Drug Organization (ΕΟΦ), the National Ethics Committee (ΕΕΔ), and the Scientific Council of the respective Hospital.
Can I participate in any clinical trial that is conducted in the department where I am on follow up?
Every clinical trial relates to a specific disease and specific the criteria determine which patients can participate or not. Both the inclusion and exclusion criteria are very carefully selected by the researchers for safety reasons, but also in order to generate accurate results.
You can be informed about the active clinical trials of the Haematology Department of the University of Ioannina from this site.
For more information, you can find all the clinical trials conducted globally at the following websites:
http://clinicaltrials.gov, https://www.clinicaltrialsregister.eu/
If you are interested in participating in a clinical trial which is conducted in another department in Greece or abroad you are welcome to do so. The doctors of the Department of Haematology of the University of Ioannina would be happy to refer you if you are already under our care but also welcome any new patients referred to our department for future clinical care.
Who covers the financial cost of a clinical trial?
Clinical trials are conducted and sponsored by several organizations: pharmaceutical companies, academic institutions, medical societies or foundations or Non-Governmental organizations (named as sponsors).
The Sponsor covers the financial cost of the intervention (free drugs), the medical examinations and the compensation of all the people involved during the conduct of the trial.
The financial management of the clinical trials is done by the Special Research Accounts of the University (ΕΛΚΕ) or Special Research and Development Accounts of the Greek Health Services (ΥΠΕ), within the National Health System (ΕΣΥ) the Ministry of Health or the relevant authorities where the clinical trial is conducted.
What happens when the clinical trial is completed?
When the required number of the participants is reached and all the clinical data are collected a statistical analysis follows, which has been determined prior to the conduct and is specified in the trials protocol.
The results are announced to the authorities, (ie reported at website https://www.clinicaltrials.gov/ct2/info/results), will be presented in major medical conferences and will be published in peer-reviewed medical journals so that the whole scientific community is informed.
Questions you can ask your physician/investigator before you sign the informed consent:
What is the purpose of the study?
What are the possible benefits: short-term and long-term.
What are the possible side effects?
Which alternative treatment options are studied?
How long will the trial last?
How often do you have to visit hospital?
Have similar trials been conducted before?
Does the investigator have any previous experience?
Could I contact someone who is already participant in the clinical trial?
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