As in the case of medicinal products, special testing programmes are carried out on a specific group of persons in order to check and confirm the efficacy and safety of the medical device on the human body. In view of the possible effects and risks to human health and life associated with such studies, the requirement to obtain consent and the procedure for carrying them out are strictly regulated by law. Act of 20 May 2010 on Medical Devices (Journal of Laws) U. of 17 June 2010, as amended. (zm.) defines a clinical trial as a designed and planned systematic human examination undertaken to verify the safety or performance of a particular medical device, medical device or active implantable medical device.
Its proper course and the state of health of its participants is the responsibility of the clinical investigator, who in the case of an active medical device for implantation can only be a doctor, and in the case of another type of medical device – a doctor or other person with professional qualifications necessary to conduct a clinical examination of a given medical device. Such a person is primarily obliged to:
(1) providing medical care for clinical trial subjects;
(2) monitoring the compliance of the clinical trial carried out with the provisions of the Act;
(3) to report a serious adverse event to the sponsor, except in the case of an event which the investigator's protocol or brochure specifies as not requiring immediate notification.
In addition to the investigator, the law also imposes responsibility for the taking up and conduct of a clinical trial on the sponsor.
As shown, the primary purpose of a clinical trial conducted under normal conditions of use of the device is:
(1) verification that the characteristics and performance of the device comply with the essential requirements, and
(2) identify any adverse reactions and assess whether they pose a risk that is acceptable, taking into account the intended use of the device and the benefits to the patient.
The subject of the test shall be the person who participates in it and in whom the test device or comparative control method is used or which is diagnosed by the test device or the comparative control method. The Law expressly states that the best interests of the trial subject are of paramount importance to the interest of science or society, which results, inter alia, in the fact that the subject of the study, after being informed of the substance, significance, effects of the clinical trial and the risks involved, must give informed consent to participate in the study; a document confirming informed consent shall be kept together with the clinical trial documentation and a procedure shall be provided to ensure that the withdrawal of the subject from the clinical trial does not harm him or her and that the right of the trial subject to ensure his or her physical and mental integrity, privacy and the protection of personal data is respected. The use of incentives and financial gratification is permitted only in the case of clinical trials conducted on adult and healthy subjects, in other situations only compensation incurred by the participant is allowed. In addition, the law provides for specific restrictions when conducting clinical trials involving minors.
Before a device is transferred to clinical trials, its manufacturer shall carry out a conformity assessment of the device. The Act also regulates the basic principles to which every clinical trial should comply, namely:
(1) be carried out on the basis of a test plan reflecting the latest scientific, medical and technical knowledge, in such a way as to confirm or subdue the characteristics of the device declared by the manufacturer;
(2) include an adequate number of observations to guarantee the scientific validity of applications;
(3) relate to all relevant characteristics of the device, including the safety and performance of the device and its impact on patients;
(4) be carried out under conditions similar to the conditions of use of the device;
(5) be carried out in accordance with procedures appropriate to the device;
(6) be conducted in accordance with ethical principles relating to the protection of human rights and the dignity of the human being.
As a general rule, a clinical trial can only be started after the President of the Office has been authorised to conduct it, as requested by the trial sponsor (a similar procedure is used when a clinical trial has been authorised to be amended). Subsequently, the President of the Office shall have a maximum of 60 days (from the date of application) to issue an administrative decision indicating whether he allows or refuses to allow a clinical trial or to make changes to a clinical trial. The circumstances in which the President of the Office refuses to grant such authorisation are expressly specified:
(1) the clinical trial does not meet or, after the amendments have been made, does not comply with the requirements laid down by law;
(2) the conformity assessment of the device intended for the clinical trial has been carried out incorrectly;
(3) the device does not meet essential requirements other than those covered by the clinical trial or the extent of the changes in the clinical trial;
(4) the device or its clinical trial or changes in its clinical trial may present unacceptable risks to the life, health or safety of the trial subjects or clinical investigators;
(5) the advisability or scientific legitimacy of conducting a clinical trial or making changes to the clinical trial has not been demonstrated.
The above-wing authorisation is of a constitutional nature and the person conducting a clinical trial of the device without such authorisation is subject to a fine, a penalty of restriction of liberty and even a term of imprisonment of up to 2 years. The same sanctions shall apply to anyone who conducts a clinical investigation of the device, endangering the life or health of the subjects of the study.
In carrying out clinical trials, it is essential to assign medical records with a full description of adverse events or serious adverse events revealed during the trial; and clinical data on the safety or performance of a medical device resulting from their use, on the basis of which the manufacturer or his authorised representative shall carry out a clinical evaluation of the medical device in order to confirm compliance with the essential requirements concerning the characteristics and performance of the device under assessment and to assess adverse reactions and accept the benefit-risk balance under normal conditions of use. In turn, the most drastic and dangerous situations are referred to as severe adverse events, which led the subject of the clinical trial to:
(a) death,
(b) severe deterioration of health:
– resulting in a life-threatening illness or injury,
– resulting in permanent impairment of the structure or function of the body,
– requiring hospitalisation or prolongation of hospitalisation already carried out,
– requiring medical intervention in order to prevent permanent impaired structure or function of the body,
(c) foetal death, endangering the life of the foetus, congenital defect or perinatal injury.
In the event of any event which could affect the safety of the subjects of the study, the sponsor or clinical investigator shall take measures to ensure the safety of the study subjects and shall stop or devie from the conduct of the study itself. In addition, the sponsor shall immediately, within a maximum of 7 days from the date of the occurrence of the incident, provide the President of the Office and the bioethical committee which has reviewed the clinical trial with information on its occurrence (a similar obligation is incumbent on it if there is a serious adverse event). The President of the Office shall then notify the competent authority of the Member State in whose territory the clinical trial is conducted of a serious adverse event.
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