The legislative process for the long-awaited Law on clinical trials of medicinal products for human use. The new regulation is intended to bring Polish law in line with EU regulations, but most importantly it is intended to bring order to the clinical research market in our country, making it attractive to non-commercial and commercial entities, while making it safer and more accessible to patients. The draft law provides solutions to increase Poland's competitiveness as a clinical research site by implementing transparent legal regulations enabling the application of European standards and introducing additional facilitations and mechanisms to encourage clinical research. The draft sets out additional mechanisms to support clinical trials, a new definition of non-commercial clinical trials or a new system of ethical assessment of an application for a research permit have been prepared. The bill also provides for the establishment of a Clinical Trial Participants Protection Fund and clarifies the regulations concerning the responsibility of the researcher and sponsor and the financing of services by the sponsor and the NHF. In addition, the draft provides for the establishment of a Supreme Bioethics Commission at the Medical Research Agency. At the same time, for organisational reasons it is not possible for this body to give an opinion on all applications, so they will also be reviewed by bioethics committees that will undergo the accreditation process. In contrast, the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) has been identified as the competent authority involved in the assessment of a clinical trial application.
Also new is to be a clinical trial insurance system based on a Guarantee Fund and liability insurance for the investigator and sponsor. Although, according to the draft, sponsors will be charged with additional burdens related to participation in the fund, the costs of conducting trials are to be reduced, inter alia through a reduction in the minimum guarantee amount for third-party liability insurance. Currently, regardless of the type of research, the cost of the policy can reach several hundred thousand zlotys. In addition, the draft assumes that a commission consisting of, among others, medical experts and lawyers would be appointed by the President of the Fund to examine specific claims of patients, which would rule on the legitimacy of paying out any benefit to a patient if there is a probability of a connection between the damage and the examination, regardless of fault. The Fund would be fed mainly by contributions paid by the sponsors of the clinical trial.
The bill provides for cases to be processed within a maximum of four months, which will significantly speed up the receipt of money for claims and increase patients' sense of security. Another change that is important from the point of view of patients is to provide the Medical Research Agency with access to the central trial registry maintained by URPL. This will make it possible to launch a publicly accessible clinical trials database from which patients will be able to draw information about ongoing trials.
What is a clinical trial?
Every medicine must undergo clinical trials before it can be marketed. The purpose of these is to check whether the substance that will be included in the medicine is effective and safe when used by patients with the disease in question and whether it is better than the therapies already in place, for example by comparing its effect with other therapies and medicines already available to patients. Clinical trials are carried out only after authorisation from the regulatory authority and a positive opinion from the bioethics committee. Studies of new medicines are conducted on behalf of pharmaceutical companies and provide drug manufacturers with an answer to the question of the efficacy and safety of a new medicine compared to an existing therapy or compared to a placebo. Non-commercial research is mainly conducted by universities, research institutes, associations and foundations. Every drug must undergo clinical trials before it can be approved for sale and use for patients. In the successive phases of clinical trials, efficacy and safety are assessed and the optimum dose of the study drug is determined. Clinical trials can also serve to test new methods of disease prevention and are a guarantee for the development of pharmacy and medicine.
Types of clinical trials
Depending on the purpose of the clinical trial, we can divide them into:
- commercial
- non-commercial
If the data obtained during the trial will be used to obtain a marketing authorisation for a medicinal product or medical device, to make changes to an existing authorisation or for marketing purposes, they are referred to as commercial clinical trials. They are most often conducted by pharmaceutical and biotechnology companies.
The aim of non-commercial clinical trials is to advance knowledge and clinical practice. They are not for profit, but focus mainly on analysing the efficacy and safety of drugs already on the market. They are mostly planned in key therapeutic areas, but also apply to rare diseases where new treatments are sought. They are mainly conducted by universities, research institutes, associations and foundations. Often, non-commercial clinical trials result in improved treatment standards and innovative solutions to socially relevant health problems. Therefore, conducting this type of research is very important for the health care system. Both commercial and non-commercial clinical trials, depending on the therapeutic unit, phase of the study or purpose, may involve single-centre projects as well as multi-centre, national or international studies. A single trial may involve several patients or may be conducted on a large number of patients or healthy volunteers.
The requirements for the quality of the clinical data obtained are the same for commercial and non-commercial studies. Therefore, the documentation and procedures are similar for both types of studies. They can be conducted after obtaining a positive opinion from the Bioethics Committee and approval from the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB). Both commercial and non-commercial clinical trials may be subject to inspection by the Registration Office.
Currently, Poland is not among the leading countries in the conduct of non-commercial clinical trials. These trials in Poland account for less than 5% of the total number of registered clinical trials. In the European Union, the proportion of non-commercial trials in some countries reaches as high as 40% of all clinical trials conducted. This situation is being attempted to change by the Medical Research Agency, one of whose objectives is to develop non-commercial clinical trials in our country.
Patient in clinical trials
The patient can obtain information about ongoing clinical trials from various sources. These are often research centres and attending physicians. Sometimes, however, patients look for information about ongoing trials on the Internet, where Internet portals and publicly available databases containing information about ongoing clinical trials can be helpful..
A prerequisite for entering a clinical trial is the patient's consent to take part in the trial, this is known as the 'clinical trial': informed consent to participate in a clinical trial.
Informed consent is the process by which a potential participant in a study learns all about the study and then voluntarily decides to take part. The person confirming their participation must be informed of all aspects of the study that are relevant to their decision to participate. The patient has the right to ask questions and receive comprehensive answers and explanations from the doctor before deciding to participate in the study.
Consent to participate in a clinical trial is given in writing on a so-called informed consent form. The patient receives the relevant documents when discussing the clinical trial with the attending physician: Information about the clinical trial, describing in detail the purpose and conduct of the clinical trial, and Informed consent form. In order for consent to be given correctly, the informed consent form should be personally signed and dated prior to the actual start of participation in the study by the person to be involved in the study or his or her legal representative and by the doctor conducting the consent interview. If informed consent, cannot be given in writing, oral consent in the presence of at least two witnesses shall be considered equivalent. In the case of a minor, the legal requirements describing the manner of obtaining informed consent are regulated by separate regulations - Article 25 of the Act of 5 December 1996 on the medical and dental professions - according to which the written consent of the child's statutory representative is necessary. By signing the informed consent form, the patient makes a voluntary, considered and informed decision to participate in the clinical trial. The statement also indicates that it is made after having received adequate information on the nature, significance, implications and risks of the clinical trial. The information presented to the patient shall be assessed by an independent bioethics committee, inter alia, with regard to the patient's ability to understand it. Any changes to the informed consent document or other documents containing information for clinical trial participants must be resubmitted to the bioethics committee.
The material is based on information contained in the portal https://pacjentwbadaniach.abm.gov.pl/
Igor Grzesiak - Institute for Patients' Rights and Health Education
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