The project entitled Patient in clinical trials was established in 2018 thanks to the idea of the Urszula Jaworska Foundation with the coordination of the Polish Development Fund and the cooperation and support of many individuals and institutions including NGOs as well as the public and private sector. The project was inaugurated on 14 November 2018 during a press conference of the Ministry of Health. At that time, an information campaign was launched, which used a website to popularise the topic of clinical trials: www.pacjentwbadaniach.pl.
Under a Cooperation Agreement concluded on 22 May 2019, the coordination of the project was transferred to the Agency for Medical Research. Since then, all partners have been working on the new iteration of the project, among other things at regular meetings at the ABM headquarters. The Ministry of Health has a very important advocacy role. On the other hand, the project partners from the public sector are: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Institute "Pomnik - Centrum Zdrowia Dziecka". Patients are permanently represented in the project by the Urszula Jaworska Foundation and the Polish Union of Patients' Organisations "Citizens for Health". Other partners from the biotechnology and pharmaceutical industry are: GCPpl Association, the Employers' Union of Innovative Pharmaceutical Companies INFARMA, the Polish Association of Employers of Companies Conducting Clinical Trials on Commissioning POLCRO and the PZPPF - Polish Association of Employers of the Pharmaceutical Industry. The Ombudsman for Patients' Rights and the Ministry of Entrepreneurship and Technology remain Honorary Patrons.
As a result of the joint work of the Medical Research Agency and the project partners, a new website has been created, under which the project has been operating since 17 February 2020. https://pacjentwbadaniach.abm.gov.pl/ . The ABM domain has updated the existing content, as well as added many new tabs, expanding the body of knowledge in the field of clinical trials, e.g. information on the history of clinical trials, types of clinical trials, what are medicinal product trials and what are medical device trials, and much more.
Objective
The aim of the project is to provide Polish patients and their families with reliable and up-to-date knowledge about clinical trials in the most accessible form possible and contained in a single service https://pacjentwbadaniach.abm.gov.pl/ . By spreading knowledge of clinical research, we want to dispel the myths that surround this subject, which distort the image of clinical research in the public perception. We would like the portal to https://pacjentwbadaniach.abm.gov.pl/ was a reliable source of information not only for patients, but for all those interested in the subject. Thus, everyone will find interesting and practical content provided in an understandable way. The website is a repository of knowledge on the standards, procedures and requirements for the process of entering a clinical trial, further - participation in the trial and termination of participation in a clinical trial. On the pages of the website, one can find a lot of valuable guidance on, for example, the rules for conducting clinical trials, the very qualification of patients for trials and their course, and even the history of patients who have participated in trials. The portal serves as a reminder of the importance of the role of primary care physicians (PCPs) to whom patients are referred who intend to participate in a clinical trial or who are already participants in a clinical trial. Guidance on what to ask the doctor-investigator before making an informed decision to take part in a clinical trial (before signing consent to participate in a clinical trial) is invaluable. We also provide portal users with links to currently available clinical trial databases (in Polish and English).
"Patients and their families are constantly waiting for new, increasingly effective and safer therapies. Thanks to research, advances in medicine are being made and patients can be treated with innovative medicines. However, for patients to have the chance to benefit from clinical trials, they need to understand all the 'pros and cons' of the", emphasises Bogna Cichowska-Duma, CEO of the Association of Employers of Innovative Pharmaceutical Companies INFARMA.
Challenges
In addition to coordinating the project, we would like to develop a new clinical trial search engine in the future, through which the patient will be able to obtain precise information on specific clinical trial sites recruiting patients in clinical trials for a particular disease entity. However, this solution requires legal changes. On 29 January this year, the Medical Research Agency submitted to the Minister of Health a draft bill on clinical trials of medicinal products, which contains very important changes from the patient's point of view, including the possibility of launching a more advanced clinical trials database through the Agency's access to the central register of trials maintained by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB). Thus, it will be possible to launch a publicly accessible and, importantly, Polish-language clinical trials database, from which users will be able to draw information about ongoing trials. The new regulation is intended to bring Polish law into line with EU standards, but above all to bring order to the clinical trials market in our country, making it attractive to non-commercial and commercial entities and, at the same time, safer and more accessible to patients.
We hope that the updated and updated with new content website https://pacjentwbadaniach.abm.gov.pl/ will be disseminated to a wide range of citizens to serve as a basic source of information on clinical trials and become a platform for communication with patients and/or their families. We wish to educate patients so that they can make fully informed decisions about their treatment.
As Mr Mariusz Blaszczyk - a representative of the Urszula Jaworska Foundation - informs: "Reliable and complete information about clinical trials is extremely important for patients. Patients should be able to receive it at the outset of diagnosis so that they can make informed decisions about how their treatment pathway should proceed. Currently, clinical trials are often treated as a treatment of last resort, this can make it difficult for patients to assess the benefits and risks of clinical trials. We should change this."
More on the Facebook profile https://www.facebook.com/pacjentwbadaniach/
Author's note: Bernadetta Wisniewska - "She works at the Medical Research Agency as a clinical research specialist in the Clinical Research Development Centre department responsible for supporting clinical research in Poland. She also acts as a coordinator within the European ECRIN-ERIC organisation, thus taking part in the establishment of the Polish branch of POLCRIN and assisting in the interaction between the ECRIN Board and its European branches and POLCRIN. She has nine years of experience working in pharmaceutical companies and CROs."