Failures in Clinical Trials in the European Union: Lessons from the Polish Experience

This summer, I attended the Network meeting for  the Fogarty International Center of Eastern Europe. I met and listened to presentations of fellow trainees and ex trainees from Poland, Romania, Latvia, Lithuania, Maldova Russia Serbia and Belarus. The presentations were diverse and impressive and addressed research ethics as well as research misconduct topics.

Though many Eastern European countries have their regulations and legal framework to oversee research, they share many of the problems existing in the Middle East. They are definitely many steps ahead in terms of research methods, conduct, authorship and ethics compared to the Middle East..

Marcin Waligora, a philosopher and a faculty member in Jagiellonian University, Poland, reviewed and  analyzed some of the problems that Poland, an ex Communist country and an emerging economy of Eastern Europe, suffers in the field of biomedical research. I met Waligora in the International Association of Bioethics Conference of 2012 where he gave a poster presentation. Waligora also attended  the Prague Network meeting where we shared experiences on bioethical issues.

In his paper titled ‘Failures in Clinical Trials in the European Union: Lessons from the Polish Experience‘, Waligora reported and analyzed the findings of 2 audits conducted by the Supreme Audit Office of Poland. The first report examined the financial funding of medical research in 13 university hospitals, which totaled 1959 clinical trials between 2006 and 2008.  The second audit, carried out by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Ministry of Health, investigated the operations of Research Ethics Committees and the audit agreements between the hospitals and sponsors of clinical research between 2006 and 2009 in the same 13 university hospitals.

In Poland, the medical schools are independent and they are permitted to establish their hospitals, which are eligible for public funds provided by the National Health Fund. The medical schools are under the auspices of the Ministry of Higher Education while their hospitals are supervised by the Ministry of Health and the Ministry of Higher Education.

The reports expressed alarming deficiencies at a national as well as regional and institutional levels. It stated the presence of ‘uneconomical, illegal and unreliable activities as well as the potential to expose patients to harm […] Pharmaceutical companies […] have more influence in conducting, financing and financial control of clinical research than public institutions’.

At a national level, there is no efficient system to regulate clinical trials and their finances. The MoH did not properly supervise the work of the Office for Registration of Medicinal Products, which in turn lacked clear cut regulations for acquiring the relevant paperwork and necessary authentication of research. The Office for Registration of Medicinal Products allowed research to be conducted even though it was rejected by REC, they did not possess all documentation or details of registered clinical trials and they did not perform enough audits to clinical research sites. The office carried out only one audit compared to 9 audits by FDA and 3 by European Medical Agency.

In respect to regional and institutional shortfalls, the report stated that 9 of the 13 hospitals have procedures or lack of that could ‘possibly (be) dangerous to life or health of research subjects’. The hospitals heads did not necessarily wait for REC approval before performing medical research, nor acquire all the relevant documents necessitated by law. Basic information such as the number of enrolled research participants and the protocols of existing trials were not available.

In his analysis, Waligora emphasized the importance of issuiance and implementation of regulations regarding conflict of interest in biomedical research. He stated that conflict of interest is addressed in physician’s code of ethics, which is not legally binding.

In addition, there is a need for more control of clinical trials financial aspects. The good news is, currently, there is a bill for a ‘ Law of clinical trials with clinical therapeutic products and veterinary therapeutic products’, which only needs approval by the Polish Parliament and the President’s authorization to be enacted. The new law will regulate the finances as well as address conflict of interest in biomedical research. At institutional level, Waligora recommended the drafting of policies to address conflict of interest

In respect to the lack of proper implementation of regulations, Waligora stated that the new law is appropriate if enacted. However, the new law does not attend to the issue of RECs oversight.  Establishing of independent bodies at institutional level, whose function is to oversee clinical trials, could solve this problem.

Waligora also pointed out concerns with the language of laws where words such as ‘patient’ instead of ‘research participants’ and ‘doctor’ instead of ‘researchers’ are still being used. He gave the example of the Pharmaceutical Law, which according to him is ‘unclear, outdated and chaotic’. In addition, the law has clauses that are conflicting with the Physicians code of Ethics. Such inconsistency could contribute to the shortfalls in clinical trial regulations.

Waligora’s paper has provided a comprehensive  review and clear analysis to some of the issues that Poland is currently facing in regards to medical research. His paper could be a roadmap to countries in the Middle East drafting laws and guidelines to regulate biomedical research. Similar shortfalls can be avoided in countries such as Egypt who is currently drafting a law to regulate clinical trials.

No comments yet.

Leave a Reply

Designed & Developed by Web Ideations