Joanna Krakowiak

Will new clinical trials act eliminate irregularities?

Recent reports on disproportionate fees for doctors conducting clinical trials and the hospitals where they work are not the only problem. Conducting sometimes dozens of trials at one medical facility seriously reduces the quality of the research.

For many years Poland has been a popular location for clinical trials of new drugs. The attraction for pharmaceutical companies sponsoring the trials has been the high skill level of the doctors, the well-developed network of medical facilities, and the relatively low costs. Unfortunately, according to a report by the Polish government accounting office (NIK) published on 29 July 2010, conducting numerous trials at the same time within one medical centre has a negative impact on the quality of the trials. A proposed new Act on Clinical Trials of Medicinal Products and Veterinary Medicinal Products could eliminate the irregularities.

How is it now?

In order to conduct a clinical trial, the sponsor, a contract research organisation hired to act for the sponsor, or the researcher must obtain a positive recommendation from a bioethics commission and a permit from the Ministry of Health to conduct the trial. Then the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products enters the trial in the Central Register of Clinical Trials.

The agencies participating in authorisation of trials review extensive documentation, including research protocols, the patients’ consent forms, and the agreement among the sponsor (or CRO representing it), the researcher and the facility. They do not check, however, how many trials are being conducted at the same time at one hospital or whether a researcher conducting trials of several drugs has a conflict of interest.

What may change?

The Ministry of Health has drawn up an outline for an Act on Clinical Trials of Medicinal Products and Veterinary Medicinal Products (latest version dated 11 June 2010). The act would provide comprehensive regulation of issues related to clinical trials and replace the current regulations included in the Pharmaceutical Law dated 6 September 2001. Several of the key proposals, particularly in light of the report from the government accounting office, are discussed below.

Hospital director must approve chief researcher

When hiring the chief researcher, the sponsor of a trial would have to obtain the consent of the director of the medical facility for the researcher’s involvement. This is designed to prevent situations where the director of a hospital is not aware that hospital staff are involved in a clinical trial.

Conflict of interest statement

The outline for the new act provides for a mandatory statement concerning any conflict of interest. It is not clear yet how detailed the required information would be, or whether the statement would follow an official form. Most likely a statement would have to be filed not only by the chief researcher and members of the research team, but also by members of the bioethics commission and the bioethics appeal board, experts issuing an opinion on the study, and inspectors reviewing the study.

Information on the number of trials underway

It is proposed that prior to beginning a clinical trial, the chief researcher would be required to notify the bioethics commission of any other current or planned clinical trials he or she is involved in. The research facility would be required to maintain a website containing information about the number of trials conducted, with the title of each trial and the name of the chief researcher.

Single agreement for clinical trial

In the interest of transparency in the financial arrangements made between the parties, the sponsor would be required to enter into a single written agreement for conducting the clinical trial, among the sponsor, the chief researcher and the research facility. It would be necessary to specify in the agreement the fee payable to the chief researcher for conducting the clinical trial and the fee for the research facility. In practice these agreements would be tripartite, among the sponsor (or CRO acting for the sponsor), the researcher and the facility. This would not represent a major change, because tripartite agreements are already being used instead of the more traditional approach of two separate agreements—one between the sponsor and the researcher, and one between the sponsor and the research facility.

It is hard to say when the outline will be followed by a bill to enact these solutions or when a bill might be approved. The proposal may evolve during the course of the legislative process. Given the critical findings of the report by the government accounting office, the legislation may move forward quickly. The hope is that the new regulations provide more effective oversight of clinical trials without imposing too many additional burdens on the parties.

Joanna Krakowiak, radca prawny, a member of the Life Science and Regulatory Law practice group at Wardyński & Partners