Possibilities and problems of Belgian general practitioners: Initiating a clinical trial

Since the introduction of the Law of May 7, 2004 concerning experiments on the human person (LEH), no request for a clinical trial has been formulated by Belgian general practitioners. We met numerous legal and practical problems on writing a Randomized Clinical Trial (RCT) which compared homeopathic medicines with cetirizine for the treatment of allergic rhinitis. Thus we listed the requirements and evaluated if it would be possible to initiate a homeopathic trial by general practitioners in Belgium. The literature was reviewed, inquiries were made in services and agencies (the department of clinical trials of the Federal Agency for medicinal products, ethics commissions), lawtexts and regulations analysed. The problems we encountered on making up the RCT will be described. The department of Research and Development confirmed that our trial was the first clinical trial initiated by general practitioners since the LEH establishing the rules to perform clinical trials and clarifying them in different circulars, had been introduced. Performing a non-commercial trial, the general practitioner investigator is responsible not only for writing the protocol of the trial and the required documents to be delivered to the Ethics Committee but also for the contacts with the Competent Authorities, even if the medication under study is delivered by a pharmaceutical firm. We conclude that a clinical trial conducted by general practitioners is hard to perform. An important amount of funds is needed, much time has to be spent to collect all the legal documents and numerous practical problems have to be solved.