Patient Protection in Clinical Trials Marek Czarkowski Bioethic Committee Warsaw Chamber of Physicians
Factors affecting security and rights of research participants International regulations Domestic law Ethics code Ethics committees Central Record of Clinical Investigations Insurance protection Human factor
Constituting an independent ethic committee (EC) What is better to elect or to nominate members of EC? Are these two methods really protecting dignity, rights, safety and well-being of research participants with the same power? Should university or institute EC members be recruited from the university or institute staff? What about independence of the members of university or institute EC? Medical universities and institutes profit from clinical trials. WHO or European operational guidelines describe conflict of interest during EC activity but do not when an EC is constituting! Why we do not prefer to prevent conflict of interest?
Multicenter clinical trials In Poland and some others EU countries sponsor chooses EC. Sponsor is responsible for nomination of domestic coordinating investigator of multicenter clinical trial. Polish law order sponsor to submit clinical trial documentation to this EC where domestic coordinating investigator is subordinate to. Thus sponsor decides which EC will review and follow up clinical trial. In Poland regional EC prepares an opinion about regional investigator and regional clinic (where this trial will be held) within 14 days. After that term domestic coordinator s EC may give a positive opinion - implied consent.
Follow-up procedure and reversion of the positive decision In Poland EC is obliged to follow up and review progress of the clinical trial, changes in protocol, patient information, insurance principles, informed consent form, suspected, unexpected serious adverse reactions (SUSARs), serious unexpected adverse events. In Poland reversion of the positive decision of EC is not possible. There is no legal way to stop clinical trial in accordance to the decision of EC.
Insurance coverage - investigators In Poland majority of investigators have no insurance policy. Only main investigators in every clinic have insurance policy. Subinvestigators, nurses and all other members of the scientific group are not insured. Typical obligatory insurance policy for physicians does not cover participation in clinical trials or any other scientific investigations
Placebo and patient s security Possible reason of placebo use: new drug may be less effective than the old one. Nevertheless the new drug might be effective versus placebo. What about placebo in long lasting clinical trials with fatal end points?
II Phase Clinical Trials Research participants receive effective life protecting drug gratis. When the trial is finished this life protecting therapy is stopped. Research participant cannot cover expenses of the further life protecting therapy. Social health service has no right to cover these expenses because the new drug was not registered yet. Research participant dies. Can we accept this legal procedure? Foundation to protect these participants?
Serious Adverse Event Is it possible to evaluate the risk of the study drug on the basis of single SAE reports? Can EC prepare a professional statistical analysis of SAE? EC fig leaf of the study drug? EC should review periodic reports of the professional safety committees Safety drug committees should have to be established by EC but not sponsor Members of this Safety drug committees professional qualification requirements and free from conflict of interest All expenses of the Safety drug committees covered by sponsor Safety drug committees responsible for the safety of the drug (periodic certificate and periodic reports).
Insurance coverage trial subjects Insurance policy in trial subjects should not be a civil liability insurance.
Insurance coverage trial subjects Insurance policy in trial subjects should not be liability insurance. Ubezpieczenie powinno opierać się na założeniu odpowiedzialności za szkody bez względu na winę czy niestaranność, natomiast w związku z faktem udziału chorego w danym badaniu klinicznym. Taka forma ubezpieczenia stwarza znacznie wyższe prawdopodobieństwo uzyskania odszkodowania przez poszkodowanego ponieważ w tym typie ubezpieczenia nie jest konieczne udowadnianie winy. Niestety w Polsce wprowadzono obowiązek ubezpieczenia typu odpowiedzialności cywilnej (kwiecień 2004). W rzeczywistości zmniejsza to w sposób istotny prawdopodobieństwo uzyskania odszkodowania, szczególnie w przypadku gdy sponsorem wieloośrodkowego badania jest podmiot zagraniczny.
Ochrona ubezpieczeniowa Ubezpieczenie powinno opierać się na założeniu odpowiedzialności za szkody bez względu na winę czy niestaranność, ubezpieczenie w związku z faktem udziału chorego w danym badaniu klinicznym. Taka forma ubezpieczenia stwarza znacznie wyższe prawdopodobieństwo uzyskania odszkodowania przez poszkodowanego ponieważ w tym typie ubezpieczenia nie jest konieczne udowadnianie winy. Niestety w Polsce wprowadzono obowiązek ubezpieczenia typu odpowiedzialności cywilnej (kwiecień 2004). W rzeczywistości zmniejsza to w sposób istotny prawdopodobieństwo uzyskania odszkodowania, szczególnie w przypadku gdy sponsorem wieloośrodkowego badania jest podmiot zagraniczny.