The relevance and quantity of clinical research has caused concern and regulation is claimed to hinder clinical research. This paper compares clinical research regulations in Finland to those of England, Canada, and the USA around 2010-2011.
Several approaches and data sources were used, including semi- or unstructured interviews of experts. For the analysis, a theoretical framework was made, data from various sources was synthesized, and features of the systems were simplified and classified. The various specific names and terms used in the data were changed into general ones.
Common structures for the regulation existed in all four countries, but the details and scope varied. The research regulated within the main system was determined by research type (Finland), the financer of the health system (England), or research site (Canada, USA). Only Finland had specific legislation on medical research. The overriding impression of the regulatory systems was one of complexity. All countries had extra regulation for drug research. The types of drug research covered varied from trials with unlicensed (new) products or new indications (USA and Canada), to all types of interventional drug research (England), where 'interventional' was interpreted broadly (Finland). The complexity of regulations had led to the creation of various big and small businesses to help researchers and sponsors. There was notable variation in the role played by the public research funder. The role played by health care was difficult to study and seemed to involve varying interests as researchers were also health care employees. Research ethics committees were important and their tasks also included aspects other than ethics.
This study revealed that a comparison between countries can provide useful insights into the distinctive aspects of each country's system, as well as identifying common features that require international action.
Notes
Cites: IRB. 2007 Mar-Apr;29(2):7-1317847609
Cites: N Engl J Med. 2011 Sep 22;365(12):1145-5021787202
Little has been published either concerning the total number of research projects in connection with clinical development of drugs or the number of projects financially supported by the industry.
From the archives of the five regional Norwegian Research Ethical Committees (REC), all research projects in connection with clinical development of drugs for the years 2000 and 2004 were analysed with the intention of finding the number of projects financially supported by the industry, the type of research institution, the industrial company, the topic of the research as classified in the international Anatomic Therapeutic Classification system (ATC), the research phase and the approval status of the drug by the Norwegian Medicines Agency (NMA).
The total number of research projects for the clinical development of drugs for the years 2000 and 2004 was 489, and 75.7% were financially supported by the industry. More than two-thirds of the projects were done in academic institutions and about one-third were equally divided between public health hospitals and private health service/hospitals. Eight of the 88 drug companies involved were among the world's largest and supported 38% of the projects. Fifty-nine percent of all the projects were within four therapeutic groups: antineoplastic/immunomodulating agents, nervous system, cardiovascular system and alimentary tract/metabolism. The distribution of research phases was as follows: phase I 1.2%, phase II 16.4%, phase III 26.6% and phase IV 55.8%. In the phase IV drug trials, drugs had been approved for sale by the NMA.
The share of research projects related to the development of drugs supported by the industry is high. Research independent of the industry is of importance to avoid bias and selective publications and to prevent research as a means of marketing. Independent research should be encouraged and financially supported by sources with no connection to the drug industry.
