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of negotiation between departments and individuals. But what of the external elements, particularly regulatory and ethics approvals? The former is, fortunately, reasonably easy to plan, because, in most countries, there are clear limits to the time and effort required to meet the regulators' requirements. Much more difficult is the matter of ethics approval. Across the European Union, ethics committee practices vary enormously, so that, when planning a multinational study, good local knowledge is essential. Even within the U.K. there is little consistency, especially since the demise of single central approval for multicenter studies. Theoretically, local research ethics committees (LRECs) are expected to follow Department of Health guidelines [1], but, if they choose not to do so, there is apparently no redress, so one may be presented with unexpected delays in particular centers because of widely varying LREC practices. There is a move towards rationalization in the U.K. in the form of a two-level approval process. A central committee will review the study and, if approved, pass it on to local committees for ratification. This has already been tried in at least one region in the U.K. with the result that it took up to six months to obtain approval because each LREC insisted on full review instead of ratification. Perhaps, here we have something to learn from the U.S., where the LREC equivalent, the Institutional Review Board (IRB) has clearer responsibilities and reporting lines and such delays are less common. In Australia, central approval is still possible, and the ethics committee sees itself as a more of a partner in research rather than a regulator, and very rapid study startup is possible. |
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The message here is that, if you do not have compelling reasons to conduct your studies in any particular country, be creative with your planning, and consider the big advantages you might gain in another part of the world. One European multinational does more clinical research in Australia than in any country outside its home base. If you are forced to live with the problems outlined above, obtain the best and most recent information you can from the LRECs and from their users, and build this realistically into your plans. The plans might not look as good as you would like, but you will have a better chance of keeping to them. |
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D.
Quantity, Quality, Timeliness |
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Any discussion of clinical research planning and conduct sooner or later gravitates to the question of patient recruitment. The clinical version of Murphy's law states that as soon as you start a study, all the patients with that disease disappear! How realistically one can plan for recruitment |
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