How Should We Design and Conduct Sensible Clinical Research in Japan?

Misconduct of valsartan trials raised doubts about quality of physician-initiated clinical research, which is principally required for sensible clinical practice. As a consequence the ethics guideline from the government has been largely revised and all guidelines will be incorporated into legislation. We should, however, bear in our mind that strict regulation primarily applied to pharma trials for approval, let alone monitoring and audit does not necessarily improve quality of physician-initiated clinical research but rather might impede them like as EU directive. The key principles underlying physician initiated clinical research such as forming research hypotheses from sensible clinical questions, feasible and pragmatic designs and conducts for unbiased assessment of effectiveness and safety, avoiding indirectness as for interventions and patients, appropriate handling serious adverse events rather than the regulation should be discussed preferentially. Unlike translational clinical research for the development of new drugs and devices, infrastructures, resources of researchers and methodology of trials are not sufficiently discussed and developed for physician-initiated clinical research. There remain many unsolved clinical questions in Cardiology such as appropriate target for risk factors, post-approval safety assessment of new drugs and devices, and markers for individualized therapy. In this symposium, we are keen to discuss such matters to facilitate the performance of Japanese clinical trials providing reliable (rather than unduly accurate) evidence for the improvement of clinical practice in the field of cardiology.