Promotion of clinical trials and clinical research

<p>The practical application of unapproved and off-label drugs requires a path that spans the four worlds of insurance, regulatory affairs, research, and medical care. Each area has its own system for advanced medicine, clinical trials, specific clinical research, off-label use, etc., and the multiple paths that interconnect them enable the use of such drugs under the final objective of insurance medical care.</p><p>In response to the occurrence of cases of inadequacy regarding antihypertensive drugs, the Clinical Trials Act established the necessary procedures to ensure the quality of clinical studies, protect the subjects, and manage conflicts of interest of researchers, with the aim of restoring trust in clinical studies in Japan. The Act also established a system for disclosing information on the provision of funds for clinical research. However, since this law does not regulate the alteration of clinical research data, high ethical standards continue to be required from individual researchers.</p><p>The Specified Clinical Research Investigator (Research Investigator), who has now become the ultimate responsible person, in place of the director of the implementing institution, and the Certified Review Board, which exercises a certain degree of discretionary power via national approval instead of the conventional facility installation, will have a heavy duty to fulfill. In particular, investigators will need support due to new administrative procedures, financial burdens, and intellectual burdens such as judgments regarding eligibility and off-label use.</p><p>In order to address the reduction in clinical trials that occurred due to introduction of the new GCP, the government implemented three clinical trial activation plans, for 14 consecutive years. All of the measures we have undertaken to promote clinical trials and clinical research have been continuously developed from these three activation plans. The concept of the Clinical Research Core Hospital was also born from these plans.</p><p>The Clinical Research Core Hospital is an ARO platform comprising multiple bases, that supports the clinical research foundation of all of Japan, and comprehensively supports not only its own facilities, but also Japanese medical institutions. Only hospitals that meet certain requirements for approval are allowed to monopolize names under the Medical Law. Such hospitals will collect excellent researchers, patients seeking new treatments, and clinical trial consultations from companies. We would like Clinical Research Core Hospitals to challenge a variety of issues, not only in Japan, but also by conducting international joint clinical research.</p><p>Enlightenment and dissemination to citizens and patients begin with the provision of information, through the promotion of “participation,” and is about to transition to the promotion of “involvement.” Since involvement is based on the formation of a consensus among stakeholders, it is possible to use a workshop-type consensus building method in which multiple stakeholders participate, and to proceed with a consensus method that does not rely on majority voting in the presence of facilitators.</p><p>Looking ahead to the conclusion of ongoing efforts to promote clinical research and clinical trials, the following will be realized in the not too distant future: RCT exceptions, sharing individual participant data from clinical trials, development and implementation of research plans based on consensus building with patients and citizens, and implementation of a mechanism to provide maximized, rationalized services via a combination of different platforms.</p>