Background: A primary concern of clinical trials is the protection of subjects, which is part of the voluntary consent process. However, the issues regarding informed consent, including the patients' lack of understanding of trials due to the complexity of informed consent documents (ICDs), continues to be debated. This study was conducted to determine the current state and issues of ICDs using the quality standards of Decision Aid (DA), as a basis for developing DAs for trials.

Methods: ① Two independent evaluators assessed 20 ICDs using the quality of decision-making parameters (DQ standards). The evaluation was based on a two-point scale. ② Semi-structured interviews were conducted with 16 stakeholders. The interview contents were categorized and analyzed per the DQ standards domains.

Results: The evaluation of ICDs revealed that more than half of the forms contained insufficient information required for good quality decision-making. The interviews also showed similar results, a predominantly negative opinion toward ICDs, and concerns about the neutrality of explanations provided by the medical staffs.

Conclusion: Existing ICDs may not be useful for good-quality decisions. Results suggested the following need to be addressed for good-quality decision-making for clinical trial participation: a more precise delineation between participation and non-participation, a correct comprehension and interpretation of numerical information about trials, and think about what matters most to patients, neutral decision support. Therefore, it is necessary to develop DAs based on these results.

It might be difficult for parents to understand the details of a clinical trial and give permission for their children's participation. In this research, we conducted a questionnaire survey of factors influencing the parents' decision on whether to give permission for their infant's participation in a randomized controlled double-blinded clinical trial on the prevention of atopic dermatitis. The number of valid responses were 131 (the response rate 70%), and no significant difference was observed in employment rate, time for travel, and distance to the hospitals between participant and non-participant groups. Parents who gave permission to participate in the clinical trial (105 parents) tended to feel the information given was easy to understand, and had better understanding of the randomized controlled trial, compared to the ones who did not give permission (26 parents). The most common reason for giving permission was the recommendation by their physicians who referred them to the trial sites, and the second most common reason was their interest in clinical research and contribution to the prevention in the future.

The reasons for not giving permission were clinical trial requirements, including treatment (powders taken orally everyday), number of visits, Oral food challenge test in hospital, daily diary, and laboratory tests.

Development of better explanatory materials and methods to improve understanding of clinical trials may be of great benefit.

In the aftermath of the investigation of misconduct in the research of an antihypertensive drug, the quality assurance of planning, operations and results/data became an emergent issue for investigator initiated clinical studies. The recently enacted guidelines and laws on the clinical studies oblige researchers to follow many procedures to assure and maintain the quality in an objective way. The compliance with these regulations, however, would tremendously increase the workload of researchers and further would make the tasks cumbersome and complicated. Then, to facilitate the clinical trials complying with the regulations, we have consolidated the clinical study support systems adopting an existing project management method. Based on our previous experiences, we clarified all the essential tasks to support clinical studies, analyzed and readjusted the interdependence among the tasks, and finally structured the efficient work flow. With regards to essential documents, the forms have been prepared with common format, which resulted in labor-saving as much as possible, and all the documents are now saved in a dedicated server following a predetermined rule. Furthermore, the computerized system was constructed using commercially available business-management software in order to manage the work efficiently and the information in an integrated fashion. The system consolidation has brought the efficiency and homogenization of our support work, and is thought to have resulted in facilitation of clinical studies in our hospital.