Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital.

BACKGROUND: Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis. RESULTS: Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01). CONCLUSIONS: The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC's ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials.

Survey of practices and policies relating to the use of complementary and alternative medicines and therapies in New South Wales cancer services.

AIMS: To examine policies and practices relating to the provision, prescription and monitoring of complementary and alternative medicine and therapies (CAM) in conventional cancer services in NSW. METHODS: Self-administered questionnaire sent to directors of all 65 eligible cancer services in NSW in 2009. RESULTS: Forty-three services responded to the survey (response rate 66%). Only six (14%) services reported having formal policies about CAM. Most (n = 33, 77%) expected that patients would be asked about CAM use during their initial assessment. Eight services (19%) provided and/or prescribed CAM for patients, and most of these (n = 7) recorded details of CAM use in patients' records. Only four (9%) services permitted CAM practitioners from the community to attend inpatients, whereas 24 (56%) permitted inpatients to bring in their own CAM. Most of these services (n = 17) required medical approval for the use of CAM. Of the latter, most (n = 13) recorded the use of approved CAM, but only seven recorded use of unapproved CAM and only three refused permission to continue use of unapproved CAM. CONCLUSION: Most cancer services in NSW recognise potential CAM use by patients and expect medical staff to ask patients about their use of CAM. While few cancer services provided or prescribed CAM, over half permitted inpatients to bring their own CAM into hospital. There was little control over the use of CAM, however, and monitoring was lax. Given the wide usage of CAM by patients with cancer, this lack of control may compromise clinical outcomes, with potentially dangerous consequences.

Ethics and rural healthcare: what really happens? What might help?

Relatively few articles discuss the ethical issues that accompany healthcare in rural areas. This article presents and discusses the key findings obtained from multi-method research studies conducted over a 9-year period of time in a multi-state rural area. It challenges the efficacy of current models for bioethics, shows what kinds of ethical issues develop in rural communities, and offers a framework for envisioning resources and approaches that may be more appropriate.

A case report: ethics of a proposed qualitative study of hospital closure in an Australian rural community.

BACKGROUND: The GP and qualitative researcher use similar patient-centred approaches, but their roles are different. Guidelines for conducting GP research in small communities are limited. I planned a qualitative study about hospital closure in a small rural Australian town where I worked. Few studies have researched community reaction to hospital closure and this process of change. METHODS: I used historical analysis to improve external reliability, and purposeful sampling to develop and pre-test a qualitative semi-structured research instrument. Newspaper articles, minutes and tape recordings of public meetings, annual reports from 1991 to 1997, quality assurance data and interviews with two health professionals were analysed in this process. These sources were coded using content and thematic analysis. Ethical issues arose during early stages of planning. Ethical guidelines and bioethics principles were discussed with colleagues and a member of an ethics committee. I validated my findings with three other community members involved in the hospital closure. RESULTS: Themes of a transition, from resistance to change and divisions between key stake holders, to a need to appreciate the benefits of change emerged in coding material from 1991 to 1997. The principle of non-maleficence outweighed the principle of beneficence in this study. Existing health services could be harmed by examining the process of change after spending time and resources to reconcile community differences. Individuals could be harmed as confidentiality in a small community was difficult to maintain, and discussions about sensitive issues could produce adverse public criticism. The autonomy of participants to give informed consent was complicated by the author providing clinical services in the community, raising concerns about patients feeling an obligation to participate. CONCLUSIONS: A justified case for discontinuing this study was made by the researcher on ethical grounds. Use of bioethical principles and community representatives to validate findings was a useful technique to guide decisions in a small rural community. This discussion has application in planning other small community studies.