Availability of post-trial access in clinical trials: a review of clinical trial protocols submitted to the research ethics board of the University of the Philippines Manila.

Objectives: Ethics guidelines such as the Declaration of Helsinki and the CIOMS International Ethical Guidelines for Health-related Research Involving Humans require the sponsors, in cooperation with relevant stakeholders, to provide post-trial access (PTA) to intervention and knowledge, especially in clinical trials held in resource-poor regions. To date, we have very limited knowledge in terms of whether PTA is provided at all, and in what form. To partially address this current limitation, this study wished to explore whether, for which type of drugs and in what form PTA is provided in the Philippines. Methods: We looked at all the clinical trial protocols submitted to the University of the Philippines Manila from 2012 to 2017. A total of 193 clinical trial protocols were included in the study. To identify whether, for which drug type and in what form PTA is provided, we gathered the following information: start and end date of the trial, name of study drug, tested indication of the study drug, region the sponsor is from, type/category of the study drug, type of funding agency, provisions for PTA (yes or no) and the explanation for the provisions. PTA provisions were further described according to the form in which PTA was provided and the types of drugs that were given PTA. Results: Of the 193 protocols, 51.81% indicated PTA, though PTA in the form identified in guidelines can be partially accounted for in only 29.5% (57). The most common form of PTA is the provision or sharing of information (40). None of the protocols provided PTA in the form of access to intervention after the trials, with the possible exemption of 10 protocols that declared future evaluation of the sponsor for PTA depending on patient need, and another seven that might offer the option to transfer to an open-label extension study after the trial. Conclusion: More work is needed if PTA, as stipulated in ethics guidelines, is to be reflected in reality.

What information and the extent of information research participants need in informed consent forms: a multi-country survey.

BACKGROUND: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. METHODS: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). RESULTS: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). CONCLUSIONS: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

Community-directed educational intervention for malaria elimination in Bhutan: quasi-experimental study in malaria endemic areas of Sarpang district.

BACKGROUND: As per the World Malaria Report 2011, there was a 17% reduction in morbidity and 26% reduction in mortality in 2010, compared to 2000. In Bhutan, there were only 194 malaria cases in 2011 as compared to 5,935 cases in 2000. As the country moves towards an elimination phase, educating the community and empowering them on malaria prevention and control is imperative. Hence, this study was conducted to elucidate the effectiveness of the community-directed educational intervention on malaria prevention and control in malaria-endemic areas of Sarpang district, Bhutan. METHODS: This quasi-experimental study design was conducted using both qualitative and quantitative data collection methods. In-depth interviews and focus group discussions were carried out in addition to household survey using a structured questionnaire conducted before and after the intervention. Intervention was conducted using community action groups, who were provided with training and which then developed action plans for implementation of interventions within their communities. RESULTS: The study resulted in a significant improvement in knowledge and attitude in intervention as compared to control during the post-intervention survey (p < 0.001). The practice score was higher in the control group both during pre- and post-intervention, however, the mean ( ±sd) score of practice in intervention group increased from 6.84 ± 1.26 in pre-intervention to 8.35 ± 1.14 in post-intervention (p < 0.001), where as it decreased from 9.19 ± 1.78 to 9.10 ± 1.98 in the control group (p = 0. 68). When comparing pre- and post- in the intervention group, there was significant improvement during post-intervention in knowledge, attitude and practice (p < 0.001). CONCLUSIONS: The findings from this study corroborate that community-directed interventions can be utilized as an effective means for improving knowledge, attitude and practice in the malaria-endemic areas of Bhutan. Further studies are needed to see the long-term effect and sustainability of such interventions.

Health and Gross National Happiness: review of current status in Bhutan.

Worldwide, contemporary measures of the success of health development programs have been mostly in terms of the reduction of mortality and morbidity as well as increasing longevity. While these goals have yielded much-needed health improvements, the subjective outcomes of these improvements, as experienced by individuals and the communities, have not been considered. Bhutan, under the overarching policy of Gross National Happiness, has provided due consideration to these subjective indicators. Here, we report on the current status of health and happiness in Bhutan as revealed by conventional objective indicators and subjective Gross National Happiness indicators. The current literature on health in Bhutan in relation to the Gross National Happiness Survey conducted by the Centre of Bhutan Studies has been reviewed. Bhutan has made great strides within a short period of modernization, as shown by both objective and subjective indicators. Tremendous challenges lie ahead to achieve the ultimate goal of health and happiness, and how Bhutan articulates its path to modernization may be a lesson for the rest of the world.

Malaria prevention and control in Bhutan: successes and challenges.

This paper highlights on the current malaria situations in Bhutan and its challenges for future prevention and control strategies. In Bhutan, malaria affects more than half of the entire population, mostly residing in the southern districts bordering with Indian states of Assam and West Bengal. Over the past ten years, due to concerted efforts, the morbidity and mortality due to malaria has significantly declined. These preventive and control measures focused on the mass distribution of long lasting insecticidal treated nets, focal indoor residual spray and use of artemisinin-based combination therapies. However, considerable challenge lies ahead and research is needed to generate local evidence for sustainable elimination of malaria from Bhutan. The article should be of value and interest to planners, malaria programs and for future researchers on malaria in Bhutan.