Dataset Information

Subjects' views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study.

ABSTRACT: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information.Focus groups, short self-administered questionnaires.Boston, Dallas, Detroit, Oklahoma City.Current and recent subjects in clinical trials, primarily for chronic diseases.93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists.Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a "fair" price; these views were less demanding than those of non-US subjects in other studies. However, our participants' views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results.

SUBMITTER: Sofaer N

PROVIDER: S-EPMC3044680 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Subjects' views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study.

Sofaer N N Thiessen C C Goold S D SD Ballou J J Getz K A KA Koski G G Krueger R A RA Weissman J S JS

Journal of medical ethics 20090301 3

<h4>Objectives</h4>To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information.<h4>Design</h4>Focus groups, short self-administered questionnaires.<h4>Setting</h4>Boston, Dallas, Detroit, Oklahoma City.<h4>Participants</h4>Current and recent subjects in clinical trials, primarily for chronic diseases.<h4>Results</h4>93 individuals participated in 10 focus groups. Many tho ...[more]

PMID: 19251971

Similar Datasets

Project description:BACKGROUND:Overweight and obese adolescents are reported to be less physically active than their peers. Research-based knowledge about their views may contribute to a better understanding of key factors that may foster or undermine motivation for physical activity, and provide knowledge for the future development of interventions. This paper explores experiences of physical activity among overweight adolescents, age 13-14 years, participants in Young & Active, a web-based controlled trial intervention to increase physical activity (ClinicalTrials.gov NCT01700309). The theoretical perspective is based on Self-Determination Theory. METHODS:Two qualitative post-intervention research interviews, with a nine-month interval, were conducted with 21 adolescents, 15 girls and 6 boys to study short-term and long-term changes. The informants were recruited from a total of 84 participants from the Young & Active intervention group. Data were analyzed using qualitative content analysis. RESULTS:The participants associated physical activity with organized sports and physical education classes at school, and as a means of promoting good health and attractive bodies. A majority of the adolescents said that they experienced their health as poorer than other youths, and expressed worries about their fitness and future health. Mastering a physical activity, being together with friends and having fun promoted motivation to perform sports. Not mastering an activity, or not knowing the others made them less motivated. None of the adolescents highlighted the importance of informal active living when asked about their understanding and experiences of physical activity. Consistency was found between the first and second interviews. CONCLUSION:This study adds to limited research on overweight and obese adolescents' experiences of physical activity. The participants' views reflect opinions in society about physical activity, and its importance for health. Viewing physical activity as conducted within organized sports makes it necessary to look into how these are organized, structured and led, and what can be done to support self-esteem, autonomous motivation and participation. The ability to choose among available, affordable and desirable physical activities, together with friends, may promote participation and maintenance.

Project description:OBJECTIVES:Vitiligo is a relatively common autoimmune condition causing loss of skin pigment. Around 1 in 100 people in the UK develop vitiligo. It can have a significant impact on quality of life for many of those affected. How people access information and help for vitiligo may influence how they manage such impact. We aimed to explore people's views and experiences of seeking health information and help for vitiligo. DESIGN:Qualitative analysis of free-text responses to four open-ended questions in an online survey. SETTING:Online survey conducted in the UK between February and March 2016. PARTICIPANTS:A survey link was emailed to 675 members of The Vitiligo Society, a UK-based charity providing information and support for people with vitiligo. One hundred and sixty-one members responded to the survey (24%). RESULTS:Many participants wrote extensive free text, often reporting frustration with help-seeking. They perceived general practitioners (GP) as their primary source of advice but felt that GPs had low awareness of available treatments. Where GPs appeared sympathetic or signposted towards further information this was appreciated, even where people felt their GP had not seemed knowledgeable. Many felt that vitiligo was dismissed by health professionals including GPs and dermatologists as 'cosmetic', which upset those who experienced substantial impact. Participants expressed concerns about the credibility of online information on vitiligo and the need for reliable, detailed information, as well as a desire for support with managing its psychosocial impact. CONCLUSIONS:Information and help-seeking needs of people with vitiligo currently appear to be poorly met, even among members of The Vitiligo Society, who are likely to have received more information than others. People with vitiligo would welcome greater health professional awareness of available vitiligo treatments. Acknowledging the psychosocial impacts of vitiligo and signposting towards credible information are also welcomed.

Project description:Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight.

Dataset Information

Subjects' views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study.

Publications

Subjects' views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets