Clinical trials – A brave new partnership: A new doctor–patient working relationship in research (original) (raw)
Related papers
The natural history of conducting and reporting clinical trials: interviews with trialists
Trials, 2015
Background: To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. Methods: Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008. Results: A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations. Conclusion: Our results confirm that the conduct and reporting of some trials can be inadequate. Interviews with researchers identified aspects of clinical research that can be especially challenging: establishing appropriate and relevant outcome variables to measure, use of and adherence to the study protocol, recruiting of study participants and reporting and publishing the study findings. Our trialists considered the prestige and impact factors of academic journals to be the most important criteria for selecting those to which they would submit manuscripts.
The ethics of future trials: qualitative analysis of physicians' decision making
Trials, 2016
The decision to conduct a randomized controlled trial (RCT) in a field raises ethical as well as scientific issues. From the clinical equipoise literature, future trials are justifiable if there is "honest, professional disagreement in the community of expert practitioners as to the preferred treatment". Empirical data are sparse about how clinicians apply the principles of equipoise to the justification of future RCTs. For example, selective decontamination of the digestive tract (SDD) is not widely used in critical care practice despite the strength of the evidence base and therefore provides a unique opportunity to learn how clinicians think about the ethics of further RCTs in critical care. In an international interview study of views of healthcare professionals about SDD, we undertook a secondary analysis of qualitative data collected using a Theoretical Domains Framework of clinical behaviour. We adopted a general descriptive approach to explore how physicians determ...
Trials, 2007
Address: 1Department of Primary Health Care, University of Oxford, Oxford, UK, 2ESRC Centre for Economic and Social Aspects of Genomics (CESAGen), School of Social Sciences, Cardiff University, Cardiff, UK, 3Centre for Family Research, University of Cambridge, ...
”The invisible”: Participant's experiences in clinical trials
Perspectives in Clinical Research
Background: The paper discussing the perspectives of clinical trial participants about the various aspects of CTs is based on the primary research conducted by Sama in 2012-13. Methodology: In-depth interviews were conducted with 36 CT participants from the states of New Delhi, Gujarat, Maharashtra and Andhra Pradesh. In addition to CT participants, other key informants including investigators, representatives of Contract Research Organizations (CROs), sponsor, Ethics Committee (EC) members etc. were also interviewed to develop a comprehensive understanding of the functioning of the CT sector. Findings and Discussion: The paper describes the perspectives of participants on the relevant aspects of recruitment into CTs, reasons for participation in CTs, informed consent, adverse events and compensation. The role played by the push and pull factors in recruitment, the information asymmetry, the power imbalance between the health-care provider and seeker, the role of sociocultural factors, etc., are explored in the paper. Combined with the insights from other stakeholders, the study gives an understanding about the chasm between regulations and realities in the Indian CT sector. Further, the paper briefly explores the recent changes and amendments in the laws governing the CT sector that is aimed at improving the conduct of CTs and uphold the rights of participants. Conclusion: Participants are the most important stakeholders in a CT setting. It is imperative that their voices are heard and their rights upheld for the ethical conduct of CTs.
CLINICAL TRIALS: PERSPECTIVES OF MEDICAL COMMUNITY
Asian Journal of Pharmaceutical and Clinical Research, 2020
Objective: The objective of the study was to determine the knowledge, attitude, and perception about clinical trials (CTs) among medical community of a tertiary care institution. Methodology: This was a questionnaire-based cross-sectional study conducted in the Department of Pharmacology, Government Medical College in Central Kerala for a period of 1 year. In a sample population of 690 comprising medical undergraduates (3 rd phase), residents, and doctors in Medical Education Service (MES), 309 questionnaires were distributed randomly assuming 80% response to achieve the sample size of 247. Knowledge, attitude, and perceptions were quantified with a cumulative score with a scoring scheme of +1 for a correct response/positive attitude/positive perception and 0 for an incorrect response/no response/negative attitude/negative perception. The data were analyzed using SPSS 16, the knowledge, attitude, and perception were expressed as mean score as well as proportion. Results: The response rate was 95.79%. Of the 296 completed responses, 158 (53.4%) were from medical undergraduates, 62 (20.9%) from residents, and 76 (25.7%) from doctors in MES. The mean knowledge was 14.8±3.79 (maximum score 25). The mean attitudinal score was 7.07±1.82 (maximum score 10). The mean score of the participants on perception (maximum score=10) about CTs conducted in India was 4.11±2.02 which denoted a negative perception. Conclusion: The participants had good knowledge and positive attitude about CTs, however, all the three groups of participants had negative perception about CTs currently conducted in India.
Do doctors have a duty to take part in pragmatic randomised trials?
BMJ (Clinical research ed.), 2017
For society to benefit from new clinical knowledge the expectation should be to participate in research, writes Marion K Campbell; Charles Weijer and colleagues agree but argue that the fundamental need for consent makes this an imperfect duty