Ethics of randomized clinical trials.

Emanuel, Ezekiel J.; Patterson, W. Bradford

doi:10.1200/jco.1998.16.1.365

Cited by 29 publications

(15 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Indeed, Emmanuel and Patterson [25] go so far as to state that 'the only legitimate justification' for randomisation is 'that the patient chooses to be altruistic.' Certainly the idea that patients should be involved in research is strongly endorsed by non-patients and patients alike [5,8-11,14].…”

Section: Introductionmentioning

confidence: 99%

Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial

Canvin

Jacoby

2006

Trials

View full text Add to dashboard Cite

Background: Epilepsy is a common neurological condition, in which drugs are the mainstay of treatment and drugs trials are commonplace. Understanding why patients might or might not opt to participate in epilepsy drug trials is therefore of some importance, particularly at a time of rapid drug development and testing; and the findings may also have wider applicability. This study examined the role of patient perceptions in the decision-making process about recruitment to an RCT (the SANAD Trial) that compared different antiepileptic drug treatments for the management of new-onset seizures and epilepsy.

show abstract

Section: Introductionmentioning

confidence: 99%

Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial

Canvin

Jacoby

2006

Trials

View full text Add to dashboard Cite

show abstract

“…12 Discussion of clinical trials may be perceived to interfere with the physician-patient relationship, compromising the doctors' duty of care. 13 Some doctors are uncomfortable with the dual role of clinician and researcher. 14 Others express concern that the admission of uncertainty, the stringency of trial design and the random allocation of treatment may undermine the patients' need at a time of great vulnerability, to place faith in a caring doctor to navigate the route to an optimal outcome.…”

Section: Introductionmentioning

confidence: 99%

Attitudes to randomized clinical trials amongst out‐patients attending a medical oncology clinic

Ellis

Dowsett

Butow

et al. 1999

Health Expectations

View full text Add to dashboard Cite

Objective To assess the understanding of and attitudes towards randomized clinical trials amongst patients attending oncology outpatient clinics.Design Cross-sectional survey.Subjects Patients attending medical oncology out-patient clinics at a Sydney teaching hospital.Main outcome Patients' willingness to participate in a randomized clinical trial.Results Sixty consecutive patients were surveyed. The mean age was 55.2 (SD 14) years. Eighty-eight per cent of respondents thought that patients should be asked to participate in trials testing new treatments, however, only a third would consider participating in a randomized trial themselves. If a trial was endorsed by an independent cancer information service such as the NSW Cancer Council, 72% of respondents would be more likely to participate. Knowledge about randomized trials was not high. Respondents scored a median of 3 out of 7 (interquartile range, 2±4) correct answers to a series of questions about randomized trials. Patients willing to participate in a randomized trial were more likely to perceive the doctor favourably (P 0.05), less likely to perceive trials as experimental (P 0.05) and less likely to perceive trials as representing an inconvenience or loss of control (P 0.09).Conclusions Understanding amongst patients of the need for and mechanisms of randomized clinical trials is not good. This may contribute to the di culties investigators face in seeking consent for clinical trials. Evaluation of new strategies to educate the public and patients about randomized trials is needed. Involvement of consumers in the design and conduct of clinical trials and evaluation of strategies to improve doctors' communication of clinical trial information is also required.

show abstract

“…Although widely recognized as providing the cornerstone for clinical investigation, in recent years the role of the randomized phase III trial has come under increasing scrutiny [1][2][3][4][5]. From concerns with the ethics of selecting an appropriate "control arm" to the issue of individual physician belief, when entering a patient onto a randomized trial, that the study arms satisfy the moral principle of equipoise [6], many have questioned the conduct of and the need for randomized trials.…”

mentioning

confidence: 99%

“…However, it is critical that we continue to analyze the settings in which randomized trials are considered mandatory, as opposed to optional. An appropriate ethical justification for the conduct of all clinical trials, including randomized phase III studies, must always be provided, with the potential for serious debate [1][2][3][4][5][6][14][15][16].…”

mentioning

confidence: 99%

Randomized trials in oncology: A fertile ground for controversy

Markman

2003

Curr Oncol Rep

View full text Add to dashboard Cite

Ethics of randomized clinical trials.

Cited by 29 publications

References 0 publications

Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial

Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial

Attitudes to randomized clinical trials amongst out‐patients attending a medical oncology clinic

Randomized trials in oncology: A fertile ground for controversy

Contact Info

Product

Resources

About