Clinical trials in the 21st century: The case for participant‐centered research¶

Gross, Deborah; Fogg, Louis

doi:10.1002/nur.10010

Cited by 61 publications

(63 citation statements)

References 37 publications

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“…Randomization of patients into clinical trials however precludes patient choice and therefore may result in resistance to participation in clinical trials [35]. The perception of treatment as a threat to freedom of choice has been correlated with poor compliance in some vulnerable populations [36].…”

Section: Random Approachmentioning

confidence: 99%

“…The perception of treatment as a threat to freedom of choice has been correlated with poor compliance in some vulnerable populations [36]. Participant-centered clinical research, which addresses the patients' goals, interests, and abilities has been advocated by some authors [35]. Not only is it proposed that this decreases attrition from clinical trials, but may also align the research strategy with the patient's goals of care.…”

Section: Random Approachmentioning

confidence: 99%

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Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

2011

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With more rapid advances in potential treatments for brain tumours, the number of clinical trials for brain tumour patients is rising. In the context of the challenges of recruitment and enrollment of patients with brain tumors, the dichotomy between the paucity of subjects and abundance of clinical trials creates a unique ethical dilemma, whereby a single patient may be eligible for several studies. Here, we identify and present three approaches for recruiting and enrolling patients who may be eligible for several trials. The ethical implications of the full disclosure, paternalistic, and random approaches are discussed. The full disclosure approach presents information to patients regarding all ongoing concurrent trials, allowing them to make an informed decision, while the paternalistic approach allows the healthcare providers to select the trial for which they believe the patient is most suitable. These introduce the biases into circumstances where equipoise is necessary and risk selection bias in study design. The random approach randomly allocates patients to each trial, which may erode patient autonomy and decrease trial enrollment. Brain tumor patients comprise a vulnerable population and it remains incumbent on healthcare providers to maintain the highest ethical standards when approaching them for clinical research. Changes in clinical trial design are required to mitigate the conflicts created by competition for patients. Keywords Brain tumors Á Clinical trials Á Ethics Á Patient enrollment Á Patient recruitment Illustrative caseA previously healthy 50 year old female, recently diagnosed with non-small cell lung carcinoma presents to a multi-disciplinary neuro-oncology clinic for evaluation of a single 1.5 cm metastasis in the right temporal lobe, discovered on screening magnetic resonance imaging (MRI). Standard treatment options would include surgical resection with adjuvant whole brain radiation therapy (WBRT), WBRT with radiosurgery boost or WBRT alone. She is also eligilible for two clinical trials offered at the hospital at which she is receiving treatment. One investigates the efficacy of a small molecular tyrosine kinase inhibitor in combination with radiosurgery and one investigates the inclusion of WBRT with radiosurgery treatment. The multi-disciplinary team meets to inform the patient of the institutional standard-of-care treatments and the two clinical trials available. They are faced with the challenge of effectively, fairly and ethically presenting the treatment options available.

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Section: Random Approachmentioning

confidence: 99%

Section: Random Approachmentioning

confidence: 99%

Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

2011

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“…Some of these articles focus upon obtaining informed consent and working participant-centred [7,8,13]. Wilkes and Beale [42] found that one ethically troubling situation for research nurses can be the experienced role conflict between being a nurse providing care and being a research assistant.…”

Section: Introductionmentioning

confidence: 98%

Ethical Dilemmas and Ethical Competence in the Daily Work of Research Nurses

2009

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In spite of the growing interest in nursing ethics, few studies have focused on ethical dilemmas experienced by nurses working with clinical studies as 'research nurses'. The aim of the present study was to describe and explore ethical dilemmas that Swedish research nurses experience in their day-to-day work. In a qualitative study a purposeful sample of six research nurses from five wards of differing disciplines in four Swedish hospitals was interviewed. The analysis displayed several examples of ethical dilemmas, primarily tensions between the nurses' obligations to the study and to the patients involved. A guiding moral principle for the nurses was patient-centeredness, where the interest of research must not override the interest of the patient. In situations where tensions between research and patient interests occurred, and doctors and nurses disagreed upon the judgement, the nurses sometimes chose to follow the doctors' advice, and thus acted against their own moral judgment. Such situations seemed to create feelings of moral distress among the nurses. They described their profession as being 'invisible' and as lacking opportunities for ethical competence building. The conclusion is that research nurses frequently experience severe and difficult ethical dilemmas in their daily work. They need to be acknowledged as a particular profession in the health care organisation and encouraged to develop their specific ethical competence.

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“…Some of the cited authors were making such a call (e.g., Gross & Fogg, 2001), but many were not. Instead, they were asking for consideration of ways to improve how RCTs are conducted.…”

Section: Lack Of Precision In Language Argumentmentioning

confidence: 99%

An alternative view on “an alternative paradigm”

Ward

Donovan

Serlin

2003

Research in Nursing & Health

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The strengths in this article lie in the reinforcement of important procedures for enhancing the internal and external validity of intervention studies. For example, the authors highlight the importance of using theory to guide study design, operationalization of key variables, and data analysis. They emphasize that an important goal of research is to identify which participants, under what circumstances respond in what ways to interventions. They stress that to do this, investigators must use theory to identify factors that may affect the implementation of interventions and/or influence outcomes. They encourage researchers to keep descriptive reports of reasons why potential participants decline to join a study, information that is useful for modifying current study procedures or future study design. Finally, they emphasize the importance of developing protocols for intervention delivery, training study personnel in the theory underlying the intervention, and explaining the principles guiding individualization of the intervention for each participant. These are all excellent recommendations for intervention research.Unfortunately, the authors suggest that the recommendations represent an "alternative method for clinical research". In reality, most of the recommendations are part of the current, standard approach to conducting randomized controlled trials (RCTs). In fact, the narrow, and often erroneous, characterization of the assumptions and goals of RCTs sets up a straw dog argument that is then used to frame several proposed solutions. Perhaps most importantly, critiques of the randomized trial are presented, with nothing new to offer as a substitute for randomization. Although it has long been known that conducting randomized trials in clinical settings is challenging, there is no substitute for randomization when it comes to controlling selection bias and allowing the causal inference that the intervention being tested is responsible for the outcomes observed (Shadish, Cook, & Campbell, 2002).

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Clinical trials in the 21st century: The case for participant‐centered research¶

Cited by 61 publications

References 37 publications

Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials

Ethical Dilemmas and Ethical Competence in the Daily Work of Research Nurses

An alternative view on “an alternative paradigm”

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