Person‐centric clinical trials: Ethical challenges in recruitment and data transparency for improved outcomes

Robbins, David; Curro, Frederick A.; Mattison, John E.

doi:10.1002/jcph.308

Cited by 5 publications

(3 citation statements)

References 7 publications

(7 reference statements)

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“…Based on our study the perceived information about the purpose of the clinical studies were weak. There are a number of ethical issues related to informed consent, handling and transparency of data in clinical studies ( Robbins et al, 2014 ). Informed consent is the cornerstone of human research subject protection.…”

Section: Discussionmentioning

confidence: 99%

The Perceived Information in Obtained From the Informed Consent in Iranian Patients With Cancer in Clinical Studies

Ghiyasvandian¹,

Bolourchifard²,

Yekta³

2014

GJHS

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Objective:One of the basic issues in clinical studies is to receive the informed consent; that is to say, all the activities applied in patient’s involvement in the information, decision-making, ability and volunteering in diagnosis, cure and care. In as much as most cancer patients require information about their individual needs, the present study is conducted to determine the perceived information from the informed consent of clinical studies in cancer patients.Methods:This is a descriptive study. Fifty cancer patients hospitalized for participating in the clinical study was chosen according to the convenience sampling. Tools used in this research included the questionnaire (individual and social features) and the check list about patient’s right and cancer patient’s information before and after receiving informed consent in clinical studies (10 items on a Likert rating scale). To validate the study, content and formal validation was used. Data in this research were analyzed using descriptive statistics (frequency, mean and standard deviation) and the software of SPSS 16.Result:In general, the mean of the scores obtained from cancer patients’ perceived information before completing the informed consent of the clinical studies was 14±3.5 and after consent of the clinical studies was 16±2.4. The cancer patients’ perceived information before and after consent of the clinical studies was weak.Conclusions:Based on the findings of the present study, the rate of the information the cancer patients received, before completing the informed consent form, was low, but after completing the informed consent form this rate was again low. Therefore, conducting similar and wider studies is recommended to unveil the factors affecting perceiving information and how to promote the quality of the informed consent in other hospitals in Iran.

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Section: Discussionmentioning

confidence: 99%

The Perceived Information in Obtained From the Informed Consent in Iranian Patients With Cancer in Clinical Studies

Ghiyasvandian¹,

Bolourchifard²,

Yekta³

2014

GJHS

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“…Several investigators however have criticized the methodology employed in the clinical trial environment due to the variability, lack of consistency, and reproducibility of the various stimuli used in the assessment [37,40,41]. Furthermore, the lack of patient/person-based outcomes in clinical trials that evaluate the efficacy of desensitizing products needs to be addressed [42].…”

Section: Clinical Diagnosis Of Dh (Including Differential Diagnosis)mentioning

confidence: 99%

Management of Dentin Hypersensitivity

Gillam¹

2015

Curr Oral Health Rep

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]). This search strategy generated a large number of papers on the topic of dentin hypersensitivity (DH); however, there were limited data on management strategies that could be successfully implemented in clinical practice. Although there have been a number of treatment paradigms published in the literature, there is a need for simple pragmatic guidelines to be recommended to the clinician in order to successfully manage the condition in the clinical environment. Furthermore, despite the published claims of clinical efficacy for both in-office and over-the-counter products there does not appear to be one ideal desensitizing agent than can be recommended to be used for the condition. The importance of educating both the clinician and the patient in the identification, prevention, and management of DH is paramount if the condition is to be successfully monitored and treated.

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“…The variables in private practice are accountability and controlling costs due in large part to defensive medicine, waste, redundancy and especially fraud estimated to be some 65 billion per year [24]. Additionally, with the concept of ‘big data’ where clinical outcomes are based on a large number of clinical inputs every person becomes accountable for their clinical outcome and treatment result [25]. If the concept of shared decision making and/or responsibility is the focus then every person’s encounter, whether it is for research or an annual visit should be a data point with ensured integrity.…”

Section: Person-centricity: Fulcrum For Clinical Research and Healthmentioning

confidence: 99%

Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a practice-based translational network

Curro

Robbins²,

Naftolin

et al. 2015

Clinical Investigation

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A person-centric clinical trial is inclusive of both the investigator and the person and as such represents point-of-use data generated at the practice level and encompasses both health and disease. Raising the clinical encounter to a research encounter and providing an infrastructure to support a level of quality assurance creates a synergy for efficiency for healthcare delivery. The interface of translational studies and clinical research poses an opportunity, whereby person-centricity can support transparency, facilitate informed consent, improve safety, enhance recruitment and compliance, improve dissemination of results, implement change and help close the translational gap. The model represents robust clinical data from persons of record allowing for improved interpretation of drug/device side-effects and for regulatory reviewers to expedite the approval process.

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Person‐centric clinical trials: Ethical challenges in recruitment and data transparency for improved outcomes

Cited by 5 publications

References 7 publications

The Perceived Information in Obtained From the Informed Consent in Iranian Patients With Cancer in Clinical Studies

The Perceived Information in Obtained From the Informed Consent in Iranian Patients With Cancer in Clinical Studies

Management of Dentin Hypersensitivity

Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a practice-based translational network

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