A need to try everything: patient participation in phase I trials

Moore, Sally

doi:10.1046/j.1365-2648.2001.01715.x

Cited by 62 publications

(116 citation statements)

References 26 publications

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“…Others report that early-phase oncology research subjects sometimes feel burdened by the repetitive procedures and time commitment involved (30,31). These same routines and research interactions, however, may also provide some psychological benefits, such as feelings of comfort and increased control (17,32).…”

Section: Ethics Of Phase I Oncologytrialsmentioning

confidence: 99%

The Ethics of Phase 0 Oncology Trials

Abdoler

Taylor

Wendler

2008

Clinical Cancer Research

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Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.

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Section: Ethics Of Phase I Oncologytrialsmentioning

confidence: 99%

The Ethics of Phase 0 Oncology Trials

Abdoler

Taylor

Wendler

2008

Clinical Cancer Research

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“…However, communication regarding the general concepts of phase 1 studies during the first outpatient visit is critical and influences whether patients proceed with the trial process. Currently, there is a paucity of quantitative research assessing how patients' preconceptions change before and after the clinical consultation 15, 19. Pre‐ and postconsultation questionnaires using a quantitative assessment of patient's expectations and perceptions would facilitate improved communication by the clinical team.…”

Section: Introductionmentioning

confidence: 99%

A study of motivations and expectations of patients seen in phase 1 oncology clinics

Dolly

Kalaitzaki

Puglisi

et al. 2016

Cancer

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BACKGROUNDTo better inform clinical practice, this study was aimed at capturing patients' motivations for enrolling in phase 1 trials and at quantifying their expectations of the benefits, risks, and commitment associated with clinical trials and the impact of the initial consultation on their expectations.METHODSThis was a single‐center, prospective, quantitative study of newly referred adult patients considering their first phase 1 oncology trial. Participants completed questionnaires before they were seen and an abbreviated follow‐up version after their consultation.RESULTSQuestionnaires were completed by 396 (99%) and 301 (76%) before and after the clinic, respectively. Participants ranked the possibility of tumor shrinkage (84%) as the most important motivation for considering a phase 1 trial; this was followed by no alternative treatments (56%), their physician's recommendation (44%), and the fact that the research might benefit others (38%). When they were asked about the potential personal benefit, 43% predicted tumor shrinkage initially. After the consultation, this increased to 47%. Fourteen percent of patients expected a cure. When asked about risks, 71% of the participants expected moderate side effects. When asked about expectations of time commitments, a majority of patients did not anticipate weekly visits, although this was understood by 93% of patients after the consultation. Overall, patients were keen to consider trials and when asked before and after the consultation 72% and 84% were willing to enroll in studies, respectively.CONCLUSIONSThis study reports that more than 80% of patients enroll in early‐phase clinical oncology trials motivated by the potential of a clinical benefit, with approximately half expecting tumor shrinkage and approximately a tenth anticipating a cure. The typical phase 1 response rate is 4% to 20%, and this discrepancy exemplifies the challenges faced by patients and healthcare professionals during their interactions for phase 1 studies. Cancer 2016;122:3501–3508. © 2016 American Cancer Society

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“…Patient acceptance of a referral may depend on such factors and upon others as well, e.g., the time required and the perceived likelihood of treatment success. Also, patients are more likely to volunteer for a clinical trial addressing an existing critical health problem than one targeting preventive care (such as smoking cessation) [39][40][41][42]. These differences complicate any comparison of recruitment results across different clinical and research domains.…”

Section: Recruitment Resultsmentioning

confidence: 99%

Electronic health records as a tool for recruitment of participants' clinical effectiveness research: lessons learned from tobacco cessation

Fraser

Christiansen²,

Adsit³

et al. 2012

Behav. Med. Pract. Policy Res.

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Translating tobacco dependence treatments that are effective in research settings into real-world clinical settings remains challenging. Electronic health record (EHR) technology can facilitate this process. This paper describes the accomplishments and lessons learned from a translational team science (clinic/research) approach to the development of an EHR tool for participant recruitment and clinic engagement in tobacco cessation research. All team stakeholdersresearch, clinical, and IT-were engaged in the design and planning of the project. Results over the first 17 months of the study showed that over one half of all smokers, coming in for any type of clinic appointment, were offered participation in the study, a very high level of adherent use of the EHR. Study recruitment over this period was 1,071 individuals, over 12 % of smokers in the participating clinics. KEYWORDSElectronic health records, Recruitment, Tobacco cessation BACKGROUND While research advances have extended the effectiveness and reach of tobacco dependence treatment over the past two decades, the disjointed process for bringing laboratory advances into clinical practice has often resulted in interventions that yield diminished effects in real world use [1][2][3][4][5]. One approach to address this "translation gap" is to develop and test interventions in real world clinical settings whenever possible. However, research conducted in these settings poses challenges that can compromise internal validity (e.g., reduce the accurate assessment of outcomes) or render the intervention context unrepresentative of real world conditions (e.g., due to burdensome consent processes, confidentiality regulations, and assessment burdens). Despite these limitations, strategies are available that can foster enhanced translation. For instance, in the case of interventions designed for use in healthcare settings, research designs can enhance translation by leveraging existing clinic infrastructure and

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A need to try everything: patient participation in phase I trials

Cited by 62 publications

References 26 publications

The Ethics of Phase 0 Oncology Trials

The Ethics of Phase 0 Oncology Trials

A study of motivations and expectations of patients seen in phase 1 oncology clinics

Electronic health records as a tool for recruitment of participants' clinical effectiveness research: lessons learned from tobacco cessation

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