| Title |
How do researchers decide early clinical trials?
|
|---|---|
| Published in |
Medicine, Health Care and Philosophy, February 2016
|
| DOI | 10.1007/s11019-016-9685-6 |
| Pubmed ID | |
| Authors |
Hannah Grankvist, Jonathan Kimmelman |
| Abstract |
Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Scientists | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 15 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Italy | 1 | 7% |
| Unknown | 14 | 93% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 4 | 27% |
| Researcher | 3 | 20% |
| Student > Doctoral Student | 2 | 13% |
| Student > Master | 2 | 13% |
| Student > Bachelor | 1 | 7% |
| Other | 1 | 7% |
| Unknown | 2 | 13% |
| Readers by discipline | Count | As % |
|---|---|---|
| Nursing and Health Professions | 2 | 13% |
| Medicine and Dentistry | 2 | 13% |
| Social Sciences | 2 | 13% |
| Philosophy | 1 | 7% |
| Economics, Econometrics and Finance | 1 | 7% |
| Other | 3 | 20% |
| Unknown | 4 | 27% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 12 February 2016.
All research outputs
#19,017,658
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Outputs from Medicine, Health Care and Philosophy
#478
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#291,478
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Outputs of similar age from Medicine, Health Care and Philosophy
#10
of 11 outputs
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