Terminating clinical trials without sufficient subjects
Medical research involving human subjects can be risky and burdensome. Therefore, such research must be reviewed and approved by a Research Ethics Committee (REC). To guarantee the safety of the subjects, it is very important that these studies be conducted in accordance with the approved protocol....
| Authors: | ; ; ; |
|---|---|
| Format: | Electronic Article |
| Language: | English |
| Check availability: | HBZ Gateway |
| Journals Online & Print: | Drawer...
|
| Fernleihe: | Fernleihe für die Fachinformationsdienste |
| Published: |
BMJ Publ.
2012
|
| In: |
Journal of medical ethics
Year: 2012, Volume: 38, Issue: 7, Pages: 413-416 |
| Online Access: |
Volltext (JSTOR) Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
MARC
| LEADER | 00000caa a22000002 4500 | ||
|---|---|---|---|
| 001 | 1816143839 | ||
| 003 | DE-627 | ||
| 005 | 20230427161305.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 220908s2012 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/medethics-2011-100020 |2 doi | |
| 035 | |a (DE-627)1816143839 | ||
| 035 | |a (DE-599)KXP1816143839 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 1 |2 ssgn | ||
| 100 | 1 | |a Damen, Lianne |e VerfasserIn |4 aut | |
| 245 | 1 | 0 | |a Terminating clinical trials without sufficient subjects |
| 264 | 1 | |c 2012 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 520 | |a Medical research involving human subjects can be risky and burdensome. Therefore, such research must be reviewed and approved by a Research Ethics Committee (REC). To guarantee the safety of the subjects, it is very important that these studies be conducted in accordance with the approved protocol. An important issue in this respect is whether studies include the requisite number of subjects based on the research question. The research question is unlikely to be answered reliably if the requisite number of subjects is not met. In such cases, subjects are exposed to unnecessary risks and burdens. In this descriptive study, the authors evaluated how frequently studies are completed with the required number of subjects. Moreover, the authors identified the characteristics of research that does and does not include the required number of subjects. The results of this study show that a considerable proportion of studies (41/107) were terminated although they failed to recruit a sufficient number of subjects. Furthermore, the authors found that investigator-initiated studies have significantly (p=0.028) more problems in recruiting the requisite number of subjects than studies initiated by pharmaceutical companies. Potential solutions are discussed to reduce the number of studies that do not include a sufficient number of subjects. | ||
| 700 | 1 | |a van Agt, Frans |e VerfasserIn |4 aut | |
| 700 | 1 | |a de Boo, Theo |e VerfasserIn |4 aut | |
| 700 | 1 | |a Huysmans, Frans |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of medical ethics |d London : BMJ Publ., 1975 |g 38(2012), 7, Seite 413-416 |h Online-Ressource |w (DE-627)323607802 |w (DE-600)2026397-1 |w (DE-576)260773972 |x 1473-4257 |7 nnns |
| 773 | 1 | 8 | |g volume:38 |g year:2012 |g number:7 |g pages:413-416 |
| 856 | |3 Volltext |u http://www.jstor.org/stable/23273289 |x JSTOR | ||
| 856 | 4 | 0 | |u https://doi.org/10.1136/medethics-2011-100020 |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u http://jme.bmj.com/content/38/7/413.abstract |x Verlag |z lizenzpflichtig |3 Volltext |
| 935 | |a mteo | ||
| 936 | u | w | |d 38 |j 2012 |e 7 |h 413-416 |
| 951 | |a AR | ||
| ELC | |a 1 | ||
| ITA | |a 1 |t 1 | ||
| LOK | |0 000 xxxxxcx a22 zn 4500 | ||
| LOK | |0 001 418559772X | ||
| LOK | |0 003 DE-627 | ||
| LOK | |0 004 1816143839 | ||
| LOK | |0 005 20220908053556 | ||
| LOK | |0 008 220908||||||||||||||||ger||||||| | ||
| LOK | |0 035 |a (DE-Tue135)IxTheo#2022-08-03#BA1A7DE41FD65799186A6D6E06BD1D36B90C6025 | ||
| LOK | |0 040 |a DE-Tue135 |c DE-627 |d DE-Tue135 | ||
| LOK | |0 092 |o n | ||
| LOK | |0 852 |a DE-Tue135 | ||
| LOK | |0 852 1 |9 00 | ||
| LOK | |0 866 |x JSTOR#http://www.jstor.org/stable/23273289 | ||
| LOK | |0 935 |a ixzs |a ixrk |a zota | ||
| OAS | |a 1 |b inherited from superior work | ||
| ORI | |a SA-MARC-ixtheoa001.raw | ||