Quantifying the risks of non-oncology phase I research in healthy volunteers: Meta-analysis of phase I studies

BMJ (Online)

Volumn 350, Issue , 2015, Pages

  Emanuel, Ezekiel J ^a,b   Bedarida, Gabriella ^c   Macci, Kristy ^c   Gabler, Nicole B ^a   Rid, Annette ^d   Wendler, David ^e  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c PFIZER INC   (United States)

^d KING'S COLLEGE LONDON   (United Kingdom)

^e NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ADVERSE DRUG REACTION; ARTICLE; BELGIUM; CLINICAL ASSESSMENT; CONGENITAL MALFORMATION; DISABILITY; DISEASE SEVERITY; DROWSINESS; DRUG INDUSTRY; DRUG RESEARCH; FEMALE; FOOD AND DRUG ADMINISTRATION; HEADACHE; HOSPITAL ADMISSION; HUMAN; HUMAN EXPERIMENT; LENGTH OF STAY; MALE; META ANALYSIS; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PREDICTION; PRENATAL DRUG EXPOSURE; PRIORITY JOURNAL; RESEARCH SUBJECT; RISK ASSESSMENT; SYSTEMATIC REVIEW; UNITED STATES; SINGAPORE;

BELGIUM; CLINICAL TRIALS, PHASE I AS TOPIC; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HEALTHY VOLUNTEERS; HUMANS; RISK ASSESSMENT; SINGAPORE; UNITED STATES;

EID: 84939222174     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h3271     Document Type: Article

References (21)

1. Emanuel EJ, Wendler D, Grady C. What makes research ethical? JAMA 2000; 283: 2701-11.
2. Lemmens T, Elliott C. Justice for the professional guinea pig. Am J Bioethics 2001; 1: 51-3.
3. Shamoo AE, Resnick DB. Strategies to minimize risks and exploitation in phase one trials on health subjects. Am J Bioethics 2006; 6: W1-13.
4. Elliott C, Abadie R. Exploiting a research underclass in phase I clinical trials. N Engl J Med 2008; 358: 2316-7.
5. Fisher JA Medical research for hire: the political economy of pharmaceutical clinical trials. Rutgers University Press, 2009.
6. Kass NE, Myers R, Fuchs EJ, et al. Balancing justice and autonomy in clinical research with health volunteers. Clin Pharmacol Ther 2007; 82: 219-27.
7. Fisher JA Feeding and bleeding: the institutional banalization of risk to healthy volunteers in phase 1 pharmaceutical clinical trials. Science Technology Human Values 2015; 40: 199-226. http://sth.sagepub.com/content/early/2014/10/15/0162243914554838.abstract.
8. Rosenthal E. When drug trials go horribly wrong. New York Times 2006 Apr 7. www.nytimes.com/2006/04/07/world/europe/07iht-drug.html?pagewanted=all&-r=0.
9. Sheridan C. TeGenero fiasco prompts regulatory rethink. Nat Biotechnol 2006; 24: 475-6.
10. Emanuel EJ, Miller FG. Money and distorted ethical judgment about research: an ethical assessment of the TeGenero TGN1412 Trial. Am J Bioethics 2007; 7: 76-81.
11. Horstmann E, McCabe MS, Grochow L, et al. Risks and benefits of phase I oncology trials, 1991 through 2002. N Engl J Med 2005; 352: 895-904.
12. Roberts TG, Goulart BH, Squitieri L, et al. Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 2004; 292: 2130-40.
13. Kumagai Y, Fukazawa I, Momma T, et al. A nationwide survey on serious adverse events in healthy volunteer studies in Japan. Clin Pharmcol Ther 2006; 79: P71.
14. Lutfullin A, Kuhlmann J, Wensing G. Adverse events in volunteers participating in phase I clinical trials: a single center five year survey in 1,559 subjects. Int J Clin Pharmacol Ther 2005; 43: 217-26.
15. Sibille M, Deigat N, Janin A, et al. Adverse events in phase I studies: a report in 1015 healthy volunteers. Eur J Clin Parmacol 1998; 54: 13-20.
16. Orme M, Harry J, Routledge P, et al. Health volunteer studies in Great Britain: the results of a survey into 12 month activity in this field. Br J Clin Pharmacol 1989; 27: 125-33.
17. Title 21 Code of Federal Regulations part 321, subpart B, section 32(a). Investigational new drug applications, IND safety reporting. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32.
18. Nicolson TJ, Mellor HR, Roberts RR. Gender differences in drug toxicity. Trends Pharmacol Sci 2010; 31: 108-14.
19. Martin RM, Biswas PN, Fremantle SN, et al. Age and sex distribution of suspected adverse drug reactions to newly marketed drugs in general practice in England: analysis of 48 cohort studies Br J Clin Pharmacol 1998; 46: 505-11.
20. Cryder CE, London AJ, Volpp KG, et al. Informative inducement: study payment as a signal of risk. Soc Sci Med 2010; 70: 455-64.
21. Stunkel L, Benson M, McLellan L, et al. Comprehension and informed consent: assessing the effect of a short consent form. IRB 2010; 32: 1-9.