Assessing the Remedy: The Case for Contracts in Clinical Trials

REFERENCES

• Agosti , V. , Nunes , E. and Ocepeck-Welikson , K. 1996 . Patient factors related to early attrition from an outpatient cocaine research clinic . American Journal of Drug and Alcohol Abuse , 22 ( 1 ) : 29 – 39 .
   PubMed Web of Science ®Google Scholar
• Allchin , D. 2001 . Error types . Perspectives on Science , 9 ( 1 ) : 38 – 58 .
   Google Scholar
• Atiyah , P. S. 1985 . The rise and fall of freedom of contract , Oxford : Oxford University Press .
   Google Scholar
• Bagshaw , S. M. and Bellomo , R. 2008 . The need to reform our assessment of evidence from clinical trials: A commentary . Philosophy, Ethics and Humanities in Medicine , 3 : 23
   PubMedGoogle Scholar
• Burch , D. 2001 . Taking the medicine , London : Chatto and Windus, The Random House Group, Limited .
   Google Scholar
• Church , A. H. 1993 . Estimating the effect of incentives on mail survey response rates: A meta-analysis . Public Opinion Quarterly , 57 : 62 – 79 .
   Web of Science ®Google Scholar
• Clarke , R. Ability and responsibility for omissions . Papers Presented at the American Philosophical Association Pacific Division Meeting . March 1993 . Philosophical Studies: An International Journal for Philosophy in the Analytic Tradition , Vol. 73 , pp. 195 – 208 . (2/3)
   Google Scholar
• Crouch , R. A. and Arras , J. D. 1998 . AZT trials and tribulations . Hastings Center Report , 28 ( 6 ) : 26 – 34 .
   PubMed Web of Science ®Google Scholar
• Daar , A. S. 1997 . Ethics of xenotransplantation: Animal issues, consent and likely transformation of transplant ethics . World Journal of Surgery , 21 : 975 – 982 .
   PubMed Web of Science ®Google Scholar
• Dawson , A. J. and Yentis , S. M. Contesting the science/ethics distinction in the review of clinical research . Journal of Medical Ethics , 33 165 – 167 .
   PubMed Web of Science ®Google Scholar
• Department of Health . 2009 . Guidance on the routine collection of Patient Reported Outcome Measures (PROMs) , Her Majesty's Stationary Office . Available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_092647 (accessed October 2010)
   Google Scholar
• DeVita , D. A. , White , M. C. , Zhao , X. , Kaidarova , Z. and Murphy , E. L. 2009 . Determinants of subject visit participation in a prospective cohort study of HTLV infection . BMC Medical Research Methodology , 9 : 19
   PubMed Web of Science ®Google Scholar
• Edwards , S. J. L. 2005 . Research participation and the right to withdraw . Bioethics , 19 ( 2 ) : 112 – 130 .
   PubMed Web of Science ®Google Scholar
• Edwards , S. J. L. 2009 . The rationale for ethics review of research by committee . Research Ethics Review , 5 ( 4 ) : 147 – 150 .
   Google Scholar
• Edwards , S. J. L. 2010 . Science and society: The scope of ethics review . Research Ethics Review , 6 ( 2 ) : 53 – 56 .
   Google Scholar
• Edwards , S. J. L. , Lilford , R. J. , Braunholtz , D. and Jackson , J. 1997 . Why “underpowered” trials are not necessarily unethical . Lancet , 350 : 804 – 807 .
   PubMed Web of Science ®Google Scholar
• Epstein , R. A. 1975 . Unconscionability: A critical reappraisal . Journal of Law & Economics , 18 : 293
   Web of Science ®Google Scholar
• Fabricatore , A. N. , Wadden , T. A. , Moore , R. H. , Butryn , M. L. , Gravallese , E. A. , Erondu , N. E. , Heymsfield , S. B. and Nguyen , A. M. 2009 . Attrition from randomized controlled trials of pharmacological weight loss agents: A systematic review and analysis . Obesity Reviews , 10 ( 3 ) : 333 – 341 .
   PubMed Web of Science ®Google Scholar
• Farnsworth , A. E. 1998 . Changing your mind: The law of regretted decisions , New Haven, CT : Yale University Press .
   Google Scholar
• Food and Drug Administration . 2008 . Guidance for sponsors, clinical investigators, and IRBs data retention when subjects withdraw from FDA-regulated clinical trials , Washington, DC : U.S. Department of Health and Human Services .
   Google Scholar
• Fried , C. 1981 . Contract as promise: A theory of contractual obligation , Cambridge, MA : Harvard University Press .
   Google Scholar
• Kleinig , J. 1983 . John Stuart Mill and voluntary slavery contracts . Australian Journal of Political Science , 18 ( 2 ) : 76 – 83 .
   Google Scholar
• Goldman , A. I. , Holcomb , R. , Perry , M. H. Jr. , Schnaper , H. W. , Fitz , A. E. and Frohlich , E. D. 1982 . Can dropout and other noncompliance be minimized in a clinical trial? Report from the Veterans Administration National Heart, Lung and Blood Institute cooperative study on antihypertensive therapy: Mild hypertension . Controlled Clinical Trials , 3 ( 2 ) : 75 – 89 .
   PubMedGoogle Scholar
• Groeneveld , I. F. , Proper , K. I. , Van Der Beek , A. J. , Hildebrandt , V. H. and van Mechelen , W. 2009 . Factors associated with non-participation and drop-out in a lifestyle intervention for workers with an elevated risk of cardiovascular disease . International Journal of Behavioral Nutrition and Physical Activity , 6 : 80
   PubMed Web of Science ®Google Scholar
• Hollis , S. and Campbell , F. 1999 . What is meant by intention to treat analysis? Survey of published randomised controlled trials . British Medical Journal , 319 : 670 – 674 .
   PubMed Web of Science ®Google Scholar
• Hellard , M. E. , Sinclair , M. I. , Forbes , A. B. and Fairley , C. K. 2001 . Methods used to maintain a high level of participant involvement in a clinical trial . Journal of Epidemiology and Community Health , 55 : 348 – 351 .
   PubMed Web of Science ®Google Scholar
• Honoré , A. M. 1971 . “ Causation and remoteness of damage ” . In International Encyclopedia of Comparative Law , Vol. xi , The Hague: : M. Nijhoff . chap. 7
   Google Scholar
• Kimel , D. 2005 . From promise to contract: Towards a liberal theory of contract , Oxford : Hart .
   Google Scholar
• Jansen , V. A. , Stollenwerk , N. , Jensen , H. J. , Ramsay , M. E. , Edmunds , W. J. and Rhodes , C. J. 2003 . Measles outbreaks in a population with declining vaccine uptake . Science , 301 : 804
   PubMed Web of Science ®Google Scholar
• Laurence , D. R. 2005 . Participants in research: Patients in clinical trials are protected by consumer regulation . British Medical Journal , 331 : 110
   PubMedGoogle Scholar
• El-Khorazaty , M. N. , Johnson , A. A. , Kiely , M. , El-Mohandes , A. A. , Subramanian , S. , Laryea , H. A. , Murray , K. B. , Thornberry , J. S. and Joseph , J. G. 2007 . Recruitment and retention of low-income minority women in a behavioural intervention to reduce smoking, depression, and intimate partner violence during pregnancy . BMC Public Health , 7 : 233
   PubMed Web of Science ®Google Scholar
• Langford , A. T. , Resnicow , K. , Davis , R. E. , Alexander , G. L. , Calvi , J. , Weise , C. and Tolsma , D. 2010 . Ethnic Identity predicts loss-to-follow-up in a health promotion trial . Contemporary Clinical Trials , 31 ( 5 ) : 414 – 418 .
   PubMed Web of Science ®Google Scholar
• Larson , E. L. , Cohn , E. G. , Meyer , D. D. and Boden-Albala , B. 2009 . Consent administrator training to reduce disparities in research participation . Journal of Nursing Scholarship , 41 ( 1 ) : 95 – 103 .
   PubMed Web of Science ®Google Scholar
• Lemmens , T. and Elliott , C. 1999 . Guinea pigs on the payroll: The ethics of paying research subjects . Accountability in Research , 7 ( 1 ) : 3 – 20 .
   PubMedGoogle Scholar
• Liu-Seifert , H. , Zhang , S. , D’Souza , D. and Skljarevski , V. 2010 . A closer look at the baseline-observation-carried-forward (BOCF) . Patient Preference and Adherence , 4 : 11 – 16 .
   PubMed Web of Science ®Google Scholar
• McKendrick , E. 2003 . Contract law , 5th ed , Basingstoke, UK : Palgrave .
   Google Scholar
• McCarthy , K. D. , Nurudeen , S. , Armstrong , A. , Levens , E. and Nieman , L. K. 2010 . Recruitment and retention of women for clinical leiomyoma trials . Contemporary Clinical Trials , 31 ( 1 ) : 44 – 48 .
   PubMed Web of Science ®Google Scholar
• Mallinckrodt , C. , Clark , W. S. and David , S. R. 2001 . Type I error rates from mixed effects model repeated measures versus fixed effects ANOVA with missing values imputed via last observation carried forward . Drug Information Journal , 35 : 1215 – 1225 .
   Web of Science ®Google Scholar
• Martin , K. A. , Bowen , D. J. , Dunbar-Jacob , J. and Perri , M. G. 2000 . Who will adhere? Key issues in the study and prediction of adherence in randomized controlled trials . Controlled Clinical Trials , 21 ( 5 ) : S195 – S199 .
   Google Scholar
• Miller , D. 1991 . “ Introduction ” . In Liberty , Edited by: Miller , D. New York : Oxford University Press .
   Google Scholar
• Miller , F. and Wertheimer , A. 2009 . The ethics of consent , New York : Oxford University Press .
   Google Scholar
• Miller , F. and Wertheimer , A. 2008 . Payment for research participation: A coercive offer? . Medical Ethics , 34 : 389 – 392 .
   Google Scholar
• Mintzer , M. Z. , Stoller , K. B. and Griffiths , R. R. 1999 . A controlled study of flumazenil-precipitated withdrawal in chronic low-dose benzodiazepine users . Psychopharmacology (Berlin) , 147 ( 2 ) : 200 – 209 .
   PubMed Web of Science ®Google Scholar
• Molnar , F. J. , Man-Son-Hing , M. , Hutton , B. and Fergusson , F. 1999 . Have last-observation-carried-forward analyses caused us to favour more toxic dementia therapies over less toxic alternatives? A systematic review . Open Medicine , 3 ( 2 ) : 31 – 50 .
   Google Scholar
• Moore , M. 1999 . Causation and responsibility . Social Philosophy & Policy , 16 ( 2 ) : 1 – 51 .
   Web of Science ®Google Scholar
• Myers , W. R. 2000 . Handling missing data in clinical trials: An overview . Drug Information Journal , 34 : 525 – 533 .
   Web of Science ®Google Scholar
• Narveson , J. 2002 . Collective responsibility . Journal of Ethics , 6 : 179 – 198 .
   Google Scholar
• NHS Act. The National Health Service Act . 2006 . Her Majesty's Stationary Office and Queen's Printer Acts of Parliament, London . Available at: http://www.legislation.gov.uk/ukpga/2006/41/contents
   Google Scholar
• Newell , D. J. 1978 . Type II errors and ethics . British Medical Journal , iv : 1789
   Google Scholar
• Parfit , D. 1986 . Reasons and persons , New York : Oxford University Press .
   Google Scholar
• Parrish , R. K. 2006 . The European Glaucoma Prevention Study and the Ocular Hypertension Treatment Study: Why do two studies have different results? . Current Opinion in Ophthalmology , 17 ( 2 ) : 138 – 141 .
   PubMed Web of Science ®Google Scholar
• Peppercorn , J. , Shapira , I. , Collyar , D. , Deshields , T. , Lin , N. , Krop , I. , Grunwald , H. , Friedman , P. , Partridge , A. H. , Schilsky , R. L. and Bertagnolli , M. M. 2010 . Ethics of mandatory research biopsy for correlative end points within clinical trials in oncology . Journal of Clinical Oncology , 28 ( 15 ) : 2635 – 2640 .
   PubMed Web of Science ®Google Scholar
• Raboud , J. M. , Montaner , J. S. G. , Thorne , A. , Singer , J. , Schechter , M. T. and the Canadian HIV Trials Network A002 Study Group . 1996 . Impact of missing data due to dropouts on estimates of the treatment effect in a randomized trial of antiretroviral therapy for HIV-infected individuals . Journal of Acquired Immune Deficiency Syndromes & Human Retrovirology , 12 ( 1 ) : 46 – 55 .
   PubMedGoogle Scholar
• Rabinowitz , J. and Davidov , O. 2008 . The association of dropout and outcome in trials of antipsychotic medication and its implications for dealing with missing data . Schizophrenia Bulletin , 34 ( 2 ) : 286 – 291 .
   PubMed Web of Science ®Google Scholar
• Shih , W. J. and Quan , H. 1997 . Testing for treatment differences with dropouts present in clinical trials—A composite approach . Statistics in Medicine , 16 : 1225 – 1239 .
   PubMed Web of Science ®Google Scholar
• Salk , J. E. 1953 . Studies in human subjects on active immunization against poliomyelitis . Journal of the American Medical Association , 151 : 1081 – 1098 .
   PubMed Web of Science ®Google Scholar
• Sprague , S. , Leece , P. , Bhandari , M. , Tornetta , P. , Schemitsch , E. and Swiontkowski , M. F. 2003 . Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery . Controlled Clinical Trials , 24 ( 6 ) : 719 – 725 .
   PubMedGoogle Scholar
• Siddiqui , F. , Pajak , T. F. Watkins-Bruner , D. 2008 . Pretreatment quality of life predicts for locoregional control in head and neck cancer patients: A radiation therapy oncology group analysis . International Journal of Radiation Oncology Biology Physics , 70 : 353 – 360 .
   PubMed Web of Science ®Google Scholar
• Stone , R. 2003 . The modern law of contract , 5th ed , London : Cavendish .
   Google Scholar
• Trebilcock , M. J. 1992 . The limits of freedom of contract. , Cambridge, MA : Harvard University Press .
   Google Scholar
• Ulmer , M. , Robinaugh , D. , Friedberg , J. P. , Lipsitz , S. R. and Natarajan , S. 2008 . Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention . Contemporary Clinical Trials , 29 ( 5 ) : 705 – 710 .
   PubMed Web of Science ®Google Scholar
• Vanderpool , H. Y. 1998 . Critical ethical issues in clinical trials with xenotransplants . Lancet , 351 : 1347 – 1350 .
   PubMed Web of Science ®Google Scholar
• Wilkinson , M. and Moore , A. 1997 . Inducement in research . Bioethics , 11 : 373 – 389 .
   PubMed Web of Science ®Google Scholar
• Williams , G. 1961 . The risk principle . Law Quarterly Review , 77 : 179 – 212 .
   Google Scholar
• Williams , H. C. 2008 . Evidence based dermatology , New York : Wiley .
   Google Scholar
• Wright , R. W. 1988 . Causation, responsibility, risk, probability, naked statistics, and proof: Pruning the bramble bush by clarifying the concepts . Iowa Law Review , 73 : 1001 – 1077 .
   Web of Science ®Google Scholar