Search results for 'Clinical trial' (try it on Scholar)

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  1. Rachel A. Nakash, Jane L. Hutton, Sarah E. Lamb, Simon Gates & Joanne Fisher (2008). Response and Non‐Response to Postal Questionnaire Follow‐Up in a Clinical Trial – a Qualitative Study of the Patient's Perspective. Journal of Evaluation in Clinical Practice 14 (2):226-235.score: 216.0
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  2. Audrey R. Chapman & Courtney C. Scala (2012). Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy. Kennedy Institute of Ethics Journal 22 (3):243-261.score: 204.0
    The transition of novel and potentially promising medical therapies into their initial human clinical trials can engender conflicting pressures. On the one side, because Phase I trials raise greater ethical and human protection challenges than later stage clinical trials, there is a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials, especially if the FIH trial involves (...)
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  3. Laura Buccini, Donald Iverson, Peter Caputi & Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.score: 204.0
    The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under (...)
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  4. Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.score: 204.0
    The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under (...)
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  5. Scott Brian Saxman (2014). Ethical Considerations for Outcome‐Adaptive Trial Designs: A Clinical Researcher's Perspective. Bioethics 28 (7).score: 198.0
    In a typical comparative clinical trial the randomization scheme is fixed at the beginning of the study, and maintained throughout the course of the trial. A number of researchers have championed a randomized trial design referred to as ‘outcome-adaptive randomization.’ In this type of trial, the likelihood of a patient being enrolled to a particular arm of the study increases or decreases as preliminary information becomes available suggesting that treatment may be superior or inferior. While (...)
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  6. H. J. Sutherland, E. M. Meslin & J. E. Till (1994). What's Missing From Current Clinical Trial Guidelines? A Framework for Integrating Science, Ethics, and the Community Context. Journal of Clinical Ethics 5 (4):297-303.score: 186.0
    The purpose of the work was to produce a framework to guide the development of meritorious clinical trial proposals. The framework consists of essential features of rigourous methodology, ethical acceptability, and a component referred to as "community context". These three domains were woven together in a checklist format under the headings of general, scientific and ethical considerations. Since texts concerning clinical trial methodology do not integrate ethics criteria and ethics guidelines do not provide detailed scientific criteria (...)
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  7. Kirstin Borgerson (2013). Are Explanatory Trials Ethical? Shifting the Burden of Justification in Clinical Trial Design. Theoretical Medicine and Bioethics 34 (4):293-308.score: 184.0
    Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, (...)
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  8. Jonathan Kimmelman (2004). Valuing Risk: The Ethical Review of Clinical Trial Safety. Kennedy Institute of Ethics Journal 14 (4):369-393.score: 180.0
    : Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are (...)
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  9. R. Dal-Re, J. Espada & R. Ortega (1999). Performance of Research Ethics Committees in Spain. A Prospective Study of 100 Applications for Clinical Trial Protocols on Medicines. Journal of Medical Ethics 25 (3):268-273.score: 180.0
    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a (...)
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  10. Mark Sheehan & Steve Clarke (2009). The Duty to Disclose Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):24 - 32.score: 180.0
    Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to (...)
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  11. S. Matthew Liao, Mark Sheehan & Steve Clarke (2009). The Duty to Disclose Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):24-32.score: 180.0
    Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to (...)
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  12. Paul M. Ndebele, Douglas Wassenaar, Esther Munalula & Francis Masiye (2012). Improving Understanding of Clinical Trial Procedures Among Low Literacy Populations: An Intervention Within a Microbicide Trial in Malawi. [REVIEW] BMC Medical Ethics 13 (1):29-.score: 180.0
    Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n= 124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative (...)
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  13. Barbara K. Redman, Thomas N. Templin & Jon F. Merz (2006). Research Misconduct Among Clinical Trial Staff. Science and Engineering Ethics 12 (3):481-489.score: 180.0
    Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators (...)
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  14. Charles Weijer, Benjamin Freedman, Abraham Fuks, James Robbins, Stanley Shapiro & Myriam Skrutkowska, What Difference Does It Make to Be Treated in a Clinical Trial? A Pilot Study.score: 180.0
    OBJECTIVE: Pilot study to characterize treatment differences between patients treated in clinical trials and those treated in a clinical setting. Previous studies have shown higher survival rates for participants in trials of cancer therapy. This difference is observed even after rates are adjusted for important covariates such as age and stage of disease. DESIGN: Retrospective chart review. SETTING: Oncology outpatient department in a tertiary care hospital. PATIENTS: Ninety women 18 to 70 years of age with early-stage breast cancer (...)
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  15. D. N. Shaffer (2006). Equitable Treatment for HIV/AIDS Clinical Trial Participants: A Focus Group Study of Patients, Clinician Researchers, and Administrators in Western Kenya. Journal of Medical Ethics 32 (1):55-60.score: 180.0
    Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial. Design: Qualitative study with focus groups. Setting: Teaching and referral hospital and rural health centre in western Kenya. Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Results: Eighty nine individuals participated in a total of 11 focus groups (...)
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  16. J. M. Liu, W. C. Lin, Y. M. Chen, H. W. Wu, N. S. Yao, L. T. Chen & J. Whang-Peng (1999). The Status of the Do-Not-Resuscitate Order in Chinese Clinical Trial Patients in a Cancer Centre. Journal of Medical Ethics 25 (4):309-314.score: 180.0
    OBJECTIVE: To report and analyse the pattern of end-of-life decision making for terminal Chinese cancer patients. DESIGN: Retrospective descriptive study. SETTING: A cancer clinical trials unit in a large teaching hospital. PATIENTS: From April 1992 to August 1997, 177 consecutive deaths of cancer clinical trial patients were studied. MAIN MEASUREMENT: Basic demographic data, patient status at the time of signing a DNR consent, or at the moment of returning home to die are documented, and circumstances surrounding these (...)
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  17. Adriana A. Carvalho & Luciane R. Costa (2013). Mothers' Perceptions of Their Child's Enrollment in a Randomized Clinical Trial: Poor Understanding, Vulnerability and Contradictory Feelings. BMC Medical Ethics 14 (1):52.score: 176.0
    Little is known about the views of mothers when their children are invited to participate in randomized clinical trials (RCTs) investigating medicines and/or invasive procedures. Our goal was to understand mothers’ perceptions of the processes of informed consent and randomization in a RCT that divided uncooperative children into three intervention groups (physical restraint, sedation, and general anesthesia) for dental rehabilitation.
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  18. Charles Weijer, Benjamin Freedman, Stanley Shapiro, Abraham Fuks, Myriam Skrutkowska & Maria Sigurjonsdottir, Assessing the Interpretation of Criteria for Clinical Trial Eligibility: A Survey of Oncology Investigators.score: 174.0
    OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they (...)
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  19. Nathalie Thilly, Serge Briançon, Yves Juillière, Edith Dufay & Faiez Zannad (2003). Improving ACE Inhibitor Use in Patients Hospitalized with Systolic Heart Failure: A Cluster Randomized Controlled Trial of Clinical Practice Guideline Development and Use. Journal of Evaluation in Clinical Practice 9 (3):373-382.score: 174.0
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  20. Ann Freeman Cook & Helena Hoas (2013). The Truth About the Truth: What Matters When Privacy and Anonymity Can No Longer Be Promised to Those Who Participate in Clinical Trial Research? Research Ethics 9 (3):97-108.score: 162.0
    The ramifications of including genetic components in the clinical studies conducted in non-academic settings create unique ethical challenges. We used a qualitative research design consisting of semi-structured interviews that took place between October 2010 and September 2012. The sample consisted of 80 participants − 38 physicians and 42 coordinators − who worked across a number of different settings, including clinics, private practices, small hospitals, free standing research centers, and blended hospital-institutes in both rural and urban communities in 13 states (...)
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  21. Claire Snowdon, Diana Elbourne & Jo Garcia (2007). Declining Enrolment in a Clinical Trial and Injurious Misconceptions: Is There a Flipside to the Therapeutic Misconception? Clinical Ethics 2 (4):193-200.score: 162.0
    The term 'therapeutic misconception' (TM) was introduced in 1982 to conceptualize how some psychiatry trial participants perceived and interpreted their involvement in research. TM has since been identified in many settings and is a major component in research ethics discussions. A qualitative study included a subgroup of interviews with five parents (two couples, one mother) who declined to enrol their baby in a neonatal trial. Analysis suggested the possibility of a counterpart to TM which, given the original terminology, (...)
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  22. N. Lipsman, P. Giacobbe, M. Bernstein & A. M. Lozano (2012). Informed Consent for Clinical Trials of Deep Brain Stimulation in Psychiatric Disease: Challenges and Implications for Trial Design. Journal of Medical Ethics 38 (2):107-111.score: 160.0
    Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of (...)
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  23. L. McGoey & E. Jackson (2009). Seroxat and the Suppression of Clinical Trial Data: Regulatory Failure and the Uses of Legal Ambiguity. Journal of Medical Ethics 35 (2):107-112.score: 156.0
    This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently (...)
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  24. N. Sofaer, C. Thiessen, S. D. Goold, J. Ballou, K. A. Getz, G. Koski, R. A. Krueger & J. S. Weissman (2009). Subjects' Views of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results From the Experiences of Participants in Clinical Trials (EPIC) Study. Journal of Medical Ethics 35 (3):183-188.score: 156.0
    Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA (...)
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  25. Jeffrey M. Drazen (2002). Who Owns the Data in a Clinical Trial? Science and Engineering Ethics 8 (3):407-411.score: 156.0
    Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my opinion, data from both (...)
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  26. Jacek Spławiński, Jerzy Kuźniar, Krzysztof Filipiak & Waldemar Zieliński (2006). Evaluation of Drug Toxicity in Clinical Trials. Science and Engineering Ethics 12 (1):139-145.score: 156.0
    An increasing number of drugs removed from the market because of unacceptable toxicity raises concerns regarding preapproval testing of drug safety. In the present paper it is postulated that the non-inferiority type of trial should be abandoned in favor of the superiority trial with active controls and less stringent (p<0.1, both for efficacy and toxicity) statistics. This approach will increase sensitivity of detection of drug-induced adverse effects at the expense of increasing false positive results regarding the difference in (...)
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  27. N. Johnson, R. J. Lilford & W. Brazier (1991). At What Level of Collective Equipoise Does a Clinical Trial Become Ethical? Journal of Medical Ethics 17 (1):30-34.score: 156.0
    It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are equally (...)
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  28. Diana Rose, Jasna Russo & Til Wykes (2013). Taking Part in a Pharmacogenetic Clinical Trial: Assessment of Trial Participants Understanding of Information Disclosed During the Informed Consent Process. [REVIEW] BMC Medical Ethics 14 (1):34.score: 156.0
    This study is the first to examine the understandings that participants have of the consent process in a pharmacogenetic trial of anti-depressant medication.
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  29. Selma R. Tsuji, Alvaro N. Atallah, Fernando C. Aranha, Antonio P. Tonhom, Antonio C. Siqueira & Délcio Matos (2009). Cluster Randomized Clinical Trial (ISRCTN23732000) to Evaluate the Effectiveness of a Diagnosis Recognition and Treatment Guide for Depressive Disorders in Primary Care. Journal of Evaluation in Clinical Practice 15 (1):222-225.score: 156.0
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  30. Sarojini Nadimpally, Vaibhao Ambhore, Deepa Venkatachalam & Jyoti Bajpai (2013). The Means or the End?: Experiences of Clinical Trial “Subjects” in India. Asian Bioethics Review 5 (4):344-362.score: 150.0
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  31. Jennifer Bell & Anita Ho (2011). Authenticity as a Necessary Condition for Voluntary Choice: A Case Study in Cancer Clinical Trial Participation. American Journal of Bioethics 11 (8):33-35.score: 150.0
    The American Journal of Bioethics, Volume 11, Issue 8, Page 33-35, August 2011.
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  32. Leonardo D. De Castro (2013). Clinical Trial Subjects in India—Lessons for Asia. Asian Bioethics Review 5 (4):293-295.score: 150.0
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  33. Nicole Hassoun (2009). The Duty to Disclose (Even More) Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):33-34.score: 150.0
  34. Deborah Hellman (2002). Evidence, Belief, and Action: The Failure of Equipoise to Resolve the Ethical Tension in the Randomized Clinical Trial. Journal of Law, Medicine and Ethics 30 (3):375-380.score: 150.0
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  35. S. Matthew Liao, Mark Sheehan & Steve Clarke (2009). Disclosing Clinical Trial Results: Publicity, Significance and Independence. American Journal of Bioethics 9 (8):3-5.score: 150.0
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  36. Udo Schüklenk & Carlton Hogan (1996). Patient Access to Experimental Drugs and AIDS Clinical Trial Designs: Ethical Issues. Cambridge Quarterly of Healthcare Ethics 5 (03):400-.score: 150.0
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  37. Justin Oakley (2009). Respecting Participant Autonomy and the Disclosure of Clinical Trial Results. American Journal of Bioethics 9 (8):38-38.score: 150.0
  38. Monique A. Spillman & Robert M. Sade (2007). Clinical Trials of Xenotransplantation: Waiver of the Right to Withdraw From a Clinical Trial Should Be Required. Journal of Law, Medicine and Ethics 35 (2):265-272.score: 150.0
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  39. John Banja & Boadie Dunlop (2009). Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):39-41.score: 150.0
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  40. L. J. Burgess & D. Pretorius (2012). FDA Abandons the Declaration of Helsinki: The Effect on the Ethical Aspects of Clinical Trial Conduct in South Africa and Other Developing Countries. South African Journal of Bioethics and Law 5 (2).score: 150.0
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  41. Christine Hauskeller & Dana Wilson-Kovacs (2010). Traveling Across Borders—The Pitfalls of Clinical Trial Regulation and Stem Cell Exceptionalism. American Journal of Bioethics 10 (5):38-40.score: 150.0
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  42. Sandeep Kadimpati, Jennifer B. McCormick, Yichen Chiu, Ashley B. Parker, Aliya Z. Iftikhar, Randall P. Flick & David O. Warner (forthcoming). Utilizing Focus Groups with Potential Participants and Their Parents: An Approach to Inform Study Design in a Large Clinical Trial. Ajob Empirical Bioethics:140131193327006.score: 150.0
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  43. Jennifer E. Miller (2013). How a Clinical Trial Registry Became a Symbol of Misinformation. Hastings Center Report 43 (6):11-12.score: 150.0
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  44. Kavita Shah & Frances Batzer (2009). Improving Subject Recruitment By Maintaining Truly Informed Consent: A Practical Benefit of Disclosing Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):36-37.score: 150.0
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  45. Anthony Vernillo (2009). Disclosure of Adverse Clinical Trial Results—Should Legal Immunity Be Granted to Drug Companies? American Journal of Bioethics 9 (8):45-47.score: 150.0
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  46. L. D. Buccini, D. Iverson, P. Caputi, C. Jones & S. Gho (2009). Assessing Clinical Trial Informed Consent Comprehension in Non-Cognitively-Impaired Adults: A Systematic Review of Instruments. Research Ethics 5 (1):3-8.score: 150.0
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  47. Scott Burris & Corey Davis (2009). Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation? American Journal of Bioethics 9 (11):48-54.score: 150.0
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  48. Zhao Chen, Katherine Cheng, Zandra Walton, Yuchuan Wang, Hiromichi Ebi, Takeshi Shimamura, Yan Liu, Tanya Tupper, Jing Ouyang & Jie Li (2012). A Murine Lung Cancer Co-Clinical Trial Identifies Genetic Modifiers of Therapeutic Response. In Jeffrey Kastner (ed.), Nature. Mit Press. 613-617.score: 150.0
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  49. Sal Cruz–Flores (2011). To Recruit or Not to Recruit for a Clinical Trial. Narrative Inquiry in Bioethics 1 (2):68-70.score: 150.0
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  50. Renee Claire Fox & Judith P. Swazey (2004). "He Knows That Machine is His Mortality": Old and New Social and Cultural Patterns in the Clinical Trial of the AbioCor Artificial Heart. Perspectives in Biology and Medicine 47 (1):74-99.score: 150.0
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