Arts and Humanities Commons^™

Trial By Error, Charles Weijer

Charles Weijer

No abstract provided.

The Ethical Analysis Of Risk, Charles Weijer

Charles Weijer

No abstract provided.

Clinical Equipoise And Not The Uncertainty Principle Is The Moral Underpinning Of The Randomised Controlled Trial, Charles Weijer, Stanley Shapiro, Kathleen Glass

Charles Weijer

No abstract provided.

Reporting The Study Populations Of Clinical Trials. Clear Transmission Or Static On The Line?, Stanley Shapiro, Charles Weijer, Benjamin Freedman

Charles Weijer

In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories …

What's The Price Of A Research Subject?, Charles Weijer

Charles Weijer

No abstract provided.

Placebo-Controlled Studies In Schizophrenia: Ethical And Scientific Perspectives. Panel Discussion, T. Lemmens, P. Appelbaum, W. Carpenter, C. Mccarthy, C. Peterson, D. Streiner, Charles Weijer

Charles Weijer

No abstract provided.

Placebo-Controlled Trials In Schizophrenia: Are They Ethical? Are They Necessary?, Charles Weijer

Charles Weijer

The current controversy as to the proper role of the placebo control in the evaluation of new treatments for schizophrenia requires an analysis that is sensitive to both ethical and scientific issues. Clinical equipoise, widely regarded as the moral foundation of the randomized controlled trial (RCT), requires the use of best available treatment as the control in RCT. Scientific criticisms of the use of an active control are examined and none present an insuperable barrier to the use of an active control. Indeed, scrutiny of the most recent argument for the use of placebo controls, 'assay sensitivity', suggests that the …

Consensus-Seeking Roundtable On Placebos In Clinical Research, Charles Weijer

Charles Weijer

No abstract provided.

Bioethics For Clinicians: 16. Dealing With Demands For Inappropriate Treatment, Charles Weijer, Peter Singer, Bernard Dickens, Stephen Workman

Charles Weijer

Demands by Patients or their Families for treatment thought to be inappropriate by health care providers constitute an important set of moral problems in clinical practice. A variety of approaches to such cases have been described in the literature, including medical futility, standard of care and negotiation. Medical futility fails because it confounds morally distinct cases: demand for an ineffective treatment and demand for an effective treatment that supports a controversial end (e.g., permanent unconsciousness). Medical futility is not necessary in the first case and is harmful in the second. Ineffective treatment falls outside the standard of care, and thus …

A Study In Contrasts: Eligibility Criteria In A Twenty-Year Sample Of Nsabp And Pog Clinical Trials, Abraham Fuks, Charles Weijer, Benjamin Freedman, Stanley Shapiro, Myriam Skrutkowska, Amina Riaz

Charles Weijer

We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP studies (explanatory trials) and POG studies (pragmatic trials) suggest that large numbers of eligibility criteria are not necessary for quality studies. …

Reb Review Of Research Proposals Involving Placebo Controls, Charles Weijer

Charles Weijer

No abstract provided.

The Placebo Effect, Charles Weijer

Charles Weijer

No abstract provided.

Do Patients With Breast Cancer Participating In Clinical Trials Receive Better Nursing Care?, Myriam Skrutkowska, Charles Weijer

Charles Weijer

PURPOSE/OBJECTIVES: To examine differences in nursing care received by patients with breast cancer enrolled in clinical trials and those not enrolled in clinical trials.

DESIGN: Retrospective review of clinic charts.

SETTING: Oncology outpatient department of a tertiary-care hospital. SAMPLE: 90 women with early stage breast cancer. The mean age of the women was 53 years. More than half of the women (51 of 90) were treated in a clinical trial.

METHODS: Retrospective chart review of all the nurse-patient clinic encounters for a six-month period from date of cancer diagnosis. The content of each encounter was coded using a modified version …

Spilker's Guide To Clinical Trials On Cd-Rom, Charles Weijer

Charles Weijer

No abstract provided.

Selecting Subjects For Participation In Clinical Research: An Empirical Inquiry And Ethical Analysis, Charles Weijer

Charles Weijer

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.

In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other …

Bioethics For Clinicians: 10. Research Ethics, Charles Weijer, Bernard Dickens, Eric Meslin

Charles Weijer

Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must …

Evolving Ethical Issues In Selection Of Subjects For Clinical Research, Charles Weijer

Charles Weijer

Wittgenstein, in his famous critique of philosophy, noted that the influence of an idea can be such that it alters the way that we see the world. “It is like a pair of glasses on our nose through which we see whatever we look at,” he said. “It never occurs to us to take them off.” This view of the power of an idea suggests that the interpretation of an event, and what response this event calls for, can depend upon the view one has of the world. A person who is naive about medical facts may, for example, interpret …

What Difference Does It Make To Be Treated In A Clinical Trial? A Pilot Study, Charles Weijer, Benjamin Freedman, Abraham Fuks, James Robbins, Stanley Shapiro, Myriam Skrutkowska

Charles Weijer

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 who were diagnosed in 1990. Fifty-one of the women were treated through clinical trials and 39 were treated outside of clinical …

Down With Placebolatry, Charles Weijer, Carl Elliott

Charles Weijer

No abstract provided.

Characterizing The Population In Clinical Trials: Barriers, Comparability, And Implications For Review, Charles Weijer

Charles Weijer

The definition of the study population for a clinical trial via the criteria for trial eligibility has implications for the validity of the study and its applicability to clinical practice. Though issues of equity regarding the selection of subjects for research have long been a concern of ethicists, issues regarding the impact of subject selection on a trial's generalizability have only recently attracted ethical scrutiny. After a review of the history of the ethics of subject selection, I focus on three empirical questions regarding the generalizability of clinical trials. (1) What proportion of diseased populations are studied in clinical trials? …

Monitoring Clinical Research: An Obligation Unfulfilled, Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Glass, Myriam Skrutkowska

Charles Weijer

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by …

The Duty To Exclude: Excluding People At Undue Risk From Research, Charles Weijer, Abraham Fuks

Charles Weijer

The clinical trial is the major investigational tool of clinical medicine. Two recent reports highlight the fact that the most often quoted mechanisms for the protection of research subjects, viz., research ethics board review and eligibility criteria, are insufficient to achieve this end. In this paper, we argue that the prime mechanism for the protection of persons in clinical trials should be the clinical judgement of the physician-investigator. The clinical investigator has a duty to protect subjects from both harm and undue risk. It is argued that the clinical investigator has a duty to screen for, and exclude, potential research …

The Revolution In Clinical Trials: From Burden To Benefit And Back Again, Charles Weijer

Charles Weijer

No abstract provided.

In Loco Parentis: Minimal Risk As An Ethical Threshold For Research Upon Children, Benjamin Freedman, Abraham Fuks, Charles Weijer

Charles Weijer

No abstract provided.

Demarcating Research And Treatment: A Systematic Approach For The Analysis Of The Ethics Of Clinical Research, Benjamin Freedman, Abraham Fuks, Charles Weijer

Charles Weijer

No abstract provided.