ABSTRACT To develop a more efficient way of informing potential clinical trial volunteers of exactly what they could expect during (and after) their participation in a clinical trial as well as the sponsor’s expectations from the volunteer. A multiple choice questionnaire, which was based on the criteria as specified by Guideline 5 of the International Conference of Harmonization (ICH), was administered to 28 Volunteers after only reading the Patient Information Leaflet/Informed Consent Document (PIL/PIL/ICD), to 21 Volunteers who had read the PIL/ICD and attended a question and answer session, to 17 Volunteers who had read the PIL/ICD and attended a presentation and 19 Volunteers who had read the PIL/ICD and attended a presentation and a question and answer session. In total, 85 Volunteers completed the questionnaire. The average calculated percentage* of volunteers who had only read the PIL/ICD was 61%, 63% for Volunteers who had read the PIL/ICD and attended a question and answer session, 73% for Volunteers who had read the PIL/ICD and attended a presentation and 68% for Volunteers who had read the PIL/ICD and attended a presentation and question and answer session. In total, the average calculated percentage was 66%. Eighty four percent of the total number of volunteers answered the question on withdrawal consequence incorrectly, 43% of Volunteers answered questions on side effects incorrectly and 100% of the Volunteers answered the question on the duration of storage of samples incorrectly. Despite increasing regulatory and ethical scrutiny, deficiencies still exist in Volunteer comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. Results indicated that any successful consent process should, at a minimum, include a visual communication mode. Concepts that are not well understood within the South-African context are withdrawal consequence, methodology such as double-blind or single blind, side effects, duration of archiving, treatment alternatives and the role of the investigator. *calculated % for each volunteer = score out of 25 x 100

Faculty of Health Science School of Public Health 0418444d benido_impouma@yahoo.com / Study objectives The objective of this meta-analysis was to review the comparative efficacy and tolerance of sulfadoxine-pyrimethamine (SP) given alone or in combination with one (SPAS1) or three (SPAS3) doses of artesunate in children with uncomplicated P. falciparum malaria, aged 6 months to 10 years. Specifically, it assessed cure rate, fever and parasite clearance time, gametocyte carriage and tolerability. Methods The methodology used was a systematic review and a meta-analysis of four randomised controlled trials. The primary endpoint was the parasitological cure rate at day 28. Secondary endpoint included the parasitological cure rate at day 14, time to fever and parasite clearance, gametocyte carriage and occurrence of adverse events. Results Cure rate at day 28 corrected by PCR was 2.5 times higher in the combination of SPAS3 than in SP alone (pooled OR=2.55, 95% CI 1.93 to 3.37). There was no difference in cure rate at day 28 corrected by PCR between the combination of SPAS1 and SP alone (pooled OR=1.06 95% CI 0.98 to 1.15). Fever and parasite clearance times were significantly faster in both SPAS1 and SPAS3 compared to SP alone (p<0.001). By day 28 all children on the combination therapy were agametocytaemic as opposed to those on SP alone (p<0.001). All drug regimens were well tolerated and safe. Conclusion The combination of SPAS3 is more efficacious than SP alone in treatment of children with uncomplicated P. falciparum malaria. The combination is recommended for adoption as a replacement for SP alone in areas where malaria is endemic.

Background: Inability to retain participants in a clinical trial poses a threat to clinical research as it can lead to a number of issues ultimately affecting generalisability, validity and reliability of the study. Patients with schizophrenia have been reported as particularly difficult to engage and retain in research and psychiatric treatment. This thesis aimed to improve the current understanding of the retention of people with schizophrenia in trials evaluating complex interventions. Methods: This thesis adopted a mixed method design. Quantitative methodology was used to identify the scale of attrition and to explore potential predictors of dropout. This included a systematic review and meta-analysis and a separate meta-analysis of individual patient data. Qualitative methodology was used in two studies to explore the perspectives of both trial staff and former trial participants on the factors important for retention and effective practices and strategies. Results: The results of the systematic review and meta-analysis demonstrated the rates of dropout from studies to be higher than from experimental interventions. Dropout from interventions significantly increased as the number of intervention sessions increased. The individual patient data meta-analysis found retention to be higher at the final follow-up assessment than at the penultimate one. The effect of arm allocation almost reached statistical significance pointing to the possibility of participants in the active arm having higher odds of completing the final follow-up than those in the control arm. Two qualitative studies identified barriers and facilitators to retention related to factors related to participant, researcher, study, and wider context. Some of the identified barriers were specific to schizophrenia. Conclusion: Attrition is a phenomenon that should be anticipated by trialists and prevented with the use of multiple strategies. The extent to which dropout can be minimised depends on a number of factors associated with the participant, researcher, study, and context.

No description available.

Thesis (M.A.)--Marshall University, 2003. / Title from document title page. Document formatted into pages; contains 70 p. Includes bibliographical references (p. 68-70).

Thesis (Ph. D.)--Ohio State University, 2003. / Title from first page of PDF file. Document formatted into pages; contains xiii, 241 p.; also includes graphics. Includes abstract and vita. Advisor: Heaney, Catherine, School of Public Health. Includes bibliographical references (p. 186-201).

Thesis (M.A.)--Southern California College, 2000. / Includes bibliographical references (leaves i-ix).

Thesis (Ph. D.)--University of Washington, 2003. / Vita. Includes bibliographical references (leaves 61-68).

The purpose of this study was to determine how American involvement in the war-crimes trials held in Germany after World War II affected Germany's own prosecution of war criminals from 1949 to the present. Achievement of this objective entailed determining the role of the United States in war-crimes prosecutions, relating the role to that of the other occupation powers and then discovering the specific ways that the United States influenced Germany's conduct of its own trials.The procedure involved four steps. The United States plans for the prosecution of war criminals were traced throughout the war in order to determine attitudes and roles which might have affected planning for postwar Germany. Then the proceedings of the International Military Tribunal, the Dachau trials and Nuremberg trials were studied so their characteristics could be compared with the German-conducted proceedings. A note was next made 'on every individual who was indicted or tried in the Federal Republic. Also listed were the individual's age, former position in the Nazi regime, war-crimes charge, place of trial, results of the proceedings and appeal, public reaction, and any other data which might be pertinent to the trials, such as antiSemitic and neo-Nazi revivals, and Adolf Eichmann's trial in Jerusalem.General conclusions became immediately apparent. First, the trials of war criminals would have ended at the close of the International Military Tribunal had not the United States insisted they continue. Secondly, the United States conduct of its trials at Nuremberg and Dachau planted seeds which affected Germany's prosecution of war criminals. The most important seed was a crushing burden of guilt. Guilt in turn produced rationalizations about the past deeds of the Nazis. Consequently, no real atonement for the German people could take place. The number of trials declined appreciably from 1949 to 1957. Germany's delay in accepting its guilt was also due to the fact that American authorities determined that other issues were more important, including rebuilding Germany economically and. militarily to defend the Western world against the communist menace in Eastern Europe. Thirdly, the realization that German youth were not being taught the truth about the Nazi era, that Nazi war criminals had escaped prosecution, and that former Nazis had won their way back into the government and judiciary awakened people to the need to undergo a "national self-purification," The number of trials held in Germany increased. The Eichmann Trial was part of the momentum, but the Auschwitz proceedings were almost anti-climactic, creating more apathy and indifference than anything else. So deep, however, is the burden of guilt that the statute of limitations has been removed on genocide and extended twice for murder to insure that the remaining war criminals will be punished, despite the fact that two out of every five Germans opposed the trials. Finally, although a commendable effort has been made to write the last chapter in Germany's conduct of warcrimes trials, the Bonn government has undercut the force of extending the statute of limitations by allowing a penal code reform in 1968 to end the prosecution of war criminals except in cases of murder or aiding and abetting in murder out of such base motives as racial hatred. In spite of legal delays and manoeuvers in the trial of war criminals, one can expect the proceedings to continue but to slow down and then end completely in 1979.

One of the most important questions in the planning of medical experiments to assess the performance of new drugs or treatments, is how big to make the trial. The problem, in its statistical formulation, is to determine the optimal size of a trial. The most frequently used methods of determining sample size in clinical trials is based on the required p-value, and the required power of the trial for a specified treatment effect. In contrast to the Bayesian decision theoretic approach there is no explicit balancing of the cost of a possible increase in the size of the trial against the benefit of the more accurate information which it would give. In this work we consider a fully Bayesian (or decision theoretic) approach to sample size determination in which the number of subsequent users of the therapy under investigation, and hence also the total benefit resulting from the trial, depend on the strength of the evidence provided by the trial. Our procedure differs from the usual Bayesian decision theory methodology, which assumes a single decision maker, by recognizing the existence of three decision makers, namely: the pharmaceutical company conducting the trial, which decides on its size; the regulator, whose approval is necessary for the drug to be licenced for sale; and the public at large, who determine the ultimate usage. Moreover, we model the subsequent usage by plausible assumptions for actual behaviour, rather than assuming that this represents decisions which are in some sense optimal. For this reason the procedure may be called "Behavioural Bayes" (or BeBay for short), the word Bayes referring to the optimization of the sample size. In the BeBay methodology the total expected benefit from carrying out the trial minus the cost of the trial is maximized. For any additional sales to occur as a result of the trial it must provide sufficient evidence both to convince the regulator to issue the necessary licence and to convince potential users that they should use the new treatment. The necessary evidence is in the form of a high probability after the trial that the new treatment achieves a clinically relevant improvement compared to the alternative treatment. The regulator is assumed to start from a more sceptical and less well-informed view of the likely performance of the treatment than the company carrying out the trial. The total benefit from a conclusively favourable trial is assessed on the basis of the size of the potential market and aggregated over the anticipated life-time of the product, using appropriate discounting for future years.