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Results for “Clinical Trials, Phase IV as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 91 records · Page 5Linked to original sources
PubMed2006

Clinical characteristics of psoriatic arthritis and psoriasis in dermatologists' offices.

OBJECTIVE: To describe the skin and joint disease of patients with psoriatic arthritis being treated in dermatology clinics. METHODS: A total of 1122 patients who had active psoriatic arthritis were enrolled in a Phase 4, non-randomized, open-label, single-arm, 24-week study. They were treated at 108 community and 17 academic dermatology centers. These patients experienced clinically stable, plaque psoriasis involving > or =10% body surface area and joint disease (either > or = two swollen and > or = two tender/painful joints for > or =3 months, or > or = one joint with sacroiliitis or spondylitis). RESULTS: In general, patient demographics and disease characteristics did not appear to differ between academic and community dermatology sites. Based on patient-reported assessments, patients rated the severity of their baseline joint symptoms lower than the severity of their skin disease. Baseline skin and joint disease measures were not correlated. Psoriatic arthritis was newly diagnosed in 23% of the patients. Most had received prior therapy for psoriasis, but only half had received systemic therapy for psoriatic arthritis. CONCLUSION: Assessment for joint disease in psoriasis patients being treated at dermatology clinics may facilitate earlier psoriatic arthritis diagnosis and treatment initiation, which may prevent disability and other negative impacts.

Adolescent↗
PubMed2006

Ethics and pharmaceutical medicine -- the full report of the Ethical Issues Committee of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK.

The practice of pharmaceutical medicine brings with it ethical challenges and dilemmas often very different from those encountered in the practice of clinical medicine. Having established a framework of guiding ethical principles, this report aims to look in some detail at specific areas of possible ethical concern to pharmaceutical physicians, offering practical advice and guidance on good practice. The report covers issues related to pharmaceutical research, including dissemination of research findings, communication with other health professionals and patients and involvement of pharmaceutical physicians and companies in the provision of patient services. The primacy of the interests of patients and the wider public is emphasised, and the possible impact of new developments in pharmaceutical technology is explored. It is hoped that the report will help those working in pharmaceutical medicine and act as a stimulus for wider discussion and debate.

Biomedical Research↗
PubMed1995

Financial ties as part of informed consent to postmarketing research. Attitudes of American doctors and patients.

Postmarketing research, often called phase IV trials, is intended to familiarise doctors and patients with newly approved drugs. La Puma and colleagues, in Chicago, studied doctors' and patients' attitudes to whether doctors should receive payment for taking part in such research. We asked for commentaries on their findings from four ethical experts, who put the study in a British context, present the views of patients, and examine some methodological assumptions.

Adult↗
PubMedDate not supplied

Problems with publishing results of interim analyses of randomized clinical trials.

PURPOSE: This purpose of this study was to illustrate how publication of interim analyses of randomized clinical trials (RCTs) can cause problems in the interpretation of final results. METHOD: The effect of publishing interim analyses on the results of a typical HIV RCT comparing regimens of registered antiretroviral drugs was illustrated using a simulation study. Simulations modeled an RCT comparing the effect of two treatment combinations on changes in log HIV viral load from baseline. Publication of interim results at 6 months was assumed to lead to 50% of patients switching from the poorer treatment if interim results were statistically significant (p <.05), 20% of patients switching from the poorer treatment if interim results were marginally significant (.05 < p <.20), and 10% of all patients switching treatment if interim results were not statistically significant. Three scenarios were simulated: a large treatment difference (0.4 log HIV viral load), a moderate difference (0.2 log), and no treatment difference (0.0 log). RESULTS: The simulation study showed that if the true treatment difference was large (0.4 log) the power of the trial was reduced from over 80% at 6 months to under 37% at 12 months. Furthermore, given the statistical significance of the interim analysis results at 6 months, the simulations illustrated that the trial results would appear similar at 12 months, regardless of the true underlying treatment difference. CONCLUSION: The simulations reinforce the fact that publication of interim analyses of RCTs can affect the future conduct of a trial and make interpretation of final results difficult.

Anti-HIV Agents↗
PubMed2004

The tolerability of riluzole in the treatment of patients with amyotrophic lateral sclerosis.

Riluzole is the only disease-modifying drug approved for the treatment of amyotrophic lateral sclerosis (ALS), in which it has been demonstrated to extend survival. The overall tolerability of riluzole is good and the drug can be used in all patients with ALS except those with elevated transaminase levels or active liver disease. The most frequently encountered adverse events (AEs) that appear to be attributed to riluzole are asthenia and nausea, observed in 18 and 15% of patients taking riluzole in the randomised clinical trial programme, respectively. These same AEs, albeit at a lower frequency, are also reported in Phase IV observational studies and in pharmacovigilance surveys. No unexpected AE clearly related to riluzole has emerged in the seven years that riluzole has been in extensive use in ALS patients. The most important potential safety issue with riluzole is hepatic impact with elevations of transaminases. Serum alanine aminotransferase levels more than three times the upper limit of normal are observed in 10 - 15% of patients. For this reason, strict monitoring of liver enzymes is recommended in patients with ALS taking riluzole, and treatment is contraindicated in subjects with elevated transaminases before the start of treatment. There is a suspicion that riluzole may, in rare cases, cause neutropenia, and physicians should be vigilant towards this risk.

Aged↗
PubMed1994

"How much do you get paid if I volunteer?" Suggested institutional policy on reward, consent, and research.

Pharmaceutical companies often ask practicing physicians to conduct phase IV or postmarketing research on new drugs. Companies pay physicians to enroll their patients and report dosage and side-effect information. Postmarketing research embraces a multibillion dollar effort at promotion and familiarization, but subjects' informed consent to it normally does not include physician reward. Improving investigators' financial status while increasing medical risks to phase IV subjects is ethically unsound, especially if subjects are unaware of investigators' rewards. We suggest a model policy and guidelines that affirm subjects' need for informed consent, investigators' need for recognition and support, and institutions' need to protect patients from undisclosed risk and relations.

Clinical Trials, Phase IV as Topic↗
PubMed2000

[Sense and nonsense in post-authorization surveillance].

Post-authorization surveillance studies analyze the intended use of medications in accordance with their authorized labeling. They are characterized by the principle of non-intervention, i.e. they do not take influence on the decision whether or how to treat and to survey treatment in the individual patient. These aspects define the difference between surveillance studies and phase-IV clinical trials. In consequence, surveillance studies--in contrast to phase-IV trials--are not subject to the regulations of sections 40, 41 of the German Drug Law and national and international Recommendations on Good Clinical Practice (GCP). In essence, they are pharmaco-epidemiological investigations that make use of personified patient data. Within the context of the European regulatory policies they are part of the overall pharmacovigilance effort. In Germany, surveillance studies may have an additional regulatory impact. Indeed, they may be accepted as a relevant extension to the documentation on both safety and efficacy and in some cases even as an alternative to the tedious experimental investigation thereof, provided they meet newly defined quality criteria (that are discussed here more extensively). Although not developed to this purpose and although these recommendations are mainly formal with some relevant shortcomings in defining content quality, they are an important source of reference for the individual physician to guide his decision about the value and acceptability of any surveillance study, including those not primarily intended to be used in a regulatory context.

Clinical Trials, Phase IV as Topic↗