Clinical trials




Fundamentals of clinical trials
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The clinical trial is the most definitive tool for evaluation of the applicability of clinical research. It represents a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments . It has

Source of funding and outcome of clinical trials
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Because of recent concerns about conflicts of interest and published research, the author analyzed 107 controlled clinical trials . Studies were classified as favoring either a new therapy or a traditional therapy, and as being supported by a pharmaceutical manufacturer

Evaluating patient-based outcome measures for use in clinical trials
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NHS libraries can subscribe free of charge. Public libraries can subscribe at a very reduced cost of£ 100 for each volume (normally comprising 30 40 titles). The commercial subscription rate is£ 300 per volume. Please see our website for details. Subscriptions can

Assessment of quality of life in clinical trials of cardiovascular therapies
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Eighty percent of the US health care resources are devoted to chronic diseases. The goal of therapy for most patients with chronic disease is not cure, but improvement in function as a result of decreased symptoms or severity of illness or limitation of disease progression

Participation of patients 65 years of age or older in cancer clinical trials
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Purpose: Although 61% of new cases of cancer occur among the elderly, recent studies indicate that the elderly comprise only 25% of participants in cancer clinical trials . Further investigation into the reasons for low elderly participation is warranted. Our objective was to

Patient compliance in medical practice and clinical trials
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1. Overview of Methods to Measure and Enhance Patient Compliance 2. Failure to Refill Prescriptions: Incidence, Reasons, and Remedies 4. Partial Compliance as a Source of Variance in Pharmacokinetics and Therapeutic Drug Monitoring Julie M. Backes and Jerome J. Schentag

Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma
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Purpose: To define outcome data and prognostic criteria for patients with metastatic renal cell carcinoma (RCC) treated with interferon-alfa as initial systemic therapy. The data can be applied to design and interpretation of clinical trials of new agents and treatment programs

New pathologic classification of lung cancer: relevance for clinical practice and clinical trials
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We summarize significant changes in pathologic classification of lung cancer resulting from the 2011 International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society (IASLC/ATS/ERS) lung adenocarcinoma

Randomisation in clinical trials
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Stratified block randomisation can further restrict chance imbalances to ensure the treatment groups are as alike as possible for selected prognostic variables or other patient factors. A set of permuted blocks is generated for each combination of prognostic factors. For example

Therapeutic vaccines for cancer: an overview of clinical trials
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The therapeutic potential of host‑specific and tumour‑specific immune responses is well recognized and, after many years, active immunotherapies directed at inducing or augmenting these responses are entering clinical practice. Antitumour immunization is a

Putting clinical trials into context
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In their Comment (July p 107), 1 Charles Young and Richard Horton state that those who say that systematic reviews and meta-analyses are not proper researchare wrong . Reviews and meta-analyses combine results from separate studies in an attempt to reach a

The prognostic significance of patient-reported outcomes in cancer clinical trials
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Purpose Patient-reported outcomes (PROs), routinely collected as a part of cancer clinical trials have been linked with survival in numerous clinical studies, but a comprehensive critical review has not been reported. This study systematically assessed the impact of PROs

Chemotherapy for anaplastic oligodendroglioma. National Cancer Institute of Canada Clinical Trials Group.
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Purpose: To examine the rate and duration of re-sponse fanaplastic oligodendrogliomas to dose-escalated combination chemotherapy regimen consisting of procarbazine, lomustine (CCNU), and vincristine (PCV) and to evaluate the side effects of this treatment. Methods: In

Adaptive clinical trials in oncology
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Modern oncology drug development faces challenges very different from those of the past and it must adapt accordingly. The size and expense of phase III clinical trials continue to increase, but the success rate remains unacceptably low. Adaptive trial designs can make

Involving South Asian patients in clinical trials
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Background Many randomised controlled trials have fewer South Asian participants than expected. There is a lack of ethnic minority recruitment data in many trials making assessment problematic. This study was prompted by a lack of knowledge about how South

Ethical and policy issues in international research: clinical trials in developing countries
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In addition to responding to requests for advice and recommendations from the National Science and Technology Council, NBAC also accept suggestions of issues for consideration from both the Congress and the public. NBAC also identify other bioethical issues for the purpose

American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes
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Cancer clinical trials have typically investigated agents or regimens in patients selected for study based primarily on tumor histology and clinical characteristics. This approach, when successful, has too often resulted in only small incremental improvements in overall survivalHeritable changes in gene expression that are not based upon alterations in the DNA sequence are defined as epigenetics. The most common mechanisms of epigenetic regulation are the methylation of CpG islands within the DNA and the modification of amino

Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at
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Significant progress has been made in outcome measurement procedures for osteoarthritis (OA) clinical trials and guidelines have been established by the US Food and Drug Administration, European League Against Rheumatism, the World Health Organization

Statin myopathy: a common dilemma not reflected in clinical trials
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Although statins are remarkably effective, they are still underprescribed because of concerns about muscle toxicity. We review the aspects of statin myopathy that are important to the primary care physician and provide a guide for evaluating patients on statins who present

2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer
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Despite modest improvements in the outcome of women with a diagnosis of epithelial ovarian cancer over the past decades, this disease remains most commonly diagnosed in its advanced stages and associated with poor outcomes. Thus, new knowledge generated

How much do clinical trials cost
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The cost of bringing new drugs to market and conducting clinical trials is a core concern for pharmaceutical companies, which continue to struggle with rising clinical trial costs year on year owing to more complex clinical development programmes. This complexity is driven by

Strategic physician communication and oncology clinical trials
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Purpose: Clinical trials are the primary means for determining new, effective treatments for cancer patients, yet the number of patients that accrue is relatively limited. The purpose of this study was to explore the relationship between physician behavior and patient accrual to

Subgroup analysis in clinical trials
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EBM: TRIALS ON TRIAL ever, even among experts, opinions range from only accepting pre- specified subgroup analyses supported by a very strong a priori biological rationale15 to a more liberal view in which subgroup analyses, if properly carried out and carefullySeveral studies have provided ample evidence of a clinically significant interobserver variation of the histological diagnosis of glioma. This interobserver variation has an effect on both the typing and grading of glial tumors. Since treatment decisions are based on

Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials
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Purpose: Two identical, concurrent, parallel, multicenter, randomized, double-blind, double- dummy trials were conducted to compare the efficacy and safety of zoledronic acid and pamidronate for treating hypercalcemia of malignancy (HCM). Patients and Methods

Cell therapy for cardiac repair lessons from clinical trials
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The global impetus to identify curative therapies has been fuelled by the unmet needs of patients in the context of a growing heart failure pandemic. To date, regeneration trials in patients with cardiovascular disease have used stem-cell-based therapy in the period

Meta-analysis of randomized clinical trials comparing cisplatin to carboplatin in patients with advanced non small-cell lung cancer
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Page 1. Meta-Analysis of Randomized Clinical Trials Comparing Cisplatin to Carboplatin in Patients With Advanced Non Small-Cell Lung Cancer All rights reserved. Page 2. In an attempt to circumvent cisplatin-induced toxici- ties, carboplatin, an analog of cisplatin, was introduced into clinical trials

Long-term outcome of cognitive behaviour therapy clinical trials in central Scotland
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Design An attempt was made to contact and interview all of the participants in eight randomised, controlled, clinical trials of CBT for anxiety disorders and two randomised, controlled, clinical trials of CBT for schizophrenia conducted between 1985 and 2001. Case

Development and testing of a new measure of health status for clinical trials in heart failure
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The authors developed a new measure of subjective health status for patients with heart failure. Eighty-eight patients with heart failure were asked about the impact of their condition on 123 items related to physical and emotional function. The most frequently chosen and

Invisible barriers to clinical trials : the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials
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Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute designated comprehensive cancer center, and three VICCAN

Role of KRAS and EGFR As Biomarkers of Response to Erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21
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Chang-Qi Zhu, Gilda da Cunha Santos, Keyue Ding, Akira Sakurada, Jean-Claude Cutz, Ni Liu, Tong Zhang, Paula Marrano, Marlo Whitehead, Jeremy A. Squire, Suzanne Kamel-Reid, Lesley Seymour, Frances A. Shepherd, and Ming-Sound Tsao From the Division of Applied Molecular

clinical and prognostic features of infiltrating lobular carcinoma of the breast: combined results of 15 International Breast Cancer Study Group clinical trials
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Lobular Carcinoma of the Breast: Combined Results of 15 International Breast Cancer Study Group Clinical Trials Bernhard C. Pestalozzi, David Zahrieh, Elizabeth Mallon, Barry A. Gusterson, Karen N. Price, Richard D. Gelber, Stig B. Holmberg, Jurij Lindtner, Raymond

Commercializing clinical trialsrisks and benefits of the CRO boom
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PERSPECTIVE n engl j med 357; 14 www. nejm. org october 2007 1366 pants later tested positive for the disease. The company, now called PharmaNet, shut down its Florida site and settled a resulting shareholder class action lawsuit for $28.5 million in August 2007. In 2006

Outcome measures to be used in clinical trials in systemic lupus erythematosus
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The optimal outcome measures to be employed in clinical trials of systemic lupus erythematosus (SLE) have yet to be determined. Useful instruments should assess disease outcome in terms of all organ system involvement, as well as measures important to the

Never too old Age should not be a barrier to enrollment in cancer clinical trials
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Throughout Europe and the US, over 60% of the total incidence of cancer occurs in the elderly (≥ 65 years) population, a patient group that requires particular consideration when making treatment decisions due to a number of factors. Despite this, elderly patients are

IGF-1 receptor inhibitors in clinical trials early lessons
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The insulin-like growth factor pathway plays a major role in cancer cell proliferation, survival and resistance to anti-cancer therapies in many human malignancies, including breast cancer. As a key signaling component of IGF system, the IGF-1 receptor is the target of

Globalized clinical trials and informed consent
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emberg Code and the 1964 Declaration of Helsinki (see box). 2 The situation has not improved. For example, late last year, the Food and Drug Administration (FDA) decided that research studies submitted to it for review need no longer be bound by the Declaration of