Regulatory Issues Unique to Clinical Trials on Periodontal Diagnostic Methods and Devices

Many studies have tried to understand the mechanism of endometriosis and its manner of manifestation. However, the only method of diagnosis considered as the gold standard in endometriosis is an invasive method called exploratory laparoscopy. Hence, there is a need to identify non-invasive or minimally invasive methods to minimize patients’ suffering, thus increasing their addressability at the earliest possible staging of the disease, and to diagnose this condition as soon as possible. miRNAs (microRNAs) and lncRNAs (long-noncoding RNAs) are potential non-invasive diagnostic methods for endometriosis. Multiple clinical trials indicate that miRNA can be used as a non-invasive method in the diagnosis and differentiation of endometriosis stages.

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A Comparative Review of Erythropoiesis Stimulating Agents

Journal of Pharmacy Practice ◽

10.1177/0897190008319270 ◽

2008 ◽

Vol 21 (6) ◽

pp. 424-430

Author(s):

Nicole L. Metzger ◽

Kerry E. Francis ◽

Stacy A. Voils

Keyword(s):

Chronic Kidney Disease ◽

Clinical Trials ◽

Kidney Disease ◽

Tumor Progression ◽

Safety And Efficacy ◽

Regulatory Issues ◽

Erythropoiesis Stimulating Agents ◽

Disease States ◽

Comparative Review ◽

The Us

Erythropoiesis stimulating agents have been used for more than a decade in patients with chronic kidney disease, malignancy, and other disease states where anemia is common. Recently, several clinical trials have questioned the safety and efficacy of these agents. Thrombosis and increase in tumor progression as well as a potential increase in mortality have been noted in some trials and have generated growing concern regarding whether these agents should remain on the US market. Subsequently, reimbursement from some payers for erythropoiesis stimulating agent administration has become somewhat restrictive. We address the pharmacology, pharmacokinetics, pharmacodynamics, safety, efficacy, and pharmacoeconomics of erythropoiesis stimulating agents as well as emerging regulatory issues pertaining to the administration of erythropoiesis stimulating agents.

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Important Variables for Halitosis Clinical Trials: Causes, Diagnostic Methods and Treatments

JBR Journal of Interdisciplinary Medicine and Dental Science ◽

10.4172/2376-032x.1000119 ◽

2014 ◽

Vol 02 (03) ◽

Author(s):

Vinicius Pedrazzi Jeronimo Manco

Keyword(s):

Clinical Trials ◽

Diagnostic Methods

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Regulatory issues for clinical trials at EORTC

European Journal of Cancer ◽

10.1016/s0959-8049(01)00443-9 ◽

2002 ◽

Vol 38 ◽

pp. 142-146 ◽

Cited By ~ 3

Author(s):

A.J. Baeyens ◽

D. Lacombe

Keyword(s):

Clinical Trials ◽

Regulatory Issues

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European Respiratory Society statement: diagnosis and treatment of pulmonary disease in α1-antitrypsin deficiency

European Respiratory Journal ◽

10.1183/13993003.00610-2017 ◽

2017 ◽

Vol 50 (5) ◽

pp. 1700610 ◽

Cited By ~ 96

Author(s):

Marc Miravitlles ◽

Asger Dirksen ◽

Ilaria Ferrarotti ◽

Vladimir Koblizek ◽

Peter Lange ◽

...

Keyword(s):

Clinical Trials ◽

Pulmonary Disease ◽

Pulmonary Emphysema ◽

Specific Treatment ◽

Diagnostic Methods ◽

European Respiratory Society ◽

Increased Risk ◽

Antitrypsin Deficiency ◽

History Of ◽

Never Smokers

α1-antitrypsin deficiency (AATD) is the most common hereditary disorder in adults. It is associated with an increased risk of developing pulmonary emphysema and liver disease. The pulmonary emphysema in AATD is strongly linked to smoking, but even a proportion of never-smokers develop progressive lung disease. A large proportion of individuals affected remain undiagnosed and therefore without access to appropriate care and treatment.The most recent international statement on AATD was published by the American Thoracic Society and the European Respiratory Society in 2003. Since then there has been a continuous development of novel, more accurate and less expensive genetic diagnostic methods. Furthermore, new outcome parameters have been developed and validated for use in clinical trials and a new series of observational and randomised clinical trials have provided more evidence concerning the efficacy and safety of augmentation therapy, the only specific treatment available for the pulmonary disease associated with AATD.As AATD is a rare disease, it is crucial to organise national and international registries and collect information prospectively about the natural history of the disease. Management of AATD patients must be supervised by national or regional expert centres and inequalities in access to therapies across Europe should be addressed.

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Clinical research in surgical oncology: An analysis of clinicaltrials.gov.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.591 ◽

2012 ◽

Vol 30 (4_suppl) ◽

pp. 591-591 ◽

Cited By ~ 1

Author(s):

Amber S Menezes ◽

Alison Barnes ◽

Adena S Scheer ◽

Husein Moloo ◽

Robin P Boushey ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Surgical Techniques ◽

Surgical Oncology ◽

The United States ◽

Diagnostic Methods ◽

Phase Iii ◽

Medical Specialties ◽

Surgical Interventions ◽

Adjuvant Therapies

591 Background: The conduction of randomized clinical trials has expanded in medical specialties, but to a far lesser degree in surgery. This is due to design challenges with standardization of treatment, blinding and lack of surgeon equipoise. The objective of this study was to assess the current landscape of clinical trials in surgical oncology registered at clinicaltrials.gov. Methods: Data was extracted from clinicaltrials.gov using the following search engine criteria: ‘Cancer’ as Condition, ‘Surgery OR Operation OR Resection’ as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. The search was performed on March 23, 2011 by three investigators in parallel. The total number of oncology trials was also obtained. Results: Of 9990 oncology trials, 1049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%; 1.3% of all oncology trials) manipulated a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Trials assessing adjuvant therapies focused on systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%). Of the 125 trials where surgery was the manipulated variable, 59 trials (47.2%) focused on surgical techniques (including minimally invasive) or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery vs. no surgery. The majority of the 125 trials were non- randomized (72, 57.6%), and Phase III trials accounted for less than one-quarter (29, 23.2%). Conclusions: The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies, and are frequently non-randomized. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified to facilitate higher-level evidence in surgical decision making.

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Review of Clinical Trials on Effects of Oral Antioxidants on Basic Semen and Other Parameters in Idiopathic Oligoasthenoteratozoospermia

BioMed Research International ◽

10.1155/2014/426951 ◽

2014 ◽

Vol 2014 ◽

pp. 1-11 ◽

Cited By ~ 25

Author(s):

Senka Imamovic Kumalic ◽

Bojana Pinter

Keyword(s):

Clinical Trials ◽

Male Infertility ◽

Diagnostic Methods ◽

Sperm Parameters ◽

Semen Parameters ◽

Oxygen Species ◽

Male Factor ◽

Infertile Men ◽

Antioxidant Supplements ◽

Year 2000

Infertility affects 50 to 80 million people worldwide. Male factor is a cause of infertility in almost half of cases, mainly due to oligoasthenoteratozoospermia (OAT). With common diagnostic methods no cause can be found in approximately 30% of cases of male infertility due to OAT and these are considered idiopathic. Reactive oxygen species (ROS) play an important role in male infertility and are proved to be higher in infertile men; antioxidants could oppose their effect. The aim of this paper was to review the literature on clinical trials in the period from year 2000 to year 2013 studying the effects of various types of antioxidant supplements on basic and other sperm parameters and pregnancy rates in subfertile males with idiopathic OAT. The majority of studies were randomized and placebo controlled and confirmed beneficial effect of antioxidants on at least one of the semen parameters; the biggest effect was determined on sperm motility. In many of these trials combinations of more antioxidants were assessed. The optimal dosages of one or more antioxidants were not defined. We concluded that antioxidants play an important role in protecting semen from ROS and can improve basic sperm parameters in case of idiopathic OAT.

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