scholarly journals S22-2 Measures for Promoting Early-Stage Exploratory Clinical Studies and Preventing Japanese Clinical Trials' Hollowing Out --From the View Point of Pharma Industries--

2011 ◽  
Vol 42 (2) ◽  
pp. 85-86
Author(s):  
Osamu INAGAKI
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Early Stage ◽  
View Point

scholarly journals Photodynamic therapy for cancer of the pancreas – The story so far

2016 ◽  
Vol 5 (2) ◽  
Author(s):  
Stephen G. Bown
Keyword(s):  
Clinical Trials ◽  
Photodynamic Therapy ◽  
Clinical Studies ◽  
Early Stage ◽  
Response To Treatment ◽  
Normal Pancreas ◽  
Invasive Treatment ◽  
College Hospital ◽  
Stage Of Development ◽  
And Function

AbstractPancreatic cancer has long been a leading cause of cancer death. Few patients are suitable for surgery and for those who are not, the response to treatment is generally poor. No more than about 10% survive for more than a year. Recent research has focused on focal treatment for local disease control. This review covers the development of one of the most promising options, photodynamic therapy (PDT).This review covers pre-clinical and clinical studies. Laboratory work was designed to understand the effect of PDT on the normal pancreas and surrounding tissues and on transplanted cancers in the hamster pancreas to ensure safety prior to clinical application. Essentially all clinical studies have been undertaken in University College Hospital, London. Phase-I studies used the photosensitisers mTHPC and verteporfin in patients with localised but inoperable cancers.Laboratory results showed that normal pancreas, bile duct, liver, stomach and major blood vessels could tolerate PDT without any unacceptable effects on the structure and function of these organs. Necrosis that healed safely was documented in transplanted cancers. The clinical trials showed that focal necrosis could be produced in inoperable cancers with acceptable levels of complications, but considerable refinements of treatment delivery and monitoring are required before the technique will be ready for assessment in controlled clinical trials.PDT is showing promise for the minimally invasive treatment of localised pancreatic cancers, but it is still at an early stage of development. Much more work will be necessary to optimise techniques for applying PDT to these cancers and for combining it with other therapeutic options such as chemotherapy.

scholarly journals Emerging Pharmacological Treatments for Cerebral Edema: Evidence from Clinical Studies

2020 ◽  
Vol 60 (1) ◽  
pp. 291-309 ◽  
Author(s):  
Jesse A. Stokum ◽  
Volodymyr Gerzanich ◽  
Kevin N. Sheth ◽  
W. Taylor Kimberly ◽  
J. Marc Simard
Keyword(s):  
Central Nervous System ◽  
Clinical Trials ◽  
Nervous System ◽  
Cerebral Edema ◽  
Clinical Studies ◽  
Central Nervous System Disease ◽  
Ancient Egypt ◽  
Nervous System Disease ◽  
Pharmacological Treatments ◽  
System Disease

Cerebral edema, a common and often fatal companion to most forms of acute central nervous system disease, has been recognized since the time of ancient Egypt. Unfortunately, our therapeutic armamentarium remains limited, in part due to historic limitations in our understanding of cerebral edema pathophysiology. Recent advancements have led to a number of clinical trials for novel therapeutics that could fundamentally alter the treatment of cerebral edema. In this review, we discuss these agents, their targets, and the data supporting their use, with a focus on agents that have progressed to clinical trials.

scholarly journals The case for introducing pre-registered confirmatory pharmacological pre-clinical studies

2018 ◽  
Vol 38 (5) ◽  
pp. 749-754 ◽  
Author(s):  
Olivia Kiwanuka ◽  
Bo-Michael Bellander ◽  
Anders Hånell
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Clinical Trials ◽  
Brain Injury ◽  
Network Analysis ◽  
Clinical Studies ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Phase Iii Clinical Trials ◽  
Experimental Drugs

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

scholarly journals Point/counterpoint: early-stage Hodgkin lymphoma and the role of radiation therapy

Hematology ◽  
2012 ◽  
Vol 2012 (1) ◽  
pp. 313-321 ◽  
Author(s):  
Ralph M. Meyer ◽  
Richard T. Hoppe
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
Hodgkin Lymphoma ◽  
Early Stage ◽  
Trial Protocol ◽  
Radiation Oncologist ◽  
Limited Stage ◽  
Considerable Debate

Abstract The results of recent clinical trials for the management of limited-stage Hodgkin lymphoma have led to considerable debate, especially regarding the role of radiation therapy. This review highlights those recent trials and provides perspectives regarding their interpretation from a radiation oncologist and a hematologist. The trial protocol is available at http://www.nejm.org/doi/suppl/10.1056/NEJMoa1111961/suppl_file/nejmoa1111961_protocol.pdf.

scholarly journals High-cited favorable studies for COVID-19 treatments ineffective in large trials

2022 ◽  
Author(s):  
John P.A. Ioannidis
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Clinical Studies ◽  
Observational Studies ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Wide Dissemination ◽  
Highly Cited Articles ◽  
Highly Cited

Importance. COVID-19 has resulted in massive production, publication and wide dissemination of clinical studies trying to identify effective treatments. However, several widely touted treatments failed to show effectiveness in large well-done randomized controlled trials (RCTs). Objective. To evaluate for COVID-19 treatments that showed no benefits in subsequent large RCTs how many of their most-cited clinical studies had declared favorable results for these interventions. Methods. Scopus (last update December 23, 2021) identified articles on lopinavir-ritonavir, hydroxycholoroquine/azithromycin, remdesivir, convalescent plasma, colchicine or interferon (index interventions) that represented clinical trials and that had received >150 citations. Their conclusions were assessed and correlated with study design features. The ten most recent citations for the most-cited article on each index intervention were examined on whether they were critical to the highly-cited study. Altmetric scores were also obtained. Findings. 40 articles of clinical studies on these index interventions had received >150 citations (7 exceeded 1,000 citations). 20/40 (50%) had favorable conclusions and 4 were equivocal. Highly-cited articles with favorable conclusions were rarely RCTs while those without favorable conclusions were mostly RCTs (3/20 vs 15/20, p=0.0003). Only 1 RCT with favorable conclusions had sample size >160. Citation counts correlated strongly with Altmetric scores, in particular news items. Only 9 (15%) of 60 recent citations to the most highly-cited studies with favorable or equivocal conclusions were critical to the highly-cited study. Conclusion. Many clinical studies with favorable conclusions for largely ineffective COVID-19 treatments are uncritically heavily cited and disseminated. Early observational studies and small randomized trials may cause spurious claims of effectiveness that get perpetuated.

A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation

2010 ◽  
Vol 1 (1) ◽  
pp. 93-106 ◽  
Author(s):  
T. Tompkins ◽  
X. Xu ◽  
J. Ahmarani
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Clinical Findings ◽  
Chronic Diarrhoea ◽  
Helicobacter Pylori Eradication ◽  
Asian Populations ◽  
Post Market ◽  
Improve Compliance ◽  
Irritable Bowel ◽  
Study Designs

Probiotics as dietary supplements have been readily accepted by Asian populations. Use of certain probiotic preparations is widespread and the number of clinical trials undertaken with such products is unparalleled in western scientific literature. One such preparation, containing a combination of Enterococcus faecium R0026 and Bacillus subtilis R0179, has 23 publications on post-market clinical studies involving over 1,800 adults. The majority of these publications are printed in Chinese and Korean journals. This review examines the clinical findings with this probiotic combination. As mono-therapy, it has been used to overcome symptoms associated with chronic diarrhoea and irritable bowel syndrome. It has been used as co-adjuvant therapy with sulfasalazine and mesalazine to improve remission times in mild to moderate Ulcerative Colitis and to improve compliance with conventional triple therapy for Helicobacter pylori eradication. While the much of the data is preliminary and the study designs require refinement, the contribution of these trials should not be ignored. The information derived in this review will provide practitioners with practical information on appropriate applications for probiotic supplements, expected outcomes, dosing regimes, safety and reported adverse events. Furthermore, identification of problems in these trials should help researchers design better clinical trials when investigating probiotic products.

Lactulose in the Management of Constipation: A Current Review

1992 ◽  
Vol 26 (10) ◽  
pp. 1277-1282 ◽  
Author(s):  
Theresa V. Kot ◽  
Ngaire A. Pettit-Young
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Clinical Studies ◽  
Data Extraction ◽  
Point Of View ◽  
Data Synthesis ◽  
Study Selection ◽  
Beneficial Response ◽  
A Current

OBJECTIVE: To review the current published clinical studies evaluating the clinical efficacy and safety of lactulose compared with other laxatives or placebo. Adverse effects associated with lactulose are also reported. DATA SOURCES: Information was retrieved by searching the MEDLINE and EMBASE databases for clinical trials, abstracts, conference proceedings, and review articles dealing with lactulose. STUDY SELECTION: Emphasis was placed on clinical trials where lactulose was compared with other laxatives or placebo in patient populations where the diagnosis of constipation was reasonably established. DATA EXTRACTION: The methodology and results from clinical studies were evaluated. Assessment of the studies was made based on diagnosis of constipation, prior management of patients, follow-up of patients, dosage, and adverse effects. DATA SYNTHESIS: Clinical trials in geriatric patients, terminally ill patients, children, and normal and constipated subjects were reviewed. In most instances, lactulose was compared with a placebo, without incorporating the current education on dietary techniques for improving defecation. CONCLUSIONS: Generally, clinical trials have demonstrated a beneficial response compared with placebo, although sometimes that response has been only marginally better, from a clinical point of view.

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