scholarly journals Introduction of clinical trial working group activities in Oita Medical College.

1999 ◽  
Vol 30 (1) ◽  
pp. 35-36
Author(s):  
HAJIME NAKAJIMA
Keyword(s):  
Clinical Trial ◽  
Working Group ◽  
Group Activities ◽  
Medical College

scholarly journals Current challenges and opportunities for pharmacogenomics: perspective of the Industry Pharmacogenomics Working Group (I-PWG)

2021 ◽  
Author(s):  
Karina Bienfait ◽  
Aparna Chhibber ◽  
Jean-Claude Marshall ◽  
Martin Armstrong ◽  
Charles Cox ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Working Group ◽  
Direct Sequencing ◽  
Risk Scores ◽  
Pharmaceutical Companies ◽  
Patient Privacy ◽  
Clinical Implementation ◽  
Genomic Databases ◽  
Group I ◽  
Trial Participants

AbstractPharmaceutical companies have increasingly utilized genomic data for the selection of drug targets and the development of precision medicine approaches. Most major pharmaceutical companies routinely collect DNA from clinical trial participants and conduct pharmacogenomic (PGx) studies. However, the implementation of PGx studies during clinical development presents a number of challenges. These challenges include adapting to a constantly changing global regulatory environment, challenges in study design and clinical implementation, and the increasing concerns over patient privacy. Advances in the field of genomics are also providing new opportunities for pharmaceutical companies, including the availability of large genomic databases linked to patient health information, the growing use of polygenic risk scores, and the direct sequencing of clinical trial participants. The Industry Pharmacogenomics Working Group (I-PWG) is an association of pharmaceutical companies actively working in the field of pharmacogenomics. This I-PWG perspective will provide an overview of the steps pharmaceutical companies are taking to address each of these challenges, and the approaches being taken to capitalize on emerging scientific opportunities.

Achieving Consensus on Total Joint Replacement Trial Outcome Reporting Using the OMERACT Filter: Endorsement of the Final Core Domain Set for Total Hip and Total Knee Replacement Trials for Endstage Arthritis

2017 ◽  
Vol 44 (11) ◽  
pp. 1723-1726 ◽  
Author(s):  
Jasvinder A. Singh ◽  
Michelle M. Dowsey ◽  
Michael Dohm ◽  
Susan M. Goodman ◽  
Amye L. Leong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Total Knee Replacement ◽  
Knee Replacement ◽  
Joint Replacement ◽  
Working Group ◽  
Total Joint Replacement ◽  
Core Domain ◽  
Total Knee ◽  
Core Domain Set

Objective.Discussion and endorsement of the OMERACT total joint replacement (TJR) core domain set for total hip replacement (THR) and total knee replacement (TKR) for endstage arthritis; and next steps for selection of instruments.Methods.The OMERACT TJR working group met at the 2016 meeting at Whistler, British Columbia, Canada. We summarized the previous systematic reviews, the preliminary OMERACT TJR core domain set and results from previous surveys. We discussed preliminary core domains for TJR clinical trials, made modifications, and identified challenges with domain measurement.Results.Working group participants (n = 26) reviewed, clarified, and endorsed each of the inner and middle circle domains and added a range of motion domain to the research agenda. TJR were limited to THR and TKR but included all endstage hip and knee arthritis refractory to medical treatment. Participants overwhelmingly endorsed identification and evaluation of top instruments mapping to the core domains (100%) and use of subscales of validated multidimensional instruments to measure core domains for the TJR clinical trial core measurement set (92%).Conclusion.An OMERACT core domain set for hip/knee TJR trials has been defined and we are selecting instruments to develop the TJR clinical trial core measurement set to serve as a common foundation for harmonizing measures in TJR clinical trials.

scholarly journals Colchicine in the Treatment of Recurrent Oral Aphthous Ulcer -Open Clinical Trial in Bangladesh

1970 ◽  
Vol 39 (3) ◽  
Author(s):  
A Hassan ◽  
Z Ahmed ◽  
R Ali ◽  
F Ara ◽  
N Ahmed ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Oral Mucosa ◽  
Colchicine Treatment ◽  
Aphthous Ulcer ◽  
College Hospital ◽  
Medical College ◽  
Aphthous Ulceration ◽  
Benign Nature ◽  
Medical University

Background: Recurrent aphthous Ulceration (RAU) is characterized by necrotizing ulcers of the oral mucosa that persist, remit, and recur for variable periods of time. Despite the benign nature of the disease, RAU frequently affects quality of life as a result of long lasting and recurrent episodes of burning pain.Aim and objective: the aim of the study was to determine the efficacy of colchicine in treatment of recurrent oral aphthous ulcer.Methods: A clinical trial was conducted among 30 samples in the department of dermatology and venereology of Bangabandhu Sheikh Mujib Medical University and Dhaka Medical College Hospital, Dhaka. Study was performed among those who fulfilled the inclusion criteria. Data was collected from 1st September 2007 to 29th February. 2008 and enrolled data was analyzed by using statistical SPSS win 13.Results: Among 30 patients, 24 (80%) were male and 6(20%) were female. Mean age of the patients was 26.20 (±6.65) years. 26(87.7%) patients found ulcer in oral mucosa and 4(13.3%)in tongue, but previous family history was present in only 20% cases out of 30 patients. All patients experienced a marked decrease in symptoms during colchicine treatment in where; mean aphthae count was 3.27 (±1.05) before treatment and 0.43 (±0.68) during treatment. Pain score also reduced during treatment from 6.80 (±2.12) to 1.13 (±.1.11) which was statistically highly significant.Conclusions: Colchicine may be a promising modality of treatment in the therapeutic armamentarium for RAU.DOI: http://dx.doi.org/10.3329/bmj.v39i3.9948 BMJ 2010; 39(3)

scholarly journals ONCOLYTIC VIRAL THERAPY IN CANCER THERAPEUTICS

2017 ◽  
Vol 10 (10) ◽  
pp. 96
Author(s):  
Krishnan Vengadaragava Chary ◽  
Anish Bharatwaj
Keyword(s):  
Clinical Trial ◽  
Meta Analysis ◽  
Cancer Therapeutics ◽  
Drug Approval ◽  
Clinical Trial Registry ◽  
Oncolytic Viral Therapy ◽  
Medical College ◽  
Comprehensive Information ◽  
Viral Therapy ◽  
The Us

Objective: The aim of this study is to provide comprehensive information of oncolytic viral therapy, from the origin to present scenario.Methods: This observational study was conducted by the Department of Pharmacology, Saveetha Medical College, Chennai between July and December 2016. Date regarding ongoing oncolytic virotherapy trials was retrieved from clinical trial database, United States and Clinical trial registry forum, India. Tamilnogene approval details were obtained from the US-Food and Drug Administration approval new drug approval information.Results: Eleven ongoing trials in Phase I and Ia are being carried out, of which 4 viral strains such as herpes, adenovirus, measles, and reovirus are used for intracerebral malignancies. Four trials have shown superior effects and seven trial results are yet to be completed.Conclusion: Oncolytic viral therapy can be as effective as targeted therapy in battling against cancer; however, long-term efficacy and safety should be established from more studies and meta-analysis.

scholarly journals Tackling rare diseases: Clinical trials on chips

2020 ◽  
Vol 245 (13) ◽  
pp. 1155-1162 ◽  
Author(s):  
Sandra H Blumenrath ◽  
Bo Y Lee ◽  
Lucie Low ◽  
Ranjini Prithviraj ◽  
Danilo Tagle
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Collection ◽  
Rare Disease ◽  
Study Design ◽  
Rare Diseases ◽  
Working Group ◽  
Design Data ◽  
Chip Technology ◽  
Microphysiological Systems

Technological advances with organs-on-chips and induced pluripotent stem cells promise to overcome hurdles associated with developing medical products, especially for rare diseases. Organs-on-chips—bioengineered “microphysiological systems” that mimic human tissue and organ functionality—may overcome clinical trial challenges with real-world patients by offering ways to conduct “clinical trials-on-chips” (CToCs) to inform the design and implementation of rare disease clinical studies in ways not possible with other culture systems. If applied properly, CToCs can substantially impact clinical trial design with regard to anticipated key outcomes, assessment of clinical benefit and risk, safety and tolerability profiles, population stratification, value and efficiency, and scalability. To discuss how tissue chips are best used to move the development of rare disease therapies forward, a working group of experts from industry, academia, and FDA as well as patient representatives addressed questions related to disease setting, test agents for microphysiological systems, study design and feasibility, data collection and use, the benefits and risks associated with this approach, and how to engage stakeholders. While rare diseases with no current therapies were considered the ultimate target, participants cautioned against stepping onto too many unknown territories when using rare disease as initial test beds. Among the disease categories considered ideal for initial CToC tests were well-defined diseases with known clinical outcomes; diseases where tissues on chips can serve as an alternative to risky first-in-human studies, such as in pediatric oncology; and diseases that lend itself to immuno-engineering or genome editing. Participants also considered important challenges, such as hosting the chip technology in-house, the high variability of cell batches and the resulting regulatory concerns, as well as the financial risk associated with the new technology. To make progress in this area and increase confidence with the use of tissue chips, the re-purposing of approved drugs ought to be the very first step. Impact statement Designing and conducting clinical trials are extremely difficult in rare diseases. Adapting tissue chips for rare disease therapy development is pivotal in assuring that treatments are available, especially for severe diseases that are difficult to treat. Thus far, the NCATS-led National Institutes of Health (NIH) Tissue Chip program has focused on deploying the technology towards in vitro tools for safety and efficacy assessments of therapeutics. However, exploring the feasibility and best possible approach to expanding this focus towards the development phase of therapeutics is critical to moving the field of CToCs forward and increasing confidence with the use of tissue chips. The working group of stakeholders and experts convened by NCATS and the Drug Information Association (DIA) addresses important questions related to disease setting, test agents, study design, data collection, benefit/risk, and stakeholder engagement—exploring both current and future best use cases and important prerequisites for progress in this area.

The US Department of Energy's Working Group on Photoelectrochemical Hydrogen Production: Promoting Technology-Enabling Breakthroughs in Semiconductor Materials Research

2009 ◽  
Vol 1171 ◽  
Author(s):  
Roxanne Garland ◽  
Eric L. Miller
Keyword(s):  
Hydrogen Production ◽  
Working Group ◽  
Large Scale ◽  
National Laboratory ◽  
Green Economy ◽  
Current Status ◽  
Laboratory Research ◽  
Synthesis And Characterization ◽  
Silicon Alloys ◽  
Group Activities

AbstractPhotoelectrochemical (PEC) hydrogen production, using sunlight to split water, is an important enabling technology for a future “Green” economy which will rely, in part, on hydrogen as an energy currency. The traditional semiconductor-based PEC material systems studied to date, however, have been unable to meet all the performance, durability and cost requirements for practical hydrogen production. Technology-enabling breakthroughs are needed in the development of new, advanced materials systems, and toward this end, the U.S. Department of Energy’s Working Group on PEC Hydrogen Production is bringing together experts in analysis, theory, synthesis and characterization from the academic, industry and national-laboratory research sectors. Key Working Group activities, as described in this paper, include performing techno-economic analyses of large-scale PEC production systems and establishing standardized testing and screening protocols for candidate PEC materials systems. In addition, a number of Working Group “Task Forces” are focused on advancing critical PEC materials theory, synthesis and characterization capabilities for application in the research and development of broad-ranging materials systems of promise, including complex metal-oxide and -nitride compounds, amorphous silicon alloys, III-V semiconductors and the copper chalcopyrites. The current status of Working Group activities and progress is summarized.

A departmental initiative for clinical and translational research

2016 ◽  
Vol 64 (5) ◽  
pp. 1001-1005
Author(s):  
Christopher J Colombo ◽  
Stephanie Baer ◽  
Lindsay Blake ◽  
Wendy B Bollag ◽  
Rhonda Colombo ◽  
...  
Keyword(s):  
Translational Research ◽  
Working Group ◽  
Financial Support ◽  
Medical College ◽  
Research Activities ◽  
Research Mentoring ◽  
Translational Research Program ◽  
State Organizations ◽  
Academic Services ◽  
Clinical And Translational Research

To encourage departmental research activities, the Department of Medicine of the Medical College of Georgia (MCG) introduced an internally funded Translational Research Program (TRP) in 2014. Patterned after the Vanderbilt Institute for Clinical and Translational Research, the program offers research studios for project guidance, research mentoring and the availability of limited financial support through research vouchers. Additional academic services include abstract reviewing, conducting research conferences, organizing departmental research programs for students, and offering courses in biostatistics. During the first 15 months of its existence, the TRP working group addressed 132 distinct activities. Research mentoring, publications, and the conduct of research studios or voucher approvals encompassed 49% of working group activities. Other academic services constituted the remaining 51%. Twenty-four per cent of TRP committee activities involved research mentoring of 32 investigators (25% faculty and 75% trainees). Mentored projects generated 17 abstracts, 2 manuscripts and $87,000 in funds. The TRP conducted 13 research studios; trainees presented 54%. The TRP reviewed 36 abstracts for local and state organizations. Monthly research conferences and statistical courses were conducted and well attended. Our experience thus far indicates that a departmental TRP may serve to facilitate the growth of patient-oriented research with minimal financial support. It requires active engagement of volunteer faculty and departmental leadership willing to balance research with the other demands of the academic mission.

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