Assessment of the Extent of the Necessary Clinical Testing of New Biotechnological Products Based on the Analysis of Scientific Publications and Clinical Trials Reports

2015 ◽  
Author(s):  
Roman Suvorov ◽  
Ivan Smirnov ◽  
Konstantin Popov ◽  
Nikolay Yarygin ◽  
Konstantin Yarygin
Keyword(s):  
Clinical Trials ◽  
Clinical Testing ◽  
Scientific Publications ◽  
Biotechnological Products

scholarly journals Non-Patent Literature

Encyclopedia ◽  
2021 ◽  
Vol 1 (1) ◽  
pp. 198-205
Author(s):  
Gema Velayos-Ortega ◽  
Rosana López-Carreño
Keyword(s):  
Clinical Trials ◽  
Conference Proceedings ◽  
Subject Matter ◽  
Technical Standards ◽  
Scientific Publications ◽  
Patent Literature

Non-patent literature is defined as scientific publications, technical standards, conference proceedings, clinical trials, books, manuals, technical or research reports, or any other technical scientific material which is cited in patents to show what has already been published and disseminated about the invention to be patented, in order to justify its novelty. These documents are considered technically relevant to the patent granting procedure and are cited along with other patents related to the same subject matter.

Estimands—a basic element for clinical trials. Part 29 of a series on evaluation of scientific publications

2021 ◽  
Author(s):  
Moritz Pohl ◽  
Lukas Baumann ◽  
Rouven Behnisch ◽  
Marietta Kirchner ◽  
Johannes Krisam ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Basic Element ◽  
Scientific Publications

Meropenem: A New Carbapenem Antimicrobial

1994 ◽  
Vol 28 (9) ◽  
pp. 1045-1054 ◽  
Author(s):  
Randy D. Pryka ◽  
George M. Haig
Keyword(s):  
Clinical Trials ◽  
English Language ◽  
Antimicrobial Agents ◽  
Pharmacokinetic Analysis ◽  
Upper Respiratory Tract ◽  
Gram Positive ◽  
Scientific Publications ◽  
In Vitro Susceptibility ◽  
Study Selection

OBJECTIVE: To describe and then compare an investigational carbapenem antibiotic, meropenem, with the only currently available antibiotic in this class, imipenem/cilastatin. DATA IDENTIFICATION: An English language search using MEDLINE (1988–1993); Abstracts of the 31st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), 1991; and Abstracts of the 32nd ICAAC, 1992. STUDY SELECTION: All current scientific publications were reviewed for study design and quality. Emphasis was placed on susceptibility and pharmacokinetic analysis. Phase 3 clinical trials are now being completed and have only been published in abstract form. Hence, conclusions derived regarding efficacy were tempered. RESULTS: Meropenem is active against a broad spectrum of gram-positive and -negative pathogens including beta-lactamase producers. Meropenem appears to be two- to fourfold less active than imipenem against gram-positive organisms. Meropenem is two- to fivefold more active against enterobacteriaceae. The two compounds appear to be equally active against Pseudomonas aeruginosa. Pharmacokinetic disposition is also similar for imipenem and meropenem. Meropenem may exhibit greater tissue penetration. Meropenem is not labile to renal hydrolysis and can be administered without a competitive antagonist of dihydropeptidase, such as cilastatin. In clinical trials, meropenem appears to be as safe and effective as imipenem/cilastatin or ceftazidime in the treatment of infections involving soft tissue, urinary tract, upper respiratory tract, abdominal processes, and febrile neutropenic episodes. CONCLUSIONS: Meropenem is comparable to imipenem in terms of in vitro susceptibility pattern and pharmacokinetic disposition. Overall, meropenem seems to offer promise as the second of the carbapenem class of antibiotics. Clinical data are preliminary, and further data are needed.

scholarly journals Global trends in clinical trials involving pluripotent stem cells: a systematic multi-database analysis

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Julia Deinsberger ◽  
David Reisinger ◽  
Benedikt Weber
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Pluripotent Stem Cells ◽  
Search Algorithm ◽  
Embryonic Stem ◽  
Induced Pluripotent Stem Cell ◽  
World Health ◽  
Clinical Use ◽  
Scientific Publications ◽  
Induced Pluripotent

Abstract Pluripotent stem cells (PSCs) hold great potential for novel therapeutic approaches to regenerate or replace functionally impaired tissues. Since the introduction of the induced pluripotent stem cell technology in 2006, the number of scientific publications on this topic has constantly been increasing. However, so far no therapy based on PSCs has found its way into routine clinical use. In this study, we examined research trends related to clinical trials involving PSCs based on data obtained from ClinicalTrials.gov, the ICTRP database from the World Health Organization, as well as from a search of all individual databases that are included in the ICTRP using a multistep search algorithm. Following a stringent inclusion/exclusion procedure 131 studies remained that could be classified as clinical trials involving PSCs. The magnitude of these studies (77.1%) was observational, which implies that no cells were transplanted into patients, and only a minority of studies (22.9%) were of an interventional study type. The number of clinical trials involving induced pluripotent stem cells (iPSCs, 74.8%) was substantially higher than the one involving embryonic stem cells (ESCs, 25.2%). However, the picture changes completely when focusing on interventional studies, where in the majority (73.3%) of cases ESCs were used. Interestingly, also the study duration was significantly shorter for interventional versus observational trials (p = 0.002). When focusing on the geographical study regions, it became obvious that the greatest part of all observational trials was performed in the USA (41.6%) and in France (16.8%), while the magnitude of interventional studies was performed in Asian countries (China 36.7%, Japan 13.3%, South Korea 10.0%) and in the field of ophthalmology. In summary, these results indicate that only a limited number of trials were focusing on the actual transplantation of PSCs into patients in a rather narrow field of diagnoses. The future will tell us, if the iPSC technology will ultimately overcome the current challenges and will finally make its way into routine clinical use.

scholarly journals CDEK: Clinical Drug Experience Knowledgebase

2018 ◽  
Author(s):  
Rebekah Griesenauer ◽  
Constantino Schillebeeckx ◽  
Michael S Kinch
Keyword(s):  
Clinical Trials ◽  
Active Pharmaceutical Ingredients ◽  
Clinical Testing ◽  
Drug Experience ◽  
Pharmaceutical Ingredients ◽  
Drug Databases ◽  
Regulatory Sciences ◽  
Web Platform ◽  
Clinical Drug ◽  
Clinical And Translational Research

The Clinical Drug Experience Knowledgebase (CDEK) is a database and web platform of active pharmaceutical ingredients with evidence of clinical testing as well as the organizations involved in their research and development. CDEK was curated by disambiguating intervention and organization names from ClinicalTrials.gov and cross-referencing these entries with other prominent drug databases. Approximately 43% of active pharmaceutical ingredients in the CDEK database were sourced from ClinicalTrials.gov and cannot be found in any other prominent compound-oriented database. The contents of CDEK are structured around three pillars: active pharmaceutical ingredients (n = 22,292), clinical trials (n = 127,223), and organizations (n = 24,728). The envisioned use of the CDEK is to support the investigation of many aspects of drug development, including discovery, repurposing opportunities, chemo- and bio-informatics, clinical and translational research, and regulatory sciences.

scholarly journals What are the most promising treatments and vaccine candidates for COVID-19? A global survey of experts involved in virus research (Preprint)

2020 ◽  
Author(s):  
Bernardo Pereira Cabral ◽  
Luiza Braga ◽  
Fabio Mota
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Trial Data ◽  
Scientific Publications ◽  
Vaccine Candidates ◽  
Short Period ◽  
The World ◽  
Virus Research ◽  
Short Time ◽  
Effective Drugs

BACKGROUND The Coronavirus Disease 2019 (COVID-19) pandemic presents a great public health challenge around the world, especially given the urgency to identify effective drugs and develop a vaccine in a short period of time. Globally, there are several drug and vaccine candidates currently in clinical trials, yet it is not yet clear which will prove successful. OBJECTIVE This study addresses this gap by mapping the treatments and vaccine candidates currently in clinical trials and assessing the opinions on these candidates of virus-related researchers from all over the world. METHODS Clinical trial data were obtained from ClinicalTrials.gov and the survey’s respondents were authors of recent scientific publications related to viruses, SARS virus, coronavirus, and COVID-19 indexed in the Web of Science Core Collection. RESULTS The results show that remdesivir, immunoglobulin from cured patients and plasma are considered the most promising treatments, and ChAdOx1 and mRNA-1273 the most promising vaccine candidates. They also indicate that a vaccine could be available within eighteen months. CONCLUSIONS Changes in the clinical trial process are currently being implemented worldwide in an attempt to accelerate the discovery of an entirely new vaccine to prevent COVID-19 8. These changes may be why the respondents felt it would take such a short time to develop a vaccine. Despite the relatively high percentage of unknown answers, which may be linked to the short-term perspective of this survey and the current uncertainties surrounding the subject at hand, the results of this survey suggest that the efforts made so far to accelerate the discovery of a new vaccine are in line with its purpose. If these expectations are confirmed, perhaps the discovery that will bring an end to the COVID-19 pandemic is not so very far away

scholarly journals CDEK: Clinical Drug Experience Knowledgebase

Database ◽  
2019 ◽  
Vol 2019 ◽  
Author(s):  
Rebekah H Griesenauer ◽  
Constantino Schillebeeckx ◽  
Michael S Kinch
Keyword(s):  
Clinical Trials ◽  
Active Pharmaceutical Ingredients ◽  
Clinical Testing ◽  
Drug Experience ◽  
Pharmaceutical Ingredients ◽  
Drug Databases ◽  
Regulatory Sciences ◽  
Web Platform ◽  
Clinical Drug ◽  
Clinical And Translational Research

Abstract The Clinical Drug Experience Knowledgebase (CDEK) is a database and web platform of active pharmaceutical ingredients with evidence of clinical testing as well as the organizations involved in their research and development. CDEK was curated by disambiguating intervention and organization names from ClinicalTrials.gov and cross-referencing these entries with other prominent drug databases. Approximately 43% of active pharmaceutical ingredients in the CDEK database were sourced from ClinicalTrials.gov and cannot be found in any other prominent compound-oriented database. The contents of CDEK are structured around three pillars: active pharmaceutical ingredients (n = 22 292), clinical trials (n = 127 223) and organizations (n = 24 728). The envisioned use of the CDEK is to support the investigation of many aspects of drug development, including discovery, repurposing opportunities, chemo- and bio-informatics, clinical and translational research and regulatory sciences.

3D Printing As a Significant Achievement for Application in Posttraumatic Surgeries - A Literature Review

2020 ◽  
Vol 16 ◽  
Author(s):  
Michał Smoczok ◽  
Krzysztof Starszak ◽  
Weronika Starszak
Keyword(s):  
Clinical Trials ◽  
3D Printing ◽  
Mesh Term ◽  
Review Article ◽  
Trauma Patients ◽  
Scientific Publications ◽  
Imaging Diagnostics ◽  
Printing Technology ◽  
3D Printing Technology ◽  
Significant Achievement

Background: 3D printing is increasingly used in many fields of medicine. The broadening of knowledge in this field and the cooperation of doctors and engineers increases the interest in this technology and results in attempts to implement it at every stage of the treatment. Objective: The review aims to summarize the current literature on the use of 3D printing technology in the treatment of post trauma patients. Method: A review of available scientific publications in PubMed regarding 3D printing and its application in the context of posttraumatic procedures was carried out. Clinical Trials and Reviews from the period 2014-2019 (6-year period) were taken into consideration. The database was searched for "Printing", "ThreeDimensional" [MAJR] [MeSH Term]. Finally, 48 studies have been included in our review article. Results: 3D printing technology has a number of applications in patients who have suffered injuries. 3D printing has found application in preparation for procedures, accurate visualization of occurring injuries and complications, education of doctors and patients, prototyping, creation of synthetic scaffolding, production and implementation of target implants and rehabilitation. Conclusion: 3D printing is increasingly used in providing for the posttraumatic patients. It is necessary to conduct further research in this area and to provide development opportunities in regarding biopolymers and bioprinting. It is also necessary to improve cooperation between doctors and engineers and to create new centres that can comprehensively use 3D printing - from imaging diagnostics to the production of implants and their surgical use.

An analysis of target-specific patient resource utilization in NSCLC clinical trials.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18112-e18112
Author(s):  
Neeta Somaiah ◽  
George R. Simon
Keyword(s):  
Clinical Trials ◽  
Resource Utilization ◽  
Phase Iii ◽  
Clinical Testing ◽  
Targeted Agents ◽  
Specific Patient ◽  
New Targets ◽  
Number Of Patients ◽  
Nsclc Patients ◽  
The Impact

e18112 Background: A plethora of targeted agents are currently being evaluated in patients with NSCLC. The number of targeted agents exceeds the number of targets leading to many targeted agents being evaluated against similar targets. The identification of new targets are likely to increase exponentially in the near future given the numerous currently ongoing molecular profiling efforts. The objective of this analysis is to estimate the target-specific patient resource utilization and its impact on routine clinical care. Methods: A comprehensive search for molecularly targeted agents in clinical testing that have accrued or are accruing NSCLC patients were performed by using publically available search engines and databases. Agents were grouped according to the primary target and the phase of development. We computed the number of patients allocated to completed and ongoing phase III NSCLC trials for advanced NSCLC alone. Results: There are more than 30 categories of molecular targets accruing NSCLC patients in clinical trials. By conservative estimates, approximately 215 agents are currently undergoing clinical testing. The median number of agents per target is 7 (range 2 (HIF-1α and PDGFRα) – 24 (EGFR)). There are 7 EGFR inhibitors and 10 VEGFR inhibitors that were evaluated in phase III trials; with 36,093 and 20,313 stage IV NSCLC patients enrolled or to be enrolled in these trials, respectively. No more than 2 agents per target have been FDA approved for NSCLC to date. Further details of the analyses will be more comprehensively presented at the meeting. Conclusions: Patient resource utilization is unevenly distributed across targets. The optimal number of targeted agents to be evaluated per target remains to be defined. More emphasis on identifying new targets and targeting these with limited number of optimal agents may accelerate the advancement of the field and the impact on patient care.

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