scholarly journals OC 8469 REVIEWING INVESTIGATIONAL PRODUCT’S QUALITY ASSURANCE DOCUMENTATION IN MAJOR CLINICAL TRIAL REGISTRIES FOR POST-MARKETING CLINICAL TRIAL STUDIES

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A8.2-A8
Author(s):  
Joachim Doua ◽  
Hanneke Dominicus
Keyword(s):  
Clinical Trial ◽  
Developing Countries ◽  
Quality Assurance ◽  
International Committee ◽  
Clinical Trial Registries ◽  
Good Manufacturing Practices ◽  
Quality Testing ◽  
Post Marketing ◽  
Adequate Data

BackgroundThe proven worrisome quality of medicines marketed in developing countries also affects clinical trials (CTs) as they may be used as Investigational Medicinal Products (IMPs). By regulation, CT sponsors should assure IMP’s quality and describe their quality measures in CT protocols that should be registered in a CT Registry (CTR). To check compliance with this regulation, we reviewed major CTRs to assess the availabilities of data fields on IMP quality for post-marketing CTs.MethodsTwo reviewers independently assessed English versions of CTRs of International Committee of Medical Journal Editors (ICJME) and WHO platforms in July 2017. Each CTR was checked for availability of data fields on: brand name; manufacturer’s name; regulatory approval status; approving regulator; manufacturer’s compliance with Good Manufacturing Practices (cGMP); and quality testing (IMP appearance, impurities, microbial contamination, dosing). In case of discrepancy, consensus was sought.ResultsOf 19 CTRs identified, 8 and 6 belonged to WHO and ICMJE, respectively, and 5 were equally part of both platforms. All CTRs had an ‘intervention’ data field to capture data on IMPs and IMP comparators. Unlike all others, the Canadian CTR used ‘drug name’ rather than ‘intervention’. Only the EU CTR had data fields for ‘manufacturer’s name’, ‘product approval status’, and ‘approving authority’. None of the CTRs had data fields on ‘cGMP’ or ‘quality testing’.ConclusionNone of the CTRs of ICMJE and ICTRP has adequate data fields to establish that the source of post-marketing IMPs is of assured quality. This is astonishing given the extensive requirements in WHO and ICMJE guidelines. The gap of quality assurance fields should be bridged by adding them to CTRs. Specifically, IMP quality testing should be conducted before, during, and after clinical trial completion. Until adoption of these measures, EU-CTR should be favoured for registration of CTs conducted in developing countries.

scholarly journals Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yorokpa Joachim Doua ◽  
Hanneke Dominicus ◽  
Julius Mugwagwa ◽  
Suzelle Magalie Gombe ◽  
Jude Nwokike
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Assurance ◽  
Clinical Trial Registries ◽  
Post Marketing ◽  
Major Clinical Trial

scholarly journals Research Clinical Trial- A Review

2021 ◽  
Vol 01 (09) ◽  
Author(s):  
Dr. Ishita Attri ◽  
Keyword(s):  
Clinical Trial ◽  
Healthcare Professionals ◽  
Research Study ◽  
Research Protocol ◽  
Team Members ◽  
Roles And Responsibilities ◽  
Post Marketing Surveillance ◽  
Post Marketing

Majority of healthcare professionals are struggling with conducting and writing a protocol for a research study. Thus, the purpose of this article is to summarize significant steps and necessary guidelines for producing a standard research protocol, roles and responsibilities of various team members involved in the study, and conduction of actual clinical trial including its initiation, phases (I-III), termination or post-marketing surveillance phase. It is important to note that the quality of a clinical trial largely depends on the protocol to achieve success in the research study.

Effect of new dietary supplement on sperm quality

2012 ◽  
Vol 153 (45) ◽  
pp. 1787-1792 ◽  
Author(s):  
Mária Horváth ◽  
Endre Czeizel
Keyword(s):  
Adverse Effect ◽  
Clinical Trial ◽  
Dietary Supplement ◽  
Male Fertility ◽  
Sperm Quality ◽  
Sperm Count ◽  
Before And After ◽  
The Usa ◽  
New Treatments

Introduction: There is a decline in male fertility thus new treatments are needed. Aims: To test the efficacy of a new dietary supplement developed in the USA and registered as a curing drug in Hungary (OGYI). Methods: In a clinical trial 100 men with low sperm quality (spermium count 5–20 M/ml, good motility 10–40%, and adverse shape 30–50%) were examined. Results: Sperm parameters were measured before and after a 3-month treatment and after another 3-month without treatment. This dietary supplement statistically and clinically significantly improved sperm count and motility. In 74 cases this dietary supplement demonstrated a beneficial effect on sperm quality (more than 10% increase in sperm count, or quality of motility, or shape); in 16 cases the improvement exceeded 30%. No adverse effect could be accounted for this treatment. Conclusions: This new dietary supplement may contribute to the treatment of male infertility. Orv. Hetil., 2012, 153, 1787–1792.

CREATING WALKING LED TRANSIT STATIONS FOR WOMEN IN MALAYSIA

2020 ◽  
Vol 7 (1) ◽  
pp. 99
Author(s):  
Yong Adilah Shamsul Harumain ◽  
Nur Farhana Azmi ◽  
Suhaini Yusoff
Keyword(s):  
Quality Of Life ◽  
Developing Countries ◽  
Public Transportation ◽  
Carbon Emission ◽  
The Other ◽  
Walking Distance ◽  
The Road ◽  
On The Road ◽  
Female User

Transit stations are generally well known as nodes of spaces where percentage of people walking are relatively high. The issue is do more planning is actually given to create walkability. Creating walking led transit stations involves planning of walking distance, providing facilities like pathways, toilets, seating and lighting. On the other hand, creating walking led transit station for women uncover a new epitome. Walking becomes one of the most important forms of mobility for women in developing countries nowadays. Encouraging women to use public transportation is not just about another effort to promote the use of public transportation but also another great endeavour to reduce numbers of traffic on the road. This also means, creating an effort to control accidents rate, reducing carbon emission, improving health and eventually, developing the quality of life. Hence, in this paper, we sought first to find out the factors that motivate women to walk at transit stations in Malaysia. A questionnaire survey with 562 female user of Light Railway Transit (LRT) was conducted at LRT stations along Kelana Jaya Line. Both built and non-built environment characteristics, particularly distance, safety and facilities were found as factors that are consistently associated with women walkability. With these findings, the paper highlights the criteria  which are needed to create and make betterment of transit stations not just for women but also for walkability in general.

Developing the culture and discipline of conducting and publishing scientific research: Guiding principles

2014 ◽  
Vol 1 ◽  
pp. 1-7
Author(s):  
Daniel Obeng-Ofori
Keyword(s):  
Developing Countries ◽  
Scientific Research ◽  
Scientific Writing ◽  
Weekly Schedule ◽  
Academic Activities ◽  
Heavy Workload ◽  
Guiding Principles ◽  
Mentoring System ◽  
Critical Constraints

The pressure to publish is a fact of life in academia. Academics are expected to demonstrate that they are active researchersand that their work has been vetted by peers and disseminated in reputable scholarly forums. In practice, however, a numberof critical constraints hamper effective publication of scientific research in most developing countries. These include lackof effective mentoring system, poor facilities and inadequate funding for effective research and heavy workload where toomuch time and effort are spent in teaching, grading, meetings and other non-academic activities. In spite of these seeminglyinsurmountable challenges, with proper planning and commitment, one can still conduct research and publish to advanceones career and exchange of knowledge. The paper discusses the critical guiding principles in scientific writing and publishingin an unfriendly research environment as pertains in most universities in the developing world. The overriding principle isto cultivate the discipline of scientific writing consciously and follow it through religiously. This could be achieved if time isallocated for scientific writing in the scheme of weekly schedule of activities and made to be functional through meticulousplanning and commitment. Equally important is to avoid procedural mistakes in scientific writing. While the quality of theresearch is the single most important factor in determining whether an article will be published, a number of proceduralmistakes can help tip the balance against its publication. It should also be noted that when a manuscript is submitted to ascholarly journal, there are two audiences to satisfy: first the editor and external reviewers, and then the journal’s readers.That first group must be satisfied to create the opportunity to appeal to the second. Thus, familiarity with the style and tone ofthe specific journal is crucial.

CONCEPTUAL BASES OF ADAPTATION OF UKRAINE’S HIGHER EDUCATION TO THE STANDARDS OF EDUCATION QUALITY OF THE EUROPEAN AREA

2018 ◽  
Author(s):  
Nina Batechko
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
European Higher Education Area ◽  
Quality Of Higher Education ◽  
European Area ◽  
European Higher Education ◽  
European Standards ◽  
Conceptual Foundations

The article outlines the conceptual framework for adapting Ukrainian higher education to the Standards and Recommendations for Quality Assurance in the European higher education area. The role of the Bologna Declaration in ensuring the quality of higher education in Europe has been explained. The conceptual foundations and the essence of standards and recommendations on quality assurance in the European higher education area have been defined. The Ukrainian realities of the adaptation of higher education of Ukraine to the educational European standards of quality have been characterized.

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