scholarly journals Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

2021 ◽  
Author(s):  
Eleanor Jane Mitchell ◽  
Jalemba Aluvaala ◽  
Lucy Bradshaw ◽  
Jane P Daniels ◽  
Ashok Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Global Health ◽  
Good Clinical Practice ◽  
Research Experience ◽  
Middle Income ◽  
Middle Income Countries ◽  
Training Package

Abstract Background Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global health methodological research priority setting exercise. Methods We explored whether an enhanced training package in a neonatal feasibility study in Kenya and India, utilising elements of the train-the-trainer approach, altered clinicians and researchers’ clinical trials knowledge. A lead “trainer” was identified at each site who attended a UK-based introductory course on clinical trials. A two-day in-country training session was conducted at each hospital. Sessions included the study protocol, governance, data collection and ICH-Good Clinical Practice (GCP). To assess effectiveness of the training package, participants completed questionnaires at the start and end of the study period, including demographics, prior research experience, protocol-specific questions, informed consent and ICH-GCP. Results Thirty participants attended in-country training sessions and completed baseline questionnaires. Around three quarters had previously worked on a research study, yet only half had previously received training. Nineteen participants completed questionnaires at the end of the study period. Questionnaire scores were higher at the end of the study period, though not significantly so. Few participants ‘passed’ the informed consent and ICH-Good Clinical Practice (GCP) modules, using the Global Health Network Training Centre pass mark of ≥ 80%. Participants who reported having prior research experience scored higher in questionnaires before the start of the study period. Conclusions An enhanced training package can improve knowledge of research methods and governance though only small improvements in mean scores between questionnaires completed before and at the end of the study period were seen and were not statistically significant. This is the first report evaluating a clinical trial training package in a neonatal trial in LMICs. Due to the Covid-19 pandemic, research activity was paused and there was a significant time lapse between training and start of the study, which likely impacted upon the scores reported here. Given the burden of disease in LMICs, developing high-quality training materials which utilise a variety of approaches and build research capacity, is critical.

scholarly journals Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017246 ◽  
Author(s):  
Samuel R P Franzen ◽  
Clare Chandler ◽  
Sisira Siribaddana ◽  
Julius Atashili ◽  
Brian Angus ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Necessary Conditions ◽  
Evidence Based ◽  
Middle Income ◽  
Trial Conduct ◽  
Middle Income Countries ◽  
Barriers And Enablers ◽  
Research Systems ◽  
Clinical Trial Conduct

ObjectivesIn 2013, the WHO stated that unless low-income and middle-income countries (LMICs) become producers of research, health goals would be hard to achieve. Among the capacities required to build a local evidence base, ability to conduct clinical trials is important. There is no evidence-based guidance for the best ways to develop locally led trial capacity. This research aims to identify the barriers and enablers to locally led clinical trial conduct in LMICs and determine strategies for their sustainable development.DesignProspective, multiple case study design consisting of interviews (n=34), focus group discussions (n=13) and process mapping exercises (n=10).SettingCase studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013).ParticipantsLocal health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were purposively selected through registration searches and snowball sampling (n=100).Primary and secondary outcome measuresDiscussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified.ResultsInstitutions and individuals were variably successful at conducting trials, but there were strong commonalities in the barriers and enablers across all levels and functions of the research systems. Transferable mechanisms were summarised into the necessary conditions for trial undertaking, which included: awareness of research, motivation, knowledge and technical skills, leadership capabilities, forming collaborations, inclusive trial operations, policy relevance and uptake and macro and institutional strengthening.ConclusionsBarriers and enablers to locally led trial undertaking exist at all levels and functions of LMIC research systems. Establishing the necessary conditions to facilitate this research will require multiple, coordinated interventions that seek to resolve them in a systemic manner. The strategies presented in the discussion provide an evidence-based framework for a self-sustaining capacity development approach. This represents an important contribution to the literature that will be relevant for research funders, users and producers.

scholarly journals Good Clinical Practice (GCP) – an alternative, unarticulated narrative

2021 ◽  
pp. 01-04
Author(s):  
Samir Malhotra
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Clinical Research ◽  
Gold Standard ◽  
Scientific Community ◽  
Good Clinical Practice ◽  
Official Document ◽  
Market Expansion ◽  
New Drug Development

GCP has become the gold-standard for clinical research; initiated as a guideline pertaining to new drug development, it became a law in many countries, extending its scope to include all research. GCP is an excellent document that outlines the responsibilities of stakeholders involved in clinical research. Widely acclaimed, and deservedly so, it is considered as the “go-to” document whenever questions arise during the conduct of a clinical trial. This article presents another narrative, one that has not been articulated so far. Irrespective of whether we consider GCP as a law or a guideline, it is viewed as an “official” document, without the overt realisation that this was actually an initiative of the pharmaceutical industry, the “masters of mankind”. While the stress on documentation and monitoring in GCP was justified, its over-interpretation led to increased costs of clinical trials, with the result that smaller companies find it difficult to conduct the already expensive trials. GCP as an idea is now so entrenched within the scientific community that the real aims which led to its birth and that can be mined from the ICH website, like the need for market expansion, have remained largely unnoticed and undocumented, and are being expressed here.

scholarly journals Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators

2017 ◽  
Vol 1 (1) ◽  
pp. 8-15 ◽  
Author(s):  
Thomas P. Shanley ◽  
Nancy A. Calvin-Naylor ◽  
Ruthvick Divecha ◽  
Michelle M. Wartak ◽  
Karen Blackwell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Clinical Research ◽  
Behavioral Interventions ◽  
Task Force ◽  
Good Clinical Practice ◽  
Translational Science ◽  
Minimum Criteria ◽  
Research Professionals

IntroductionThe translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.MethodsIn 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.ResultsThis paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.ConclusionsWe anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

Analysis of Registered Clinical Trials in The WHO International Clinical Trials Registry Platform, 2005-2019: A Cross-section Study (Preprint)

2020 ◽  
Author(s):  
Fei Zhao ◽  
Wei Xue ◽  
Wenyuan Qi ◽  
Duanduan Cong ◽  
Huiqing Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Middle Income ◽  
Middle Income Countries ◽  
Increasing Trend ◽  
Clinical Trials Registry ◽  
Over Time ◽  
Trial Performance

BACKGROUND Background: World health organization and the international committee of medical journal editors call for clinical trial registration before the start of the recruitment of participants. The registration promotes transparency and accessibility to all researchers and targeted patients globally. OBJECTIVE Objective: We conducted this research to explore the tendency and change of clinical trial registration among different classifications, in order to show the development of the registered clinical trials in the world. METHODS Methods: All clinical trials which had registered in the database of the International Clinical Trials Registry Platform (ICTRP) from 2005 to 2019 were collected as the database for analysis in this study. Developments of clinical trial registration were analyzed in terms of different registries, different regions, different income country classifications by covariance analysis for the difference in clinical trial registration and Cochran-Armitage Test for trend. The sample size enrolled was analyzed to explore whether there was any change in the scale of the clinical trials over time. RESULTS Results: Totally 205,228 clinical trials were registered in the ICTRP from 2005 to 2019. The numbers of clinical trial implementation annually increased as an exponential function (R2=0.83，t=10.45，P< .001). Almost 65% of clinical trials were performed in North American and East Asia & Pacific regions. There was a significant increasing trend in the numbers of clinical trial performance over time (F=184.85, P< .001). The numbers of clinical trial registration were different significantly between different income classifications of the country (F=90.84, P< .001). The sample sizes of the same Phases of clinical trials had no significant difference adjusted by income classification over time changes (F=0.57, P= .45). CONCLUSIONS Conclusions: The clinical trials were becoming flourishing in the world. Most of the clinical trials had performed in high and upper-middle-income countries, especially North American and East Asia & Pacific. And the lower-middle-income countries had a much faster-increasing trend in the clinical trial performance.

The Development of Priority Cervical Cancer Trials: A Gynecologic Cancer InterGroup Report

2010 ◽  
Vol 20 (6) ◽  
pp. 1092-1100 ◽  
Author(s):  
Henry Charles Kitchener ◽  
William Hoskins ◽  
William Small ◽  
Gillian M. Thomas ◽  
Edward Lloyd Trimble
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Early Stage ◽  
Gynecologic Cancer ◽  
Good Clinical Practice ◽  
Middle Income ◽  
Middle Income Countries ◽  
Current State ◽  
International Participation ◽  
Cancer Trials

Since the late 1990s, when a spate of US studies reported the benefit of chemoradiation for cervical cancer, there has been a dearth of clinical trials in cervical cancer. This requires to be addressed with urgency because this disease is responsible for a quarter of a million deaths globally each year, mostly in developing countries, but therapeutic advances are required in all health care settings.The Gynecologic Cancer InterGroup (GCIG) is a worldwide collaborative of leading national groups that develops and promotes multinational trials in gynecologic cancer. In recognition of the pressing need for action, the GCIG convened an international meeting with expert representations from most of the GCIG groups and selected large centers in low- and middle-income countries. The focus was to identify consensus on several concepts for clinical trials, which would be developed and promoted by the GCIG and launched with major international participation.The first half of the meeting was devoted to a resume of the current state of the knowledge and identifying the gaps most needing new evidence. The second half of the meeting was concerned with achieving consensus on the way forward. There were 2 principal outcomes. The first was a proposal to establish, under the umbrella of GCIG, a cervical cancer trials network of centers from countries currently outside GCIG (Eastern Europe, India, Thailand, Southern Africa, and South and Central America), which could increase international participation in trials, conducted within the principles of good clinical practice. The second was to identify the priorities for clinical trials. These included additional systemic therapy before or after chemoradiation; less radical surgery for small, early-stage tumors; the use of fewer fractions to improve cost-effectiveness of treatment in centers with limited resources; and chemotherapy to improve resectability of bulky tumors.

scholarly journals An analysis of certification processes for Good Clinical Practice and project management competencies

2021 ◽  
Vol 43 ◽  
pp. 179-205
Author(s):  
Marek Zawada ◽  
◽  
Dorota Gągała ◽  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Project Management ◽  
Clinical Trial Data ◽  
Well Being ◽  
Good Clinical Practice ◽  
Validity And Reliability ◽  
Certification Process ◽  
Key Characteristics

Aim/purpose–The purpose of this paper is to clarify the certification process of the Good Clinical Practice (GCP) competencies based on a comparison with the project management (PM) certification process. This aim was accomplished by model development.Design/methodology/approach–The study was divided into three main phases: 1st phase –the identification of key characteristics of PM and GCP certification processes, 2nd phase –the development of certification models for PM and GCP, 3rd phase –the conclusions from in-depth interviews.Findings–As a result of the research, key characteristics of PM and GCP certification processes were identified, certification models for PM and GCP were developed. In addition, based on conclusions from in-depth interviews, solutions for organizing the way of confirming knowledge of GCP guidelines were proposed.Research implications/limitations–The proposed rules may be too complex and may exceed the needs and expectations of the clinical trial environment. The models focus on stakeholder relations, without the rules of certification granting procedures, to enable broader contextualization of the issues discussed in the paper. The analysis might be fragmented as it regards the sole certification process. The research refers to Poland only, hence it will be valuable to identify whether foreign authorities have the same attitude to the GCP competency certification model. It is recommended to increase the number of respondents’ interviews to obtain results of higher validity and reliability. Originality/value/contribution–The paper raises research topics at the crossroads of project management, clinical trials, and GCP, topics that have been underdeveloped so far. The results might be significant for all organizations involved in conducting clinical research projects. The findings contribute to the quality of clinical trials and provide public assurance that the rights, safety, and well-being of trial subjects are protected and the clinical trial data are credible.Keywords:project management, clinical trials, certification, Good Clinical Practice, GCP.JEL Classification:M10, O32, I11.

scholarly journals Good clinical practice: International quality standard for clinical trials

2003 ◽  
Vol 50 (1) ◽  
pp. 34-38
Author(s):  
Sinisa Radulovic
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Performance Monitoring ◽  
Experimental Studies ◽  
Clinical Trial Data ◽  
Well Being ◽  
Good Clinical Practice ◽  
Quality Standard ◽  
Scientific Quality

A clinical trial is one of the most important examples of experimental studies. Clinical trials represent an indispensable tool for testing, in a rigorous scientific manner, the efficacy of new therapies. Good Clinical Practice is an international ethical and scientific quality standard for clinical trials, concerning the design, conduct, performance, monitoring auditing, recording, analysis and reporting. This is an assurance to the public that the rights, safety and well-being of trial subjects are protected, and that clinical trial data is credible. The above definitions are consistent with the principles that have their origin in the declaration of Helsinki. The objectives of Good Clinical Practice are to protect the rights of trial subjects, to enhance credibility of data and to improve the quality of science.

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