Clinical research and good clinical practice

2001 ◽  
Vol 15 (4) ◽  
pp. 655-667 ◽  
Author(s):  
K.M. Robertson ◽  
T.J. Gan
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Good Clinical Practice

scholarly journals Obstacles in conducting clinical trials in the Saudi Arabia

2017 ◽  
Vol 4 (4) ◽  
pp. 166
Author(s):  
Salem D. Al Suwaidan ◽  
Aseel S. Alsuwaidan
Keyword(s):  
Clinical Trials ◽  
Saudi Arabia ◽  
Clinical Practice ◽  
Clinical Research ◽  
Strategic Plan ◽  
Good Clinical Practice ◽  
European Countries ◽  
Regulatory Authorities ◽  
Research Institution

<p class="abstract"><strong>Background:</strong> Conducting clinical research in accordance with the standards of regulatory authorities and within the guidelines of the good clinical practice (GCP) is a matter of concern.  It has been noticed that some increment in the conduction of clinical trials outside USA and European countries in the last two decades. The main objective of this study is to identify the magnitude of some obstacles that affect the conduction of clinical trials in accordance with the GCP.</p><p class="abstract"><strong>Methods:</strong> Developing questionnaire in accordance with the criteria of the GCP would make assessment on how to buildup infrastructure including policy and procedures of the research institution. Recommendation of the study is to perform this questionnaire every other year to assess the progress and development of the research institution.</p><p><strong>Conclusions:</strong> To identify good clinical researchers, what sort of obstacle(s) regarding conducting clinical trials, and from these obstacles how to resolve it and build up infrastructure for the research institution and also to establish the strategic plan for the research institution.</p>

scholarly journals European survey on national training activities in clinical research

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
A. Magnin ◽  
V. Cabral Iversen ◽  
G. Calvo ◽  
B. Čečetková ◽  
O. Dale ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Core Competencies ◽  
Good Clinical Practice ◽  
Specific Training ◽  
Continuous Training ◽  
Number Of Patients ◽  
Starting Point ◽  
Training Activities ◽  
Career Options

Abstract Background Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs often need to be multinational in order to recruit a sufficient number of patients. Recent studies highlighted that well-trained study personnel are a major factor to conduct such complex IITs successfully. As of today, however, no overview of the European training activities, requirements and career options for clinical study personnel exists. Methods To fill this knowledge gap, a survey was performed in all 11 member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardised questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the landscape of academic training opportunities, to facilitate the exchange of expertise and experience among countries and to identify new fields of action. Results The survey found that training for Good Clinical Practice (GCP) and investigator training is offered in all but one country. A specific training for study nurses or study coordinators is also either provided or planned in ten out of eleven countries. A majority of countries train in monitoring and clinical pharmacovigilance and offer specific training for principal investigators but only few countries also train operators of clinical research organisations (CRO) or provide training for methodology and quality management systems (QMS). Minimal requirements for study-specific functions cover GCP in ten countries. Only three countries issued no requirements or recommendations regarding the continuous training of study personnel. Yet, only four countries developed a national strategy for training in clinical research and the career options for clinical researchers are still limited in the majority of countries. Conclusions There is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation.

scholarly journals All nurses need to be research nurses

2017 ◽  
Vol 1 (5) ◽  
pp. 269-270 ◽  
Author(s):  
Patricia Eckardt ◽  
Marilyn J. Hammer ◽  
Margaret Barton-Burke ◽  
Margaret McCabe ◽  
Christine T. Kovner ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Quality Care ◽  
Good Clinical Practice ◽  
Education And Training ◽  
Validity And Reliability ◽  
Test Items ◽  
Research Nurses ◽  
Training Need ◽  
And Training

IntroductionNurses are critical to the research enterprise. However all nurses are not prepared to participate as members of the research team since education and training in clinical research nursing and nurse-specific Good Clinical Practice are not consistently included in nursing curricula. The lack of nurse education and training in clinical research and Good Clinical Practice leaves research participants vulnerable with a nursing workforce that is not prepared to balance fidelity to protocol and patient quality care and safety.MethodsA collaborative network of nurses within Clinical and Translational Science Awards and beyond was established to address this education and training need. Over a 2-year period, using expert opinion, Delphi methods, and measures of validity and reliability the team constructed curriculum and knowledge test items.ResultsA pilot modular electronic curriculum, including knowledge pretest and post-tests, in clinical research nursing and nurse-specific Good Clinical Practice competencies was developed.ConclusionsAs the scope and setting of clinical research changes, it is likely that all practicing nurses, regardless of their practice setting or specialty, will care for patients on research protocol, making all nurses, in essence, clinical research nurses. The curriculum developed by this protocol will address that workforce education and training need.

The Good Clinical Practice guideline: a bronze standard for clinical research

The Lancet ◽  
2005 ◽  
Vol 366 (9480) ◽  
pp. 172-174 ◽  
Author(s):  
David A Grimes ◽  
David Hubacher ◽  
Kavita Nanda ◽  
Kenneth F Schulz ◽  
David Moher ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Clinical Practice Guideline ◽  
Practice Guideline ◽  
Good Clinical Practice ◽  
Good Clinical Practice Guideline

scholarly journals Dishonesty, Misconduct and Fraud in Clinical Research: An International Problem

2002 ◽  
Vol 30 (4) ◽  
pp. 357-365 ◽  
Author(s):  
SI Ankier
Keyword(s):  
European Union ◽  
Clinical Practice ◽  
Clinical Research ◽  
Broad Spectrum ◽  
Good Clinical Practice ◽  
Working Environment ◽  
Unfair Advantage ◽  
Definition Of

Clinical research misdemeanours include a broad spectrum of misdeeds that misappropriate an unfair advantage or harm the rights of others. There is no internationally accepted definition of such malpractices and no generalized procedure to facilitate their reporting or correction. Those who do report research misdemeanours are often stigmatized as ‘whistleblowers’, a term that has acquired many negative connotations. Frequently, whistleblowers encounter many personal conflicts and/or may suffer victimization in their working environment. There remains a need for an internationally harmonized approach to manage these unacceptable problems. Resolution of such important issues should be catalysed by the impending need for European Union states to implement Good Clinical Practice Directive 2001/20/EC into national law.

scholarly journals ESMO Clinical Research Observatory (ECRO): improving the efficiency of clinical research through rationalisation of bureaucracy

ESMO Open ◽  
2020 ◽  
Vol 5 (3) ◽  
pp. e000662 ◽  
Author(s):  
Jose Luis Perez-Gracia ◽  
Ahmad Awada ◽  
Emiliano Calvo ◽  
Teresa Amaral ◽  
Hendrik-Tobias Arkenau ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Task Force ◽  
Good Clinical Practice ◽  
Legal Regulations ◽  
Rigorous Analysis ◽  
Research Teams ◽  
Declaration Of Helsinki ◽  
Overall Efficiency ◽  
Administrative Tasks

During the last years, there has been a dramatic increase in the administrative and bureaucratic burden associated with clinical research, which has clearly had an impact on its overall efficiency and on the activity of clinical investigators and research teams. Indeed, the supervision of the adherence of clinical research to Good Clinical Practice (GCP) guidelines and legal regulations is of the utmost importance. Yet, while such regulations have remained largely unchanged during recent years, the number of administrative tasks and their complexity have grown markedly, as supported by the results of a survey performed among 940 clinical investigators that we report in this manuscript. Therefore, many investigators believe that it has become necessary to undertake a rigorous analysis of the causes and consequences of this issue, and to create a conduit to channel the advice from experienced investigators regarding clinical research procedures, in order to improve them. Based on these premises, ESMO has launched the ESMO Clinical Research Observatory (ECRO), a task force that will analyse different aspects of clinical research. ECRO will aim to provide the views of ESMO on clinical research procedures based on the feedback from clinical investigators, under complete adherence to the Declaration of Helsinki, the GCP guidelines and any other applicable legal regulations, while at the same time showing profound respect for all the stakeholders involved in clinical research. This manuscript provides the background and rationale for the creation of ECRO, its planned activity and an analysis of the current administrative burden in clinical research with recommendations to rationalise it. Indeed, we expect that this effort shall lead to a relevant improvement in the care of patients and in the development of clinical research.

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.

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