scholarly journals Clinical Trial Oversight Committee Information

2020 ◽  
Author(s):  
Keyword(s):  
Clinical Trial ◽  
Oversight Committee ◽  
Trial Oversight

scholarly journals PO 8300 REGIONAL CENTER FOR REGULATORY EXCELLENCE IN CLINICAL TRIAL OVERSIGHT – TRAINING 2017

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A28.1-A28
Author(s):  
Delese Darko ◽  
Yvonne Adu-Boahen
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Good Clinical Practice ◽  
Training Programme ◽  
Fellowship Training ◽  
Training Methods ◽  
Health Technologies ◽  
Trial Oversight ◽  
The Impact

BackgroundThe competencies of the various national medicines regulatory agencies (NMRAs) in Africa vary which leads to generally porous regulatory systems for clinical trial oversight. Consequently, many trials have been conducted under unacceptable conditions compromising participants’ safety and data credibility and resulted in questionable outcomes that are used for making scientific judgement in addressing issues of public health in Africa.To improve the safety and quality of health technologies in Africa, the New Partnership for African Development (NEPAD) agency launched a programme to designate Regional Centres of Regulatory Excellence (RCOREs) with the specific objective of bridging existing gaps between African NMRAs through strengthening regulatory capacity of African Union member states. The Food and Drugs Authority (FDA), Ghana, was designated as RCORE for Clinical Trials oversight in May 2014.MethodsTo achieve the RCORE objectives, the FDA collaborated with the School of Public Health (SPH), University of Ghana to develop a training manual and piloted a training programme with funds from the International AIDS Vaccine Initiative (IAVI) through NEPAD.The programme, consisting of 4 compulsory modules, was organised from 6–30 November 2017 for 10 participants from Zambia, Sierra Leone, Liberia, Rwanda and Ghana. Interactive training methods in the form of theoretical and practical sessions were employed.ResultsThe pilot RCORE training was successful with expected training objectives achieved. Participants gained hands-on experience through activities like observing Good Clinical Practice inspection and a Technical Advisory Committee Meeting. Participants were given template tools to assist in developing regulatory guidelines and forms in their respective countries.A follow-up questionnaire was circulated to participants to assess the impact of the training on their work. Feedback „indicates that regulation of clinical trials has improved in their respective institutions.ConclusionThis pilot fellowship training was successful, „leading to the improvement of clinical trial regulation in the participating countries.

scholarly journals A third trial oversight committee: Functions, benefits and issues

2019 ◽  
Vol 17 (1) ◽  
pp. 106-112
Author(s):  
J Athene Lane ◽  
Carrol Gamble ◽  
William J Cragg ◽  
Doreen Tembo ◽  
Matthew R Sydes
Keyword(s):  
Data Monitoring Committee ◽  
Steering Committee ◽  
Data Monitoring ◽  
Independent Data ◽  
Trial Management ◽  
Independent Data Monitoring Committee ◽  
The Third ◽  
Monitoring Committee ◽  
Oversight Committee ◽  
Trial Oversight

Background/aims: Clinical trial oversight is central to the safety of participants and production of robust data. The United Kingdom Medical Research Council originally set out an oversight structure comprising three committees in 1998. The first committee, led by the trial team, is hands-on with trial conduct/operations (‘Trial Management Group’) and essential. The second committee (Data Monitoring Committee), usually completely independent of the trial, reviews accumulating trial evidence and is used by most later phase trials. The Independent Data Monitoring Committee makes recommendations to the third oversight committee. The third committee, (‘Trial Steering Committee’), facilitates in-depth interactions of independent and non-independent trial members and gives broader oversight (blinded to comparative analysis). We investigated the roles and functioning of the third oversight committee with multiple research methods. We reflect upon these findings to standardise the committee’s remit and operation and to potentially increase its usage. Methods: We utilised findings from our recent published suite of research on the third oversight committee to inform guideline revision. In brief, we conducted a survey of 38 United Kingdom–registered Clinical Trials Units, reviewed a cohort of 264 published trials, observed 8 third oversight committee meetings and interviewed 52 trialists. We convened an expert panel to discuss third oversight committees. Subsequently, we interviewed nine patient/lay third committee members and eight committee Chairs. Results: In the survey, most Clinical Trials Units required a third committee for all their trials (27/38, 71%) with independent members (ranging from 1 to 6). In the survey and interviews, the independence of the third committee was valued to make unbiased consideration of Independent Data Monitoring Committee recommendations and to advise on trial progress, protocol changes and recruitment issues in conjunction with the trial leadership. The third committee also advised funders and sponsors about trial continuation and represented patients and the public by including lay members. Of the cohort of 264 published trials, 144 reported a ‘steering’ committee (55%), but the independence of these members was not described so these may have been internal Trial Management Groups. Around two thirds of papers (60%) reported having an Independent Data Monitoring Committee and 26.9% neither a steering nor an Independent Data Monitoring Committee. However, before revising the third committee charter (Terms of Reference), greater standardisation is needed around defining member independence, composition, primacy of decision-making, interactions with other committees and the lifespan. Conclusion: A third oversight committee has benefits for trial oversight and conduct, and a revised charter will facilitate greater standardisation and wider adoption.

scholarly journals PO 8381 REGULATING CLINICAL TRIALS DURING AN EBOLA EMERGENCY: THE LIBERIAN EXPERIENCE

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A30.2-A30
Author(s):  
Theophilus Ndorbor ◽  
David Sumo ◽  
Juwe D Kercula ◽  
Ezekiel F Hallie
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Ebola Virus ◽  
Virus Disease ◽  
Regulatory System ◽  
Medical Emergency ◽  
Major Function ◽  
Resource Limited ◽  
Key Stakeholders ◽  
Trial Oversight

BackgroundEffective clinical trials oversight is a major function of a fully functional national medical products regulatory system. However, exercising clinical trial oversight in a resource-limited environment is challenging, in particular during an Ebola outbreak or health emergency. Until the devastating Ebola virus disease (EVD) outbreak in 2014, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) had no capacity for effective clinical trial regulation. This presentation describes the main challenges encountered by LMHRA in regulating clinical trials in Liberia during the largest EVD outbreak that affected West Africa in 2014 and 2015.MethodsBy carefully documenting activities during the EVD outbreak, interviewing key stakeholders, and discussions among the LMHRA clinical trial committee, key challenges observed during the outbreak were identified and documented.ResultsLimited financial resources, lack of expertise in clinical trials, inaccurate and insufficient information about the functions of the LMHRA, poor coordination among key stakeholders, and the lack of a well-developed regulatory framework, adversely influenced the LMHRA clinical trial oversight performance during the EVD outbreak.ConclusionIt is true that several challenges need to be addressed when regulating a clinical trial in a limited-resource environment during any disease outbreak or international medical emergency. However, the importance of building local expertise in clinical trials through mentorship and training cannot be overemphasised. By taking advantage of grants from developmental partners, national medicines regulatory authorities in resource-limited environments can develop capacity for clinical research oversight.

Randomized clinical trial of LigasureTM versus open haemorrhoidectomy

2002 ◽  
Vol 89 (2) ◽  
pp. 154-157 ◽  
Author(s):  
F. F Palazzo ◽  
D. L Francis ◽  
M. A Clifton
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial

Ciprofloxacin is more effective in treating acute pouchitis than metronidazole: A randomized clinical trial

2001 ◽  
Vol 120 (5) ◽  
pp. A453-A453 ◽  
Author(s):  
B SHEN ◽  
J ACHKAR ◽  
B LASHNER ◽  
A ORMSBY ◽  
F REMZI ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial
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