scholarly journals Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation

2021 ◽  
Author(s):  
Kenichi Nakamura ◽  
Hitoshi Ozawa ◽  
Taro Shibata ◽  
Nobuko Ushirozawa ◽  
Tomomi Hata ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Informed Consent ◽  
Research Group ◽  
Good Clinical Practice ◽  
The United States ◽  
Ethics Committee ◽  
Real World Data ◽  
Technical Requirements ◽  
Expert Working Group ◽  
Survey Results

Abstract Background The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders. Methods A total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public. Results The survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP’s scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data. Conclusion The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation.

scholarly journals Medicolegal Perspective on Physician-Induced Demand Issue

BESTUUR ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. 106
Author(s):  
Wulandari Berliani Putri ◽  
Vita Widyasari ◽  
Juliet Musabula ◽  
Muhammad Jihadul Hayat
Keyword(s):  
Clinical Practice ◽  
Informed Consent ◽  
Healthcare Providers ◽  
Legal Protection ◽  
Good Clinical Practice ◽  
Payment System ◽  
Medical Law ◽  
Induced Demand ◽  
Patients Rights ◽  
Health Regulations

<p>This study sheds light on the extent to which the medical law protects patients' rights from Physician-Induced Demand behavior. This study shows that the term of Physician-Induced Demand has not been recognized in health regulations. Meanwhile, some often fail to recall that medical law has protected patients’ right in the therapeutic transaction between doctor and patient through Act No. 29 of 2004; Minister of Health Regulations number 11 Year 2017; Act No. 44 of 2009, Civil Code and Act No. 36 of 2009. In order to reduce Physician-Induced Demand, establishing a guideline of good clinical practice, including the informed-consent guideline is urgently needed. Government should also control the quality and cost of healthcare providers as well as adequate payment system for physicians.</p><p><strong>Keywords:</strong> Physician-Induced Demand; Medical Law; Legal Protection of Patient.</p>

scholarly journals Trial in Progress: Real-World Safety and Effectiveness of Brentuximab Vedotin in Adults with CD30+ Lymphoma in China

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4552-4552
Author(s):  
Pengpeng Xu ◽  
Mingci Cai ◽  
Wendy Zhang ◽  
Wei Li Zhao
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Survival Rate ◽  
Real World ◽  
Brentuximab Vedotin ◽  
Routine Clinical Practice ◽  
Inclusion Criteria ◽  
Real World Data

Abstract Background: Clinical trials have demonstrated the effectiveness of the CD30-targeted antibody-drug conjugate brentuximab vedotin (BV) for the treatment of classical Hodgkin lymphoma (HL) and non-Hodgkin lymphoma(e.g. ALCL, PTCL-NOS, AITL, CTCL and etc.). While clinical trials are critical for establishing efficacy, collection of real-world data outside of the controlled trial setting is important to evaluate how interventions are applied and assess the effectiveness of new treatments in routine clinical practice. Inclusion criteria are often rather restrictive compared with the patient populations seen by physicians in daily practice. There are limited real-world data related to treatment with BV in China. Our study aims to obtain timely real-world knowledge in terms of safety and effectiveness of BV in CD30+ lymphoma patients in China. Study Design and Methods: The study (NCT04837222) is a real-world, prospective, multicenter study to evaluate the safety and effectiveness of BV in patients with CD30+ lymphoma in China. Consecutive CD30+ lymphoma patients treated with BV as a part of standard clinical practice will be enrolled. Key inclusion criteria includes adult patients undergoing treatment with BV or to be received with BV, patient/legal guardian must be able to read, understand, and sign the Informed Consent Form, CD30+ lymphoma by INV (any CD30 expression). Exclusion criteria includes patient who currently participates in or with plan to participate in any interventional clinical trial, any other reason that, in the investigator's opinion, makes the patient unsuitable to participate in this study. As CD30+ lymphoma is not a common disease and the affordability of novel treatment is limited, 1000 patients with CD30+ lymphoma will be recruited from almost 30 hematology centers. The physician will determine the treatment regimen, as well as the frequency of laboratory and clinical assessment according to her/his routine practice. All patients will be followed up per routine clinical practice and data will be documented at baseline/3/6/9/12/18/24 months unless withdrawal of Informed Consent, death or loss of follow-up, whichever comes first. Loss to follow-up will be minimized through active contact with participating patients thereafter to ensure almost all clinically relevant outcomes will be captured. The primary endpoint is serious adverse events. Secondary endpoints include adverse events, adverse drug reaction, dose adjustment, characteristics of patients receiving BV, use of BV, number of BV cycles administered, disease characteristics, time to next treatment, overall response rate, duration of response, progression free survival rate, overall survival rate, quality of life and cost-effectiveness ratio. Descriptive analysis will be performed for data analysis. Disclosures Zhang: Takeda Pharmaceuticals: Current Employment.

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 1230 Infrainguinal Bypass Informed Consent: An Audit Driven Standardisation Of Perioperative Risk Profiling

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
K Muhammad ◽  
H Al-Khaffaf
Keyword(s):  
Clinical Practice ◽  
Informed Consent ◽  
Relative Risk ◽  
Clinical Audit ◽  
National Level ◽  
Good Clinical Practice ◽  
Perioperative Risk ◽  
Vascular Intervention ◽  
Infrainguinal Bypass ◽  
Risk Profiling

Abstract Introduction It is a fundamental good clinical practice in our medicolegal rights era to obtain standard, adequate, and transparent informed consent before any planned intervention. Currently, there are neither national approved vascular intervention-specific consents nor explicit guidelines for it. We aim to achieve a standardisation of perioperative risk profiling of infrainguinal bypass surgical consents and produce a model one. Method A retrospective analysis of 45 infrainguinal bypass consents (audit/reaudit) between (2013-2019) retrieved to evaluate quality and completeness against GMC 2008 guidance: "Consent: patients and doctors making decisions together". Data included basic consent requirements according to guidelines and specific risks of infrainguinal bypass. It was registered with the Trust Clinical Audit Department. Results (100%) of audit and reaudit consents documented the intended benefits of surgery. Inclusion into the National Vascular Registry (NVR) was achieved (0%) in audit vs (80%) in reaudit forms. Of the 19 documented postoperative complications, reaudit significant improvement observed in % of documenting 16 items with 9 complications recorded above 50%. The maximum number of audit documented risks was 15 (79%), the median 8 (42%), and the least was 3 (16%) compared to maximum 16 (84%), the median 10 (53%) and the least was 4 (21%) when reaudited, respectively. Conclusions Deficiencies in performing and adequately completing surgical consents still occur. Introducing a national pre-printed vascular intervention-specific consent is vital for accomplishing and maintaining a good clinical practice. It should include all complications with relative % risk to minimise errors, provide good quality consent, and promote clinical practice at a national level.

scholarly journals 1186 Audit Driven Standardisation Of Perioperative Risk Profiling in Carotid Endarterectomy

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
K Muhammad ◽  
H Al-Khaffaf
Keyword(s):  
Clinical Practice ◽  
Informed Consent ◽  
Relative Risk ◽  
Carotid Endarterectomy ◽  
Clinical Audit ◽  
National Level ◽  
Good Clinical Practice ◽  
Perioperative Risk ◽  
Vascular Intervention ◽  
Risk Profiling

Abstract Introduction It is a fundamental good clinical practice in our medicolegal rights era to obtain standard, adequate, and transparent informed consent before any planned intervention. Currently, there are neither national approved vascular intervention-specific consents nor explicit guidelines for it. We aim to achieve a standardisation of perioperative risk profiling of carotid endarterectomy consents and produce a model one. Method A retrospective analysis of 65 carotid endarterectomy consents (audit/reaudit) between (2016-2019) retrieved to evaluate quality and completeness against GMC 2008 guidance: "Consent: patients and doctors making decisions together". Data included basic consent requirements according to guidelines and specific risks of carotid endarterectomy. It was registered with the Trust Clinical Audit Department. Results (90%) audit vs (87%) reaudit consents documented the intended benefits of surgery. Inclusion into the National Vascular Registry (NVR) was achieved (0%) in audit vs (60%) in reaudit forms. Of the 14 documented postoperative complications, reaudit significant improvement observed in % of documenting 12 items with 6 complications recorded above 50%. The maximum number of audit documented risks was 11 (79%), the median 6 (43%), and the least was 3 (21%) compared to maximum 13 (93%), the median 7 (50%) and the least was 5 (36%) when reaudited, respectively. Conclusions Deficiencies in performing and adequately completing surgical consents still occur. Introducing a national pre-printed vascular intervention-specific consent is vital for accomplishing and maintaining a good clinical practice. It should include all complications with relative % risk to minimise errors, provide good quality consent, and promote clinical practice at a national level.

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