scholarly journals More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant

2020 ◽  
Vol 19 ◽  
pp. 100606
Author(s):  
Teresa Swezey ◽  
F. Hunter McGuire ◽  
Patricia Hurley ◽  
Janette Panhuis ◽  
Kathy Goldstein ◽  
...  
Keyword(s):  
Clinical Investigator ◽  
Research Sponsor

scholarly journals More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant

2020 ◽  
Author(s):  
Teresa Swezey ◽  
F. Hunter McGuire ◽  
Patricia Hurley ◽  
Janette Panhuis ◽  
Kathy Goldstein ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Health And Safety ◽  
Good Clinical Practice ◽  
Structured Interviews ◽  
Knowledge And Skills ◽  
Clinical Investigator ◽  
Trial Quality ◽  
Industry Standard ◽  
Training Frequency ◽  
Research Sponsor

Background: Good clinical practice (GCP) training is the industry standard for ensuring the quality conduct of registrational clinical trials. However, concerns have been raised about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. Methods: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure the quality conduct of clinical trials. We used applied thematic analysis to analyze the data. Results: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants’ health and safety. Respondents acknowledged that GCP principles address each of these critical tasks; however, they described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the relevance of GCP training to investigators and their delegates. Conclusion: Our findings indicate that although investigators and sponsors recognize that GCP training addresses critical tasks necessary to the quality conduct of clinical trials, they articulated the need for significant improvement in the design, content, and presentation of GCP training.

DOES YOUR CLINICAL INVESTIGATOR UNDERSTAND THE CONSEQUENCES OF NON-COMPLIANCE?

2000 ◽  
Vol 7 (3) ◽  
pp. 135-145 ◽  
Author(s):  
Brian J. Donato ◽  
Thomas R. Gibson
Keyword(s):  
Clinical Investigator

Association between sites of metastases (mets) and outcomes with immune checkpoint inhibitor (ICI) therapy for advanced urothelial carcinoma (aUC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 445-445
Author(s):  
Dimitrios Makrakis ◽  
Leonidas Nikolaos Diamantopoulos ◽  
Vadim S Koshkin ◽  
Ajjai Shivaram Alva ◽  
Mehmet Asim Bilen ◽  
...  
Keyword(s):  
Cox Regression ◽  
Factor Model ◽  
Poor Response ◽  
Specific Tumor ◽  
Research Sponsor ◽  
Prognostic Implications ◽  
Advanced Urothelial Carcinoma ◽  
Metastatic Sites ◽  
Ecog Ps ◽  
Sites Of Metastases

445 Background: Different metastatic sites have variable prognostic implications in aUC. However, details on response and outcomes with ICI for particular mets is still unknown. We hypothesized that bone and liver mets would have poor response and outcomes with ICIs. Methods: We performed a retrospective cohort study in patients (pts) with aUC who received ICI. We compared overall response rate (ORR) and overall survival (OS) between pts with different mets at ICI initiation. We developed 4 different models: 1) lymph node (LN) only vs other; 2) visceral mets (bone, lung, liver) vs other; 3) bone + liver mets vs bone without liver vs liver without bone vs neither and 4) 6 factor model: a. LN +/- soft tissue/locoregional recurrence b. lung +/- (a) c. bone +/- (b) d. liver +/- (c) e. central nervous system (CNS) +/- (d) and f. other. ORR and OS were compared among groups using multivariable (adjusting for ECOG PS and hemoglobin<10g/dl) logistic regression and cox regression, respectively. Results: We identified 984 pts (24 institutions); 703 and 696 were included in OS and ORR analyses, respectively. Median age at ICI start was 71 (range 32-93), 77% white race, 74% men, 67% ever smokers, 72% pure UC, 18% upper tract UC, 55% extirpative surgery. Prevalence of LN, lung, bone and liver mets at ICI start was 74%, 32%, 27% and 21%, respectively. LN-only mets had significantly higher ORR (44% vs 22%, OR 2.6, p<0.05) and longer mOS (22 vs 8 months, HR 0.5, p<0.05) vs other mets. Visceral mets had significantly lower ORR (21% vs 35%, OR 0.5, p<0.05) and shorter mOS (7 vs 17 months, HR 1.8, p<0.05) vs non-visceral mets. Pts with bone and liver mets had significantly lower ORR and shorter OS vs those with bone or liver mets, which both had significantly lower ORR and shorter OS vs those with neither and with LN +/- local recurrence (Table). Conclusions: In the context of ICI treatment, bone, liver, lung or CNS mets were associated with lower ORR and/or shorter OS, and bone and liver mets were particularly associated with low ORR and short OS. LN-only mets were associated with higher ORR and longer OS. Further work is needed to interrogate site-specific tumor-host immune interactions and identify biomarkers. Research Sponsor: None[Table: see text]

scholarly journals The path ahead for MD/PhD programs in Canada Commentary on Jones et al.

2016 ◽  
Vol 39 (4) ◽  
pp. 140
Author(s):  
Norman D Rosenblum
Keyword(s):  
Clinical Investigator ◽  
Investigative Medicine ◽  
Phd Programs

The paper by Jones and colleagues, published in this edition of Clinical Investigative Medicine, contributes to our understanding of Canadian MD/PhD Programs. While there has been little published on this subject by the Canadian programs, themselves, this paper is the most recent in a series by leaders of the Clinical Investigator Trainee Association of Canada (CITAC). The authors are to be commended for their efforts and productivity.

scholarly journals Scientific overview: CSCI-CITAC annual general meeting and young investigator’s forum 2010

2011 ◽  
Vol 34 (1) ◽  
pp. 105
Author(s):  
Mike Berger ◽  
Dominick Bosse ◽  
M Sara Kuruvilla ◽  
Pencilla Lang ◽  
Jean-Christophe Murray ◽  
...  
Keyword(s):  
General Meeting ◽  
Annual General ◽  
Canadian Society ◽  
Young Investigator ◽  
Annual General Meeting ◽  
Award Recipient ◽  
Clinical Investigator ◽  
Research Questions ◽  
Medical Disciplines

In 2010, the annual general meeting of the Clinical Investigator Trainee Association of Canada – Association des cliniciens-chercheurs en formation du Canada (CITAC-ACCFC) and the Canadian Society for Clinician Investigators (CSCI) was held between September 20 and 22 in Ottawa. Several globally-renowned scientists, including this year’s CSCI/Royal College Henry Friesen Award recipient, Dr. Paul Kubes, Distinguished Scientist Award recipient, Dr. Gideon Koren and Joe Doupe Young Investigator Award recipient, Dr. Torsten Neil, discussed a variety of topics relating to the role of technology in medicine. The meeting was well attended by clinician scientists and trainees from across Canada and offered trainees mentorship and networking opportunities in addition to showcasing their research at the young investigator forum. The aim of this scientific overview is to highlight the research presented by trainees at both the oral plenary session as well as the poster presentation sessions of this meeting. Similar to last year’s meeting [1], research questions being investigated by trainees covered the spectrum of medical disciplines, encompassing both basic science as well as clinical areas, and are summarized below. [1] Ong Tone, S., Dugani, S., Marshall, H., Shamji, M.F., Murray, J-C., and Bossé, D. 2010 Scientific overview of the CSCI-CITAC 2009 conference. Clin Invest Med 33: E69-72, E73-67

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