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.

scholarly journals PO 8564 WHAT IS CLINICAL TRIAL QUALITY? A QUALITATIVE STUDY BASED ON INTERVIEWS WITH DIFFERENT STAKEHOLDERS CONDUCTING CLINICAL TRIALS IN SUB-SAHARAN AFRICA

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A54.1-A54
Author(s):  
Angela Lazarova ◽  
Claudia Fuchs ◽  
Christian Burri
Keyword(s):  
Clinical Trials ◽  
Qualitative Study ◽  
Web Search ◽  
Sub Saharan Africa ◽  
Quality Factors ◽  
Structured Interviews ◽  
Trial Quality ◽  
Resource Limited ◽  
Quality Aspects ◽  
Sub Saharan

BackgroundThere is no unified, broad definition for quality in clinical trials (CTs). Besides the explicit quality requirements in international guidelines and national legislation, however, there are broader factors to consider, including specific setting-related aspects influencing quality needs, quality perception and local implementation of guidelines. Our objective was to identify these factors from a resource-limited settings perspective (in this case, sub-Saharan Africa).MethodsIn March-April 2018, we conducted a qualitative study based on semi-structured interviews with participants from three stakeholder groups (monitors, sponsors, and investigators) conducting CTs in sub-Saharan Africa. We identified the interviewees either through CT registry platforms, a web search or by reference. We aimed to include 10–20 participants per stakeholder group. After consent, the interviews were held in person (via Skype or telephone), recorded, and transcribed verbatim. The interview questionnaire addressed a CT quality definition and quality factors during the CT process. We performed the analysis using the framework method.ResultsSo far, we included 21 participants (17 investigators, two sponsors, two monitors). Eight (8) (from sub-Saharan Africa) and 13 (not from sub-Saharan Africa) who contributed to CTs in 19 different countries in sub-Saharan Africa. Quality definitions mentioned so far were variable. A repeated statement was that the quality definition should be broad and include a system of multiple aspects and layers. We will interview more experts with sponsor and monitor experience in May 2018 and elaborate these quality aspects and layers. We will discuss these results with regards to a comprehensive quality framework for CTs currently under development for Northern countries by another Swiss research team.ConclusionCT quality was perceived in variable ways, as was the relevance of the aspects across different CT steps. Structuring the multifaceted layers of CT quality will facilitate appropriate and efficient CT quality management in sub-Saharan Africa.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

scholarly journals COVD-07. THE IMPACT OF COVID-19 ON PATIENTS AND CAREGIVERS AFFECTED BY BRAIN TUMORS: THE PATIENT NAVIGATOR PERSPECTIVE

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii22-ii22
Author(s):  
Kyle Walsh
Keyword(s):  
Clinical Trials ◽  
Brain Tumor ◽  
Clinical Care ◽  
Structured Interview ◽  
Patient Navigator ◽  
Structured Interviews ◽  
Social Distancing ◽  
Tumor Patient ◽  
Patient Navigators ◽  
The Impact

Abstract BACKGROUND Preliminary evidence indicates that glioma patients are at higher risk for COVID-19 complications due to systemic immunosuppression. Interruptions in cancer care may exacerbate patient and caregiver anxiety, but surveying patients/caregivers about their COVID-19 experiences is often limited by attainable sample sizes and over-reliance upon single-institution experiences. METHODS To explore how COVID-19 is impacting brain tumor patients/caregivers across the U.S., we performed semi-structured interviews with brain tumor patient navigators employed by two different 501(c)3 nonprofit organizations. A semi-structured interview guide was used, utilizing prompts and open-ended questions to facilitate dialogue. A core set of COVID-19 topics were covered, including: financial issues, coping strategies, geographic variability, variability by tumor grade/histology, disruptions in care continuity, accessing clinical trials, psychosocial issues, and end-of-life care. Interviews were audio-recorded, transcribed, and organized by discussion topic to identify emerging themes. Inductive sub-coding was completed using the constant comparison method, within and between transcripts. RESULTS/CONCLUSIONS Ten patient navigators were interviewed between April 15th and May 8th, with interviews lasting approximately one hour (range 38-77minutes). Navigators reported having contact with 183 unique brain tumor families during the pandemic (range 7–38 families per navigator). High concordance emerged across narratives, revealing important considerations for the neuro-oncology workforce. The most prominent theme was increased caregiver burden, attributed to maintaining social distancing by reducing visits from home-health aides and friends/family. A related theme that applied to both patients and caregivers was increased social isolation due to social distancing, suspension of in-person support groups, and church/temple closures. Accessing clinical trials was a recurrent issue, exacerbated by patients’ increasing unwillingness to travel. Glioblastoma patients, especially those with recurrent tumors, expressed greater reluctance to travel. Access to standard-of-care treatment was rarely interrupted, but reduced access to supportive services – especially physical and occupational therapy – was identified as an emerging COVID-related deficiency in clinical care.

scholarly journals Oc021—Clinical Trials Registry And Good Clinical Practice: In Indian Scenario

2013 ◽  
Vol 35 (8) ◽  
pp. e9
Author(s):  
A. Prakash ◽  
B. Medhi ◽  
S. Kaur ◽  
S. Kumari ◽  
P. Sarotra
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Good Clinical Practice ◽  
Clinical Trials Registry ◽  
Indian Scenario

Adaptive clothing features to support daily exercising needs of muscular dystrophy victimized women in Sri Lanka

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Niromi Seram ◽  
Rivini Mataraarachchi ◽  
Thanuri Jayaneththi
Keyword(s):  
Muscular Dystrophy ◽  
Sri Lanka ◽  
Research Effort ◽  
Health And Safety ◽  
Psychological Needs ◽  
Daily Basis ◽  
Structured Interviews ◽  
Content Type ◽  
Daily Exercise ◽  
Custom Made

Purpose Exercising is a key approach adopted by muscular dystrophy patients to halt the weakening of muscles as it can eventually lead to serious immobility issues. Though it is essential to exercise on a daily basis for healthy living, there is no mention of any research effort in the current literature regarding the development of an apparel product for these mobility-affected patients that might assist them both in meeting their exercising needs and providing them some comfort in their daily living. Thus, this paper aims to focus on identifying the specific needs of muscular dystrophy victims and proposing special adaptive clothing solutions to support their daily exercise and mobility needs. Design/methodology/approach To achieve the objectives of this study, attention was focused on the muscular dystrophy afflicted women in Sri Lanka. Semi-structured interviews were conducted with the female victims of muscular dystrophy and their lifestyles were observed carefully; additional data were gathered by holding semi-structured interviews with their physiotherapists. Further, interviews were conducted with both garment technologists and fabric technologists too. Data gathered through these methods were analyzed qualitatively using the principles of thematic analysis and then aggregate conclusions were drawn. Findings It was observed that the patients were engaged in special activities such as exercising three times a day besides following their normal day-to-day activities to maintain and develop muscle strength. It soon became evident that these women found it difficult to perform their daily exercise routines with their regular clothing and were looking for custom made clothing they could wear all day long in comfort and avoid the problems that arose while exercising. The study specifies the requirements that must be met to satisfy both generic and specific needs. Considering all these aspects some adaptive clothing solutions were proposed to support daily exercising activity with respect to comfort, convenience, health and safety, as well as socio-cultural and psychological needs. Originality/value The area of fusing generic and specific features to support the daily exercising needs of muscular dystrophy victims is an untouched field of experimentation and being a need of the disabled, the present study marks a milestone on the way to a novel area of apparel design, besides exploring a new field of research.

scholarly journals EMEA and Gene Therapy Medicinal Products Development in the European Union

2003 ◽  
Vol 2003 (1) ◽  
pp. 3-8 ◽  
Author(s):  
Marisa Papaluca Amati ◽  
Francesco Pignatti ◽  
Alexis Nolte ◽  
Nirosha Amerasinghe ◽  
Daniel Gustafsson ◽  
...  
Keyword(s):  
Gene Therapy ◽  
European Union ◽  
Clinical Trials ◽  
Good Clinical Practice ◽  
Evaluation Agency ◽  
The European Union ◽  
Medicinal Products ◽  
Regulatory Processes ◽  
National Competent Authorities ◽  
Practice Implementation

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The responsibility for the authorization of clinical trials remains with the national competent authorities (NCA) acting in a harmonized framework from the scientific viewpoint. With the entry into force of a new directive on good clinical practice implementation in clinical trials as of 1 May 2004, procedural aspects will also be harmonized at EU level. Scientifically sound development of medicinal products is the key for the successful registration of dossiers and for contributing to the promotion and protection of public health. The objective of this paper is to introduce the EMEA regulatory processes and scientific activities relevant to GT medicinal products.

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 EFFICACY OF SPIRULINA FOR ALLERGIC RHINITIS

2021 ◽  
Author(s):  
Iury Gomes Batista ◽  
Osmar Cleyton Person ◽  
Fernando Veiga Angelico Junior ◽  
Priscila Bogar
Keyword(s):  
Clinical Trials ◽  
Allergic Rhinitis ◽  
Randomized Clinical Trials ◽  
Nasal Congestion ◽  
Control Group ◽  
Cochrane Central Register ◽  
Level Of Evidence ◽  
Runny Nose ◽  
Trial Quality ◽  
Central Register

Introduction: Allergic rhinitis is a condition of high prevalence in the population and widely studied, with several treatments being consecrated for its control. Spirulina is a dietary supplement that modulates immune function, and has been shown to modulate the inflammatory response of allergic rhinitis. Purpose: To evaluate spirulina in the treatment and control of allergic rhinitis. Material and Methods: This is a systematic review of randomized clinical trials. Searches were performed for randomized clinical trials relating spirulina to allergic rhinitis in five electronic databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), LILACS (1982-2021) AND SCOPUS (2021). Two investigators independently extracted data and assessed trial quality. Results: Two clinical trials involving a total of 215 patients were included. Both studies assessed the efficacy of spirulina in improving allergic rhinitis as the primary outcome. The first study described a significant reduction in runny nose, nasal congestion and itching over time of medication use (p 0.001) and in the second study the prevalence of rhinorrhea (P = 0.021), nasal congestion or obstruction (P = 0.039) and decreased smell (P = 0.030) were significantly less in the experimental group than in the control group. Conclusions: The included studies were in favor of the use of spirrulina. However, the level of evidence is very low and limited. We should have caution due to the small number of clinical trials and participants in these studies. It is recommended to carry out new RCTs following the CONSORT standardization.

scholarly journals Use of telephone and web interfaces of interactive response technology at clinical investigator sites in clinical trials

2019 ◽  
Vol 16 (3) ◽  
pp. 297-305
Author(s):  
Anna-Leena Saarela ◽  
Anja Walzer ◽  
Anne Mari Juppo
Keyword(s):  
Clinical Trials ◽  
Online Survey ◽  
Service Providers ◽  
Focal Point ◽  
Interactive Voice Response ◽  
End Users ◽  
Web Interface ◽  
Web Interfaces ◽  
Clinical Investigator ◽  
The Web

Background Interactive response technologies are used in clinical trials to provide services such as automated randomization and medication logistics management. The objective of this article is to investigate the usage of telephone (Interactive Voice Response) and web (Interactive Web Response) interfaces of interactive response technologies at clinical investigator sites in clinical trials, to obtain information about the preferences of interactive response technology end users between the telephone and web interfaces, and to explore the relevance of the telephone interface in this setting. Methods The data consist of an online survey conducted in spring 2016 with clinical investigators, study nurses, and pharmacists in 13 countries. Results Ninety-eight percent of survey respondents preferred the web interface over the telephone interface, the most important reason being superior usability. However, the respondents indicated the usability of interactive response technology interfaces is not optimal, and lack of integration and consistency across systems is common. A vast majority of interactive response technology end users at clinical sites prefer to use the web interface over the telephone interface, but most also feel there would need to be a back-up system. Conclusions Based on the results, it would be beneficial to improve the usability of the interactive response technology interfaces, and to increase consistency across systems from the current level. Support to and training of the users, as well as clarifying the responsibilities between sites and the sponsor should also be a focal point. Study sponsors should explore with interactive response technology service providers how removing the telephone interface would impact future studies, and whether there could be a more efficient means to achieve a reliable back-up to the web interface instead of a dedicated telephone interface.

Tumours of the brain and skull

2011 ◽  
Author(s):  
Robert Grant
Keyword(s):  
Decision Making ◽  
Cell Biology ◽  
Good Clinical Practice ◽  
Quality Standard ◽  
Adverse Event Reporting ◽  
Multidisciplinary Teams ◽  
Frameless Stereotaxy ◽  
Scientific Quality ◽  
Trial Conduct ◽  
Trial Quality

Over the last 10 years, there have been several important advances in cell biology, molecular genetics, and targeted therapies in neuro-oncology. Improved neurosurgical techniques such as frameless stereotaxy, awake craniotomy, and intra-operative MRI, safer methods of directing radiotherapy, new chemotherapy approaches, and novel modalities of therapy provide optimism that there will eventually be some improvements in treatment-related morbidity and survival. There has also been an increasing change from individual clinician decision making to decision making by multidisciplinary teams of neurosurgeons, neurologists, clinical oncologists, neuropathologists, neuroradiologists, and specialist nurses with the aim of improving decision making, management planning across specialties, communication, and enrolment in suitable clinical trials. In addition, Good Clinical Practice guidelines, an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials, increases the onus and responsibilities on clinical investigators to perform trials to the highest standard and to have the trials externally monitored, and the trial conduct and results audited. While these obligatory and statutory responsibilities are labour intensive and time consuming, they should improve the quality of trials by limiting the possibility of unintentional bias or fraud. Improving the recording of serious adverse event reporting through trial quality assurance and quality control procedures will help ensure that a balanced view of the effects of a drug or procedure is identified earlier than in the past. It will be interesting to see how research develops over the next decade.

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