Selection and Training of Clinical Trial Monitors

1999 ◽  
pp. 341-353
Author(s):  
Willem Ezerman
Keyword(s):  
Clinical Trial ◽  
And Training

Architecture of an Integrated Collaboration Portal for Clinical Trial

2015 ◽  
pp. 127-162
Author(s):  
Partha Chakraborty
Keyword(s):  
Clinical Trial ◽  
Development Cost ◽  
Training Activities ◽  
The Cost ◽  
Key Events ◽  
Document Review ◽  
Patient Enrollment ◽  
And Training ◽  
Clinical Trial Activity

Collaboration is defined as the actions for individuals and teams to work together for a common goal. There are several bottlenecks to an efficient and effective collaborative model of clinical trial including: the lack of a centralized, consistent, globally accessible platform to manage and store essential study related documentation; inconsistent or incomplete work assignments; inefficient notification of key events requiring follow-on action; and incomplete, missing, expired, or redundant documentation and training activities and need to maintain multiple credential to access various system, Removing these barriers is an important part of establishing an environment that fosters collaboration among all constituencies involved in managing clinical trial keeping them connected, informed, and on task by providing access to everyone at any time, from anywhere.The case study below introduces need of an integrated clinical collaboration platform, addressing key functionality of such an platform and describes the architecture & design consideration to industrialize such a platform. The intended audience of this case study is the architects & designers of similar systems. The clinical trial activity for a drug in research is approximately 70% of the overall drug development cost. It is estimated that 4% of the cost of a trial is in 'rework' involving communication, regulatory issues, patient enrollment, document review and replacement of patients. The integrated clinical collaboration platform has potential to eliminate significant amount of cost of re-work, which is in order of $3.5M per trial.

Increasing Health Literacy to Improve Clinical Trial Recruitment

2018 ◽  
pp. 94-108
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Trial Recruitment ◽  
Negative Perception ◽  
Consent Forms ◽  
Clinical Trial Recruitment ◽  
And Training

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.

scholarly journals Cancer Clinical Trials in Africa—An Untapped Opportunity: Recommendations From AORTIC 2019 Conference Special Interest Group in Clinical Trials

2021 ◽  
pp. 1358-1363
Author(s):  
Abiola Ibraheem ◽  
Colin Pillai ◽  
Ifeoma Okoye ◽  
J. Joshua Smith ◽  
Diane Reidy-Lagunes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sub Saharan Africa ◽  
Cancer Clinical Trials ◽  
Future Directions ◽  
Secondary Purpose ◽  
Health Care Burden ◽  
Sub Saharan ◽  
Cancer Disparity ◽  
And Training

Cancer is now a formidable health care burden in sub-Saharan Africa (SSA) due to lifestyle westernization and longer life expectancy. The exponential increase in cancer incidence coupled with high mortality rate is not comparable with that seen in westernized countries. To address global cancer disparity, globalization of cancer clinical trials to involve sub-Saharan Africa can serve as a platform where innovative targeted therapies can be made available to patients in the environ. In the 2019 African Organization for Research and Training in Cancer (AORTIC) conference held at Maputo, Mozambique, a group of clinical trialists spanning across multiple continents highlighted the opportunities in Africa for the conduct of cancer clinical trials. The secondary purpose of the meeting was to address the belief that Africa was incapable of conducting interventional cancer trials but showed the in-continent strengths, such as available capacities, trained local clinical trialists with clinical trial experiences, clinical trial consortia, local capabilities, mapping out logistics, ethical consideration, political will, real-time benefits of clinical trials to clinical practice, and future directions for trials.

Medication safety in cancer clinical trials: An analysis of medication error reports at a comprehensive cancer center

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6547-6547 ◽  
Author(s):  
M. P. Kane ◽  
K. Fessele ◽  
J. Gordilis-Perez ◽  
S. Schwartz ◽  
S. Lisi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medication Errors ◽  
Education And Training ◽  
Standards Of Care ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Healthcare Team ◽  
Improvement Project ◽  
And Training

6547 Background: Although medication errors comprise 10–25% of all medical errors, little is known concerning the occurrence or types of medication errors occurring while treating patients on a clinical trial. Therefore, we retrospectively reviewed the medication errors reported in patients enrolled on clinical trials at our center. Methods: As part of a multidisciplinary continuous quality improvement project, from January 2003 through December 2006, we collected voluntary reports of medication errors in adult and pediatric patients on clinical trials involving both oral and intravenous chemotherapy. All reports were classified prospectively regarding clinical trial involvement, severity category (A to I) per the National Coordination Council on Medical Error Reporting and Prevention, type, cause, and where in the medication use process the error occurred. Results: There were 163 reports involving patients treated on clinical trials. The most common errors were those corrected prior to reaching the patient in 68% of events (Category A&B), while 31% reached the patient but did not result in harm (Category C&D), with 1% resulting in temporary patient harm (Category E&F). The most common type of errors were prescribing (66%), improper dose (42%), and omission errors (9%). Not following an institutional procedure or the protocol was the primary cause for these errors (39%), followed by the written order (30%), and poor communication involving both the healthcare team and the patient (26%). The processes where the errors initiated were in prescribing 47%, administration 10%, dispensing 6%, and monitoring 5%. Conclusion: Medication errors do occur in clinical trials, however the majority of these are corrected prior to reaching the patient or do not result in harm. Not following an institutional procedure or the protocol was the most common cause of error. This is most likely due to the protocol procedures differing from existing standards of care. Protocol-specific education through the Centralized Education and Training Service, a shared resource within our cancer center, addresses this issue enhancing the quality and safety of clinical trials through the education and training of healthcare professionals. No significant financial relationships to disclose.

Therapist facilitative interpersonal skills and training status: A randomized clinical trial on alliance and outcome

2015 ◽  
Vol 26 (5) ◽  
pp. 511-529 ◽  
Author(s):  
Timothy Anderson ◽  
Mary Ellen J. Crowley ◽  
Lina Himawan ◽  
Jennifer K. Holmberg ◽  
Brian D. Uhlin
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Interpersonal Skills ◽  
Training Status ◽  
And Training

scholarly journals Efficacy of Psycho-educational Program on Burden of Caregivers of Children with Epilepsy: A clinical trial

2021 ◽  
Vol 10 (2) ◽  
Author(s):  
Zeinab Balouchi ◽  
Saied Pahlavanzadeh ◽  
Nasrollah Alimohammadi
Keyword(s):  
Clinical Trial ◽  
Caregiver Burden ◽  
Control Group ◽  
Educational Training ◽  
Significant Difference ◽  
Epileptic Children ◽  
The Mean ◽  
And Control ◽  
Educational Training Program ◽  
And Training

Background: Long-term care of the children with epilepsy and lack of psycho-educational training will lead to caregiver burden. Objectives: The aim of this study was to evaluate the effect of a psycho-educational training program on caregiver burden in families with pediatric epileptic children. Methods: This is a clinical trial study with two groups of experimental and control with three stages of Before, Immediately later, One month after the intervention. The population of the study consisted of family caregivers of children with epilepsy referring to Imam Hossein and Kashani Hospitals in Isfahan, Iran. Seventy families of children (ages 6 - 18years) with epilepsy participated in this study in 2018. The samples were randomly assigned to experimental (35) and control (35) groups using sequential convenience sampling method. The experimental group received a psycho-educational training program in eight sessions (90-minute) in four groups (8 - 9 members), and training was held two sessions a week. The control group participated in three sessions and expressed their problems and experiences. Data were collected using a demographic questionnaire and Zarit Burden Interview (ZBI) that consisted of 22 items and a 5-point Likert scale. Descriptive and inferential statistical methods and SPSS18 were used for data analysis. Results: Before the intervention, there was no statistically significant difference between the two groups of experimental and control in terms of caregiver burden (P = 0.917). However, there was a significant difference between the three time stages in the intervention group after the intervention (P < 0.05; f = 3.511). Meanwhile, the mean score of caregiver burden decreased during the intervention period than before the study (P < 0.05; f = 166.60), while the mean score of caregiver burden did not increase significantly in the control group over time (P = 0.036). Conclusions: The results showed that in a family with school-age epileptic children, appropriate programs and training methods are needed to decrease caregiver burden; so it is necessary to develop and use such programs by the treatment team members.

scholarly journals Implementing oncology clinical trials in Nigeria: A model for Capacity building.

2020 ◽  
Author(s):  
Atara Ntekim ◽  
Abiola Ibraheem ◽  
Adenike Sofoluwe ◽  
Toyosi Adepoju ◽  
Mojisola Oluwasanu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Teaching Hospitals ◽  
Mortality And Morbidity ◽  
Trained Personnel ◽  
Oncology Clinical Trials ◽  
Clinical Equipment ◽  
Poor Infrastructure ◽  
And Training ◽  
Research Pharmacist

Abstract Background: There is both higher mortality and morbidity from cancer in low and medium income countries (LMICs) compared with high income countries (HICs). Clinical trial activities and development of more effective and less toxic therapies have led to significant improvements in morbidity and mortality from cancer in HICs. Unfortunately, clinical trials remain low in LMICs due to poor infrastructure and paucity of experienced personnel to execute clinical trials. There is an urgent need to build local capacity for evidence based treatment for cancer patients in LMICs. Methods: We conducted a survey at facilities in four Teaching Hospitals in South West Nigeria using a checklist of information on various aspects of clinical trial activities. The gaps identified were addressed using resources sourced in partnership with investigators at HIC institutions. Results: Deficits in infrastructure were in areas of patient care such as availability of oncology pharmacists, standard laboratories and diagnostic facilities, clinical equipment maintenance and regular calibrations, trained personnel for clinical trial activities, investigational products handling and disposals and lack of standard operating procedures for clinical activities. There were two GCP trained personnel, two study coordinators and one research pharmacist across the four sites. Interventions were instituted to address the observed deficits in all four sites which are now well positioned to undertake clinical trials in oncology. Training on all aspects of clinical trial was also provided.Conclusions: Partnerships with institutions in HICs can successfully identify, address, and improve deficits in infrastructure for clinical trial in LMICs. The HICs should lead in providing funds, mentorship and training for LMIC institutions to improve and expand clinical trials in LMIC countries.

DEVELOPMENT AND ESTABLISHMENT OF A QUALITY-FRAMEWORK FOR THE LENA PROJECT

2015 ◽  
Vol 101 (1) ◽  
pp. e1.70-e1
Author(s):  
Agnes M. Ciplea ◽  
Karl Kleine ◽  
Björn B. Burckhardt ◽  
Stephanie Läer ◽  
Jörg Breitkreutz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Phase I ◽  
Phase I Study ◽  
Quality System ◽  
Team Approach ◽  
Project Leader ◽  
Team Members ◽  
Quality Framework ◽  
And Training

BackgroundThe LENA (Labeling of Enalapril from Neonates up to Adolescents) project has been initiated to improve the healthcare of children with heart failure by an enalapril orodispersible mini-tablet. The LENA consortium combines academic clinical research centers, SMEs (small and medium-sized enterprises) and a patient/parent advocacy organization. The objective of the project requires to comply with respective GxP regulations like Good Manufacturing Practice (GMP), Good Clinical (Laboratory) Practice (GCP/“GCLP”1) and Good Vigilance Practice (GVP). The project team is comprised of sub-teams experienced in paediatric clinical practice, medicines development, clinical research and project management, but not all team members work in an appropriate quality framework. Aim: To establish a well-documented, efficient quality system applying a new approach for ensuring quality in all trial aspects by combining existing organization-related quality system elements of the project partners with newly developed SOPs and overarching, integrating trial-specific elements to ensure a reliable quality environment for the LENA Phase I clinical trial.MethodsBased on the network-structure of the project organization, a strategy based on a team approach with joint responsibilities for the quality conduct of the project was pursuit, forming a QM Team consisting of the project leader, the leaders for pharmaceutical and clinical development and an external quality expert. The team compiled a quality manual and an organizational chart displaying the sub-teams and their responsibilities. Another responsibility of the team is the integration of existing SOPs and Work Instructions as well as the creation of procedures at the project level and furthermore the verification of appropriate qualification of all staff involved in the project through CVs, job descriptions and training records.ResultsFor the Phase I study, a thorough analysis of all existing relevant SOPs and Work Instructions, forms and other quality elements was performed, uncovered trial-related processes were identified and a work plan was established to fill the gaps with the smallest possible number of newly developed organization-related SOPs/Work Instructions and by preparing trial-specific process manuals. Demonstration of the trial team members was ensured by completing documentation concerning CVs, job description and training records. Among the sub-teams, the GCLP environment of the bioanalytical laboratory was started from scratch and could adequately support the LENA Phase I study by “GCLP” quality work and sample logistics.ConclusionThe consortiums approach enabled the preparation of a comprehensive, reliable GxP compliant quality system within a short timeframe and with the limited resources of a publicly funded project.1 “GCLP” is used as acronym for a quality system established in compliance with “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples” (EMA/INS/GCP/532137/2010; 28 February 2012)The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA).

Clinician or Clinical Trialist: The Physician’s Dilemma

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Formal Training ◽  
Pharmaceutical Companies ◽  
Training And Education ◽  
Know How ◽  
Site Staff ◽  
And Training

The main objective is to help physicians carry out those aspects of clinical trials described in this book. . . .Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). . . . . . . —[ICH-GCP 2.8]. . . It is hardly rational to expect people to do things properly unless they are shown how, so that the importance of formal training and education for everyone involved with the pharmaceutical industry should be self-evident. The perpetuation of bad habits by those who are poorly trained and educated, whether in pharmaceutical companies or at investigator sites, is one of the root causes of the inefficiencies in drug development. Yet, while few people (whether or not they actually educate people properly) would dispute the importance of well-trained employees, it is uncommon for most companies to insist that all of those upon whom they depend are properly trained as well. Among those who are rarely trained to meet the required standards of excellence are CRO staff and investigators and their site staff. Negotiations with CROs rarely involve an assessment of how the various tasks are performed and whether or not they are carried out to the standards expected by the sponsor staff. This is not to imply that sponsor employees are better at what they do than CRO staff. What is true, however, is that sponsor employees should know how to do things the way the sponsor wants them done, which in turn should correspond to the sponsor’s notion of excellence. CROs will always profess to have all the processes requested by a sponsor, so that a laissez-faire attitude pervades negotiations. However, CROs quite understandably have their own ways of working, and unless alternatives are specified contractually, what the CRO does is what the sponsor gets. The next logical step after specifying what is wanted is to provide the necessary training for CRO staff. Where education and training are most needed and are carried out most poorly is in the case of clinical trial investigators.

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