scholarly journals Medicare Advantage: Reforms Needed to Ensure Access to Clinical Trials

2009 ◽  
Vol 5 (3) ◽  
pp. 144-145 ◽  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Care ◽  
Clinton Administration ◽  
Medicare Advantage ◽  
Medicare Payment ◽  
The Way

A Clinton administration Executive Memorandum authorized Medicare payment for routine costs associated with clinical trials and recognized the role of clinical trials in patient care. However, a loophole in Medicare Advantage regulations has created a disparity in the way clinical trial services are covered for these enrollees.

scholarly journals The role of a data manager at a clinical trial center: the experience of the Alessandria hospital, Italy

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Fabio Giacchero ◽  
Carolina Pelazza ◽  
Serena Panpa ◽  
Marinella Bertolotti ◽  
Tatiana Bolgeo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Reference Period ◽  
Job Description ◽  
Data Manager

Objectives: To define the Data Manager (DM) job description within the Clinical Trial Center (CTC) of the Alessandria Hospital (AO AL). To identify the number of authorized clinical studies after the implementation of three DMs in the CTC of the AO AL. Methods: The activities of the DM within the CTC of the AO AL take place in the activation, management and conclusion of clinical trials. The activities were monitored through specific indicators from June 01st, 2019 to May 31st, 2020. Results: During the reference period, an increased authorized studies were observed. Conclusion: The implementation of DMs in the CTC of AO AL has been demonstrated the importance of the figure itself, which, although it has not professionally recognized yet, is found to be fundamental in clinical research.

scholarly journals The role of community advisory boards in community-based HIV clinical trials: a qualitative study from Tanzania

2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Godwin Pancras ◽  
Bruno F. Sunguya ◽  
Nathanael Sirili ◽  
Emmanuel Balandya ◽  
Eligius Lyamuya ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phenomenological Approach ◽  
Community Based ◽  
Middle Income ◽  
Advisory Boards ◽  
Institutional Review ◽  
Hiv Clinical Trials ◽  
Community Advisory Boards

Abstract Background Community Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in developing countries. However, limited empirical evidence exists on the role of CABs in low and middle-income countries including Tanzania. This study aims at exploring the role of CABs in community-based HIV clinical trials conducted in Tanzania. Methodology We adopted a phenomenological approach to purposefully select HIV clinical trial stakeholders. These included CAB members, researchers and Institutional Review Board (IRB) members in Tanzania. We conducted In-depth Interviews (IDIs) with ten participants and three Focus Group Discussions (FGDs) with eighteen participants. The data were thematically analyzed with the aid of MAXQDA software version 20.2.1. Results The findings indicate that at every stage of implementation of a community-based HIV clinical trial, a functioning CAB is important for its success. This importance is based on contextualization of the informed consent process and protocol, managing rumours in the community, weighing trial risks and benefits, sensitizing the community, assisting participant recruitment, tracing and retention. However, being perceived as financial beneficiaries than community representatives emerged as a challenge to CAB members. Conclusion The study empirically indicates the need for functioning CABs in every stage of implementation of community-based HIV clinical trials. The roles of which are interwoven in serving research goals and protecting the interests of the community and that of trial participants.

European Union Clinical Trials Register: on the way to more transparency of clinical trial data

2013 ◽  
Vol 6 (5) ◽  
pp. 457-459 ◽  
Author(s):  
Gunter F Egger ◽  
Ralf Herold ◽  
Ana Rodriguez ◽  
Noémie Manent ◽  
Fergus Sweeney ◽  
...  
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
Clinical Trials ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Way

scholarly journals Managing clinical trials during COVID-19: experience from a clinical research facility

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Frances Shiely ◽  
Jean Foley ◽  
Amy Stone ◽  
Emma Cobbe ◽  
Shaunagh Browne ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Best Practices ◽  
Clinical Research ◽  
Research Facility ◽  
Clinical Research Facility ◽  
Key Issues ◽  
Practical Guidance ◽  
Trial Manager

AbstractThere is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.

scholarly journals Importance and role of independent data monitoring committees (IDMCs) in oncology clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e047294
Author(s):  
P Schöffski
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Events ◽  
Stopping Rules ◽  
Data Monitoring ◽  
Independent Data ◽  
Oncology Clinical Trials ◽  
Life Threatening ◽  
Study Participants

The role and use of independent data monitoring committees (IDMCs) has evolved over the past decades. The Food and Drug Administration and European Medicines Agency have issued guidelines on the role and functioning of such committees. In general, data monitoring committees are recommended for large, often randomised clinical trials involving life-threatening diseases, studies performed in vulnerable populations or where the experimental intervention can potentially harm the trial participant. Such committees play an important role in trials evaluating treatments with the potential to prolong life or reduce the risk of major adverse health outcomes.Typically, oncology clinical trials fall within these recommendations, as they are often large, randomised, multicentric protocols aiming at improving survival outcomes by exploring the use of study treatments that may be associated with a significant risk of serious, even life-threatening adverse events. IDMCs are required for National Cancer Institute phase III randomised trials, European Organisation for Research and Treatment of Cancer phase II/III trials with formal interim analyses, early-stopping rules or adaptive studies. The primary role of an IDMC of ensuring the safety of study participants and maintaining clinical trial integrity is particularly important in oncology trials, due to the nature of the disease, the potential for treatment toxicity and for instilling confidence that the clinical trial data are reliable. A clear understanding by IDMC members of the natural course of the disease, treatment landscape, importance and relevance of certain adverse events in trial participants, clinical trial methodology in general and stopping rules for oncology trials in particular, is crucial for the functioning of an IDMC.It is recommended that IDMC members should be experienced trialists, have a track record of strong clinical, statistical and/or methodological expertise and the required level of independence, as they play a highly important role in the protection of study participants, and in commercially and strategically important go/no decisions. Ideally, IDMC members should have relevant experience or have some training, mentorship or guidelines.

Clinical Trials Involving Minors: The Role of the Ethics Consultation in Avoiding Therapeutic Misconception

2021 ◽  
Vol 66 (Special Issue) ◽  
pp. 41-41
Author(s):  
Silvia Ceruti ◽  
◽  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Ethics Consultation ◽  
Therapeutic Misconception ◽  
Parental Consent ◽  
Research Subjects ◽  
Course Of Action ◽  
Trial Participants ◽  
Central Purpose

"Therapeutic Misconception (TM) occurs when clinical trial participants believe that the central purpose of the trial is therapeutic and that they will personally benefit from participation. If individuals who are entitled to consent to participation in a specific clinical trial do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled may potentially benefit from the intervention under study, this false belief may motivate them to participate, and in extreme cases may disqualify their consent. TM is especially frequent in fields in which the patients are highly vulnerable, such as when they are children and require parental consent. The informed consent is an essential ethical prerequisite before enrolling each and every participant in research that should protect patients through a process of dialog about a planned course of action. We argue that Ethics Consultant’s competencies may be crucial in avoiding TM: The Ethics Consultant should be involved in neonatal and paediatric clinical trials in order to face the unique vulnerability of children as research subjects, and to ensure that parental consent procedures are rigorously managed, enhancing recruitment in research trials in the context of fully understood consent. "

scholarly journals Erratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials

BMC Medicine ◽  
2016 ◽  
Vol 14 (1) ◽  
Author(s):  
Patrick P. J. Phillips ◽  
Carl M. Mendel ◽  
Divan A. Burger ◽  
Angela M. Crook ◽  
Andrew J. Nunn ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Patient Care ◽  
Limited Role ◽  
Confirmatory Clinical Trials ◽  
Culture Conversion

The multi-disciplinary meeting as a tool to identify patients for clinical trials and translational research.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14001-e14001
Author(s):  
H Winter ◽  
David Rea
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Translational Research ◽  
Solid Tumour ◽  
Outcome Data ◽  
Team Meetings ◽  
Proactive Approach ◽  
The Uk

e14001 Background: Cancer multi-disciplinary team meetings (MDTs) were established with one of the core aims to increase participation in clinical research. However, a recent Cancer Research UK study observing 624 patient MDT discussions revealed only 8 (1.3%) patients included a discussion on clinical trials. Current work in the UK looking at MDT effectiveness has explored the quality of discussions and team dynamics. However, recruitment to clinical trials has not been promoted as an indicator of an effective MDT. This study explored the role of MDTs in identifying patients for research across all solid tumour MDTs in a tertiary cancer centre. Methods: This study explored the outcome data from solid tumour MDTS; reports on the observation of solid tumour MDTs and completion of a trials and translational proforma about patient discussions on research; exploration of MDT members views on the role of MDTS in identifying opportunities for patients to participate in clinical trials and translational research. Results: MDT outcomes from all solid tumour MDTs were reviewed. Out of 7000 local MDT outcomes from Avon Cancer Registry April 2019- Set 2019. Only 409 discussions included an outcome registered with “Clinical Trial y/n” (5%). In the majority there was no mention of any consideration of clinical trial or an explicit trial documented. Conclusions: We report on the exploration of the MDT as integral to identifying patients for clinical trials and translational research. This requires input and buy in from MDT members and the identification of research champions attending MDTs. The integration of genomics data into MDTs will require a proactive approach to access clinical trials for patients with identified potential actionable targets.

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