Challenges in Opening and Enrolling Patients in Clinical Trials

2017 ◽  
pp. 139-143
Author(s):  
Julie M. Vose ◽  
Meredith K. Chuk ◽  
Francis Giles
Keyword(s):  
Clinical Trials ◽  
Scientific Integrity ◽  
Cancer Therapies ◽  
Regulatory Requirements ◽  
Cancer Treatments ◽  
Contract Research ◽  
Trial Conduct ◽  
Slowing Down ◽  
Research Organizations ◽  
Trial Participants

Clinical trials are key elements of the processes that account for many of the recent advances in cancer care, including decreased mortality rates and increased survivorship; better supportive care; and improved understanding of cancer risk, prevention, and screening. This research also has led to the validation of numerous exciting new types of cancer treatments, such as molecularly targeted therapies and immunotherapies. Clinical trials, however, are becoming more and more challenging to conduct. Research programs must comply with legal and regulatory requirements that can be inefficient and costly to implement and often are variably interpreted by institutions and sponsors and sponsors’ representatives, including contract research organizations. Some of these requirements are essential to protect the safety of trial participants, to promote the scientific integrity of research, or to ensure that trial conduct is efficient and adequately resourced. Such requirements are important to preserve. However, some requirements do not fulfill any of these goals and, in fact, hinder research and slow patient access to safe and effective treatments. This article discusses some of the identified issues that are slowing the process of cancer clinical trials, such as conservatively interpreted guidelines by pharmaceutical companies and contract research organizations; overprotective language for contracts; and patient protections by health systems and universities. The article also discusses possible solutions to these problems that are slowing down the cancer therapies that patients need.

scholarly journals Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daria Kim ◽  
Joerg Hasford
Keyword(s):  
Clinical Trials ◽  
Health Risks ◽  
Ethics Committees ◽  
Medical Community ◽  
Significant Extent ◽  
Regulatory Requirements ◽  
Trial Participants ◽  
Clinical Trials Regulation ◽  
Clinical Trial Regulation ◽  
The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

scholarly journals Challenges With Research Contract Negotiations in Community-Based Cancer Research

2016 ◽  
Vol 12 (6) ◽  
pp. e626-e632 ◽  
Author(s):  
Michael A. Thompson ◽  
Patricia A. Hurley ◽  
Bryan Faller ◽  
Jean Longinette ◽  
Katie Richter ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Community Setting ◽  
Community Research ◽  
Community Based ◽  
Community Based Research ◽  
Contract Negotiations ◽  
Contract Research ◽  
Research Organizations ◽  
Negotiation Processes ◽  
Research Contract

Purpose: Community-based research programs face many barriers to participation in clinical trials. Although the majority of people with cancer are diagnosed and treated in the community setting, only roughly 3% are enrolled onto clinical trials. Research contract and budget negotiations have been consistently identified as time consuming and a barrier to participation in clinical trials. ASCO’s Community Research Forum conducted a survey about specific challenges of research contract and budget negotiation processes in community-based research settings. The goal was to ultimately identify potential solutions to these barriers. Methods: A survey was distributed to 780 community-based physician investigators and research staff. The survey included questions to provide insight into contract and budget negotiation processes and perceptions about related barriers. Results: A total of 77% of the 150 respondents acknowledged barriers in the process. Respondents most frequently identified budget-related issues (n = 133), inefficiencies in the process (n = 80), or legal review and negotiation issues (n = 70). Of the respondents, 44.1% indicated that contract research organizations made the contract negotiations process harder for their research program, and only 5% believed contract research organizations made the process easier. The contract negotiations process is perceived to be impeded by sponsors through underestimation of costs, lack of flexibility with the contract language, and excessive delays. Conclusion: Improving clinical trial activation processes and reducing inefficiencies would be beneficial to all interested stakeholders, including patients who may ultimately stand to benefit from participation in clinical trials. The following key recommendations were made: standardization of contracts and negotiation processes to promulgate transparency and efficiencies, improve sponsor processes to minimize burden on sites, create and promote use of contract templates and best practices, and provide education and consultation.

Evaluation of Stem Cell-Derived Cellular Therapy Products

2020 ◽  
pp. 019262331989789
Author(s):  
Alys E. Bradley ◽  
Lauren Black
Keyword(s):  
Stem Cell ◽  
Study Design ◽  
Clinical Studies ◽  
Cellular Therapy ◽  
Scientific Integrity ◽  
Preclinical Studies ◽  
Cell Markers ◽  
Contract Research ◽  
Research Organizations ◽  
Case Basis

Although there is an increase in the development of new cellular therapies, few guidelines have been published to assist in the design of preclinical studies. As no product and therapeutic intention is entirely alike regulators and Contract Research Organizations need to treat each project on a case-by-case basis. One of the most important considerations in study design is to retain all tissues from the study, thereby allowing for further analysis of tissues should unexpected effects be seen in clinical studies. Input from the pathologist at the earliest stages of study design regarding animal selection, cell markers, and phased tissue examination improves the scientific integrity of the study.

Incorporating Affiliates and Contract Research Organizations into Global Clinical Trials

1999 ◽  
Vol 33 (4) ◽  
pp. 1033-1052 ◽  
Author(s):  
S. Michael Harrill ◽  
Jane M. Boswick ◽  
Taylor J. Crouch ◽  
Geraldine Cahillane ◽  
Hugh Watson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Contract Research ◽  
Research Organizations

Structure, Organization, and Knowledge Production of Clinical Trial Industry

2018 ◽  
pp. 178-201
Author(s):  
Roger Jeffery ◽  
Gerard Porter ◽  
Salla Sariola ◽  
Amar Jesani ◽  
Deapica Ravindran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
World Trade Organization ◽  
World Trade ◽  
Main Argument ◽  
Contract Research ◽  
Social Forms ◽  
Research Organizations ◽  
The World ◽  
To Come

This chapter reviews the evidence about the scale and significance of clinical trials in India. After describing some of the new social forms that service these trials it assesses the growth in their number from 2005 to 2012 and the reasons for—and implications of—a decline since then. The main argument is that the nascent Indian clinical trials industry rapidly adjusted to the opportunities provided by reforms, linked to India’s accession to the TRIPs agreement and the World Trade Organization in 2005. By contrast, Indian regulators were slow to come to terms with the challenges of responding to well-co-ordinated trial sponsors and contract research organizations.

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation

2019 ◽  
Vol 31 (8) ◽  
pp. 710-718
Author(s):  
Rajesh Ranjan ◽  
Nidhi B. Agarwal ◽  
Prem Kapur ◽  
Amit Marwah ◽  
Rizwana Parveen
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Subjects ◽  
Cross Sectional Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Cross Sectional ◽  
Contract Research ◽  
Research Organizations ◽  
Informed Consent Document

Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical trials. Majority (54%) were unaware about any informed consent document. None of them were aware of their right of profession competence, privacy and integrity, transparency, nonexploitation, and nonusage of their biological samples. Effective implementation of principles of informed consenting is largely lacking among contract research organizations in Delhi, India. This could potentially cause risk to the participants.

scholarly journals Resolution of issues in clinical trials that sponsors entrusted to Contract Research Organizations in and outside Japan

2004 ◽  
Vol 8 (2) ◽  
pp. 77-86
Author(s):  
Yoshihiro Noda ◽  
Fumiko Alaya ◽  
Hideki Watanabe ◽  
Tomomi Suzuki ◽  
Koichi Suzuki ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Contract Research ◽  
Research Organizations

Financial Conflict of Interest: an Unresolved Ethical Frontier

2001 ◽  
Vol 27 (2-3) ◽  
pp. 149-162 ◽  
Author(s):  
Jerome P. Kassirer
Keyword(s):  
Gene Therapy ◽  
Clinical Trials ◽  
Conflict Of Interest ◽  
Contract Research ◽  
Financial Conflict ◽  
Financial Gain ◽  
Research Protocols ◽  
Research Organizations ◽  
Medical Facilities ◽  
Medicine Today

Financial conflict of interest has become one of the most contentious issues in medicine today. Several decades ago studies disclosed that physicians who had investments in medical facilities were referring patients for more tests and procedures than physicians who had no such investments. More recently, physicians who forego expensive tests and treatments for patients have been accused of skimping on care for personal financial gain. Physicians who emphatically tout certain treatments have been criticized for possessing hidden financial ties to the manufacturer of the products. Some physicians engaged in clinical trials have been suspected of enrolling patients who do not strictly conform to the research protocols so that they can collect fees from contract research organizations. And in the aftermath of deaths and complications in gene therapy experiments, some scientists and their institutions have been criticized for possessing a financial stake in companies that are involved in the studies.

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