The NCI pediatric central institutional review board (PedCIRB) initiative: Progress and impact

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6632-6632 ◽  
Author(s):  
B. D. Anderson ◽  
J. Goldberg ◽  
J. Adler ◽  
L. Covington ◽  
D. Olson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Childhood Cancer Survivors ◽  
Final Approval ◽  
Patient Protection ◽  
Protocol Development ◽  
Institutional Review ◽  
Medical Institutions ◽  
Patient Advocates ◽  
Protocol Review ◽  
Central Institutional Review Board

6632 NCI has developed a central IRB (PedCIRB) to review NCI-sponsored pediatric clinical trials conducted by the Children's Oncology Group (COG). COG comprises ∼200 U.S. medical institutions and protocol activation traditionally requires separate protocol review by each local IRB (LIRB) and, subsequently, a review of each protocol amendment and significant adverse event. The PedCIRB model seeks to increase patient protection by improving the expertise of protocol reviewers and making their review available to all PedCIRB participating institutions. The PedCIRB consists of experts in pediatric oncology, pediatric medicine, nursing, pharmacy, bioethics, biostatistics, as well as patient advocates and childhood cancer survivors. The PedCIRB model also eliminates redundant reviews, reduces administrative burdens on local COG investigators and LIRBs, and can accelerate the pace of local protocol activation, thus increasing the availability of clinical trials to children with cancer. The PedCIRB conducts a full board protocol review that is available via a confidential website to participating LIRBs. LIRBs can choose to perform a facilitated review, using PedCIRB materials, that focuses on local concerns, rather than a full LIRB protocol review. If the LIRB accepts the PedCIRB review, the PedCIRB becomes the IRB of record for that protocol and takes responsibility for the review of subsequent protocol amendments, adverse events and continuing reviews. Since starting in November 2004, the PedCIRB has reviewed 59 protocols. Initial reviews resulted in 44 approvals pending modification and 15 protocols being tabled for further information. The time from protocol submission to final approval by the PedCIRB has ranged from 3 to 28 weeks with an average time of 16.9 weeks during year one and 12.7 weeks during year two of the project. As of November 2006, 117 of a possible 197 U.S. COG institutions (59%) have signed on to the PedCIRB initiative and 70% of the participating institutions have conducted facilitated reviews (total 750) for the 30 protocols available on the PedCIRB website. The PedCIRB's influence on protocol development and patient accrual timelines will be discussed. No significant financial relationships to disclose.

scholarly journals Meeting the Challenge: The National Cancer Institute’s Central Institutional Review Board for Multi-Site Research

2018 ◽  
Vol 36 (8) ◽  
pp. 819-824 ◽  
Author(s):  
Holly A. Massett ◽  
Sharon L. Hampp ◽  
Jacquelyn L. Goldberg ◽  
Margaret Mooney ◽  
Linda K. Parreco ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States ◽  
National Institutes Of Health ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Limited Data ◽  
Human Patient ◽  
Institutional Review ◽  
Central Institutional Review Board

The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.

Central IRB Review Is an Essential Requirement for Cancer Clinical Trials

2017 ◽  
Vol 45 (3) ◽  
pp. 341-347 ◽  
Author(s):  
Lowell E. Schnipper
Keyword(s):  
Clinical Trials ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Essential Requirement ◽  
Institutional Review ◽  
Legal Arguments ◽  
Central Institutional Review Board

There are compelling medical, ethical, and legal arguments that support mandating use of a central institutional review board (CIRB) for the review of clinical trials performed at multiple institutional sites. Progress against serious diseases depends on this.

scholarly journals A common goal to CARE: Cancer Advocates, Researchers, and Clinicians Explore current treatments and clinical trials for breast cancer brain metastases

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Natalie S. Joe ◽  
Christine Hodgdon ◽  
Lianne Kraemer ◽  
Kristin J. Redmond ◽  
Vered Stearns ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Brain Metastases ◽  
Detection Methods ◽  
Future Research ◽  
Breast Cancer Brain Metastasis ◽  
Patient Advocates ◽  
Breast Cancer Brain Metastases ◽  
The Brain

AbstractBreast cancer is the most commonly diagnosed cancer in women worldwide. Approximately one-tenth of all patients with advanced breast cancer develop brain metastases resulting in an overall survival rate of fewer than 2 years. The challenges lie in developing new approaches to treat, monitor, and prevent breast cancer brain metastasis (BCBM). This review will provide an overview of BCBM from the integrated perspective of clinicians, researchers, and patient advocates. We will summarize the current management of BCBM, including diagnosis, treatment, and monitoring. We will highlight ongoing translational research for BCBM, including clinical trials and improved detection methods that can become the mainstay for BCBM treatment if they demonstrate efficacy. We will discuss preclinical BCBM research that focuses on the intrinsic properties of breast cancer cells and the influence of the brain microenvironment. Finally, we will spotlight emerging studies and future research needs to improve survival outcomes and preserve the quality of life for patients with BCBM.

scholarly journals IRB Process Improvements: A Machine Learning Analysis

2017 ◽  
Vol 1 (3) ◽  
pp. 176-183 ◽  
Author(s):  
Kimberly Shoenbill ◽  
Yiqiang Song ◽  
Nichelle L. Cobb ◽  
Marc K. Drezner ◽  
Eneida A. Mendonca
Keyword(s):  
Machine Learning ◽  
Review Process ◽  
Learning Methods ◽  
Process Improvements ◽  
Machine Learning Methods ◽  
Processing Times ◽  
Institutional Review ◽  
Learning Analysis ◽  
Expensive Process ◽  
Protocol Review

ObjectiveClinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication.MethodsWe analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis.ResultsOur analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran’s Administration purview and specific staff in charge of a protocol's review.ConclusionsWe have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.

Protocol Development in Clinical Trials for Healthcare Management

2021 ◽  
pp. 1797-1814
Author(s):  
Swati Changdeo Jagdale ◽  
Asawaree Anand Hable ◽  
Anuruddha R. Chabukswar
Keyword(s):  
Study Protocol ◽  
Statistical Treatment ◽  
Healthcare Management ◽  
Eligibility Criteria ◽  
Regulatory Guidance ◽  
Protocol Development ◽  
Institutional Review ◽  
Other Information ◽  
Treatment Data ◽  
Time Allotment

Clinical trial is a part of clinical research. It is a systematic experimental biomedical study. They are carried out to evaluate the effectiveness and safety of medications or medical devices or biologics. Trials are conducted to check safety and efficacy of new drug. It includes four phases as phase I, II, III, and IV. The study is carried out according to study protocol and standard operating procedures as per good clinical practices guidelines. The study protocol is developed by the researchers and approved by an independent committee called as Institutional Review Board. Protocol is a roadmap for team of healthcare professionals involved in investigation work. It should explain the significance of research trial, location, detail procedure, methods, activities, time allotment, financial estimate and any other information required. The content of protocol are title, objective, background, eligibility criteria, study methodology, risks or adverse effects, benefits, alternative treatment, data collection, statistical treatment, regulatory guidance, and other information.

scholarly journals The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

2018 ◽  
Vol 16 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Michael P Diamond ◽  
Esther Eisenberg ◽  
Hao Huang ◽  
Christos Coutifaris ◽  
Richard S Legro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Child Health ◽  
Clinical Research ◽  
Human Development ◽  
Reproductive Medicine ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
The Impact ◽  
Review Boards

Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission’s review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7–24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. Conclusion: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health’s goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

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