IOM Report: NCI Clinical Trials Cooperative Group Programs Needs Urgent Retooling; ASCO Praises New IOM Report on Renovating NCI Cooperative Groups & Releases Survey Showing Harms of Underfunding

2010 ◽  
Vol 32 (9) ◽  
pp. 13
Author(s):  
Peggy Eastman
2007 ◽  
Vol 25 (32) ◽  
pp. 5051-5057 ◽  
Author(s):  
Deborah Watkins Bruner ◽  
Charlene J. Bryan ◽  
Neil Aaronson ◽  
C. Craig Blackmore ◽  
Michael Brundage ◽  
...  

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.


2020 ◽  
Vol 66 (3) ◽  
pp. 284-289
Author(s):  
Lucian S. Viana ◽  
Neimar de Paula Silva ◽  
Nathalie V. Balmant ◽  
Paulo A. Faria ◽  
Marceli O. Santos ◽  
...  

SUMMARY OBJECTIVE Children with renal tumors included in clinical trials have significantly better outcomes. In Brasil, the enrollment of patients in clinical trials remains challenging. Here we aimed to describe participation accrual in the Brazilian Wilms Tumor Study Group (BWTSG) and to identify barriers to trial registration of children with renal tumors. METHODS We determined the numbers of renal tumor diagnoses in 105 hospital-based cancer registries from 2001-2009. We then compared these totals with the numbers of renal tumor cases registered in the BWTSG from the same hospitals during the same time period. We also invited members of the Brazilian Pediatric Oncology Society to complete a 5-point Likert-type scale questionnaire regarding their opinions of the importance of participation in cooperative group trials. RESULTS The accrual rate of patient participation per hospital varied from 25% to 76%, and was highest in the South region. The accrual rate of hospital participation also varied according to the region (20-31%) and was highest in the Southeast region. For the questionnaire regarding the importance of participation in cooperative groups, the responses showed an agreement of >75% on 10 of the 13 statements. CONCLUSION Our results demonstrated low accrual of participation in a cooperative group trial in Brasil. We identified variations in registration rates according to geographic region and hospital, which may help targeted efforts to increase registration rates. The survey responses demonstrated that colleagues understand the importance of trial participation.


2011 ◽  
Vol 5 (6) ◽  
pp. 379-381
Author(s):  
Ralph M. Meyer ◽  
Heather A. Stanton ◽  
Wendy R. Parulekar ◽  
Fred Saad

2018 ◽  
Vol 8 (7) ◽  
Author(s):  
Sikander Ailawadhi ◽  
Susanna Jacobus ◽  
Rachael Sexton ◽  
Alexander K. Stewart ◽  
Angela Dispenzieri ◽  
...  

ESMO Open ◽  
2020 ◽  
Vol 5 (2) ◽  
pp. e000628
Author(s):  
Rolf A Stahel ◽  
Denis Lacombe ◽  
Fatima Cardoso ◽  
Paolo G Casali ◽  
Anastassia Negrouk ◽  
...  

BackgroundThe academia-industry interface is important, and, despite challenges that inevitably occur, bears the potential for positive synergies to emerge. Perceived barriers to wider collaboration in academia-industry oncology research in Europe need to be addressed, current academic cooperative group and industry models for collaboration need to be discussed, and a common terminology to facilitate understanding of both sectors’ concerns needs to be established with an eye towards improving academia-industry partnerships on clinical trials for the benefit of patients with cancer.MethodologyCAREFOR (Clinical Academic Cancer Research Forum), a multi-stakeholder platform formed to improve the direction for academic clinical trials in the field of oncology in Europe, formed the CAREFOR-Industry Working Group comprised of experienced professionals from European academic cooperative groups joined by industry representatives selected based on their activities in the area of medical oncology. They jointly discussed academic cooperative groups, clinical trials conducted between academic cooperative groups and industry, examples of successful collaborative models, common legal negotiation points in clinical trial contracts, data access, and principles of interaction.ResultsFour principles of interaction between the academia and industry are proposed: (1) clarify the roles and responsibilities of all partners involved in the study, (2) involve legal teams from an early stage; (3) acknowledge that data is an important output of the study, (4) agree on the intent of the trial prior to its start.ConclusionsThe CAREFOR-Industry Working Group describes current models, challenges, and effective strategies for academia-industry research in Europe with an eye towards improving academia-industry partnerships on clinical trials for patients with cancer. Current perceived challenges are explained, and future opportunities/recommendations for improvement are described for the areas of most significant impact. Challenges are addressed from both the academic and industry perspectives, and principles of interaction for the optimal alignment between academia and industry in selected areas are proposed.


2002 ◽  
Vol 15 (1) ◽  
pp. 42-51 ◽  
Author(s):  
Betsy M. Bickert

Malignancy is the fourth leading cause of death in persons aged 1 to 19 years. The success of the pediatric oncology cooperative group clinical trials has allowed a systematic approach to the treatment of relatively rare malignancies. Each trial builds on previous results in terms of both survival and toxicity. This article will discuss the current treatment regimens for several of the more common pediatric malignancies and their long-term complications developed through this process.


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