Phase III Trials in Pancreatic Cancer in the United States

2010 ◽  
Vol 9 (1) ◽  
pp. 59-60
Author(s):  
Edward Chu ◽  
David Cunningham ◽  
David Watkins
Keyword(s):  
United States ◽  
Pancreatic Cancer ◽  
The United States ◽  
Phase Iii ◽  
Phase Iii Trials

Public Availability of Results of Trials Assessing Cancer Drugs in the United States

2013 ◽  
Vol 31 (24) ◽  
pp. 2998-3003 ◽  
Author(s):  
Thi-Anh-Hoa Nguyen ◽  
Agnes Dechartres ◽  
Soraya Belgherbi ◽  
Philippe Ravaud
Keyword(s):  
United States ◽  
The United States ◽  
Phase Iii ◽  
Cancer Drugs ◽  
Randomized Controlled ◽  
Kaplan Meier ◽  
Phase Iii Trials ◽  
Completion Date ◽  
Public Availability ◽  
Over Time

Purpose To evaluate to what extent results of completed trials of cancer drugs conducted in the United States are publicly available at ClinicalTrials.gov, as required by the Food and Drug Administration Amendments Act (FDAAA), or are published in journals. Methods We searched ClinicalTrials.gov for cancer trials governed by the FDAAA: phase II to IV trials assessing drugs in the United States with a primary completion date between December 26, 2007, and May 31, 2010. For each trial, we also searched PubMed to identify the publication of results. We assessed the cumulative percentages of posted or published results over time by using the Kaplan-Meier method. Results We identified 646 trials, including 209 randomized controlled trials (RCTs). At 12 months after completion of the trials, the cumulative percentages of trials with results posted at ClinicalTrials.gov, published in journals, and available either at ClinicalTrials.gov or in journals were 9% (95% CI, 7% to 11%), 12% (95% CI, 10% to 15%), and 20% (95% CI, 17% to 23%), respectively, and for RCTs, the percentages were 12% (95% CI, 8% to 16%), 5% (95% CI, 2% to 8%), and 17% (95% CI, 12% to 22%), respectively. At 36 months, these percentages were 31% (95% CI, 28% to 35%), 35% (95% CI, 31% to 39%), and 55% (95% CI, 51% to 59%), respectively, and for RCTs, they were 38% (95% CI, 31% to 45%), 32% (95% CI, 25% to 39%), and 56% (95% CI, 48% to 62%), respectively. Public availability of phase III trials was 15% (95% CI, 7% to 23%) at 12 months, 39% (95% CI, 27% to 49%) at 24 months, and 64% (95% CI, 50% to 73%) at 36 months. Conclusion Despite the FDAAA, results for nearly half the trials of cancer drugs in the United States were not publicly available 3 years after completion of the trials.

scholarly journals Trends in pancreatic cancer clinical trials in the United States

2021 ◽  
Vol 9 (11) ◽  
Author(s):  
Lynn Matrisian ◽  
Maren Martinez ◽  
Allison Rosenzweig ◽  
Cassadie Moravek ◽  
Anne-Marie Duliege
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trials ◽  
The United States ◽  
Phase Iii ◽  
Cancer Type ◽  
Fda Approval ◽  
Treatment Type ◽  
Phase Iii Trials ◽  
Previously Treated Patients ◽  
Previously Treated

Trends in clinical trials for pancreatic cancer between 2011-2020 were tracked in the Pancreatic Cancer Action Network database originally designed to assist in identifying open trials for eligible patients. More than 125 trials specific for pancreatic cancer or including no more than one additional cancer type have been open each year, the majority for patients with a diagnosis of pancreatic adenocarcinoma (PAC). The trends indicate an active and progressive pancreatic cancer research community and include an increasing number of trials for previously treated patients, the emergence of trials for post-adjuvant or maintenance therapy, an increasing number of research-intensive phase 0 trials, increasing seamless phase I/II and II/III trials to improve efficiency, and an increasing number of phase III trials despite historical failures. Trials were analyzed by treatment type and included trials to optimize standard chemotherapy or radiation therapy, trials targeting tumor pathways, the stroma, or the immune system, biomarker-specified trials, and a miscellaneous category of trials testing tumor metabolism, complementary medicine approaches, or alternate energy sources. There was a dramatic increase in immunotherapy trials over this time. Several biomarker-specified trials were initiated, and FDA approval was obtained for biomarker-specified targeted agents, many in a tissue-agnostic setting, indicating an increase in a precision medicine approach to pancreatic cancer treatment. An increasing number of trials tested non-standard approaches, many which progressed to phase III. The trends suggest an encouraging trajectory of pancreatic cancer clinical research.

Cancer Survival Is (Mostly) Improving

Pained ◽  
2020 ◽  
pp. 245-246
Author(s):  
Michael D. Stein ◽  
Sandro Galea
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Pancreatic Cancer ◽  
Survival Rate ◽  
Cancer Diagnosis ◽  
Cancer Survival ◽  
Prostate Cancer Screening ◽  
Survival Rates ◽  
The United States ◽  
Cervical Cancers

This chapter discusses how the 5-year survival rates for the most common cancers in the United States improved by nearly 20% since the 1970s. While promising overall, low survival rates persist for pancreatic, liver, lung, esophageal, brain, and many other cancers. Meanwhile, 5-year survival for uterine and cervical cancers worsened. Pancreatic cancer has the lowest 5-year survival rate at 8.2%. In contrast, prostate cancer had the greatest 5-year survival increase from 67.8% to 98.6%, most likely reflecting a substantial uptick in prostate cancer screening and early detection. Five-year survival with leukemia also improved significantly, from 34.2% to 60.6%, likely resulting from improved treatments. As such, in both detection and treatment, the United States is making progress. For the millions of Americans who face a cancer diagnosis, this is cause for hope.

scholarly journals 2497. Women’s Perspectives on and Experiences with Long-acting Injectable Anti-retroviral Therapy in the United States and Spain: the Potential Role of Gender in Patient Preferences

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S866-S866
Author(s):  
Andrea R Mantsios ◽  
Miranda Murray ◽  
Tahilin Sanchez Karver ◽  
Wendy Davis ◽  
David Margolis ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Phase Iii ◽  
Future Research ◽  
People Living With Hiv ◽  
Full Time ◽  
Daily Lives ◽  
Provider Perspectives ◽  
Long Acting ◽  
Trial Participants

Abstract Background Adherence to antiretroviral therapy (ART) to treat HIV remains a critical global health challenge given its relationship with individual health outcomes and population-level transmission. Given barriers associated with oral ART adherence, and considerations of patients’ preferences, long-acting injectable (LA) ART (cabotegravir + rilpivirine) is under development and has been shown to be non-inferior to daily oral ART in Phase III trials. While most of the trial participants have been men, as LA ART gets closer to becoming available for routine clinical use, it is critical to understand how this option is perceived by women. Methods We conducted in-depth interviews with 67 individuals, 53 people living with HIV (PLHIV) and 14 healthcare providers, in 11 sites in the United States and Spain participating in Phase III LA ART trials (ATLAS, ATLAS 2-M and FLAIR). Twenty percent (10/53) of trial participants interviewed were women. Interviews explored patient and provider perspectives and experiences with LA ART, and appropriate candidates and recommendations to support use. Interviews were audio-recorded, transcribed and coded using thematic content analysis. Results Overall, several salient themes emerged regarding participant’s generally positive experiences transitioning from daily oral ART to injectable ART including: the importance of the clinical efficacy of LA ART, the ability to learn to manage injection side-effects over time, and the “freedom” reportedly afforded by LA ART logistically and psychosocially. Women interviewed shared many of the aforementioned positive perceptions of LA ART but also had some unique perspectives. Female participants discussed how LA ART was easier to integrate into their daily lives including managing their multiple roles and responsibilities, which often involved working full-time and taking care of themselves as well as their family and children. Conclusion Similar to all participants, female participants had generally positive views of LA ART. However, the gendered nature of their daily lives also led to some unique perspectives on why and how they were satisfied with LA ART that merits further exploration in future research. Disclosures All authors: No reported disclosures.

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