Differences in Funding Sources of Phase III Oncology Clinical Trials by Treatment Modality and Cancer Type

1561 Background: Surgical interventions are studied less often than medical or radiation interventions in oncology clinical trials. We characterized surgical oncology trials registered on ClinicalTrials.gov, analyzed funding sources and identified features associated with early discontinuation and results reporting. Methods: We employed a cross-sectional study design with descriptive, logistic regression, cox regression, time series and survival analyses. We downloaded all 270,172 studies registered on the Aggregate Analysis of the ClinicalTrials.gov database from October 1, 2008 to March 9, 2020. After excluding non-interventional trials, applying cancer/oncology specific Medical Subject Heading terms to the remaining trials and excluding phase 1 trials, 27,915 trials were identified for manual review. Primary exposure variables were trial focus: neoplasia site and treatment modality (surgical interventions included investigations of outcomes from surgical resection or intra-operative/peri-operative changes), and funding: industry, U.S. government, academic. Results: 26,815 trials were found to have true oncology content; 1,661 (6.2%) involved surgical oncology, representing 311,789 patients. Funding sources were: 82.7% by academic institutions, 10.9% by industry, and 6.2% by U.S. government. The most studied neoplasia sites were colorectal (17.4% of trials), breast (10.7%), gastric (10.5%), hepatic (8.6%), lung (7.5%), brain/CNS (6.7%) and cervical (6.6%). U.S. government funded surgical oncology trials had the lowest risk of early discontinuation (adjusted HR 0.65, 95% CI: 0.58-0.73, p<0.001) and the highest odds of results reporting (adjusted OR 1.35, 95% CI: 1.08-1.68, p=0.008) (Table). Conclusions: There is a paucity of surgical oncology clinical trials compared to other treatment modalities, especially in context of surgery’s role in overall cancer care. From 2008-2020 only 6.2% of trials focused on surgical oncology, and U.S. government funded trials displayed the lowest hazard of early discontinuation and highest odds of results reporting. Stakeholders should look to government funded trials as models of improvement, but must increase representation and results dissemination of surgical oncology trials to guide treatment recommendations. Surgical oncology trial features and associated early discontinuation/results reporting.[Table: see text]

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Drug cost savings in phase III hematological oncology clinical trials in a university hospital

Hematological Oncology ◽

10.1002/hon.2753 ◽

2020 ◽

Vol 38 (4) ◽

pp. 576-583

Author(s):

Chloé Herledan ◽

Florence Ranchon ◽

Vérane Schwiertz ◽

Amandine Baudouin ◽

Lionel Karlin ◽

...

Keyword(s):

Clinical Trials ◽

Drug Cost ◽

Cost Savings ◽

University Hospital ◽

Phase Iii ◽

Oncology Clinical Trials

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Trends in the content and format of main and optional consent forms in oncology clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.8_suppl.153 ◽

2017 ◽

Vol 35 (8_suppl) ◽

pp. 153-153

Author(s):

Sonja Rummell ◽

Leo Chen ◽

Winson Y. Cheung

Keyword(s):

Clinical Trials ◽

Reading Level ◽

Phase Iii ◽

Cancer Center ◽

Consent Forms ◽

Flesch Reading Ease ◽

Gi Cancer ◽

Oncology Clinical Trials ◽

Cancer Studies ◽

Over Time

153 Background: Informed consent forms (ICFs) should provide prospective subjects with an opportunity to balance the risks and benefits of study participation. However, there are growing concerns about the quality of ICFs. Optional ICFs are also increasingly used as the number of companion studies and biomarker evaluations requiring additional tests become more frequent. We examined trends in the content and format of main and optional ICFs. Methods: ICFs from clinical trials at a tertiary cancer center in British Columbia from 2000 to 2015 were reviewed. We focused on breast or gastrointestinal (GI) cancer studies. Readability was evaluated with the Flesch Reading Ease Score (FRES) and Flesch Kincaid Grade Level (FKGL) where a higher FRES (maximum 100) and a lower FKGL (maximum 12) indicated easier readability. We applied t-tests and linear regressions to examine variations among clinical trials and changes over time. Results: We identified 133 main ICFs of which 70% had optional ICFs and where 57% and 43% were breast and GI cancer studies. Phase III trials (44%), industry funded investigations (70%), and studies involving palliative therapies (72%) were most common. Trials from recent years were more likely to have optional ICFs than those from earlier years (p < 0.001). The median length and median word count in main and optional ICFs were 16 and 6 pages and 6183 and 1862 words, respectively. These changed significantly over time whereby main ICFs increased approximately by 1 page and 364 words per year over the 15 year period (p < 0.001). Industry funded trials also had longer ICFs (p = 0.006). Study methods, risks, and confidentiality occupied 29%, 20%, and 11% of the content on ICFs, respectively. Sections pertaining to eligibility (p < 0.001) and screening procedures (p = 0.007) also increased with time, particularly for industry funded studies (p = 0.006). In terms of readability, optional ICFs were generally more difficult to read than main ICFs (FRES 48.3 vs 50.0, p = 0.024; FKGL 11.8 vs 11.1, p < 0.001), especially in recent years (p < 0.001). Conclusions: This is one of the first analyses to include optional ICFs. Length of ICFs is increasing and readability is discordant with the average reading level of potential trial participants.

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1065P Adverse events reporting in phase III oncology clinical trials of checkpoint inhibitors: A systematic review

Annals of Oncology ◽

10.1016/j.annonc.2020.08.1185 ◽

2020 ◽

Vol 31 ◽

pp. S725

Author(s):

M-L. Joulia ◽

A. Barhli ◽

C. Tournigand ◽

E. Kempf

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Events ◽

Checkpoint Inhibitors ◽

Phase Iii ◽

Oncology Clinical Trials

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Trends and regional variation in women's representation as principal investigators (PI) in phase III gynecologic oncology clinical trials

Gynecologic Oncology ◽

10.1016/s0090-8258(21)01248-8 ◽

2021 ◽

Vol 162 ◽

pp. S314-S315

Author(s):

Jessica Jou ◽

Allison Brodsky ◽

Lindsey Charo ◽

Pratibha Binder ◽

Cheryl Saenz ◽

...

Keyword(s):

Clinical Trials ◽

Regional Variation ◽

Gynecologic Oncology ◽

Phase Iii ◽

Women's Representation ◽

Principal Investigators ◽

Women’S Representation ◽

Oncology Clinical Trials

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Immunotherapy as a treatment strategy in advanced stage and recurrent endometrial cancer: review of current phase III immunotherapy clinical trials

Therapeutic Advances in Medical Oncology ◽

10.1177/17588359211001199 ◽

2021 ◽

Vol 13 ◽

pp. 175883592110011

Author(s):

Ramez N. Eskander ◽

Matthew A. Powell

Keyword(s):

Clinical Trials ◽

Endometrial Cancer ◽

Standard Of Care ◽

Phase Iii ◽

Oncologic Outcomes ◽

Current Phase ◽

Advanced Stage ◽

Cancer Review ◽

Oncology Clinical Trials ◽

Recurrent Endometrial Cancer

The treatment of advanced stage, metastatic or recurrent endometrial cancer remains a clinically difficult scenario. Although combination carboplatin and paclitaxel is an effective standard-of-care regimen, alternate strategies have shown promise, particularly in biomarker select populations. In an effort to improve oncologic outcomes, investigators are exploring novel immunotherapy combinations. In this review, we discuss the clinical rationale and design of current phase III immuno-oncology clinical trials in patients with advanced stage or recurrent endometrial cancer.

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Trends in pancreatic cancer clinical trials in the United States

Medical Research Archives ◽

10.18103/mra.v9i11.2578 ◽

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.

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Global drug development in cancer: A cross-sectional study of clinical trial registries

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.2520 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 2520-2520

Author(s):

P. Hertz ◽

B. Seruga ◽

L. W. Le ◽

I. F. Tannock

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Drug Development ◽

Phase Ii ◽

New Drugs ◽

Phase Iii ◽

Cancer Site ◽

Cancer Type ◽

Clinical Trial Registries ◽

Global Drug Development

2520 Background: Clinical trials are increasingly funded by industry. High costs of drug development may lead to attempts to develop new drugs in more ‘profitable’ (i.e., more prevalent) as compared to ‘less profitable’ (i.e., more deadly) cancers. Here we determine the focus of current global drug development. Methods: We determined characteristics of phase II and III clinical trials evaluating new drugs in oncology, which were registered with WHO International Clinical Trial Registries between 01/2008 and 06/2008. Estimates of incidence, mortality, and prevalence in the more- and less-developed world (MDW, LDW) were obtained from GLOBOCAN 2002. Simple correlation analysis was performed between the number of clinical trials and incidence, mortality and prevalence per cancer site after log transformation of variables. Results: We identified 399 newly registered trials. Of 374 trials with information about recruitment, 322 (86.1%) and 39 (10.4%) recruited patients only from the MDW and LDW, respectively, while 13 (3.5%) had worldwide recruitment. 229 (58%) of trials were sponsored by industry and 324 trials were phase II (81%). Most trials (and most phase III trials) evaluated treatments for globally prevalent cancers: breast, lung, prostate, and colorectal cancer (Table). Prevalence of a particular cancer type in both the MDW and LDW correlated significantly with the number of clinical trials (Pearson r = 0.63 and 0.55; p = 0.01 and 0.03, respectively). In contrast, mortality in the MDW (Pearson r = 0.73; p= 0.002), but not in the LDW (Pearson r = 0.38; p= 0.17), correlated significantly with the number of clinical trials. Conclusions: Global drug development in cancer predominates in globally prevalent cancers, which are a more important cause of mortality in the MDW than in the LDW. Cancer sites that are major killers globally, and especially in the LDW (e.g., stomach, liver, and esophageal cancer) should receive priority for clinical research. [Table: see text] No significant financial relationships to disclose.

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Speed of accrual into published phase III oncology trials: A comparison across geographic locations.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.6074 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 6074-6074

Author(s):

Nancy R. Ruther ◽

Alcee Jumonville ◽

Michelle A. Mathiason ◽

Ann E. Emmel ◽

Sandra K Wee ◽

...

Keyword(s):

Phase Iii ◽

Funding Source ◽

Cancer Type ◽

Cooperative Groups ◽

Geographic Locations ◽

Funding Sources ◽

Therapeutic Trials ◽

Number Of Patients ◽

The Us ◽

The Mean

6074 Background: There is a perception that patient accrual may be slower in the US than it is in Europe (Wang-Gillam A et al, J Clin Oncol 2010;28:3803-3807). However, a systematic study has not been performed. We seek to determine the speed at which patients are accrued into published phase III oncology trials across geographic locations and to identify factors that may influence this process. Methods: We searched MEDLINE and identified all original phase III oncology therapeutic trials published in 2006-2010 (N = 567). Trials with no reported activation and completion dates were excluded (n = 20). Accrual speed per trial was expressed as patients per month and was calculated by dividing the number of patients enrolled by number of months a trial was open. Results: The 547 trials included in our study enrolled 281,340 patients. Most trials were for adults only (95.6%), late stage cancers (77.5%), and involved multinational participation (44.1%). Funding sources were cooperative groups (45.5%), industry (33.8%) and academic centers (20.5%). The top 5 cancers studied were hematologic (19.2%), gastrointestinal (16.5%), lung (16.3%), breast (15.4%), and gynecologic (8.4%). Trial results were negative (57.4%), positive (38.2%), or equivalent (4.4%). The mean (+SD) accrual speeds varied according to trial location (multinational [25.0+25.4], US [13.3+16.5], other countries [11.4+15.7], Europe [8.7+11.8]; [P= .001]), funding source (industry [28.3+24.7], cooperative groups [13.3+19.0], academic [6.8+6.5]; [P= .001]), and cancer type (breast [24.0+29.4], gastrointestinal [20.2+24.2], lung [19.3+22.7], gynecologic [15.3+19.2], hematologic [11.2+10.7]; [P= .001]). After adjusting for funding source, accrual speeds were significantly different across trial locations only in 2 cancers: gastrointestinal (multinational [25.2+3.7], US [24.1+8.2], Europe [11.5+3.7], other [7.5+8.5]; P= .046) and gynecologic (multinational [28.9+5.4], other [10.5+7.8], US [6.6+5.3], Europe [4.2+5.9]; P= .004) studies. Conclusions: Among published phase III oncology trials, multinational studies accrued patients faster in gastrointestinal and gynecologic cancers and at a similar speed in other cancers.

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