Measuring the Incremental Cost of Clinical Cancer Research

2001 ◽  
Vol 19 (1) ◽  
pp. 105-110 ◽  
Author(s):  
Dana P. Goldman ◽  
Michael L. Schoenbaum ◽  
Arnold L. Potosky ◽  
Jane C. Weeks ◽  
Sandra H. Berry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Incremental Cost ◽  
Cancer Patients ◽  
Phase Ii ◽  
The United States ◽  
Phase Iii ◽  
Ongoing Effort ◽  
Cancer Trials ◽  
The Cost

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute–sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

scholarly journals Unconventional Anticancer Agents: A Systematic Review of Clinical Trials

2006 ◽  
Vol 24 (1) ◽  
pp. 136-140 ◽  
Author(s):  
Andrew J. Vickers ◽  
Joyce Kuo ◽  
Barrie R. Cassileth
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Dose Finding ◽  
Phase Iii ◽  
High Dose ◽  
Free Text ◽  
Phase Ii Trials ◽  
Off Label

Purpose A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer. Methods MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol. Results We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data. Conclusion Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.

Nanomedicines for enhanced permeability and retention (EPR)-stratified patients have the potential to improve treatment outcomes

2021 ◽  
Author(s):  
Moataz Dowaidar
Keyword(s):  
Clinical Trials ◽  
Treatment Outcomes ◽  
Cancer Patients ◽  
Survival Rates ◽  
The United States ◽  
Improve Treatment ◽  
Enhanced Permeability And Retention ◽  
Wide Range ◽  
The Cost

Nanomedicines are being tasked with boosting the efficacy of existing immunotherapies. Understanding the pathophysiology of the targeted tumors is critical for devising the optimum strategy. The corticosteroid dexamethasone has recently been discovered to promote tumor perfusion and nanomedicine accumulation. Only a limited percentage of patients, however, respond to immune checkpoint blockage (ICB). In the United States, for example, it is believed that ICB therapy is ineffective for about 87 percent of cancer patients. The care of enhanced permeability and retention (EPR)-stratified patients has the potential to improve treatment outcomes. Treating patients with several metastatic foci with varying amounts of EPR impact could increase nanomedicine impact in cancer patients, but only losartan has yet to reach clinical trials. Other medication repurposing techniques have been proposed for the increased efficacy of small medicines and antibodies, but they are still in clinical trials and need to be tested in human patients. The treatment of these patients could improve the effectiveness of nanomedi-based immunotherapy and reduce the toxicity of chemotherapy and radiation therapy. This could have a positive effect on cancer patients' survival rates and quality of life, as well as on the cost of treatment. The potential of nanomedicines to deliver a wide range of immunomodulating drugs and modulate their action in space

Early Detection of Toxicity and Adjustment of Ongoing Clinical Trials: The History and Performance of the North Central Cancer Treatment Group’s Real-Time Toxicity Monitoring Program

2002 ◽  
Vol 20 (23) ◽  
pp. 4591-4596 ◽  
Author(s):  
Richard M. Goldberg ◽  
Daniel J. Sargent ◽  
Roscoe F. Morton ◽  
Michelle R. Mahoney ◽  
James E. Krook ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Cancer Treatment ◽  
Real Time ◽  
Monitoring Program ◽  
The United States ◽  
Phase Iii ◽  
North Central ◽  
Chemotherapy Drugs ◽  
The North

ABSTRACT: Prospective clinical trials are the gold standard for evidence-based methodology used to support changes in the practice of medicine. Clinical researchers, regulatory agencies, payers, and the public embrace the conduct of phase I, II, and III clinical trials as integral to improving patient care. The National Cancer Institute (NCI) funds a number of cooperative oncology groups to conduct such clinical trials in the United States. In order to protect enrolling patients, the NCI requires expedited reporting to allow rapid identification of severe side effects on NCI-sponsored clinical trials. However, chemotherapy drugs frequently cause predictable side effects, the rapid reporting of which would potentially overwhelm the system. This article describes the development and documents the performance of a real-time toxicity reporting system implemented by the North Central Cancer Treatment Group. The goal of this system is to supplement the currently required NCI adverse event monitoring procedures and to permit study teams to identify the need to modify ongoing clinical trials. The system has proven its value in the monitoring of phase II and III trials, including trial N9741, a three-arm, phase III, advanced colorectal cancer chemotherapy study exploring combinations of irinotecan, oxaliplatin, and fluorouracil. We believe the methods described present opportunities for improving patient safety in clinical research.

How Sociodemographics, Presence of Oncology Specialists, and Hospital Cancer Programs Affect Accrual to Cancer Treatment Trials

2002 ◽  
Vol 20 (8) ◽  
pp. 2109-2117 ◽  
Author(s):  
Warren B. Sateren ◽  
Edward L. Trimble ◽  
Jeffrey Abrams ◽  
Otis Brawley ◽  
Nancy Breen ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Health Insurance ◽  
Cancer Treatment ◽  
Cancer Patients ◽  
Asian American ◽  
The United States ◽  
Health Maintenance ◽  
Treatment Trials ◽  
The Impact

PURPOSE: We chose to examine the impact of socioeconomic factors on accrual to National Cancer Institute (NCI)–sponsored cancer treatment trials. PATIENTS AND METHODS: We estimated the geographic and demographic cancer burden in the United States and then identified 24,332 patients accrued to NCI-sponsored cancer treatment trials during a 12-month period. Next, we examined accrual by age, sex, geographic residence, health insurance status, health maintenance organization market penetration, several proxy measures of socioeconomic status, the availability of an oncologist, and the presence of a hospital with an approved multidisciplinary cancer program. RESULTS: Pediatric patients were accrued to clinical trials at high levels, whereas after adolescence, only a small percentage of cancer patients were enrolled onto clinical trials. There were few differences by sex. Black males as well as Asian-American and Hispanic adults were accrued to clinical trials at lower rates than white cancer patients of the same age. Overall, the highest observed accrual was in suburban counties. Compared with the United States population, patients enrolled onto clinical trials were significantly less likely to be uninsured and more like to have Medicare health insurance. Geographic areas with higher socioeconomic levels had higher levels of clinical trial accruals. The number of oncologists and the presence of approved cancer programs both were significantly associated with increased accrual to clinical trials. CONCLUSION: We must work to increase the number of adults who enroll onto trials, especially among the elderly. Ongoing partnership with professional societies may be an effective approach to strengthen accrual to clinical trials.

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

scholarly journals Evaluation of the Value of Attribution in the Interpretation of Adverse Event Data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group Investigation

2010 ◽  
Vol 28 (18) ◽  
pp. 3002-3007 ◽  
Author(s):  
Shauna L. Hillman ◽  
Sumithra J. Mandrekar ◽  
Brian Bot ◽  
Ronald P. DeMatteo ◽  
Edith A. Perez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Randomized Clinical Trials ◽  
Study Drug ◽  
Phase Iii ◽  
Oncology Group ◽  
North Central ◽  
American College Of Surgeons ◽  
Group Trial

Purpose In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data. Patients and Methods Patients in the placebo arm of two phase III trials—North Central Cancer Treatment Group Trial 97-24-51 (carboxyamino-triazole v placebo in advanced non–small-cell lung cancer) and American College of Surgeons Oncology Group Trial Z9001 (imatinib mesylate v placebo after resection of primary gastrointestinal stromal tumors)—were studied. Attribution was categorized as unrelated (not related or unlikely) and related (possible, probable, or definite). Results In total, 398 patients (84 from Trial 97-24-51 and 314 from Trial Z9001) and 7,736 AEs were included; 47% and 50% of the placebo-arm AEs, respectively, were reported as related. When the same AE was reported in the same patient on multiple visits, the attribution category changed at least once 36% and 31% of the time. AE type and sex (Trial Z9001) and AE type and performance status (Trial 97-24-51) were associated with a higher likelihood of AEs being deemed related. Conclusion Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.

Treatment and secondary prevention of venous thrombo -embolism in cancer patients

2012 ◽  
Vol 32 (02) ◽  
pp. 139-144 ◽  
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Initial Period ◽  
Factor Xa ◽  
Secondary Prophylaxis ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancer-associated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3–6 months. New oral anti-coagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE also in cancer patients. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

National survey on the effect of oncology drug shortages in clinical practice: A Hematology Oncology Pharmacy Association (HOPA) survey.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13609-e13609
Author(s):  
Sarah Hudson-Disalle ◽  
David L. DeRemer ◽  
Larry W Buie ◽  
Mark Hamm ◽  
Jeffrey Pilz ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Cancer Patients ◽  
Medication Errors ◽  
The United States ◽  
Adverse Outcomes ◽  
Common Disease ◽  
Drug Shortages ◽  
Oncology Drug ◽  
The Impact

e13609 Background: Drug shortages are a clear and growing challenge. Prominent shortages included oncology medications and supportive care products essential for the care of cancer patients. Oncology drug shortages often result in disruptions in the timing of chemotherapy treatments, alterations in the dose or regimen administered, or even missed doses when alternative agents are unavailable. The purpose of this survey was to characterize the impact of oncology drug shortages across the United States, including the experiences of health care organizations, resource implications, and the impact on patient safety, patient care, and clinical trials. Methods: A 34-item online survey was distributed to HOPA membership of the Hematology Oncology Pharmacy Association to gather information on shortages of oncology drugs (i.e., all drugs essential in the care of cancer patients, including supportive care agents. Results: Sixty-eight organizations completed the survey; almost all completed by pharmacists, and analysis completed. Sixty-three percent of institutions reported one or more drugs shortages a month, with a 34.33% increase in 2019 from 2018. Sixty four percent of responded had incurred increased costs from oncology drugs shortages, with 7% noting reimbursement issues when switched to brand name therapies due to shortages. Treatment delays, reduced doses or alternative regimens were reported by 74.63% of respondents. The most common disease states which causes a dose delay of treatment included Acute Lymphocytic Leukemia, Lymphoma and Multiple Myeloma with dose reductions noted in 36.36%, 36.36 and 15.91%. The top five oncology drugs on shortage included epirubicin, flutamide, decitabine, mechlorethamine, dactinomycin with the top 5 supportive care drugs on shortage being noted as hydrocortisone, bivalirudin, promethazine, mycophenolate sodium and scopolamine. Respondents noted medication errors related to oncology drug shortages at 4.48%, with noted errors including incorrect conversion from iv to oral etoposide and incorrect EMR drug builds. Oncology Drug shortages impacted clinical trials in 13.4% of respondents in which 54.55% of respondents noting patients not being enrolled in clinical trials. Conclusions: A survey of US oncology pharmacists and technicians indicated that oncology drug shortages occurred frequently in 2020. Shortages led to delays in chemotherapy and changes in treatment or omission, complicated clinical research and increased the risk of medication errors and adverse outcomes.

Offline Well Abandonment SIMOPs: An 81 Well Phase I & II Case Study Enabling ABEX Reduction in South East Asia

2021 ◽  
Author(s):  
Steven A. Canny ◽  
Jane Amarin ◽  
Verapich Pinprayong ◽  
Chumpae Sratongroy ◽  
Pancharat Pitchayang ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Business Performance ◽  
Net Present Value ◽  
Balance Sheet ◽  
Pressure Control ◽  
Phase Iii ◽  
Well Abandonment ◽  
The Cost

Abstract In the decommissioning phase of oilfield facility lifecycles, focus pivots from positive net present value to executing the care and preservation, then decommissioning in the safest and most environmentally sensitive manor, and at the lowest total cost of ownership. Asset Retirement Obligation (ARO) is a long-term liability carried on the balance sheet, as a provision for the cost to return a wellsite to pre-exploration condition. The reduction of abandonment and decommissioning expenditure (ABEX) in executing compliant operations is a key business performance factor, and critical in executing higher volumes of wells earlier than planned. In doing so maximizing value to company shareholders, residents, industries and government level stakeholders. In the case study, an offline pre-abandonment and Phase I primary reservoir isolation project is presented, which seeks to maximize net project efficiency via offline wellbore intervention, executing the primary reservoir isolation of the wellbore via rigless techniques. This approach contributed to ABEX reductions by up to 40% per well vs the planned approval for expenditure (AFE) provisions taken for the operations. The project execution structure utilized offline intervention and Phase I primary reservoir isolation of 81 wellbores, across 5 wellhead platforms and 47 days continuous operations. Operations were part of a simultaneous operation (SIMOPS) project, as an offline work front located on the wellhead platform (WHP) weather deck. A second work front for Phase II and Phase III well abandonment operations, is executed concurrently, from the jack-up rig cantilever above the WHP. Live well operations are conducted concurrently by both work fronts, through the Christmas Tree (XT) and pressure control equipment in Phase I, and through the drilling riser and blowout preventor for Phase II and Phase III, to maximize productivity when the rig is on location. The scope of operations included wellhead qualification, wellbore access and preparation, well kill, injectivity testing, various wellbore preparation and cement placement techniques, pressure testing and lubrication of the wellbore. The operator's system engineering, design of operations and planning agility are key to its success. Acute focus was given to the batching of operations and delivery of these in a phased approach to increase productivity and maintain high service delivery through repetition of tasks. The project successfully executed Incident Free Operations (IFO) with 100% productive time and facilitated combined project performance, which delivered wells up to 44% ahead of the planned AFE. To enable this, over 4.19 million feet of slickline was run, conveying 428 bottom hole assemblies (BHAs), preparing the wellbores to isolate 804 primary reservoirs, and 2 intermediate reservoirs.

PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines

2020 ◽  
pp. 106002802094352
Author(s):  
Mary B. Gadarowski ◽  
Rima I. Ghamrawi ◽  
Sarah L. Taylor ◽  
Steven R. Feldman
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Data Extraction ◽  
Botulinum Toxin Type A ◽  
Botulinum Toxin Type ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Study Selection ◽  
Pubmed Database ◽  
Phase Ii And Iii

Objective: PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug. Data sources: A systematic literature review was performed using the terms “glabellar lines AND prabotulinumtoxinA” in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies. Study Selection and Data Extraction: Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( P < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; P < 0.001). PrabotulinumtoxinA was well tolerated across all studies. Relevance to Patient Care and Clinical Practice: This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians. Conclusion: PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.

Sign in / Sign up

Export Citation Format

Share Document