Direct impact of clinical research in metastatic renal cell carcinoma (mRCC): A cost-effectiveness analysis of patient care outcomes and cost savings in a real-life scenario of a large public university hospital in Spain.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 637-637
Author(s):  
Silvia Garcia-Garro ◽  
Pablo Gajate ◽  
Esther Gómez-de-Salazar ◽  
Teresa Alonso Gordoa ◽  
Miguel Angel Rodriguez-Sagrado ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Research ◽  
Public Health System ◽  
Real Life ◽  
Cost Savings ◽  
University Hospital ◽  
Direct Impact

637 Background: Public health sustainability is a major concern worldwide. Clinical research is considered to leverage patient care outcome but also can lead costs savings and, subsequently, to maintain public health system. Thus, we analyzed the direct impact of clinical research in terms of improvement in clinical outcomes and costs related to research in patients with mRCC in real-life setting. Methods: We retrospectively collected data related to overall survival (OS) and direct health care costs from all mRCC patients who were treated with oral anti-tumour medication and followed at the Medical Oncology Department of Ramón y Cajal University Hospital in Madrid, between January 2010 and February 2017. A statistical analysis comparing the outcomes of patients included in clinical trials versus those not included was conducted. Results: In the study period, 65 patients were newly diagnosed with mRCC and received treatment. Those patients included in clinical trials showed higher median OS (91 vs. 29 months. HR 0.389; 95% CI: 0.150: 1.000; p=0.04). Median direct cost per mRCC patient in ‘real-life’ was €67,376. Median cost for a patient enrolled in at least one clinical trial was €53,673 vs. €63,834 for those who were never recruited for a trial. Participation in clinical trials contributed to a decrease in total health expenditure by 9.02% (€362,367), mainly due to reduction in the cost of medications and diagnostic tests (91.46% vs. 8.54%, respectively). Furthermore, clinical trial participants have required less number of hospitalizations (0.08 vs. 1.75) and emergency visits (0.39 vs. 3.2) per patient. Conclusions: Under the public health system perspective, participation in clinical trials is related to an improvement in overall survival as well as direct and indirect cost savings in mRCC patients.

Incremental Drug Treatment Cost in HIV-Positive Patients in Industry-Sponsored Clinical Trials

2008 ◽  
Vol 42 (11) ◽  
pp. 1586-1591 ◽  
Author(s):  
Rosario Santolaya Perrín ◽  
Fernando J García López
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Therapy ◽  
Cost Savings ◽  
Drug Costs ◽  
Extra Cost ◽  
University Hospital ◽  
Study Entry ◽  
The Cost ◽  
Mean Cost

Background: Drugs used in clinical trials supported by the pharmaceutical industry are supplied free of charge by the companies. However, maintenance of treatment with those drugs when the trials have finished can generate extra cost for patients who participated in the trials. Objective: To assess whether HIV-infected patients' participation in clinical trials results in drug cost savings or increases. Methods: An analysis of alt antiretrovirals dispensed to HIV-infected outpatients prior to, during, and after their participation in clinical trials in a university hospital during a 2-year period was conducted. Only patients who completed the trial during the study period were included. The following outcomes were measured: (1) cost saved (difference between cost per day during the trial and cost per day before study entry), (2) cost generated (difference between cost per day at the end of the trial and cost per day before study entry), (3) balance between cost saved and cost generated, and (4) number of days that a patient received a drug once the trial was finished to generate cost, considering costs saved. All data were extracted from the hospital pharmacy database. A stratified analysis by type of clinical trial (ordinary or expanded use) was undertaken. Results: Data from 61 patients were analyzed. The cost of drug therapy during patient participation in a clinical trial was lower than the cost prior to inclusion. Therefore, mean drug savings of $10.38 (US) per patient day resulted (95% CI –5.9 to 14.84), The mean cost generated was $8.74 per patient day (95% CI 3.95 to 13.52). Conclusions: A patient's participation in a clinical trial or expanded-access clinical trial generated extra cost once the trial had finished because the cost of drug therapy was higher at the end of the study. In our study, the daily drug costs saved during the trial were similar to the daily drug costs generated.

Clinical Trial Participation Is Associated With Improved Outcome in Women With Ovarian Cancer

2009 ◽  
Vol 19 (1) ◽  
pp. 124-128 ◽  
Author(s):  
William R. Robinson ◽  
Joyce Ritter ◽  
April S. Rogers ◽  
Sean Tedjarati ◽  
Christy Lieberenz
Keyword(s):  
Ovarian Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Confidence Interval ◽  
Clinical Research ◽  
Trial Participation ◽  
Gynecologic Oncology Group ◽  
Histologic Subtype ◽  
Urban Versus

Objectives:To determine the effect of participation in clinical trials on survival of women with ovarian cancer. Disease-specific factors and demographics were also examined.Methods:A total of 158 women were treated for ovarian cancer at a regional cancer center. All patients were offered treatment with surgery/chemotherapy and were screened at diagnosis for participation in clinical research. Progression-free and overall survival, as well as demographic- and treatment-related data, were recorded.Results:Fifty-three participated in clinical trials and 105 did not. On-study versus off-study subjects were similar in age (64.1 vs 63.5 years), ethnicity (87% vs 85% white), performance status (100% 0-1 Gynecologic Oncology Group scale), and urban versus rural lifestyle (58% vs 55% urban). Stage of disease, histologic subtype, and type/amount of therapy were also similar. Kaplan-Meier analysis showed superior overall survival for on-study subjects (median, 46 vs 25 months, 95% confidence interval, 1.0299-2.1505 months, P = 0.0343). A trend toward improved progression-free survival approached significance for on-study subjects (median, 23 vs 9 months, 95% confidence interval, 0.9545-2.0022 months, P = 0.0866).Conclusions:Women with ovarian cancer who participate in clinical trials at this institution have improved survival compared with those who are treated with standard therapies. No other factors examined were associated with treatment completion or survival. Further, participation in clinical research does not vary by age, ethnicity, urban versus rural lifestyle, or cancer stage or histologic subtype. However, disclosure of this information to potential clinical trial participants may represent an ethical conflict and should be carefully considered in light of existing ethical guidelines for human subject research.

Evaluation of drug cost avoidance resulting from conduct of cancer clinical trials in a community-based oncology practice.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 66-66
Author(s):  
Amit Sanyal ◽  
James M. Heun ◽  
Brittany Glynn ◽  
Ryan Porter ◽  
Daniel Wellner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Health Plan ◽  
Cost Savings ◽  
Investigational Drug ◽  
Cancer Clinical Trials ◽  
Community Based ◽  
Hospital System ◽  
Cost Avoidance

66 Background: Aim: To prospectively evaluate cost avoidance during routine conduct of cancer clinical trials in a community based integrated delivery network (IDN) consisting of a health services provider group, a health insurance plan and a hospital system. Only 2%–7% of adult cancer patients participate in clinical trials nationwide [1]. Inadequate funding and concerns about financial viability have been identified as factors that impede clinical trial accrual in the community oncology setting. ‘Cost-avoidance’, defined as dollars that would have been spent to purchase medications but were not spent because of study-related interventions [3] has been proposed as one mechanism to overcome this. Methods: Anti-cancer and hematology drugs provided by intergroup as well as pharmaceutical industry-based trial sponsors to patients enrolled in oncology clinical research were tabulated. Analysis of cost avoidance was restricted to patients covered by the IDNs health plan. Additionally, drugs provided by the trial sponsor were included in the analysis only if they represented a normal standard of care for the disease state. Cost avoidance was defined as the net ingredient cost of the drugs that would have been spent by the health plan for patient care if drugs provided by trial sponsors were not available. Results: Between January 2020 and April 2021, 25 patients covered by the IDN were recruited into clinical trials. Cost savings resulted from 7 targeted and immuno-oncology medications. Net cost avoidance in 2020 was $1,229,798 while that in 2021 till date has been $892,783. The realized cost savings has allowed recruitment of additional clinical research staff as well as expansion of clinical research to rural regional sites served by the IDN. Conclusions: Anticancer drugs provided free of charge by clinical trial sponsors render significant cost savings, ensuring viability and even expansion of oncology clinical research in community based IDNs. References: National Health Expenditure Data. 2018, U.S. Centers for Medicare & Medicaid Services: Baltimore, MD 21244. McDonagh MS, M.S., Naden E., Costs and savings of investigational drug services. American Journal of Health-Systems Pharmacy, 2000. 57: p. 40-43.[Table: see text]

Repurposed Antiviral Drugs for the Treatment of COVID-19: Syntheses, Mechanism of Infection and Clinical Trials

2020 ◽  
Vol 21 ◽  
Author(s):  
Subha Sankar Paul ◽  
Goutam Biswas
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Molecule ◽  
Mode Of Action ◽  
Antiviral Drugs ◽  
Public Health Emergency ◽  
Advanced Stage ◽  
Clinical Trial Results

: COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

scholarly journals Are survival and mortality rates associated with recruitment to clinical trials in teenage and young adult patients with acute lymphoblastic leukaemia? A retrospective observational analysis in England

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017052 ◽  
Author(s):  
Rachael Hough ◽  
Sabrina Sandhu ◽  
Maria Khan ◽  
Anthony Moran ◽  
Richard Feltbower ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Acute Lymphoblastic Leukaemia ◽  
Lymphoblastic Leukaemia ◽  
Relative Survival ◽  
Data Repository ◽  
Trial Participation ◽  
Patient Benefit ◽  
Cancer Data

ObjectiveParticipation rates in clinical trials are low in teenagers and young adults (TYA) with cancer. Whilst the importance of clinical trials in informing best practice is well established, data regarding individual patient benefit are scarce. We have investigated the association between overall survival and trial recruitment in TYA patients with acute lymphoblastic leukaemia (ALL).DesignRetrospective.SettingNational (England) TYA patients treated for ALL.Participants511 patients aged 15–24 years diagnosed with ALL between 2004 and 2010 inclusive, of whom 239 (46.7%) participated in the UKALL2003 trial.Outcome measuresPatients were identified using National Clinical Trial (UKALL2003) and Cancer Registry (National Cancer Data Repository, English National Cancer Online Registration Environment) Databases. Relative survival rates were calculated for trial and non-trial patients and observed differences were modelled using a multiple regression approach. The numbers and percentages of deaths in those patients included in the survival analysis were determined for each 3-month period, p values were calculated using the two-tailed z-test for difference between proportions and 95% CIs for percentage deaths were derived using the binomial distribution based on the Wilson Score method.ResultsPatients treated on the trial had a 17.9% better 2-year survival (85.4% vs 67.5%, p<0.001) and 8.9% better 1-year survival (90.8% vs 81.9%, p=0.004) than those not on the trial. 35 (14.6%) patients recruited to the trial died in the 2 years following diagnosis compared with 86 (32.6%) of those not recruited (p<0.001).ConclusionsTYA patients recruited to the clinical trial UKALL 2003 in England had a lower risk of mortality and a higher overall survival than contemporaneous non-trial patients. These data underline the potential for individual patient benefit in participating in a clinical trial and the importance of international efforts to increase trial participation in the TYA age group.Trial registration numberISRCTN07355119.

scholarly journals Estimands: bringing clarity and focus to research questions in clinical trials

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e052953
Author(s):  
Timothy Peter Clark ◽  
Brennan C Kahan ◽  
Alan Phillips ◽  
Ian White ◽  
James R Carpenter
Keyword(s):  
Clinical Trial ◽  
Sensitivity Analysis ◽  
Clinical Trials ◽  
Clinical Research ◽  
Recent Work ◽  
Treatment Effect ◽  
Research Question ◽  
Probability Of Success ◽  
Research Questions

Precise specification of the research question and associated treatment effect of interest is essential in clinical research, yet recent work shows that they are often incompletely specified. The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials introduces a framework that supports researchers in precisely and transparently specifying the treatment effect they aim to estimate in their clinical trial. In this paper, we present practical examples to demonstrate to all researchers involved in clinical trials how estimands can help them to specify the research question, lead to a better understanding of the treatment effect to be estimated and hence increase the probability of success of the trial.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital

2014 ◽  
Vol 11 (6) ◽  
pp. 673-680 ◽  
Author(s):  
Michael Weisskopf ◽  
Guido Bucklar ◽  
Jürg Blaser
Keyword(s):  
Information System ◽  
Clinical Trials ◽  
Clinical Research ◽  
Hospital Admissions ◽  
Clinical Information System ◽  
Clinical Information ◽  
University Hospital ◽  
Trial Registry ◽  
Trial Participants ◽  
Year 2013

Background: Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. Methods: In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient–trial–assignment–tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. Results: The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of hospital admission alerts of trial participants, 107 running trials have activated this option, including 48 out of 97 studies (49.5%) registered in the year 2013, generating approximately 85 alerts per month. Conclusions: The popularity of the presented tools in the clinical information system illustrates their potential to facilitate the conduct of clinical trials. The tools also allow for enhanced transparency on trials conducted at the hospital. Future studies on monitoring and inspection findings will have to evaluate their impact on quality and safety.

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