scholarly journals The Benefits and Savings from Publicly Funded Clinical Trials of Prescription Drugs

2008 ◽  
Vol 38 (4) ◽  
pp. 731-750 ◽  
Author(s):  
Dean Baker
Keyword(s):  
Clinical Trials ◽  
Prescription Drugs ◽  
Current System ◽  
Public Health Care ◽  
Publicly Funded ◽  
The Public ◽  
Drug Companies ◽  
Perverse Incentives ◽  
Lower Drug ◽  
Clinical Drug

The current system of financing for clinical drug trials creates numerous perverse incentives. Since the trials are typically performed or controlled by the company who owns the patent, it has enormous incentives to report positive findings and conceal results that indicate the drug might be ineffective or even harmful. In addition, the large patent rents earned by drug companies are justified by the need to recoup research costs, approximately half of which are attributable to clinical trials. This article outlines a system of publicly financed clinical trials under which all results are fully available to the public. The system would be financed by paying lower drug prices under the Medicare drug program and other public health care programs.

The Lugano Statements on Controlled Clinical Trials

1987 ◽  
Vol 15 (1) ◽  
pp. 2-22 ◽  
Author(s):  
A. L. Blum ◽  
T. C. Chalmers ◽  
E. Deutsch ◽  
J. Koch-Weser ◽  
A. Rosén ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Consensus Conference ◽  
Controlled Clinical Trial ◽  
Controversial Issues ◽  
Controlled Clinical Trials ◽  
Best Interest ◽  
The Public ◽  
Drug Companies ◽  
The Face

During a consensus conference in Lugano, Switzerland, 175 statements on controlled clinical trials were drafted by 47 representatives from academia, governmental registration agencies and industry in nine countries. Their opinion on these statements was similar to that of 47 ‘matched pairs’ who did not attend the conference. Thus, the opinion of participants and non-participants appears to reflect the general opinion of those currently involved in designing, conducting and analysing controlled clinical trials. The Lugano statements give answers to the following questions: Is the controlled clinical trial in a crisis? What is the motivation to perform controlled clinical trials? Is it possible for a physician participating in a controlled clinical trial to act in the patient's best interest? Is it possible to obtain truly informed consent in a controlled clinical trial? When is it ethical to withhold active treatment in a controlled clinical trial? What are the controversial issues in the design of a good controlled clinical trial? Is there a double standard with respect to efficacy and adverse drug reactions in controlled clinical trials? What are the alternatives to controlled clinical trials and when should they be performed? How can sponsor bias be minimized? How should an ethics committee decide whether a controlled clinical trial is Should? ethical registration agencies become directly involved in the planning and conduct of controlled clinical trials? Do the declarations of Tokyo and Helsinki facilitate the conduct of ethically valid controlled clinical trials? Is it possible to create an international standard for the conduct and regulation of controlled clinical trials? Why do messages from controlled clinical trials filter into medicine so slowly? Is it possible to bridge the gap between controlled clinical trials and clinical reality? What are the costs of doing and not doing controlled clinical trials? When should drug companies decide to start a trial programme with a specific compound? Is there public hostility against controlled clinical trials? If so, how can it be reduced? The respondents almost unanimously felt that controlled clinical trials are a must; the public must be told that progress in medicine depends on controlled clinical trials, that patients often benefit from participating in them and that the alternative, practising in the face of constant uncertainty, is worse than the possible disadvantages related to the conduct of the trial.

Bidirectional consultative process as a novel methodology to develop a pan-Canadian cancer quality initiative.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 80-80
Author(s):  
Gunita Mitera ◽  
Mary Agent-Katwala ◽  
Geoffrey A. Porter ◽  
Heather E. Bryant ◽  
Terrence Sullivan
Keyword(s):  
Quality Improvement ◽  
Public Health Care ◽  
Publicly Funded ◽  
Electronic Information ◽  
Senior Administrators ◽  
Electronic Survey ◽  
The Public ◽  
Secondary Distribution ◽  
Consultative Process ◽  
Survey Responses

80 Background: To foster pan-Canadian quality improvement strategies in cancer diagnosis and treatment, a new publically funded opportunity was launched though a Request for Proposals (RFP). Methods to develop RFPs in the public health care sector are variable. To generate enthusiasm and ensure appropriateness and relevance of the RFP, a novel methodology was developed to refine and validate the focus of the RFP. Methods: An extensive multi-pronged bi-directional consultative process helped identify and engage with clinical experts, senior administrators, and other relevant stakeholders. In-person discussions with relevant stakeholders, an electronic stakeholder engagement survey, and two interactive electronic information sessions (Webinars) were included. The intent of the eBlast was to seek survey responses and also to build awareness of the upcoming opportunity. An eBlast engaged stakeholders and stakeholder networks for the electronic component of the bi-directional process. Secondary distribution encouraged wide-spread dissemination. The survey and recorded Webinar were publically posted online. Results: Approximately 30 in-person consultations occurred and the electronic survey and Webinar details were sent to approximate 1,000 individuals and external networks. 80 responses were received along with 76 Webinar attendees. Feedback was received from a representative cross-section of the Canadian quality community as measured by geographical distribution and discipline. There was general pan-Canadian agreement that the quality topic chosen was relevant and appropriate. Through this methodology refinements were made to finalize the organization and content of the RFP. Conclusions: When developing a national call for a publicly-funded quality improvement opportunity, it is imperative to ensure the topic considered is relevant, appropriate, and there is interest from stakeholders to apply. A bi-directional consultative process is a novel and economical method to ensure wide reaching engagement from relevant pan-Canadian stakeholders. This methodology can also be leveraged to refine and validate the final quality topic considered.

DEVELOPMENT OF THE UKRAINIAN FORENSIC MEDICAL INSTITUTIONS IN THE ХХ CENTURY

2017 ◽  
Vol 17 ◽  
pp. 446-456
Author(s):  
V. V. Yusupov
Keyword(s):  
Forensic Medicine ◽  
Medical Examination ◽  
Public Health Care ◽  
Biological Research ◽  
The Public ◽  
Medical Institutions ◽  
Forensic Institutions ◽  
Post War ◽  
Medical Examinations ◽  
The Chairs

The issue of development of forensic institutions of Ukraine in the ХХ century was studied. Until 1917, forensic medical examinations were conducted in the medical compartments of the provincial administrations, at the departments of forensic medicine of universities and in hospitals - by police doctors. The chairs of forensic medicine existed in the St. Vladimir Kyiv University, Kharkiv, Novorosiisk and Lviv Universities. Real organization of Ukrainian forensic medical institutions began in 1919 with the creation of the Medical Examination Department at the People’s Commissariat of Health. In 1923, the Main forensic medical inspection, headed by M. S. Bokarius, was founded. In the provinces the positions of forensic medical inspectors were created. In 1927 the sections of biological research were established in the Kharkiv, Kyiv and Odesa institutes of scientific andforensic expertise,where separate forensic examinations were conducted. In 1949 the institutions of forensic medical examination of the USSR were merged into the Bureau of Forensic Medical Examination, in Ukraine it was held in 1951. It was proved that forensic medical institutions developed at the following chronological stages: 1) until 1917 - forensic medical service in the Ministry of Internal Affairs; 2) 1917-1941 - prewar formation of forensic medical institutions; 3) 1941-1949 -forensic medical institutions during the war and in the first post-war years; 4) 1949-1990s - period of development of the bureau of forensic medical examinations of the countries of the USSR; 5) since the 1990s - development of expert institutions in the public health care system in independent postSoviet states. It’s stressed that formation of the forensic institutions in Ukraine is closely related with the development of forensic medicine departments of higher educational establishments. Forensic medicine departments were the basisfor practicalforensic medicine, professors provided daily assistance to forensic medical experts.

Health Care

2018 ◽  
Author(s):  
Pierre Pestieau ◽  
Mathieu Lefebvre
Keyword(s):  
Health Care ◽  
Technological Progress ◽  
Health Care Systems ◽  
Third Party ◽  
Medical Expenditure ◽  
Public Health Care ◽  
The Public ◽  
Common Features ◽  
Care Systems

This chapter reviews the public health care systems as well as their challenges. It first shows how expenditure on health care has evolved in previous decades and deals with the reasons for the growth observed in almost every European country. It emphasizes the role of technological progress as a main explanatory factor of the increase in medical expenditure but also points to the challenges facing cost-containment policies. Especially, the main common features of health care systems in Europe, such as third-party payment, single provider approach and cost-based reimbursement are discussed. Finally the chapter shows that although inequalities in health exist in the population, health care systems are redistributive. Reforms are thus needed but the trade-off between budgetary efficiency and equity is difficult.

scholarly journals Clinical trial registries as Scientometric data: A novel solution for linking and deduplicating clinical trials from multiple registries

2021 ◽  
Author(s):  
Christian Thiele ◽  
Gerrit Hirschfeld ◽  
Ruth von Brachel
Keyword(s):  
Clinical Trials ◽  
Random Forest ◽  
Random Forest Model ◽  
Scientometric Analysis ◽  
Data Set ◽  
The Public ◽  
Forest Model ◽  
Clinical Trial Registries ◽  
Multiple Primary ◽  
Clinical Trials Registry

AbstractRegistries of clinical trials are a potential source for scientometric analysis of medical research and serve important functions for the research community and the public at large. Clinical trials that recruit patients in Germany are usually registered in the German Clinical Trials Register (DRKS) or in international registries such as ClinicalTrials.gov. Furthermore, the International Clinical Trials Registry Platform (ICTRP) aggregates trials from multiple primary registries. We queried the DRKS, ClinicalTrials.gov, and the ICTRP for trials with a recruiting location in Germany. Trials that were registered in multiple registries were linked using the primary and secondary identifiers and a Random Forest model based on various similarity metrics. We identified 35,912 trials that were conducted in Germany. The majority of the trials was registered in multiple databases. 32,106 trials were linked using primary IDs, 26 were linked using a Random Forest model, and 10,537 internal duplicates on ICTRP were identified using the Random Forest model after finding pairs with matching primary or secondary IDs. In cross-validation, the Random Forest increased the F1-score from 96.4% to 97.1% compared to a linkage based solely on secondary IDs on a manually labelled data set. 28% of all trials were registered in the German DRKS. 54% of the trials on ClinicalTrials.gov, 43% of the trials on the DRKS and 56% of the trials on the ICTRP were pre-registered. The ratio of pre-registered studies and the ratio of studies that are registered in the DRKS increased over time.

scholarly journals The Disclosure Decision of Foreign Clinical Trials in China: Moderating Effects of Firms’ Contingencies

SAGE Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 215824402110163
Author(s):  
Tariq H. Malik ◽  
Chunhui Huo
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Risk Taking ◽  
Academic Community ◽  
Moderating Effects ◽  
The Public ◽  
Industrial Enterprises ◽  
Unit Increase ◽  
Clinical Trial Results ◽  
Clinical Trial Activity

Result disclosure of clinical trial posts a conflicting logic between private secrecy and public interest. Despite ethical and legal requirements for disclosing clinical trial results, clinical trials’ sponsors tend to withhold the results. We explored the location, timing, and rationale behind the withheld clinical trial results. Based on the entrepreneurial orientation (EO) perspective, we propose that organizational EO contingencies moderate the disclosure decision. We used the completed clinical trial projects in China by foreign and domestic sponsors. First, we found that a unit increase in the sponsor’s experience can increase the disclosure about 1.01 times. Second, we found that industrial enterprises disclose results about 3.7 times more than universities do. Third, we found that foreign clinical trial projects in China tend to disclose 3.9 times more than domestic projects. We link these findings to two types of audience. First, we inform the academic community on the theory and empirics regarding risk-taking behavior in the biopharmaceutical industry’s clinical trial activity. Second, we address the general audiences concerned about the ethical and socioeconomic wellbeing of the public.

scholarly journals The impact of end-userś participation (cancer patients) during the optimization process

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
S Houwaart
Keyword(s):  
End Users ◽  
Public Health Care ◽  
Optimization Process ◽  
Patient Organization ◽  
End User ◽  
The Public ◽  
Patient Organizations ◽  
Crucial Information ◽  
The Individual ◽  
The Impact

Abstract End-user (e.g. patients or the public) testing of information material is becoming more common in the German public health care system. However, including the end-user (in this case patients) in an optimisation process and thus enabling a close collaboration while developing PIMs is still rare. This is surprising, given the fact that patients provide the exact perspective one is trying to address. Within the isPO project, a patient organization is included as a legal project partner to act as the patient representative and provide the patient's perspective. As such, the patient organization was included in the PHR approach as part of the PIM-optimisation team. During the optimisation process, the patients gave practical insights into the procedures of diagnosing and treating different types of cancer as well as into the patient's changing priorities and challenges at different time points. This was crucial information for the envisioned application of the individual PIMs and their hierarchical overview. Moreover, the developed PIM-checklist enabled the patients to give detailed feedback to the PIMs. With their experience of being in the exact situation in which the PIMs will be applied, their recommendations, especially on the wording and layout of the materials, have been a valuable contribution to the PIM optimisation process. In this part of the seminar, we will take a closer look at the following skill building aspects: What is gained from including patients as end-users in the development and optimization of PIM?How can we reach patients to contribute to a PIM optimization process? Which requirements and prerequisites do patients have to provide to successfully work on an optimisation team?How to compromise and weigh opinions when different ideas occur? Altogether, this part will construct a structured path of productive patient involvement and help to overcome uncertainties regarding a collaboration with patient organizations.

scholarly journals Changes in the activity levels and financing sources of Israel’s private for-profit hospitals in the wake of reforms to the public-private divide

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Royi Barnea ◽  
Adi Niv-Yagoda ◽  
Yossi Weiss
Keyword(s):  
Health Insurance ◽  
Surgical Procedures ◽  
Health Expenditure ◽  
Medical Center ◽  
Waiting Times ◽  
Publicly Funded ◽  
Private Hospitals ◽  
The Public ◽  
For Profit ◽  
Elective Surgical Procedures

Abstract Background The Israeli National Health Insurance Law provides permanent residents with a basket of healthcare services through non-profit public health insurance plans, independently of the individual’s ability to pay. Since 2015, several reforms and programs have been initiated that were aimed at reinforcing public healthcare and redressing negative aspects of the health system, and specifically the constant rise in private health expenditure. These include the “From Reimbursement-to-Networks Arrangement”, the “Cooling-off Period” program and the program to shorten waiting times. The objectives of this study were to identify, describe, and analyze changes in private hospitals in 1) the volume of publicly and privately funded elective surgical procedures; and 2) private health expenditure on surgical procedures. Methods Data on the volume and funding of surgical procedures during 2013–2018 were obtained from Assuta Medical Center, Hertzelia Medical Center, the Israeli Ministry of Health and the Central Bureau of Statistics. The changes in the volume and financing sources of surgical activities in private hospitals, in the wake of the reforms were analyzed using aggregate descriptive statistics. Results Between 2013 and 2018 the volume of surgical activities in private for-profit hospitals increased by 7%. Between 2013 and 2017, the distribution of financing sources of surgical procedures in private hospitals remained stable, with most surgical procedures (75–77%) financed by the voluntary health insurance programs of the health plans (HP-VHI). In 2018, following the regulatory reforms, a significant change in the distribution of financing sources was observed: there was a sharp decline in the volume of HP-VHI-funded surgical procedures to 26%. Concurrently, the share of publicly-funded surgical procedures performed in private hospitals increased to 56% in 2018.,. During the study period, private spending on elective surgical procedures in private hospitals declined by 53% while public funding for them increased by 51%. Conclusions and policy implications In the wake of the reforms, there was a substantial shift from private to public financing of elective surgical activity in private hospitals. Private for-profit hospitals have become important providers of publicly-funded procedures. It is likely that the reforms affected the public-private mix in the financing of elective surgical procedures in those hospitals, but due to the absence of a control group, causality cannot be proven. It is also unclear whether waiting times were shortened. Health reforms must be accompanied by a clear and comprehensive set of indicators for measuring their success.

scholarly journals Virus Eradication and Synthetic Biology: Changes with SARS-CoV-2?

Viruses ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 569
Author(s):  
Jean-Nicolas Tournier ◽  
Joseph Kononchik
Keyword(s):  
Clinical Trials ◽  
Synthetic Biology ◽  
Viral Disease ◽  
Virus Eradication ◽  
Disease Eradication ◽  
The Public ◽  
The Past ◽  
The World ◽  
Significant Effort

The eradication of infectious diseases has been achieved only once in history, in 1980, with smallpox. Since 1988, significant effort has been made to eliminate poliomyelitis viruses, but eradication is still just out of reach. As the goal of viral disease eradication approaches, the ability to recreate historically eradicated viruses using synthetic biology has the potential to jeopardize the long-term sustainability of eradication. However, the emergence of the severe acute respiratory syndrome-coronavirus (SARS-CoV)-2 pandemic has highlighted our ability to swiftly and resolutely respond to a potential outbreak. This virus has been synthetized faster than any other in the past and is resulting in vaccines before most attenuated candidates reach clinical trials. Here, synthetic biology has the opportunity to demonstrate its truest potential to the public and solidify a footing in the world of vaccines.

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