Clinical trials screening: An opportunity to increase medical care access

Background. The organization of clinical trials (CTs) requires the participation and coordination of healthcare providers, patients, public and private parties. Obstacles to the participation of any of these groups pose a risk of lowering the potential for the implementation of CTs. Researchers are a key human resource in conducting of CT. Their motivation for participation can have a significant impact on the recruitment and retention of patients, on the quality of the data collected, which determines the overall outcome of the study. Aims to assess the factors affecting the inclusion of Russian physicians-researchers in CT, and to determine their role in relations with patients-participants. Materials and methods. The study was organized as a part of the Russian multicenter face-to-face study. A survey was conducted of researchers from 10 cities of Russia (20172018). The participation in the survey for doctors was anonymous and voluntary. Results. The study involved 78 respondents. Most research doctors highly value the importance of research for science (4,84 0,39), society (4,67 0,46) and slightly lower for participating patients (4,44 0,61). The expectations of medical researchers are related to improving their financial situation and attaining new experience (n = 14; 18,18%). However, the opportunity to work with new technologies of treatment and diagnosis (n = 41; 52,56%) acted as a motivating factor. According to the questionnaire, the vast majority of research doctors (n = 29; 37,18%) believe that the main reason for patients to participate in CT is to receive quality and free medical care. The most significant obstacle to the inclusion of participants in CT was the side effects of the study drug (n = 38; 48,71%). Conclusions. The potential of clinical researchers in Russia is very high. The patient-participant acts for the research doctor as the subject of the study, and not the object, so the well-being of the patient is not indifferent to the doctor. However, the features of the functioning of our health care system form the motivation of doctors-researchers (additional earnings, professional self-development) and the way they perceive the motivation of patients (CT as an opportunity to receive quality medical care).

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Defining the Threshold of Permissible Risk for Non-therapeutic Clinical Trials with Children in Europe

European Journal of Health Law ◽

10.1163/15718093-12341420 ◽

2017 ◽

Vol 24 (4) ◽

pp. 414-431

Author(s):

Katherine Wade*

Keyword(s):

Clinical Trials ◽

Medical Care ◽

Medicinal Products ◽

Council Of Europe ◽

Therapeutic Trials ◽

Research With Children ◽

Individual Trial ◽

The One ◽

Definition Of ◽

Trial Participants

Abstract It is important that clinical research with children is encouraged so that they are not exposed to the dangers of extrapolation from adult treatments. Clinical trials with investigational medicinal products (imps) are an important part of improving medical care for children. Both the 2001 Clinical Trials Directive and the 2014 Regulation recognise the need for such research, including the need for non-therapeutic trials with imps. However, it is also recognised that a balance must be struck between permitting tailored medical care for children as a group on the one hand, and protecting individual trial participants from harm on the other. A central issue in striking this balance relates to defining the threshold of risk which should be permitted in such research. This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with imps and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the us.

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Disparities in Health Status and Health Care Access and Use Among Older American Indians and Alaska Natives and Non-Hispanic Whites in California

Journal of Aging and Health ◽

10.1177/0898264312444309 ◽

2012 ◽

Vol 24 (5) ◽

pp. 799-811 ◽

Cited By ~ 12

Author(s):

Giyeon Kim ◽

Ami N. Bryant ◽

R. Turner Goins ◽

Courtney B. Worley ◽

David A. Chiriboga

Keyword(s):

Health Care ◽

Health Status ◽

Medical Care ◽

American Indians ◽

Health Care Access ◽

Alaska Natives ◽

California Health Interview Survey ◽

Health Care Needs ◽

Care Needs ◽

Care Access

Objectives: The present study compared the characteristics of health status and health care access and use among older American Indians and Alaska Natives (AIANs) to those of non-Hispanic Whites (NHWs). Methods: Data were drawn from the 2009 California Health Interview Survey, with a total of 17,156 adults aged 60 and older (198 AIANs and 16,958 NHWs) analyzed. Results: Older AIANs reported poorer physical and mental health than did NHWs. AIANs were less likely than NHWs to see a medical doctor and have a usual source of medical care and were more likely than NHWs to delay getting needed medical care and report difficulty understanding the doctor at their last visit. Discussion: These findings highlight the vulnerability and unmet health care needs of older AIANs. More research on the older AIAN population is clearly needed to document their health care needs in order to better inform efforts to reduce health disparities.

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Evaluating the Financial Impact of Clinical Trials in Oncology: Results From a Pilot Study From the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project

Journal of Clinical Oncology ◽

10.1200/jco.2000.18.15.2805 ◽

2000 ◽

Vol 18 (15) ◽

pp. 2805-2810 ◽

Cited By ~ 27

Author(s):

Charles L. Bennett ◽

Tammy J. Stinson ◽

Victor Vogel ◽

Lyn Robertson ◽

Donald Leedy ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Pilot Study ◽

Medical Care ◽

Phase Ii ◽

Third Party ◽

Disease Stage ◽

Cancer Center ◽

Policy Debate ◽

Economic Analyses

PURPOSE: Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. METHODS: Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. RESULTS: The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P = .4) CONCLUSION: Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

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Patient care and clinical trials in gynecological oncology: Implications of the COVID-19 pandemic.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.5564 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 5564-5564

Author(s):

Sara Nasser ◽

Christina Fotopoulou ◽

Murat Guktekin ◽

Desislava Dimitrova ◽

Philippe Morice ◽

...

Keyword(s):

Clinical Trials ◽

Medical Care ◽

Patient Care ◽

Healthcare Professionals ◽

Clinical Pathways ◽

Trial Participation ◽

Early Stage Disease ◽

Gynecological Oncology ◽

Cardiopulmonary Support ◽

The Impact

5564 Background: This is a prospective international Survey to evaluate the impact of the COVID-19 Pandemic on the management of patients with gynecological malignancies from the multidisciplinary physicians' perspective, with particular focus on clincial infrastructures, and trial participation. Methods: The anonymous online survey consisted of 53 COVID-related questions. It was sent to all healthcare professionals in gynaecological oncology centres across Europe and the Pan-Arabian region from April 2020 to October 2020. All healthcare professionals treating women with gynecological cancers were able to participate in the survey. Results: A total of 243 answers were collected from 30 different countries. The majority (73%) of participants were gynecological oncologists from university hospitals(71%) with at least an Intensive care unit with cardiopulmonary support available at their institutions. Most institutions continued to perform elective surgeries only for oncological cases (98%). Patients had to wait on average 2 weeks longer for their surgery appointments compared to previous years(range 0-12 weeks). Cases that were prioritised for surgical intervention across all tumors (Ovarian, Endometrium, Cervical) were early stage disease (74%), primary situation (61%), and good ECOG status (63%). The radicality of surgery did not change in the majority of cases (78%) across all tumor types. During the pandemic, only 38% of clinicians stated they would start a new clinical trial. 45% stated the pandemic has negatively impacted the financial structure and support for clinical trials. 79% do not routinely screen patients included in trials for SARS CoV2. Overall, approx. 20% of clinicians did not feel well informed regarding clinical pathways for COVID-19 patients throughout the pandemic. The majority preferred regular updates and training via Webinars (75%), followed by tumorboards and interdisciplinary conferences (45%). 30% of clinicians stated that they are currently experiencing difficulties in providing adequate medical care due to staff shortage. Conclusions: Despite well-established guidelines for patient care and performing clinical trials in gynecological oncology, the COVID-19 pandemic has impacted clinical research, and financial structures. Longer waiting times for operative interventions, less support for clinical trials and concerns regarding provision of adequate medical care and triaging patients are very real. This survey underlines the necessity for building robust emergency algorithms tailored to gynecological oncology patients in the future.

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Satisfaction and perceptions of research participants in clinical and translational studies: An urban multi-institution with CTSA

Journal of Clinical and Translational Science ◽

10.1017/cts.2020.20 ◽

2020 ◽

Vol 4 (4) ◽

pp. 317-322

Author(s):

Priscilla Adler ◽

Jane Otado ◽

John Kwagyan

Keyword(s):

Clinical Trials ◽

Health Care Professionals ◽

Access To Health Care ◽

Quality Care ◽

Delivery Of Care ◽

Participant Satisfaction ◽

Research Participants ◽

Care Access ◽

Degree Of Satisfaction ◽

Research Volunteers

AbstractPurpose:To examine research participants’ levels of satisfaction and perceptions and aid researchers to better engage research volunteers from all racial and ethnic populations in clinical trials. A participant satisfaction survey was developed that focused on three domains to reflect satisfaction with delivery of care, environment, and center operations. In addition, the survey contained open-ended questions to reflect overall experiences and perceptions. Two hundred and seventy-eight participants (55% African American and 29% non-Hispanic Whites) with an average age of 52 years completed the survey.Results:The results indicated that the majority of the participants rated their satisfaction very highly across all domains. Ninety percent stated they were very satisfied/satisfied or very strongly agreed/agreed in the three domains. Obtaining high-quality care/access to health care professionals (60%), learning more about their illness/disease (60%), and helping others (57%) were noted as important factors in choosing to participate in a trial. Regarding overall experience, majority of respondents stated that friendliness, expertise of staff, learning more about their disease, and contributing to science were important. Further, financial compensation was not a primary motivation for participation. A majority of participants stated that they would participate in future studies and would recommend a friend or a family member to participate in clinical trials.Conclusions:The findings indicate that the degree of satisfaction with the research staff and with the specific trial itself are important determinants for enrolling, completing a study, and for participating in future trials.

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Productivity Benefits of Medical Care: Evidence from US-Based Randomized Clinical Trials

Value in Health ◽

10.1016/j.jval.2018.01.009 ◽

2018 ◽

Vol 21 (8) ◽

pp. 905-910

Author(s):

Alice J. Chen ◽

Dana P. Goldman

Keyword(s):

Clinical Trials ◽

Medical Care ◽

Randomized Clinical Trials

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Systematic Planning of Clinical Documentation

Methods of Information in Medicine ◽

10.1055/s-0038-1634638 ◽

1996 ◽

Vol 35 (01) ◽

pp. 25-34 ◽

Cited By ~ 14

Author(s):

R. Haux ◽

F. Leiner

Keyword(s):

Clinical Trials ◽

Medical Care ◽

Study Protocol ◽

Clinical Documentation ◽

Controlled Clinical Trials ◽

Documentation System ◽

Potential Part ◽

Systematic Planning ◽

The Individual ◽

Design Options

AbstractAll information obtained from a patient in the course of medical care is a potential part of clinical documentation. The documentation usually serves a number of different purposes. The task of a documentation system is to fulfil these purposes in a methodically correct manner and as economically as possible. This requires that the properties of the documentation system be planned systematically with a view to the goals pursued. To support systematic planning, a “documentation protocol” is proposed analogous to the “study protocol” used for controlled clinical trials. The individual sections of the proposed documentation protocol are described and the design options which exist in the corresponding planning phases are pointed out. Experience gained by the application of the documentation protocol is discussed.

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