Clinical trials — the personal perspective of the research physician?

2020 ◽  
Vol 75 (3) ◽  
pp. 256-263
Author(s):  
Maria Y. Egorova ◽  
Irina A. Shuvalova ◽  
Olga I. Zvonareva ◽  
Igor D. Pimenov ◽  
Olga S. Kobyakova ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
New Technologies ◽  
Healthcare Providers ◽  
Study Drug ◽  
Well Being ◽  
Personal Perspective ◽  
Public And Private ◽  
Factors Affecting ◽  
To Receive

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).

scholarly journals Factors affecting retention in the Philippine National Rural Physician Deployment Program from 2012 to 2019: a mixed methods study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Erika Louise L. Flores ◽  
Edric Matthew R. Manahan ◽  
Miguel Paulo B. Lacanilao ◽  
Isabella Ma. Beatriz T. Ladaw ◽  
Mico Martin B. Mallillin ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Healthcare Providers ◽  
Well Being ◽  
The Philippines ◽  
Social Needs ◽  
Factors Affecting ◽  
Work Related ◽  
Universal Healthcare ◽  
The Individual ◽  
Rural Physician

Abstract Background To address the maldistribution of healthcare providers and the shortage of physicians in geographically isolated and disadvantaged areas of the Philippines, the Philippine National Rural Physician Deployment Program, or more commonly known as the Doctors to the Barrios (DTTB) program was established in 1993. However, as of 2011, only 18% of the DTTBs chose to stay in their assigned municipalities after their two-year deployment, termed retention. This study aims to identify the individual, local, work, national, and international factors affecting the retention of DTTBs in their assigned communities after their two-year deployment. Methods A descriptive, mixed-methods, explanatory design was used. For the quantitative part, the modified and updated Stayers Questionnaire was given to all current DTTBs present in a Continuing Medical Education session in the Development Academy of the Philippines. Descriptive statistics were then presented. For the qualitative part, individual, semi-structured key informant interviews were conducted in-person or via phone with current and alumni DTTBs from 2012 to 2019. Proceedings of the interviews were transcribed, translated, and analyzed thematically. Results 102 current DTTBs participated in the quantitative part of our study, while 10 current and former DTTBs participated in the interviews. Demographic factors and location, personal beliefs, well-being, friends and family dynamics, and perceptions about work were the individual factors identified to affect retention. Social working conditions, career development, and infrastructure, medical equipment, and supplies were among the work factors identified to affect retention. Geography, living conditions, local social needs, and technology were among the local factors identified to affect retention. Compensation, the recently signed Universal Healthcare Law, and Safety and Security were identified as national factors that could affect retention. International factors did not seem to discourage DTTBs from staying in their communities. Conclusions A host of individual, work-related, local, national, and international factors influence the DTTB’s decision to be retained in different, complex, interconnected, and dynamic ways. We also identified implementation issues in the DTTB program and suggested interventions to encourage retention.

Factors affecting the offering and enrollment of patients on clinical trials in radiation oncology.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17571-e17571
Author(s):  
Shayna Eliana Rich ◽  
Nancy Price Mendenhall
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
General Population ◽  
Proton Therapy ◽  
New Technologies ◽  
Patient Acceptance ◽  
Proton Radiation ◽  
Available N ◽  
Treatment Approaches ◽  
Factors Affecting

e17571 Background: Improvements in cancer treatment require significant patient involvement in research, which may be particularly limited for new technologies such as proton radiation therapy. Studies with biased referrals or enrollment may not be generalizable to a general population. This study examines the reasons why patients were not offered or refused enrollment in clinical trials at the University of Florida Proton Therapy Institute (UFPTI). Methods: All patients seen at UFPTI between April-October 2012 for proton therapy for tumor sites with a clinical trial available (N=463) had information collected prospectively regarding whether they were offered enrollment and consented for clinical trials, and the reasons for each decision. The majority of patients had already secured funding for proton therapy. Results: Seven percent (34/463) of patients were ineligible for an available clinical trial, due to study exclusion criteria, concerns for patient safety based on comorbidity, or concerns for data integrity (e.g., other non-skin cancer within five years). Only 3% (9/275) of eligible patients were not offered a clinical trial. Forty-four percent (99/226) of patients offered a clinical trial refused. The most common reasons for refusal included: discomfort with lack of mature data, dislike of protocol, fear that protocol is not best option for disease control, and fear of side effects. Although UFPTI treats a variety of malignancies, the overwhelming majority of those who refused consent were prostate adenocarcinoma patients, who often self-referred for proton therapy. Conclusions: Despite near universal availability of clinical trials at UFPTI, less than half of patients enroll in clinical trials. The greatest factor for non-enrollment appears to be patient acceptance. Despite the availability of non-randomized trials with fairly standard treatment approaches, 44% refused to enroll on clinical trials, suggesting discomfort for less well documented treatment approaches. Further studies should examine whether findings are similar among all US cancer patients, as patients seeking proton therapy may not resemble the general population.

scholarly journals The introduction of new technologies for out-patient care for tuberculosis patients during the COVID-19 pandemic in the Republic of Sakha (Yakutia)

2021 ◽  
Vol 98 (12) ◽  
pp. 20-24
Author(s):  
A. F. Kravchenko ◽  
E. S. Prokopiev ◽  
L. P. Yakovleva ◽  
A. M. Lukina ◽  
E. F. Luginova ◽  
...  
Keyword(s):  
Medical Care ◽  
Patient Care ◽  
New Technologies ◽  
Well Being ◽  
Practical Experience ◽  
Tuberculosis Patients ◽  
New Organizational Forms ◽  
The Republic ◽  
Scientific Practical ◽  
At Home

During the COVID-19 pandemic in the Russian Federation associated with restrictions and quarantine, in order to ensure the quality and availability of tuberculosis medical care to the population of the Republic of Sakha, it became necessary to improve and search for new organizational forms of out-patient care.The objective of the study: to analyze the use of new technologies in out-patient care for tuberculosis patients in the Republic of Sakha (Yakutia) during the COVID-19 pandemic.Result: Scientific Practical Phthisiology Center introduced the following information and digital technologies to ensure the availability and quality of medical services to the population of the republic during the COVID-19 pandemic: Cloud Polyclinic, Telemedical Consultations, Radiological Information System of APK ArchiMed , Video-Controlled Treatment at Home, and Hospital at Home.All technologies have demonstrated their efficacy for remote medical consultations and contacting patients online. Based on practical experience, these technologies provided the following: improvement of medical care provided to the population through consultations, maintaining good contact with the patient, monitoring patients' well-being, and drug in-take. They assured compliance with general federal and regional anti-epidemic recommendations to prevent the spread of the new coronavirus infection.

scholarly journals FINAL Results of an Phase, Multicenter, Randomied, Controlled OPEN LEVEL Trial: Decitabine Therapy in Patients with Myelodysplastic Syndromes

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3865-3865
Author(s):  
Zonghong Shao ◽  
Hui Liu ◽  
Hao Jiang ◽  
Hongyan Tong ◽  
Ruixiang Xiang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Adverse Events ◽  
Myelodysplastic Syndromes ◽  
Overall Response Rate ◽  
Response Rate ◽  
Conflicts Of Interest ◽  
Study Drug ◽  
Overall Response ◽  
To Receive

Abstract Background: DNA hypomethylating agent, decitabine, has become the current standard therapy for patients with higher-risk myelodysplastic syndromes (MDS). Decitabine was launched in China in August 2009 without clinical trials. According to some retrospective studies, the efficacy and safety are similar to those reported in other countries, but there is still a lack of large-scale prospective clinical trials. So we start a prospective clinical trial in China to compare the effect and safety of decitabine in MDS, which was registered at clinicaltrials.gov (NCT02013102). Design: Adults with intermediate or high risk MDS by the International Prognostic Scoring System (IPSS≥0.5) were randomized to receive either decitabine 20 mg/m2 IV daily for 5 days (arm Ⅰ) or decitabine 12 mg/m2 IV daily for 8 days (arm Ⅱ) every four weeks. Patients continued to receive study drug for 4 cycles until death, disease progression, intercurrent illness preventing further administration of treatment, unacceptable adverse event or decision by the patient to withdraw from the study. And supportive care were permitted. The primary end point was overall response rate (ORR, CR+mCR+PR) by International Working Group (IWG 2006) criteria, secondary end points included CR, mCR, PR, HI, safety, et al. Results: We enrolled a total of 198 patients between 8/2013 and 12/2017, among which 7 patients didn't take decitabine, and 191 were included in the analysis. 94 in arm Ⅰ recieved decitabine and 97 in arm Ⅱ. 32.8% of patients withdrew from the study for a variety of reasons, including progression and death (5.1%), personal decision (13.6%), adverse events (6.6%), and other causes (7.6%). The median age of patients in arm Ⅰ was 54.88 years old and 54.82 years old in arm II. The median follow-up was 106 days for patients in both arms. The patients received a mean 2.5 cycles of decitabine therapy for arm Ⅰ and 2.0 cycles for arm Ⅱ. The overall response rate was 39.3% in total, and 41.5% and 38.1% (p=0.6598) for patients in arm Ⅰ and arm Ⅱ, respectively. And CR was 18.1% and 14.4% (p= 0.5584) , PR was 6.4% and 3.1% (p=0.3257) , mCR was 17.0% and 20.6% (p=0.5814) , HI was 3.2% and 1.0% (p=0.3633) , for patients in armⅠand armⅡ, respectively (Table 1). Among all patients, 38.7% were intermediate-1 risk, 40.3% were intermediate-2 risk, 20.4% were high risk. Analysis of response by MDS patient subtypes is shown in Table 2. Those who were higher risk experienced higher ORR and CR, while the difference is not significant between two arms (p>0.05). As expected, cytopenias were the most frequent complications (76.4%). Grade 3-4 neutropenia, thrombocytopenia and anemia considered to be at least possibly related to the study drug occurred at rates of 23.0%, 34.6%, and 34.6% of patients, respectively. Nonhematologic adverse events were also common including abnormal metabolism and nutrition (23.40% vs 18.56%), abnormal gastrointestinal function (29.79% vs 41.24%), cardiac disorders (11.70% vs 14.43%), infection and infectious diseases (32.98% vs 36.08%), abnormal skin and subcutaneous tissue and so on, which were no significant differences between two ams. During the study there were 17 SAE, only 7 cases were possibly related to drug therapy, such as pulmonary infection, Sepsis, myelosuppression, intracranial hemorrhage, hepatic failure, and arrhythmia. Conclusions: The use of 5-day and 8-day schedule decitabine is safe and effective in patients with intermediate and high risk MDS, among which there was no significant differences. Disclosures No relevant conflicts of interest to declare.

scholarly journals Factors affecting retention in the Doctors to the Barrios Program (Philippines) from 2012 to 2019: A Mixed Methods Study

2021 ◽  
Author(s):  
Erika Louise Lapitan Flores ◽  
Edric Matthew Rivera Manahan ◽  
Miguel Paulo Bernardo Lacanilao ◽  
Isabella Ma. Beatriz Tinio Ladaw ◽  
Mico Martin Baligod Mallillin ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Healthcare Providers ◽  
Well Being ◽  
The Philippines ◽  
Social Needs ◽  
Factors Affecting ◽  
Work Related ◽  
Universal Healthcare ◽  
Shortage Of Physicians ◽  
The Individual

Abstract BACKGROUND: To address the maldistribution of healthcare providers and the shortage of physicians in geographically isolated and disadvantaged areas of the Philippines, the Doctors to the Barrios (DTTB) program was established in 1993. However, as of 2011, only 18% of the DTTBs chose to stay in their assigned municipalities after their two-year deployment, termed retention. This study aims to identify the individual, local, work, national, and international factors affecting the retention of DTTBs in their assigned communities after their two-year deployment. METHODS: A descriptive, mixed-methods design was used. For the quantitative part, the modified and updated Stayers Questionnaire was given to all current DTTBs present in a Continuing Medical Education session in the Development Academy of the Philippines. Descriptive statistics were then presented. For the qualitative part, individual, semi-structured key informant interviews were conducted in-person or via phone with current and alumni DTTBs from 2012 to 2019. Proceedings of the interviews were transcribed, translated, and analyzed thematically. RESULTS: 102 current DTTBs participated in the quantitative part of our study, while 10 current and former DTTBs participated in the interviews. Demographic factors and location, personal beliefs, well-being, friends and family dynamics, and perceptions about work were the individual factors identified to affect retention. Social working conditions, career development, and infrastructure, medical equipment, and supplies were among the work factors identified to affect retention. Geography, living conditions, local social needs, and technology were among the local factors identified to affect retention. Compensation, the recently signed Universal Healthcare Law, and Safety and Security were identified as national factors that could affect retention. International factors did not seem to discourage DTTBs from staying in their communities. CONCLUSIONS: A host of individual, work-related, local, national, and international factors influence the DTTB’s decision to be retained in different, complex, interconnected, and dynamic ways. We also identified implementation issues in the DTTB program and suggested interventions to encourage retention.

scholarly journals The SWIMS CD-ROM Pilot: Using Community Development Principles and Technologies of the Information Society to Address Identified

10.28945/2770 ◽  
2004 ◽  
Author(s):  
Daniel Teghe ◽  
Bruce A. Knight ◽  
Cecily Knight
Keyword(s):  
Community Development ◽  
Information Society ◽  
New Technologies ◽  
Well Being ◽  
Pilot Project ◽  
Informational Needs ◽  
Cd Rom ◽  
Factors Affecting ◽  
Education Professionals ◽  
The Social

In this paper we describe a pilot project to develop and assess the potential of CD-ROM based resources to address the identified informational needs of a community of education professionals. We focus on the development process, although we also briefly describe the project evaluation and its results. The context in which the pilot was developed and implemented was the Social Well-being in Mackay Schools Program, in which a model was being developed to address issues of young people presenting ‘at risk’ within educational settings. The development and distribution of the CD-ROM was not an easy or straightforward task, requiring extensive research and community consultation. It also required drawing on theoretical and methodological insights from across disciplines (especially from Community Development and Education) to develop a contextually relevant understanding of the factors affecting the informational needs of the community, and of the ways in which the process of addressing these needs might lead to the empowerment of its members. The ease with which the relevant technologies were accessed and used by researchers and community workers who possessed no formal or advanced training in the use of ICTs indicated that the ‘new’ technologies can readily complement and assist in community development, thus giving impetus to the thesis that new forms of empowerment are possible because of the advent of the Information Society.

scholarly journals Factors Affecting Retention in the Philippine National Rural Physician Deployment Program From 2012 to 2019: A Mixed Methods Study

2021 ◽  
Author(s):  
Erika Louise L. Flores ◽  
Edric Matthew R. Manahan ◽  
Miguel Paolo B. Lacanilao ◽  
Isabella Ma. Beatriz T. Ladaw ◽  
Mico Martin B. Mallillin ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Healthcare Providers ◽  
Well Being ◽  
The Philippines ◽  
Social Needs ◽  
Factors Affecting ◽  
Work Related ◽  
Universal Healthcare ◽  
The Individual ◽  
Rural Physician

Abstract BACKGROUND: To address the maldistribution of healthcare providers and the shortage of physicians in geographically isolated and disadvantaged areas of the Philippines, the Philippine National Rural Physician Deployment Program, or more commonly known as the Doctors to the Barrios (DTTB) program was established in 1993. However, as of 2011, only 18% of the DTTBs chose to stay in their assigned municipalities after their two-year deployment, termed retention. This study aims to identify the individual, local, work, national, and international factors affecting the retention of DTTBs in their assigned communities after their two-year deployment. METHODS: A descriptive, mixed-methods design was used. For the quantitative part, the modified and updated Stayers Questionnaire was given to all current DTTBs present in a Continuing Medical Education session in the Development Academy of the Philippines. Descriptive statistics were then presented. For the qualitative part, individual, semi-structured key informant interviews were conducted in-person or via phone with current and alumni DTTBs from 2012 to 2019. Proceedings of the interviews were transcribed, translated, and analyzed thematically. RESULTS: 102 current DTTBs participated in the quantitative part of our study, while 10 current and former DTTBs participated in the interviews. Demographic factors and location, personal beliefs, well-being, friends and family dynamics, and perceptions about work were the individual factors identified to affect retention. Social working conditions, career development, and infrastructure, medical equipment, and supplies were among the work factors identified to affect retention. Geography, living conditions, local social needs, and technology were among the local factors identified to affect retention. Compensation, the recently signed Universal Healthcare Law, and Safety and Security were identified as national factors that could affect retention. International factors did not seem to discourage DTTBs from staying in their communities. CONCLUSIONS: A host of individual, work-related, local, national, and international factors influence the DTTB’s decision to be retained in different, complex, interconnected, and dynamic ways. We also identified implementation issues in the DTTB program and suggested interventions to encourage retention.

scholarly journals Technology and Caregiving: Emerging Interventions and Directions for Research

2020 ◽  
Vol 60 (Supplement_1) ◽  
pp. S41-S49 ◽  
Author(s):  
David A Lindeman ◽  
Katherine K Kim ◽  
Caroline Gladstone ◽  
Ester Carolina Apesoa-Varano
Keyword(s):  
Family Caregivers ◽  
New Technologies ◽  
Mixed Reality ◽  
Distribution Channel ◽  
Research Priorities ◽  
Well Being ◽  
Privacy And Security ◽  
Factors Affecting ◽  
New Era ◽  
Support Family

Abstract An array of technology-based interventions has increasingly become available to support family caregivers, primarily focusing on health and well-being, social isolation, financial, and psychological support. More recently the emergence of new technologies such as mobile and cloud, robotics, connected sensors, virtual/augmented/mixed reality, voice, and the evermore ubiquitous tools supported by advanced data analytics, coupled with the integration of multiple technologies through platform solutions, have opened a new era of technology-enabled interventions that can empower and support family caregivers. This paper proposes a conceptual framework for identifying and addressing the challenges that may need to be overcome to effectively apply technology-enabled solutions for family caregivers. The paper identifies a number of challenges that either moderate or mediate the full use of technologies for the benefit of caregivers. The challenges include issues related to equity, inclusion, and access; ethical concerns related to privacy and security; political and regulatory factors affecting interoperability and lack of standards; inclusive/human-centric design and issues; and inherent economic and distribution channel difficulties. The paper concludes with a summary of research questions and issues that form a framework for global research priorities.

scholarly journals The effect of social-cultural factors on foreign students' well being: Evidence from Thailand universities

2020 ◽  
Author(s):  
Dao Duy Tung
Keyword(s):  
Foreign Students ◽  
Positive Impact ◽  
Academic Adjustment ◽  
Well Being ◽  
Cultural Factors ◽  
Public And Private ◽  
Factors Affecting ◽  
The Difference ◽  
Primary Focus ◽  
The University

The aim of this study was the primary focus of the international students remains on the academic adjustment aspect, which stays as the cornerstone of their well-being and satisfaction. The questionnaire data collected from four universities, both public and private, were analyzed to provide proof. The results from methods analyzing data stated that there was a positive impact of social-cultural factors affecting well-being. And this research finds no significant evidence of the difference in levels of adaptation between male and female students. The finding also implies that the university and the authority should focus on the positives of the issue, possibly needs some more attention to derive benefits from this potent sector.

Science, art and drug discovery: a personal perspective

2000 ◽  
Vol 99 (4) ◽  
pp. 255-260 ◽  
Author(s):  
Simon F. CAMPBELL
Keyword(s):  
Clinical Trials ◽  
Erectile Dysfunction ◽  
Drug Discovery ◽  
New Technologies ◽  
Traditional Approach ◽  
Phosphodiesterase Inhibitor ◽  
Research Programme ◽  
Personal Perspective ◽  
The Impact ◽  
Male Erectile Dysfunction

The research programme that started in 1985 led to the approval of Sildenafil (Viagra®), in 1998, as the first oral treatment for male erectile dysfunction. The initial project objective was the design and synthesis of novel inhibitors of phosphodiesterase that would increase tissue levels of cGMP, and that could be beneficial for the treatment of cardiovascular conditions. Starting from zaprinast, a weak phosphodiesterase inhibitor, computer modelling guided rational medicinal chemistry to achieve significant increases in potency and selectivity for the 5-isoenzyme within a novel series of pyrazolopyrimidinones. Optimization of structure–activity relationships and pharmacokinetic properties led to sildenafil, which proved essentially devoid of cardiovascular activity in clinical trials. However, the emerging role of nitric oxide and cGMP in controlling blood flow in the penis suggested that sildenafil would have a beneficial effect on erectile function. This hypothesis was confirmed by extensive clinical trials in nearly 5000 patients and the Food and Drug Administration approved sildenafil in March 1998 for male erectile dysfunction. Sildenafil is now available in over 100 countries and more than 150 million tablets have been dispensed worldwide. The sildenafil research programme reflects a traditional approach to drug discovery, but pressures to improve productivity have prompted major investments in genome sciences and new technologies. The impact of these initiatives on the drug discovery paradigm will be discussed, particularly with respect to shortening time scales between identifying gene sequences and submitting innovative products for regulatory approval.

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