Cooperative group and pharmaceutical sponsored clinical trials: Perceptions of U.S. community oncologists.

e13571 Background: Many community-based oncologists in the US participate in clinical trials. These trials largely fall into two categories: trials run by cooperative (co-op) groups, funded and supported by the National Cancer Institute and trials developed, and supported by the pharmaceutical (pharma) industry. This study aimed to assess participation in, and perceptions regarding, co-op versus pharma trials among US community oncologists. Methods: We invited healthcare providers (HCP) across the continental US to attend 4 virtual meetings held between September and November 2020. Participants submitted their demographic information and responses to targeted questions regarding their opinions about co-op- and pharma-sponsored trials via a web-based pre-meeting survey. We evaluated participant HCP practice demographics and survey responses using descriptive statistics. Results: Of 259 surveyed participants, HCPs specialized in hematology-oncology (57%) and medical oncology (40%) with mean (median) 19 (18) years’ clinical experience. Most HCPs (178; 69%) reported participating in clinical research, and of these, 137 (77%) participated in co-op-led and 156 (88%) participated in pharma-led clinical research. HCPs preferred participating in both pharma and co-op (49%), pharma only (22%), and co-op only (11%) trials, while 18% preferred not to participate. Co-op trials were considered more prestigious to lead (86%), less likely to imply a conflict of interest (59%), and to address more pertinent questions (58%), while pharma trials had perceived advantages of better compensation (61%) and superior efficiency (48%). Co-op trials were perceived as not being financially sustainable (69%) and slower to accrue patients (85%) than pharma-led trials. Relatedly, in a hypothetical scenario of competing trials with identical design, the majority (60%) of HCPs preferred enrolling a loved one in a co-op trial. HCPs practicing in facilities with academic affiliation (34%) and in non-academic (66%) settings reported similar perceptions about co-op- and pharma-led trials; though, HCPs in academic settings were more likely to participate in clinical research compared to those in non-academic settings (82% vs. 62% [ P=0.001], respectively). Conclusions: In our survey of experienced HCPs, co-op-led clinical trials were perceived generally more favorably than pharma-led trials, even with concerns regarding cost, feasibility, and slower recruitment. However, despite their preference for co-op trials, HCPs were more likely to participate in pharma-led trials. Almost a third of surveyed HCPs are not participating in clinical trials and a fifth do not wish to. These findings can inform stakeholders (co-op trial leadership, pharma drug development teams, and patient advocacy groups) regarding appropriate education, design, and messaging regarding future clinical trials in oncology.

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Automated data extraction software for medical summary using text mining (T-Library)

10.7287/peerj.preprints.27685 ◽

2019 ◽

Author(s):

Tomohide Yamada ◽

Yoshinobu Kondo ◽

Ryo Momosaki

Keyword(s):

Clinical Trials ◽

Deep Learning ◽

Clinical Research ◽

Data Extraction ◽

Healthcare Providers ◽

Clinical Information ◽

Patient Records ◽

Unstructured Text ◽

Risk Engine ◽

Easy Operation

The electronic medical record (EMR) is a source of clinical information and is used for clinical research. Clinical researchers leverage this information by employing staffs to manually extracting data from the unstructured text. This process can be both error-prone and labor-intensive. This software (T-Library) is a software which automatically extracts key clinical data from patient records and can potentially help healthcare providers and researchers save money, make treatment decisions and manage clinical trials. This software saves labor for data transcription in clinical research. This is a vital step toward getting researchers rapid access to the information they need. This is also the attempt to cluster patients’ morbid states and establish accurate and constantly updated risk engine of complications’ crises, using deep learning. Strengths: 1) Quick and Easy operation URL: http://www.picoron.com/tlibrary/

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The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-020-00173-9 ◽

2020 ◽

Vol 54 (6) ◽

pp. 1461-1472

Author(s):

L. Horavova ◽

K. Nebeska ◽

L. Souckova ◽

R. Demlova ◽

P. Babula

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Healthcare Providers ◽

Paediatric Population ◽

Current Status ◽

Therapeutic Area ◽

Healthcare Provision ◽

Non Profit ◽

Pharmaceutical Industries ◽

Design Characteristics

Abstract Introduction Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work. Method A retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications. Results The search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results. Conclusion The main shortcomings—specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.

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Automated data extraction software for medical summary using text mining (T-Library)

10.7287/peerj.preprints.27685v2 ◽

2019 ◽

Author(s):

Tomohide Yamada ◽

Yoshinobu Kondo ◽

Ryo Momosaki

Keyword(s):

Clinical Trials ◽

Deep Learning ◽

Clinical Research ◽

Data Extraction ◽

Healthcare Providers ◽

Clinical Information ◽

Patient Records ◽

Unstructured Text ◽

Risk Engine ◽

Easy Operation

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Automated data extraction software for medical summary using text mining (T-Library)

10.7287/peerj.preprints.27685v1 ◽

2019 ◽

Author(s):

Tomohide Yamada ◽

Yoshinobu Kondo ◽

Ryo Momosaki

Keyword(s):

Clinical Trials ◽

Deep Learning ◽

Clinical Research ◽

Data Extraction ◽

Healthcare Providers ◽

Clinical Information ◽

Patient Records ◽

Unstructured Text ◽

Risk Engine ◽

Easy Operation

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Automated data extraction software for medical summary using text mining (T-Library)

10.7287/peerj.preprints.27685v3 ◽

2019 ◽

Author(s):

Tomohide Yamada ◽

Yoshinobu Kondo ◽

Ryo Momosaki

Keyword(s):

Clinical Trials ◽

Deep Learning ◽

Clinical Research ◽

Data Extraction ◽

Healthcare Providers ◽

Clinical Information ◽

Patient Records ◽

Unstructured Text ◽

Risk Engine ◽

Easy Operation

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Clinical trials — the personal perspective of the research physician?

Annals of the Russian academy of medical sciences ◽

10.15690/vramn1356 ◽

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).

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

10.2196/preprints.17630 ◽

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.

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Intelligent Drug Development

10.1093/oso/9780199974580.001.0001 ◽

2014 ◽

Author(s):

Michael Tansey

Keyword(s):

Clinical Trials ◽

Cost Effectiveness ◽

Drug Development ◽

Clinical Research ◽

Development Process ◽

Drug Development Process ◽

Individual Trial ◽

Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

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Healing experience for family caregivers after an intensive care unit death

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2018-001561 ◽

2019 ◽

pp. bmjspcare-2018-001561 ◽

Cited By ~ 2

Author(s):

Susan DeSanto-Madeya ◽

Dan Willis ◽

Julie McLaughlin ◽

Aristotle Boslet

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Family Caregivers ◽

Phenomenological Study ◽

Healthcare Providers ◽

Loved One ◽

Hermeneutic Phenomenological ◽

Telephone Interviews ◽

Hermeneutic Phenomenological Study ◽

Purposive Sample

ObjectivesFamily caregivers suffer a high burden of emotional and psychological distress following the death of a loved one in the intensive care unit and often struggle to heal in the weeks following their loss. The purpose of this hermeneutic phenomenological study was to describe and interpret the experience of healing for family caregivers six weeks following the death of a loved one in the ICU.MethodsSemi-structured telephone interviews were conducted with a purposive sample of twenty-four family caregivers six weeks following the death of their loved ones in the ICU. Qualitative analysis techniques were used to identify common themes central to the experience of healing across all interviews.ResultsSeven themes were interpreted from the data: searching for clarity from a time of uncertainty; riding an emotional rollercoaster; seeking peace in one’s decisions; moving forward with each new day; taking comfort in the memories; valuing layers of support; and discovering life on one’s own.ConclusionBy identifying and gaining an understanding of healing following the death of a loved one in the ICU, nursing and other healthcare providers have an opportunity to promote healing and positively impact family caregiver’s bereavement.

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Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research

Journal of Clinical Nursing ◽

10.1111/jocn.15911 ◽

2021 ◽

Author(s):

Elizabeth Biswell R ◽

Michael Clark ◽

Michela Tinelli ◽

Gillian Manthorpe ◽

Joanne Neale ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Social Care ◽

Research Nurse

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