Oncologic patients attitudes and participation in clinical trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18029-e18029
Author(s):  
Nethanel Asher ◽  
Ido Wolf ◽  
Sharon Pelles ◽  
Ravit Geva
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Center ◽  
Internal Validity ◽  
Past Experience ◽  
Basic Knowledge ◽  
Future Research ◽  
Academic Education ◽  
Oncologic Patients ◽  
Validity Tests

e18029 Background: Clinical trials are an essential part of the oncological care. However, literature indicates low accrual of only 2-4% of the oncologic population. One of the leading known barriers is the patient's hesitant attitude toward participation. This study aimed to evaluate the patients' population treated in the Tel Aviv Sourasky Medical Center (TASMC) oncology division and their understanding of clinical research in order to improve local recruitment strategies. Methods: An observatory, questionnaire based research was conducted. Patients receiving active oncology treatment in the TASMC oncologic day care unit were asked to complete an anonymous questionnaire, which was comprised of two main parts: the first evaluate demographic information and past experience in clinical research. The second investigated basic knowledge true/false test regarding clinical trials. The questionnaire was validated by both external and internal validity tests (α-Cronbach validity test) and was approved by the local ethics committee. Results: Two hundred patients completed the questionnaires. Median age was 60. 64% would consider participating in a clinical study. 23% (N = 46) had past experience in research, and compared to those with no experience they were found to have higher academic education (67.4% vs 36.9%, p < 0.0001), be more secular (76.1% vs 58.3, p = 0.037) and to have a better understanding of medical research (84.4%, vs 36.5%, p < 0.0001). They were also more inclined to participate in a future research (73% vs 44.9%, p = 0.01). Of those who would decline to participate and had failed the knowledge test (score less than 60%), the most frequent concern was related to the placebo arm (p = 0.055), ability to reject consent, and to trust issues with the treating oncologist. Conclusions: Despite a noteworthy readiness to enroll in clinical trials among the TASMC oncologic population, there were found significant knowledge and basic understanding gaps regarding clinical trials. Further efforts are needed to better understand specific accrual barriers and to develop an adapted information system.

scholarly journals Oncologic patients’ misconceptions may impede enrollment into clinical trials: a cross-sectional study

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Nethanel Asher ◽  
Ari Raphael ◽  
Ido Wolf ◽  
Sharon Pelles ◽  
Ravit Geva
Keyword(s):  
Clinical Trials ◽  
Medical Center ◽  
Cross Sectional Study ◽  
Past Experience ◽  
Basic Knowledge ◽  
Future Research ◽  
Academic Education ◽  
Sectional Study ◽  
Cross Sectional ◽  
Oncologic Patients

Abstract Background Clinical trials are an essential source for advances in oncologic care, yet the enrollment rate is only 2-4%. Patients' reluctance to participate is an important barrier. This study evaluates patients' level of understanding and attitudes towards clinical trials. Methods This cross-sectional study was conducted in the oncology department and day care unit at the oncology division Tel Aviv Sourasky Medical Center, Israel. From January 2015 to September 2016. Two-hundred patients’ currently receiving active anti-cancer therapy at a large tertiary hospital completed an anonymous questionnaire comprised of demographic information, past experience in clinical research and basic knowledge on clinical trials. Results The majority of respondents did not meet the minimum knowledge level criteria. In those who replied they would decline to participate in a clinical trial, concern were related to potential assignment to the placebo arm, provision of informed consent and trust issues with their oncologist. Those with sufficient knowledge were significantly more interested in participating. Patients with past experience in clinical trials had a higher level of academic education, were less religious, had a better understanding of medical research and were inclined to participate in future research. Conclusions Misperceptions of clinical trials may contribute substantially to the unwillingness to participate in them.

scholarly journals Oncologic Patients' Misconceptions May Impede Enrollment Into Clinical Trials

2021 ◽  
Author(s):  
Nethanel Asher ◽  
Ari Raphael ◽  
Ido Wolf ◽  
Sharon Pelles ◽  
Ravit Geva
Keyword(s):  
Clinical Trials ◽  
Medical Center ◽  
Good Clinical Practice ◽  
Tertiary Hospital ◽  
Past Experience ◽  
Basic Knowledge ◽  
Future Research ◽  
Academic Education ◽  
Adequate Knowledge ◽  
Oncologic Patients

Abstract Background Clinical trials are an essential source for advances in oncologic care, yet the enrollment rate is only 2-4%. Patients' reluctance to participate is an important barrier. This study evaluates patients' level of understanding and attitudes towards clinical trials.Methods Two-hundred patients receiving active anti-neoplastic therapy at a large tertiary hospital completed an anonymous questionnaire comprised of demographic information, past experience in clinical research and basic knowledge on clinical trials. Results The majority of respondents did not meet the minimum knowledge level criteria. The concerns of those who replied that they would decline to participate in a clinical trial were related to assignment to the placebo arm, provision of informed consent and trust issues with their oncologist. Those with adequate knowledge were significantly more interested in participating in. Patients with past experience in clinical trials had a higher level of academic education, were less religious, had a better understanding of medical research and were inclined to participate in future research.Conclusions Misperceptions of clinical trials may contribute substantially to the unwillingness to participate in them.Trial registration The study was approved by the Tel Aviv Sourasky Medical Center ethics committee (0565-14-TLV January 7th, 2015) and it was conducted in full accordance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. Agreement to respond to the questionnaire was taken as formal consent to participate in this study.

Challenges to Conducting Multicenter Clinical Research

2008 ◽  
Vol 19 (2) ◽  
pp. 164-169
Author(s):  
Sharon Y. Irving ◽  
Martha A.Q. Curley
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Quantitative Research ◽  
Scientific Evidence ◽  
Internal Validity ◽  
Controlled Clinical Trials ◽  
Level Of Evidence ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Multicenter Clinical Trials

Nursing care provided to patients and their families should be based on strong scientific evidence. In the quantitative research paradigm, the highest level of evidence is derived from conclusive randomized controlled clinical trials. Multicenter clinical research allows the accrual of sufficient numbers of diverse participants in a shorter period of time and improves the generalizability of the study findings. Clinical research is inherently complex; the complexity exponentially increases when conducting multicenter clinical trials. Investigators are challenged to maintain the internal validity of the study and the sustained commitment and collaboration of numerous disciplines over the study period. This article presents 10 essential points to consider when conducting multicenter clinical research.

Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective

1999 ◽  
Vol 17 (5) ◽  
pp. 1601-1601 ◽  
Author(s):  
Christopher K. Daugherty
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
Communication Process ◽  
Consent Process ◽  
Future Research ◽  
Trial Participation ◽  
Therapeutic Research

PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term “informed consent” is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.

scholarly journals Improving Participant Adherence in Clinical Research of Traditional Chinese Medicine

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Wenke Zheng ◽  
Bai Chang ◽  
Jing Chen
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Clinical Research ◽  
Large Scale ◽  
Patient Adherence ◽  
Internal Validity ◽  
Poor Adherence ◽  
Trial Protocol ◽  
Past Experiences

Ensuring good participant adherence in clinical trials plays an important role in that poor adherence may jeopardize the internal validity of the trial. Improving adherence in clinical trials on traditional Chinese medicine (TCM) has long been a concern for Chinese researchers who are conducting clinical trials. Drawing on from our past experiences in managing patient adherence in large-scale clinical trials, we identified factors that influence adherence and categorized them by sources into factors with respect to the trial protocol, on the part of the patients and the investigators. On this basis, we developed a series of ways to improve participants’ adherence, while taking into account the characteristics of TCM trials, in the hope of providing reference for peer clinical researchers.

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.

Intelligent Drug Development

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.

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

2021 ◽  
Author(s):  
Elizabeth Biswell R ◽  
Michael Clark ◽  
Michela Tinelli ◽  
Gillian Manthorpe ◽  
Joanne Neale ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Social Care ◽  
Research Nurse

scholarly journals Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes

2021 ◽  
Author(s):  
C. Madeira ◽  
L. Hořavová ◽  
F. dos Santos ◽  
J. R. Batuca ◽  
K. Nebeska ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Czech Republic ◽  
Clinical Research ◽  
Systematic Search ◽  
European Countries ◽  
The Czech Republic ◽  
Research Outcomes ◽  
Funding Policies ◽  
Funding Agencies ◽  
First Time

Abstract Objectives Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes. Methods A retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed. Results IICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs’ publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%). Conclusion The better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.

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