Clinical Trial Outcomes

Martinez, Robin

doi:10.1016/j.jchf.2018.12.003

Cited by 6 publications

(5 citation statements)

References 767 publications

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“…Controlled clinical studies are recommended in the evaluation phase [ 55 ] to quantify the rehabilitation improvement with the exercises. The experiment, participants, and measurements must be defined according to the type of therapy [ 56 ]. If patients or therapists detect problems in the prototype created in an iteration, it must be solved in the previous iteration of the requirement or user context phase.…”

Section: Resultsmentioning

confidence: 99%

Standardizing the Development of Serious Games for Physical Rehabilitation: Conceptual Framework Proposal

Beristain-Colorado¹,

Ambros-Antemate²,

Vargas-Treviño³

et al. 2021

JMIR Serious Games

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Background Serious games have been used as supportive therapy for traditional rehabilitation. However, most are designed without a systematic process to guide their development from the phases of requirement identification, planning, design, construction, and evaluation, which reflect the lack of adaptation of rehabilitation requirements and thus the patient’s needs. Objective The aim of this study was to propose a conceptual framework with standardized elements for the development of information systems by using a flexible and an adaptable process centered on the patient’s needs and focused on the creation of serious games for physical rehabilitation. Methods The conceptual framework is based on 3 fundamental concepts: (1) user-centered design, which is an iterative design process focused on users and their needs at each phase of the process, (2) generic structural activities of software engineering, which guides the independent development process regardless of the complexity or size of the problem, and (3) gamification elements, which allow the transformation of obstacles into positive and fun reinforcements, thereby encouraging patients in their rehabilitation process. Results We propose a conceptual framework to guide the development of serious games through a systematic process by using an iterative and incremental process applying the phases of context identification, user requirements, planning, design, construction of the interaction devices and video game, and evaluation. Conclusions This proposed framework will provide developers of serious games a systematic process with standardized elements for the development of flexible and adaptable software with a high level of patient commitment, which will effectively contribute to their rehabilitation process.

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Section: Resultsmentioning

confidence: 99%

Standardizing the Development of Serious Games for Physical Rehabilitation: Conceptual Framework Proposal

Beristain-Colorado¹,

Ambros-Antemate²,

Vargas-Treviño³

et al. 2021

JMIR Serious Games

View full text Add to dashboard Cite

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“…The moment of clinical trial withdrawal is crucial for patients and their families, who have invested time and hope in the trials. For cancer patients facing life-threatening and life-limiting illnesses, what happens at trial exit is just as significant as what happens at entry (Martinez, 2019;Ulrich et al, 2021). Extended dosing presents a new treatment option for patients who have Survival plots of overall survival for treated and control groups.…”

Section: Discussionmentioning

confidence: 99%

Benefit assessment of extended dosing in cancer patients after their withdrawal from clinical trials

Yang,

Huang,

Heng

et al. 2023

Front. Pharmacol.

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Background: Clinical trials have been widely recognized as an effective treatment approach by physicians and cancer patients alike. Physicians’ evaluations suggest that many patients are likely to continue experiencing benefits from extended dosing of investigational new drugs even after withdrawing from clinical trials.Objective: Given the uncertainty surrounding the efficacy and safety of investigational new drugs, it is essential to continually assess the benefits of extended dosing for patients.Methods: The trial group for this study comprised patients who requested extended dosing after withdrawing from clinical trials at Hunan Cancer Hospital between 2016 and 2020. The control group consisted of patients who received conventional treatment and were enrolled in a 1:1 ratio. Follow-up assessments were conducted every 3 months for both groups, and included monitoring of patients’ health status, survival time, disease control or remission, treatment modalities received, and medical costs.Results: A total of twenty-three patient pairs were successfully matched for this study. The Ethics Committee approved extended dosing for all patients in the trial group, with an average gap period of 16.48 days between their withdrawal from clinical trials and continuous access to the investigational drugs. The median overall survival for patients after withdrawal from clinical trials was 17.3 months in the extended dosing group and 12.9 months in the control group, with no significant difference observed between the two groups (p > 0.250). The median total cost of treatment after the previous clinical trial was 38,006.76 RMB, of which the median cost of therapeutic drugs for conventional treatment was 15,720 RMB, while extended dosing was provided free of charge.Conclusion: Extended dosing can indeed provide benefits, including survival benefits and economic benefits, to cancer patients after their withdrawal from clinical trials and will clinically present an additional treatment option for patients.

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“…A CT is any research conducted on human subjects to determine or confirm the clinical, pharmacological, and pharmacodynamic effects of one or more products under the investigation; it is conducted to detect the adverse reactions as well as to study the absorption, distribution, metabolism, and elimination in order to determine their efficacy or safety [ 1 ]. In order to be appropriately conducted, CTs must comply to the ethical and regulatory requirements that ensure the protection of research subjects through their inspection [ 2 ]. In Peru, the Institutional Research Ethics Committees (REC) are responsible for inspection of CTs authorized by the “Instituto Nacional de Salud” from Peru (INS)—the governing body for research in the country—from the beginning of the trial to the receipt of the final report, at appropriate intervals depending on the degree of risk posed to the research subjects [ 1 ].…”

Section: Introductionmentioning

confidence: 99%

Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru

Herrera-Añazco

Urrunaga-Pastor

Soto-Ordoñez

et al. 2023

Ther Innov Regul Sci

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Objective This study aimed to describe the results of inspection of clinical trials (CTs) and the feasibility of conducting inspections virtually in Peruvian Social Security hospitals during the pandemic of COVID-19. Methods This study described 25 CTs that were inspected during August 2021–November 2021. The data for the variables were obtained from the CT inspection database of the Social Security Sub-directorate of Regulation and Management of Health Research which includes minutes and inspection reports. We describe the characteristics of the CT included and findings during the inspections using relative and absolute frequencies. Likewise, we evaluated the feasibility of virtual inspection through a self-administered questionnaire. Results According to the findings of the inspection, 60% of CTs were on biological products, and 60% were focused on infectiology. Additionally, 64% of CTs were implemented in Lima, 52% were conducted in level IV health facilities, and 72% were funded by the pharmaceutical sector. The lack of submission of requested documents (16/25) and inadequate access to the internet (9/15) and source documents (4/15) were the primary observations during the inspection. Regarding the feasibility of virtual supervisions, most interviewees rated their understanding of instruction form as “normal” and its content as “adequate.” Similarly, in the virtual self-assessment matrix, a large proportion of interviewees rated comprehension as “normal” (7/15) and its content as “adequate” (13/15). The quality of the virtual supervision process was 8.6 ± 1.1 on a scale of 1–10. Conclusion Discrepancies in records and failure to submit requested documents were the main observations. Most interviewees considered the material to be adequate and gave an overall good rating to the virtual inspection process.

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Clinical Trial Outcomes

Cited by 6 publications

References 767 publications

Standardizing the Development of Serious Games for Physical Rehabilitation: Conceptual Framework Proposal

Standardizing the Development of Serious Games for Physical Rehabilitation: Conceptual Framework Proposal

Benefit assessment of extended dosing in cancer patients after their withdrawal from clinical trials

Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru

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