scholarly journals In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Lessons Learned ◽  
Patient Access ◽  
High Quality ◽  
Virtual Imaging ◽  
Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

scholarly journals In silico clinical trials: how computer simulation will transform the biomedical industry

2016 ◽  
Vol 3 (2) ◽  
pp. 37 ◽  
Author(s):  
Marco Viceconti ◽  
Adriano Henney ◽  
Edwin Morley-Fletcher
Keyword(s):  
Computer Simulation ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Medical Intervention ◽  
Review Article ◽  
Consensus Process ◽  
Biomedical Industry ◽  
Regulatory Evaluation ◽  
International Experts

<p class="abstract">The term ‘in silico clinical trials indicates the use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention. This review article summarises the research and technological roadmap developed by the Avicenna Support Action during an 18 month consensus process that involved 577 international experts from academia, the biomedical industry, the simulation industry, the regulatory world, etc. The roadmap documents early examples of in silico clinical trials, identifies relevant use cases for in silico clinical trial technologies over the entire development and assessment cycle for both pharmaceuticals and medical devices, identifies open challenges and barriers to a wider adoption and puts forward 36 recommendations for all relevant stakeholders to consider<span lang="EN-US">.</span></p>

Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials.

1989 ◽  
Vol 7 (7) ◽  
pp. 969-978 ◽  
Author(s):  
J Baar ◽  
I Tannock
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Oncology ◽  
Present Report ◽  
Metastatic Cancer ◽  
High Quality ◽  
Single Set

The methods used to analyze and interpret clinical trials of chemotherapy may have a major impact on the conclusions that are drawn in papers reporting them. To illustrate this problem, we constructed a hypothetical clinical trial in which patients with metastatic cancer were treated with chemotherapy. The following two articles provide reports of this trial, analyzed by methods that we would interpret as being of low and high quality, respectively. In the present report, we describe briefly the methodological differences that led to the opposite conclusions based on this single set of data. The errors of reporting and omissions of the first article (A) are similar to those that have been extracted from recent issues of the Journal of Clinical Oncology and other leading cancer journals, although they have not all appeared within a single report. This demonstration model illustrates problems in the reporting of clinical trials and suggests guidelines for improved reporting.

scholarly journals Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Hilde Nevens ◽  
Jillian Harrison ◽  
France Vrijens ◽  
Leen Verleye ◽  
Nelle Stocquart ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Selection Process ◽  
Necessary Condition ◽  
Funding Agency ◽  
Published Data ◽  
Close Monitoring ◽  
High Quality ◽  
Cost Drivers ◽  
Pragmatic Clinical Trials

Abstract Background Investigator-led multicentre randomised trials are essential to generate evidence on the optimal use of medical interventions. These non-commercial trials are often hampered by underfunding, which may lead to difficulties in gathering a team with the necessary expertise, a delayed trial start, slow recruitment and even early trial discontinuation. As a new public funder of pragmatic clinical trials, the KCE Trials programme was committed to correctly pay all trial activities in order to assure timely delivery of high-quality trial results. As no appropriate trial budget tool was readily publicly available that took into account the costs for the sponsor as well as the costs for participating sites, we developed a tool to make the budgeting of a clinical trial efficient, transparent and fair across applicants. Methods All trial-related activities of the sponsor and sites were categorised, and cost drivers were identified. All elements were included in a spreadsheet tool allowing the sponsor team to calculate in detail the various activities of a clinical trial and to appreciate the budget impact of specific cost drivers, e.g. a delay in recruitment. Hourly fees by role were adapted from published data. Fixed amounts per activity were developed when appropriate. Results This publicly available tool has already been used for 17 trials funded since the start of the KCE Trials programme in 2016, and it continues to be used and improved. This budget tool is used together with additional risk-reducing measures such as a multistep selection process with advance payments, a recruitment feasibility check by sponsor and funder, a close monitoring of study progress and a milestone-based payment schedule with the last payment made when the manuscript is submitted. Conclusions The budget tool helps the KCE Trials programme to answer relevant research questions in a timely way, within budget and with high quality, a necessary condition to achieve impact of this programme for patients, clinical practice and healthcare payers.

scholarly journals Obtaining Valid Laboratory Data in Clinical Trials Conducted in Resource Diverse Settings: Lessons Learned from a Microbicide Phase III Clinical Trial

PLoS ONE ◽  
2010 ◽  
Vol 5 (10) ◽  
pp. e13592 ◽  
Author(s):  
Tania Crucitti ◽  
Katrien Fransen ◽  
Rashika Maharaj ◽  
Tom Tenywa ◽  
Marguerite Massinga Loembé ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Laboratory Data ◽  
Lessons Learned ◽  
Phase Iii ◽  
Phase Iii Clinical Trial

Providing oncologic care with access to clinical trials to an underserved and minority population: The Mayo Clinic/Indian Health Service experience.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 79-79
Author(s):  
Donald W. Northfelt ◽  
Chara Chamie ◽  
Farhia Omar ◽  
Janet Okamoto ◽  
Timothy Mathews ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Health Service ◽  
Cancer Patients ◽  
Mayo Clinic ◽  
Clinical Care ◽  
Indian Health Service ◽  
Cancer Clinical Trials ◽  
High Quality ◽  
Indian Health

79 Background: Novel mechanisms are needed to provide high quality oncologic clinical care and clinical trial access to underserved and minority populations (UMP). UMP are underrepresented in cancer clinical trials, thus limiting the generalizability of the research. As a National Cancer Institute-Comprehensive Cancer Center, Mayo Clinic has the responsibility to ensure that its cancer care reaches a diverse patient population. Mayo Clinic in Arizona developed a clinical oncology practice in collaboration with the US Indian Health Service at Phoenix Indian Medical Center (PIMC), in part to address these needs. The relationship between Mayo and PIMC is invaluable and serves a crucial need in the community. The Mayo consultants serve as staff physicians in the “Oncology Center of Excellence” at PIMC and see 100 – 200 tribal members annually with new diagnoses of cancer or blood disorders. Being onsite at PIMC allows Mayo consultants to integrate seamlessly into the wider PIMC practice. Methods: Descriptive demographic data from the MCA-PIMC clinical practice were obtained from the PIMC practice database 2008 - 2017. Enrollment of MCA-PIMC patients into MCA cancer clinical trials were prospectively enumerated. Results: Between the time period of 2008-2017, 356 breast cancer patients and 259 colorectal cancer patients were seen by Mayo Clinic oncologists and the PIMC nurse practitioner. During the period of 2016-2017, there were 13 clinical trial referrals from PIMC with 8 of those patients being enrolled in Mayo cancer clinical trials. Conclusions: High quality oncologic clinical care can be provided via unique collaborations between academic oncology program and UMP-focused care provider. This mechanism allows access to cancer clinical trial opportunities for UMP. Prior to the established partnership, there were no Native American patients referred to clinical trials from PIMC, showing the critical pathway that has been forged. Importantly, this is the only known program of its kind in the country. By imbedding the cancer provider in the community, we are able to build trust with the underserved community and create a pathway to a quality care and clinical research.

scholarly journals Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S40-S47 ◽  
Author(s):  
Amy Callis ◽  
Victoria M Carter ◽  
Aparna Ramakrishnan ◽  
Alison P Albert ◽  
Lansana Conteh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Community Engagement ◽  
Information Needs ◽  
Human Subjects ◽  
Lessons Learned ◽  
Accurate Information ◽  
Community Acceptance ◽  
Institutional Review ◽  
The Impact

Abstract Communication contributed to 4 important aspects of the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE): recruiting participants, supporting Human Subjects Protection, building trust in the community to support the trial, and mitigating the impact of rumors and misinformation. Communication was particularly important because STRIVE was Sierra Leone’s first vaccine clinical trial and was implemented during a public health emergency. Communication efforts began months prior to trial launch, building awareness and support through sensitization sessions with stakeholders and community leaders. Community engagement activities continued throughout the trial to maintain relationships with leaders and stakeholders and disseminate accurate information, fostering trust in the trial. The communication team led recruitment with hundreds of information sessions for potential participants, facilitating the informed consent process. Communication efforts continued post-enrollment, supporting ongoing voluntary participation in the trial. Informal formative activities during the trial yielded insights on participants’ perceptions and information needs. While Centers for Disease Control and Prevention Institutional Review Board–approved activities and materials did not change, this flexible strategy allowed for responsive interactions with participants. The trial success and its community acceptance illustrated STRIVE’s successful communications efforts, owing in large part to this flexibility and commitment to community engagement. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals Resilient Clinical Trial Infrastructure in Response to the COVID-19 Pandemic: Lessons Learned from the TOGETHER Randomized Platform Clinical Trial

2022 ◽  
Author(s):  
Jamie I. Forrest ◽  
Angeli Rawat ◽  
Felipe Duailibe ◽  
Christina M. Guo ◽  
Sheila Sprague ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Health System ◽  
Lessons Learned ◽  
Research Groups ◽  
Safety And Efficacy ◽  
Target Sample Size ◽  
The World ◽  
Trial Protocols ◽  
New Evidence

In response to the COVID-19 pandemic, clinical research groups across the world developed trial protocols to evaluate the safety and efficacy of treatments for COVID-19. Despite this initial enthusiasm, only a small portion of these protocols were implemented. Of those implemented, a fraction successfully recruited their target sample size to analyze and disseminate findings. More than a year and a half into the COVID-19 pandemic, only a few clinical trials evaluating treatments for COVID-19 have generated new evidence. Productive randomized platform clinical trials evaluating COVID-19 treatments may attribute their success to intentional investments in developing resilient clinical trial infrastructures. Health system resiliency discourse provides a conceptual framework for characterizing attributes for withstanding shocks. This framework may also be useful for contextualizing the attributes of productive clinical trials evaluating COVID-19 therapies. We characterize the successful attributes and lessons learned in developing the TOGETHER Trial infrastructure using a health system resiliency framework. This framework may be considered by clinical trialists aiming to build resilient trial infrastructures capable of responding rapidly and efficiently to global health threats.

scholarly journals Bayesian Augmented Clinical Trials in TB Therapeutic Vaccination

2021 ◽  
Vol 3 ◽  
Author(s):  
Dimitrios Kiagias ◽  
Giulia Russo ◽  
Giuseppe Sgroi ◽  
Francesco Pappalardo ◽  
Miguel A. Juárez
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Posterior Distribution ◽  
In Silico ◽  
Therapeutic Vaccination ◽  
Virtual Patients ◽  
Bayesian Hierarchical ◽  
Bayesian Hierarchical Method ◽  
Joint Posterior Distribution

We propose a Bayesian hierarchical method for combining in silico and in vivo data onto an augmented clinical trial with binary end points. The joint posterior distribution from the in silico experiment is treated as a prior, weighted by a measure of compatibility of the shared characteristics with the in vivo data. We also formalise the contribution and impact of in silico information in the augmented trial. We illustrate our approach to inference with in silico data from the UISS-TB simulator, a bespoke simulator of virtual patients with tuberculosis infection, and synthetic physical patients from a clinical trial.

An Account of how Attention to Usability and Lifestyle Issues may Contribute to Protocols for Clinical Trials of Medical Devices (Preprint)

2017 ◽  
Author(s):  
Lars Rune Christensen ◽  
Lene Nielsen ◽  
Anne Sabers
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Randomized Clinical Trials ◽  
Case Report Form ◽  
Data Generation ◽  
Pragmatic Approach ◽  
Double Blind ◽  
Sham Procedure

UNSTRUCTURED Objectives: Within the field of medicine attempts have been made to establish the efficacy of new treatments with medical devises by double blind randomized clinical trials. Very precise protocols have been developed for this purpose. However, experience has shown that conducting clinical trials on medical devices may be fraught with trouble often because of the difficulty of establishing a valid sham procedure. This paper makes a contribution by showing how one may formulate protocols for clinical trials of medical devices that rely on a pragmatic approach, which includes an interest in usability and lifestyle issues, rather than a sham procedure. Our case in point is a protocol for a clinical trial, conducted by the authors, of a new kind of treatment of epilepsy with a medical device. Methods: This paper makes a methodological contribution relevant for the formulation of protocols for clinical trials of medical devises in cases where a sham devise is not practical. Results: In the paper, we make three major points: (1) abandoning basing a clinical trial of a medical device on a sham procedure, involves making choices as to the formulation of a pragmatic alternative, (2) shifting to a pragmatic evaluation based on data on for example continued use, may involve generating data on usability and lifestyle issues. Understanding to what degree noncompliance is due to usability or lifestyle issues requires attention to the design of suitable instruments for data generation, and (3) the successful formulation of a protocol for a clinical trial of a medical device (where sham is not an option) relies on a case report form (CRF) that facilitates the separation of data on the (somatic) efficacy of the treatment from data on usability and lifestyle issues. Conclusion: Digital devices play an important role in medicine today and in the future. This paper makes a contribution by showing how one may formulate protocols for clinical trials of medical devices that do not rely on a sham procedure. The approach is based on a pragmatic approach, the generating data on usability and lifestyle issues connected to the use of the devise, and the separation of these issues from the evaluation of the efficacy of the active component of the treatment.

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