Development of the CCRU kit squad: Centralization of biospecimen “kit” management.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 295-295
Author(s):  
Vanessa Speers
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Personalized Medicine ◽  
Management Practices ◽  
Online Service ◽  
Nursing Time ◽  
Software Training ◽  
Disease Site ◽  
The Right ◽  
Selection Of

295 Background: Personalized medicine has resulted in a rapid increase in biospecimens collection. Each biospecimen collected requires supplies that are provided in the form of “kits”. The number of kit types per protocol ranges anywhere from 2-60, with an average of 30 different kit types per trial. Historically, each trials nurse has managed their own kits resulting in large amounts of nursing time being spent on kit management. Kits took up a large amount of space in clinical areas, including expired kits, and they were being managed in no standardized fashion. Due to rapidly increasing biospecimen volumes, existing methods of kit management were no longer feasible and the CCRU Kit Squad was developed. Methods: Over the course of 12-mos, an extensive assessment of current kit management practices were reviewed with all disease site groups, including workflows and quantities utilized. An e-commerce software platform was selected, and semi-customized to centralize online ordering and receiving of kits, and the creation of a central location was setup for kit storage and daily operations. On-boarding of each group included retrieving existing kits from each nurse, uploading kits to the software, training each nurse to use the software, setting up accounts with each respective vendor for deliveries and re-supply, and disposing of expired kits. Results: Disease site groups were transitioned to the CCRU Kit Squad stepwise from Oct 2016 to Dec 2017 (15-mos), which included 80 nurses, 16 disease site groups, and over 400 clinical trials. By the end of 2017, the average number of kits ordered per day, and per month were 33 and 1003, respectively. Conclusions: The CCRU Kit Squad developed a centralized online service for kit management, thereby reducing administrative burden on clinical trial nurses. It has streamlined the management of biospecimen kits, eliminated wasted space in clinical areas, and facilitated the selection of the right kit for the right test at the right time.

scholarly journals Clinical trial design for progressive MS trials

2017 ◽  
Vol 23 (12) ◽  
pp. 1642-1648 ◽  
Author(s):  
Matteo Pardini ◽  
Gary Cutter ◽  
Maria Pia Sormani
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Progressive Multiple Sclerosis ◽  
Phase 2 ◽  
The Right ◽  
Selection Of Patients ◽  
Selection Of

The design of clinical trials is a key aspect to maximizing the possibility to detect a treatment effect. This fact is particularly challenging in progressive multiple sclerosis (PMS) studies due to the uncertainty about the right target and/or outcome in phase-2 studies. The aim of this review is to evaluate the current challenges facing the design of clinical trials for PMS. The selection of patients, the instrumental and clinical outcomes that can be used in PMS trials, and issues in their design will be covered in this report.

scholarly journals Key Barriers to Clinical Trial Enrolment: A Survey of Clinical Trial Staff at an NCI Designated Cancer Center

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5864-5864
Author(s):  
Amany R. Keruakous ◽  
Adam S. Asch
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cultural Bias ◽  
Cancer Center ◽  
Exclusion Criteria ◽  
Strict Inclusion ◽  
Trial Protocols ◽  
Trial Staff ◽  
Disease Site ◽  
Patient Enrolment

Background: Clinical trials, key elements of the processes that account for many of the recent advances in cancer care, are becoming more complex and challenging to conduct. The Stephenson Cancer Center (SCC) has been the lead accruer to NCI-LAP trials over the past three years, and in addition, fields investigator initiated and industry sponsored trials. To identify opportunities for continued improvement in clinical trial enrolment, we sought to identify the obstacles encountered by our clinical trial staff in these activities. Method: We conducted a survey of our research staff including all research nurses and disease site coordinators who participate in recruitment, screening, consenting, data collection and compliance. The survey, sent by email to the clinical trial list-serve at SCC (90 staff member), invited respondents to enumerate obstacles to patient participation in clinical trials. We then performed a follow up meeting with our research coordinators to clarify responses. A total of 26 responses from 90 respondents were received and tabulated by disease site. Results: The most commonly reported obstacles to enrolment were, in descending order: communication/language barriers, cultural bias, time/procedure commitment, and complexity of the trial protocol, financial logistics, comorbidities, and stringent trial criteria. Respondents identified 83 obstacles as frequently encountered obstacles to enrolment. The 83 reported obstacles were classified into 9 categories and organized by disease site as presented in tabular format (below). The most commonly identified obstacles to patient enrolment were communication and language barriers. In patients for whom Spanish is the primary language this was a universal obstacle, as there is a lack of consistent Spanish consents across the clinical trial portfolio. Cultural bias, as an obstacle was manifested as a general mistrust by prospective trial participants of experimental therapies and clinical trials. After communication and cultural bias as barriers, travel requirements and the associated expenses playing a role in patients from rural areas were identified as the most commonly encountered barrier. The complexity of trial protocols and the associated large number of clinic visits, frequent laboratory and imaging tests were also identified as common obstacles. Clinical trial complexity with strict inclusion and exclusion criteria and trial-specified biopsies were frequently cited. Implications: In this descriptive study, common barriers to patient enrolment in clinical trials were identified by clinical trial staff. Assessing barriers encountered by clinical trial staff is infrequently used as a metric for improving clinical trial enrolment, but provides important perspective. In our study, some obstacles are inherent in our patient populations, others appear to be actionable. Development of Spanish language consents and specific programs to overcome negative bias regarding clinical trials are potential areas for improvement. The complexity of clinical trial protocols and the increasingly strict inclusion/exclusion criteria, are issues that will require consideration and action at the level of the cooperative groups and industry. Disclosures No relevant conflicts of interest to declare.

Clinical trial feasibility assessment and start-up tool (CTFAST).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14089-e14089
Author(s):  
Amanda Tice ◽  
Richard Dima ◽  
Wasif M. Saif ◽  
Melissa Panzo ◽  
Sarah R. Vaiselbuh
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Population ◽  
Feasibility Analysis ◽  
Pharmacokinetic Studies ◽  
Research Experience ◽  
Team Members ◽  
Feasibility Assessment ◽  
Start Up ◽  
The Right

e14089 Background: Selecting the right clinical trials for patients remains a challenging job. The better the match between a clinical trial and the target patient population before conducting a study, the more likely the study will successfully reach the target goal of recruitment. We developed a feasibility assessment scoring system based on our vast clinical research experience, managing multiple sites across a large health system, applicable to oncology as well. Methods: Our feasibility team (FT) is responsible for identifying clinical trials and determining if they are an appropriate match for our institution and unique patient population. Once a potential trial is identified, FT performs a feasibility assessment of the research protocol to determine the resources required to conduct the trial. We developed a Clinical Trial Feasibility Assessment & Start-up Tool (CTFAST) to help sites streamline their feasibility assessments and track their trial through the start-up phase. With CTFAST a feasibility score is generated based on the cumulative value assigned to several items such as: sponsor, study type, pharmacokinetic studies, trial phase, etc. A feasibility scale is assigned as follows: > 25 – Accepted; 15-25 – On Hold; < 15- Rejected. Accepted studies are assigned a color coded priority track (fast, intermediate, routine), that allows team members to prioritize their studies accordingly. Once a study is accepted, the study is processed for enrollment. Results: CTFAST has increased productivity and clinical trial revenues by 40%. CTFAST allows for early identification of bottlenecks in workflow, thereby improving outcomes. By appropriately matching of clinical trials to our site, enrollments increased by 50% with an expanded clinical trial portfolio across 9 different departments. Study start-up times have been reduced to a minimum of 21 days and the use of time & effort has been optimized. Conclusions: CTFAST is replicable across all clinical trial sites and provides an expansive and critical feasibility analysis that is not attainable by traditional querying of investigators and questionnaires. It is an excellent work flow improvement tool as it critically analyzes all aspects of a study, prior to enrollment. When conducting an effective feasibility analysis the clinical trial site can optimize clinical trial outcomes.

scholarly journals Authors’ Responsibilities and Ethical Publishing

2018 ◽  
Vol 13 ◽  
Author(s):  
Louise Gabrielle Shewan ◽  
Andrew J. Stewart Coats ◽  
Michael Henein
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Ethics Committee ◽  
Copyright Clearance ◽  
Competing Interests ◽  
Full Responsibility ◽  
Exceptional Circumstance ◽  
Human Ethics ◽  
The Right

The International Cardiovascular Forum Journal requires authors to abide by the following guidelines:Manuscript: The corresponding author declares that the manuscript has not been published and is not under consideration elsewhere.Authorship: The corresponding author takes full responsibility for the list of authors.  Any modification to the author list including order and composition can only be approved by the Editor-in-Chief following signed agreement from all the authors listed on the original submission.Ethics: The corresponding author states that the material presented has been obtained with the approval of all appropriate animal and/or human ethics committee(s).Permissions: The corresponding author on behalf of all authors confirms whether explicit written consent to publish has been received from any people described, pictured, or recorded and that formal copyright clearance is obtained to publish any video or audio recordings.Registration of Clinical Trials: Prospective registration of any clinical trial in a publically accessible database is a requirement for later publication of such trials in ICFJ. In exceptional circumstance if the trial is not registered, or is registered retrospectively, the reasons for this must be given.Competing Interests: All authors must declare all relevant competing interests (financial, or non-financial, professional, or personal) and state all funding sources.Attribution: The corresponding author accepts full responsibility for the accurate citation and acknowledgement of any material reproduced from other publications including the author’s own prior work.It is incumbent upon the corresponding author to consult the Editor-in-Chief should there be any variance of the above. The Editor-in-Chief retains the right to retract any submission found to be in breach of the above guidelines.  

Patients Driving the Clinical Trial Designs – Democracy in Clinical Research

2019 ◽  
Vol 14 (4) ◽  
pp. 237-246
Author(s):  
Payal Bhardwaj ◽  
Jeba Kumar ◽  
Raj Kumar Yadav
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Retention Rate ◽  
Patient Centered ◽  
Regulatory Review ◽  
Patient Organizations ◽  
Patient Reported ◽  
Clinical Trial Designs ◽  
The Right

Background: Many of the clinical trials remain inefficient owing to the low retention rate, and an impact on the power of the study. In addition, regulatory bodies recommend including the patients’ experience, especially, patient-reported outcomes, while making clinical decisions, and approvals. Introduction: Patient centricity has reached the stage where patients are both willing and required to participate in clinical trial designs, regulatory review and experts on other panels. Efforts are being made in the right direction and there are multiple aspects that have been or are being addressed. Objective: The current article focuses on how to include patients in clinical trial designs, the benefits, challenges, and solutions. This means patients who were merely the participants until now, they will be the drivers of trials now, and hence the clinical trials will be more efficient and productive. Key Findings: There is a drive to enhance patients’ participation in clinical trial designs, especially, visits, efficacy outcomes and their expectations with the treatment. Patients want to remain informed, right from before participation to the completion of the trial. Patients are now an important part of regulatory review, as apparent from recent initiatives by the FDA and EMA. This will enhance patients’ awareness, and bring ownership and transparency. Various patient organizations, advocacy groups have made some great suggestions and taken initiatives in this direction. Clinical Trials Transformation Initiative, European Patient’s Academy on Therapeutic Innovation, and Patient- Centered Outcomes Research Institute are a few key initiatives. However, there is a set of challenges emanating from the complexity of trials, associated with unique mechanism of action of drugs, their efficacy and safety profiles, which has to be dealt with properly. Conclusion: Overall, the pharma domain is at the verge of putting the patient in the spotlight, to achieve a near-real democracy, where the clinical research is the by the patient, for the patient, and, of the patient.

scholarly journals BIOMARKER STRATEGIES FOR GEROSCIENCE-GUIDED CLINICAL TRIALS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S745-S746
Author(s):  
Jamie N Justice ◽  
George A Kuchel ◽  
Nir Barzilai ◽  
Stephen Kritchevsky
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Biological Aging ◽  
Expert Committee ◽  
Biomarkers Of Aging ◽  
Age Related ◽  
Trial Outcomes ◽  
Biology Of Aging ◽  
Potential Use ◽  
Selection Of

Abstract Significant progress in the biology of aging and animal models supports the geroscience hypothesis: by targeting biological aging the onset of age-related diseases can be delayed. Geroscience investigators will test this hypothesis in a multicenter clinical trial, to determine if interventions on biological aging processes can prevent accumulation of multiple age-related diseases and aging phenotypes in older adults. Prodigious activity is underway to develop markers of biological aging, but currently there is no aging biomarker consensus to support geroscience-guided clinical trial outcomes. We convened an expert committee to establish a framework for selection of blood-based biomarkers, emphasizing: feasibility/reliability; aging relevance; ability to predict clinical trial outcomes; and responsiveness to intervention. We applied this framework and identified a short-list of blood-based biomarkers with potential use in multicenter trials on aging. We review progress on efforts to test these candidate biomarkers of aging and development of biomarkers strategy for geroscience-guided clinical trials.

scholarly journals Impact of the Next-Generation Sequencing Panel on Treatment Choice in Patients with Myelodysplastic Syndrome

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4340-4340
Author(s):  
Ana Alfonso Pierola ◽  
Guillermo Montalban-Bravo ◽  
Ali N. Chamseddine ◽  
Koichi Takahashi ◽  
Feng Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Targeted Therapy ◽  
Next Generation Sequencing ◽  
Personalized Medicine ◽  
Research Funding ◽  
Somatic Mutations ◽  
Target Therapy ◽  
Current Therapy ◽  
Generation Sequencing

Abstract INTRODUCTION: Current therapy options for patients with myelodysplastic syndromes (MDS) are limited, and hypomethylating agents represent the standard of care for these patients. Next-generation sequencing (NGS) and the development of new targeted treatments are facilitating the arrival of personalized medicine as a feasible patient care paradigm. Although the concept of target therapy in MDS is new, a large number of targeted drugs are currently being tested in clinical trials. We report the experience of 812 patients with MDS who were tested using an NGS panel that included possible actionable alterations and its impact on treatment choice. METHODS: We included all MDS patient for whom an NGS-based analysis for the detection of somatic mutations in the coding sequence of a total of 28 or 53 genes was performed at The University of Texas MD Anderson Cancer Center between October 2012 to October 2015. Clinical and demographic data were obtained from clinical records. 29 genes (ABL1, AKT1, ATM, BRAF, EGFR, FBXW7, FLT3, GNAQ, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MDM2, MLL, MPL, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RET, SMO, SRC, AND STK11) were considered potentially actionable due to the possibility to be targeted with established or investigational therapeutics, either directly or indirectly. Statistical analyses were performed with the IBM SPSS Statistics 23.0 software. RESULTS:An NGS-based analysis for the detection of somatic mutations in the coding sequence of a total of 28 (n=603 patients) or 53 genes (n=209 patients) was performed in 812 patients with MDS. The median age was 70 years (range 25-91). Baseline characteristics are shown in Table 1. A total of 812 patients with MDS were evaluated. Patient characteristics are shown in Table 1. 522 patients (64%) had at least one detectable driver mutation: 234 (29%) on a potential actionable gene and 288 (35%) on non-actionable genes. The most frequently potentially actionable mutation was NRAS (n=61; 7.5%) followed by IDH2(N=48, 5.9%), and both were present on more than 5% of the patients. The frequency of all identified mutations is shown in Fig. 1. A total of 497 patients were evaluated at the time of diagnosis, with 293 patients starting therapy for their MDS. 93 (32%) of these treated patients had potentially targetable alterations, and only 15 (5%) of these patients were treated with a targeted agent. Of the 315 remaining patients, 105 (33%) had a potentially actionable alteration, and 22 (7%) started a target therapy treatment (p=0.46). 197 of the patients (59%) who had a potentially actionable alteration never received a targeted therapy, with 14% of these patients (n=28) not returning to the institution after the mutation analysis and 18% (n=36) starting new treatment due to response to current therapy. From the remaining 133 patients, documentation of discussion of enrollment in a clinical trial was present on 74% (n=98), of which 14% (n=18) of these patients preferred a non-investigational treatment, 8% (n=11) were not eligible owing to poor status or other causes, and 8% (n=10) had difficulty in meeting the study visits. Patients with mutations in potentially actionable genes were more likely to be treated on a clinical trial (102/234 [44%] vs 201/578 [35%]) (p=0.02). CONCLUSION:NGS technologies can be used to identify a significant proportion of patients (29%) with potentially actionable mutations. The presence of such mutations predicts for increased likelihood of treatment within a clinical trial. However, only a small proportion of patients (16%) with MDS and actionable alterations are treated with targeted therapy. Personalized medicine based on mutation profiles in MDS remains an area under development. The results of clinical trials currently in recruitment may change the way we treat these patients. Figure 1 Figure 1. Disclosures Jabbour: ARIAD: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Novartis: Research Funding; BMS: Consultancy. Cortes:ARIAD: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Teva: Research Funding. DiNardo:Abbvie: Research Funding; Agios: Research Funding; Celgene: Research Funding; Daiichi Sankyo: Research Funding; Novartis: Research Funding. Konopleva:Calithera: Research Funding; Cellectis: Research Funding.

scholarly journals LSD1 as a Biomarker and the Outcome of Its Inhibitors in the Clinical Trial: The Therapy Opportunity in Tumor

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Clement Agboyibor ◽  
Jianshu Dong ◽  
Clement Yaw Effah ◽  
Emmanuel Kwateng Drokow ◽  
Waqar Pervaiz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Results ◽  
Tumor Patients ◽  
Therapy Targets ◽  
Dosing Regimens ◽  
Novel Biomarkers ◽  
Selection Of

Tumors are the foremost cause of death worldwide. As a result of that, there has been a significant enhancement in the investigation, treatment methods, and good maintenance practices on cancer. However, the sensitivity and specificity of a lot of tumor biomarkers are not adequate. Hence, it is of inordinate significance to ascertain novel biomarkers to forecast the prognosis and therapy targets for tumors. This review characterized LSD1 as a biomarker in different tumors. LSD1 inhibitors in clinical trials were also discussed. The recent pattern advocates that LSD1 is engaged at sauce chromatin zones linking with complexes of multi-protein having an exact DNA-binding transcription factor, establishing LSD1 as a favorable epigenetic target, and also gives a large selection of therapeutic targets to treat different tumors. This review sturdily backing the oncogenic probable of LSD1 in different tumors indicated that LSD1 levels can be used to monitor and identify different tumors and can be a useful biomarker of progression and fair diagnosis in tumor patients. The clinical trials showed that inhibitors of LSD1 have growing evidence of clinical efficacy which is very encouraging and promising. However, for some of the inhibitors such as GSK2879552, though selective, potent, and effective, its disease control was poor as the rate of adverse events (AEs) was high in tumor patients causing clinical trial termination, and continuation could not be supported by the risk-benefit profile. Therefore, we propose that, to attain excellent clinical results of inhibitors of LSD1, much attention is required in designing appropriate dosing regimens, developing in-depth in vitro/in vivo mechanistic works of LSD1 inhibitors, and developing inhibitors of LSD1 that are reversible, safe, potent, and selective which may offer safer profiles.

Utilization and reach of the Fight Colorectal Cancer Late Stage MSS CRC Clinical Trial Finder.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3561-3561
Author(s):  
Reese Garcia ◽  
Andrea Dwyer ◽  
Sharyn Worrall ◽  
Christopher Ryan Heery ◽  
Dustin A. Deming ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Late Stage ◽  
Stage Iv ◽  
The United States ◽  
Web Based ◽  
The United Kingdom ◽  
Patient Feedback ◽  
Selection Of

3561 Background: Colorectal cancer (CRC) remains one of the most lethal cancer killers worldwide. Recently, research has shown great strides in the treatment of MSI-H mCRC using immunotherapy, however, these treatments have not been effective in MSS patients, who make up a majority of CRC cases. Due to numerous barriers, clinical trial enrollment numbers remain as low as 9% of the eligible populations, despite the reliance of many late stage CRC patients on clinical trials for treatment. Perhaps greatest of these barriers is the lack of meaningful patient-facing clinical trial matching, making advances in MSS mCRC IO clinical research extremely slow. Methods: In May 2017, Fight Colorectal Cancer (FightCRC) launched its web-based trial finder, The Late Stage MSS Trial Finder (TF) with the late Dr. Tom Marsilije, a stage IV CRC patient and researcher, and Flatiron Health. The TF is a publicly available immunotherapy-based repository of clinical trials. An algorithm automatically codes for a subset of trials from ClinicalTrials.gov to be uploaded into the tool, and trained FightCRC advocates follow a strategic logic flow to prioritize trials of highest potential benefit and lowest risk for patients. Results: Between 30 and 100 trials are uploaded into the TF for curation each week. A total of 378 trials have been indexed in the TF to date. In February 2019, a mobile application was introduced. From May 2017 to January 2019, the tool has seen > 15,000 users, yielding 26,000 searches in 105 countries; primarily from the United States, China, the United Kingdom, Canada, and France. On average, users navigate to 2.5 pages and spend > 2.5 minutes per use. Providers are using this as a tool to find clinical trials and to discuss these options in real time. CRC patient feedback confirmed the platform functionality. Conclusions: The Trial Finder is a unique tool for MSS mCRC patients pursuing clinical trials. The success of the tool may be attributed to patient focused selection of therapies that show promise. The FightCRC late stage MSS CRC trial finder is being widely utilized, in diverse settings. With our patient curators and Medical Advisory Board, FightCRC will improve the search features and outcome tracking with user feedback. The goal for the TF is to address key barriers to patient entry into clinical trials and promote patient-provider discussions to inform decision making.

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