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.

Transforming the site feasibility assessment process for oncology clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14092-e14092
Author(s):  
Dax Kurbegov ◽  
Patricia A. Hurley ◽  
David Michael Waterhouse ◽  
Grzegorz S. Nowakowski ◽  
Edward S. Kim
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Task Force ◽  
Assessment Process ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Contract Research Organization ◽  
Feasibility Assessment ◽  
Oncology Research ◽  
Start Up

e14092 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and no-value steps that impact research site resources and clinical trial participation. This project sought stakeholder feedback on recommendations to transform industry sponsor and contract research organization (CRO) processes for evaluating sites for trials. Methods: An ASCO task force developed recommendations to improve the feasibility assessment process and standardize and centralize questions and forms. A survey was conducted with sites, industry trial sponsors, and CROs to obtain feedback and assess buy-in for the recommendations. Results: Respondents were from 28 oncology research sites (19 academic, 9 community-based), 8 sponsors, and 4 CROs. All stakeholders agreed that the current process is burdensome (93% sites, 90% sponsors, 100% CROs), standardization will improve the process (86% sites, 87% sponsors, 75% CROs). All agreed a centralized portal will reduce burdens (93% sites, 100% sponsors, 75% CROs) and expedite trial start-up (89% sites, 100% sponsors, 75% CROs). Site certification was a viable option for sites (86%) and CROs (75%), but less so for sponsors (57%). Most respondents preferred a two-tier model: 1) a short site questionnaire followed by a pre-study visit for new interactions, and 2) only a pre-study site visit or a teleconference if there is an existing relationship. The greatest benefits were time savings, expedited start-up, reduction in personnel resources, and cost savings. The greatest barriers to adoption were buy-in and alignment from sponsors/CROs and insufficient information about site or protocol. Top predictors of a site’s success on a trial were physician engagement, available patients, and site experience. Conclusions: Site feasibility assessments are important for all stakeholders to establish trial suitability. However, current methods impose tremendous burdens on site resources (reported by authors elsewhere). While this sample is limited, the proposed process and standardization changes show promise to reduce burdens and costs for all stakeholders and expedite patient enrollment onto clinical trials.

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.  

scholarly journals Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

2021 ◽  
Author(s):  
Eleanor Jane Mitchell ◽  
Jalemba Aluvaala ◽  
Lucy Bradshaw ◽  
Jane P Daniels ◽  
Ashok Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Global Health ◽  
Good Clinical Practice ◽  
Research Experience ◽  
Middle Income ◽  
Middle Income Countries ◽  
Training Package

Abstract Background Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global health methodological research priority setting exercise. Methods We explored whether an enhanced training package in a neonatal feasibility study in Kenya and India, utilising elements of the train-the-trainer approach, altered clinicians and researchers’ clinical trials knowledge. A lead “trainer” was identified at each site who attended a UK-based introductory course on clinical trials. A two-day in-country training session was conducted at each hospital. Sessions included the study protocol, governance, data collection and ICH-Good Clinical Practice (GCP). To assess effectiveness of the training package, participants completed questionnaires at the start and end of the study period, including demographics, prior research experience, protocol-specific questions, informed consent and ICH-GCP. Results Thirty participants attended in-country training sessions and completed baseline questionnaires. Around three quarters had previously worked on a research study, yet only half had previously received training. Nineteen participants completed questionnaires at the end of the study period. Questionnaire scores were higher at the end of the study period, though not significantly so. Few participants ‘passed’ the informed consent and ICH-Good Clinical Practice (GCP) modules, using the Global Health Network Training Centre pass mark of ≥ 80%. Participants who reported having prior research experience scored higher in questionnaires before the start of the study period. Conclusions An enhanced training package can improve knowledge of research methods and governance though only small improvements in mean scores between questionnaires completed before and at the end of the study period were seen and were not statistically significant. This is the first report evaluating a clinical trial training package in a neonatal trial in LMICs. Due to the Covid-19 pandemic, research activity was paused and there was a significant time lapse between training and start of the study, which likely impacted upon the scores reported here. Given the burden of disease in LMICs, developing high-quality training materials which utilise a variety of approaches and build research capacity, is critical.

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 Whom should you start a company with?

2017 ◽  
Vol 30 (1) ◽  
pp. 49-76
Author(s):  
JaeYoon Lee ◽  
SooJin Oh ◽  
MyungUn Kim
Keyword(s):  
Time Perspective ◽  
Deep Level ◽  
Related Factors ◽  
Team Members ◽  
Work Related ◽  
Start Up ◽  
Big Picture ◽  
Founding Team ◽  
The Right ◽  
Start Ups

Start-ups organizations are increasing rapidly. To overcome “liability of newness,” it is essential for entrepreneurs to compose the right co-founding team. Based on the review of 57 journal articles on start-up co-founding teams and new venture teams, we found that the composition of the team, especially diversity among team members, was frequently studied. However, previous research has only focused on surface-level diversity such as gender, age, functional background, previous experience. Only a very few studies investigated deep-level diversity such as co-founding team members’ value, personality or thinking style. The present study explored what type of diversity is required in start-ups. Since this topic is rarely studied, we first conducted a qualitative study by interviewing with nineteen start-up founders and venture capitalists in Study 1. As a result we found that four individual characteristic factors (extraversion, agreeing to different idea, risk taking, optimism) and four work-related factors (business opinion, speed oriented, big-picture oriented, time perspective) were the key component of deep-level diversity. In Study 2, we conducted a quantitative study to empirically investigate these aspects by a survey to thirty start-up related individuals. The result confirmed that the diversity were required for six aspects deducted from Study 1. For the other factors of optimism and speed orientation, frequency tendency supported Study 1’s result.

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.

Reducing burdens of site feasibility assessments for conducting clinical trials.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 300-300
Author(s):  
Dax Kurbegov ◽  
Patricia A. Hurley ◽  
David Michael Waterhouse ◽  
Grzegorz S. Nowakowski ◽  
Edward S. Kim
Keyword(s):  
Clinical Trials ◽  
Task Force ◽  
Treatment Options ◽  
Cost Savings ◽  
Assessment Process ◽  
High Quality ◽  
Feasibility Assessment ◽  
Start Up ◽  
Ensure Patient Safety ◽  
Prior Relationship

300 Background: Current methods to assess site feasibility for industry-funded clinical trials are onerous and delay patient access to novel treatment options and high-quality clinical trials. Industry sponsors and contract research organizations (CROs) often probe for unnecessary and/or duplicative information. These burdens prolong trial start-up times and are a barrier to site participation in oncology trials. The American Society of Clinical Oncology (ASCO) Research Community Forum convened a task force to identify ways to improve the site feasibility assessment process. Methods: Data were collected in 3 steps: 1) survey to assess site burdens, 2) collation of sample feasibility questionnaires (FQs), and 3) stakeholder meeting to discuss potential solutions. The task force then developed recommendations for process improvements and obtained stakeholder feedback through a survey. Results: 113 oncology practices (66 community, 47 academic) reported completing a median 5 FQs and 2 pre-study site visits (PSSVs) per month. FQs took a median 2 hours to complete whereas PSSVs took a median 4 hours to complete. Most considered FQ (81%) and PSSV (91%) content redundant to information previously provided, and FQs similar between different sponsors (86%). The median time from first contact to first patient enrolled was 6 months. The 40 respondents to the stakeholder survey represented 19 academic- and 9 community-based sites, 8 industry sponsors, and 4 CROs. Most preferred a model with a short FQ plus a PSSV when there was not a prior relationship. If there was a prior relationship, either a PSSV or teleconference was preferred. All stakeholders identified time savings, expedited start-up, fewer staff resources, and cost savings as the greatest benefits. The greatest barriers to adoption were buy-in from sponsors and CROs, and insufficient information about site capabilities. Conclusions: Site feasibility assessments for industry-sponsored trials are important to ensure patient safety and access to high quality clinical trials. However, current methods are inefficient and time and resource intensive. This initiative provided insights about challenges for sites and the viability of a fundamental change to site feasibility assessments. ASCO recommendations are forthcoming on improving processes, standardizing and minimizing questions, and using portals that are effective across all trials and clinical research scenarios.

scholarly journals Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

2017 ◽  
Vol 35 (33) ◽  
pp. 3745-3752 ◽  
Author(s):  
Susan Jin ◽  
Richard Pazdur ◽  
Rajeshwari Sridhara
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Population ◽  
Trial Participation ◽  
Cancer Clinical Trials ◽  
Eligibility Criteria ◽  
New Drug ◽  
Drug Clinical Trial ◽  
Oncology Clinical Trials ◽  
Eligibility Requirements

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.

scholarly journals Partnerships and Collaborations: The Right Alliances for Clinical Trials in Africa

2020 ◽  
pp. 954-958
Author(s):  
Olusola Solarin ◽  
Sulma I. Mohammed ◽  
Ntokozo Ndlovu ◽  
Verna Vanderpuye ◽  
Victoria Olaiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Therapies ◽  
Racial Profile ◽  
Research Organizations ◽  
Heavy Burden ◽  
Empiric Data ◽  
The Right ◽  
Global Population

Africa attracts < 1% of all trials conducted around the world. The implication is that proof of safety and efficacy in Africans is lacking for a lot of new therapies. The sizeable proportion of approximately 20% of the global population that Africa represents largely does not have empiric data to support use of new therapies in a population with a distinct genetic and racial profile. Beyond the imperative of evidence-based interventions, Africans carry a disproportionately heavy burden of certain diseases, including prostate cancer, sickle cell anemia, and malaria. It therefore provides opportunity for efficient recruitment of participants for trials for such diseases. However, this advantage has not convinced sponsors to carry out clinical trials in Africa. India and China each have roughly the same population size as Africa, but each presents just one regulatory jurisdiction for clinical trials. Africa has 54 countries, and a sponsor would theoretically need to file 54 different applications to cover the entire continent. Collaboration and partnership among all stakeholders in the clinical trial ecosystem will reduce the burden on sponsors and make Africa competitive as a destination for clinical trials. Collaboration among national regulatory agencies will enable Africa to be treated as one regulatory jurisdiction and reduce administrative burden. Sites and researchers can partner to improve quality, attain necessary certifications, and increase overall efficiency. Central to all of these are clinical research organizations that can coordinate and work across borders to make clinical trial projects seamless. Ultimately, patients will benefit as quality of clinical practice improves and access to new therapies is enhanced.

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.

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