Data Collection Forms in Clinical Trials

1992 ◽  
Vol 59 (4) ◽  
pp. 428-428
Author(s):  
A. C. Metha ◽  
J. Marsh
Keyword(s):  
Clinical Trials ◽  
Data Collection

Validation of a Musculoskeletal Digital Assessment Routing Tool (DART): Protocol for a Pilot Randomised Crossover Non-Inferiority Trial (Preprint)

2021 ◽  
Author(s):  
Cabella Lowe ◽  
Harry Hanuman Sing ◽  
William Marsh ◽  
Dylan Morrissey
Keyword(s):  
Clinical Trials ◽  
Data Collection ◽  
Real World ◽  
User Satisfaction ◽  
Allocation Concealment ◽  
Trial Methodology ◽  
Primary Analysis ◽  
Digital Assessment ◽  
System Usability Scale ◽  
The Impact

BACKGROUND Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing burden on healthcare utilization. Digital technologies to improve health care outcomes and efficiency are considered a priority; however, innovations are rarely tested with sufficient rigor in clinical trials, the gold standard for clinical proof of safety and efficacy. We have developed a new musculoskeletal Digital Assessment Routing Tool (DART) that allows users to self-assess and be directed to the right care. DART requires validation in a real-world setting prior to implementation. OBJECTIVE This pilot study will assess the feasibility of a future trial by exploring key aspects of trial methodology, assess the procedures and collect exploratory data to inform the design of a definitive, randomized, crossover, non-inferiority trial to assess DART safety and effectiveness. METHODS We will collect data from 76 adult participants presenting to an NHS England GP practice with a musculoskeletal condition. Participants will complete both a DART assessment and a physiotherapist-led triage with the order determined by randomization. The primary analysis will involve an absolute agreement ICC (A,1) estimate with 95% confidence intervals between DART and the clinician for assessment outcomes sign-posting to condition management pathways. Data will be collected to allow analysis of participant recruitment and retention, randomization, allocation concealment, blinding, data collection process and bias. In addition, the impact of trial burden and potential barriers to intervention delivery will be considered. DART user satisfaction will be measured using the System Usability Scale. RESULTS A UK NHS ethics submission will be submitted during June 2021 and pending approval, recruitment will commence during August 2021 with data collection anticipated to last for 3 months. Results will be reported in a follow-up paper later in 2021. CONCLUSIONS This study will inform the design of a randomized controlled crossover non-inferiority study that will provide evidence concerning mHealth DART system clinical sign posting in an NHS setting prior to real-world implementation. Success should produce evidence of a safe, effective system with excellent usability, facilitating quicker and easier patient access to appropriate care while reducing the burden on primary and secondary care musculoskeletal services. This rigorous approach to mHealth system testing could be used as a guide for other developers of similar applications. CLINICALTRIAL This trial is registered with Clinical Trials number NCT04904029

scholarly journals Tackling rare diseases: Clinical trials on chips

2020 ◽  
Vol 245 (13) ◽  
pp. 1155-1162 ◽  
Author(s):  
Sandra H Blumenrath ◽  
Bo Y Lee ◽  
Lucie Low ◽  
Ranjini Prithviraj ◽  
Danilo Tagle
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Collection ◽  
Rare Disease ◽  
Study Design ◽  
Rare Diseases ◽  
Working Group ◽  
Design Data ◽  
Chip Technology ◽  
Microphysiological Systems

Technological advances with organs-on-chips and induced pluripotent stem cells promise to overcome hurdles associated with developing medical products, especially for rare diseases. Organs-on-chips—bioengineered “microphysiological systems” that mimic human tissue and organ functionality—may overcome clinical trial challenges with real-world patients by offering ways to conduct “clinical trials-on-chips” (CToCs) to inform the design and implementation of rare disease clinical studies in ways not possible with other culture systems. If applied properly, CToCs can substantially impact clinical trial design with regard to anticipated key outcomes, assessment of clinical benefit and risk, safety and tolerability profiles, population stratification, value and efficiency, and scalability. To discuss how tissue chips are best used to move the development of rare disease therapies forward, a working group of experts from industry, academia, and FDA as well as patient representatives addressed questions related to disease setting, test agents for microphysiological systems, study design and feasibility, data collection and use, the benefits and risks associated with this approach, and how to engage stakeholders. While rare diseases with no current therapies were considered the ultimate target, participants cautioned against stepping onto too many unknown territories when using rare disease as initial test beds. Among the disease categories considered ideal for initial CToC tests were well-defined diseases with known clinical outcomes; diseases where tissues on chips can serve as an alternative to risky first-in-human studies, such as in pediatric oncology; and diseases that lend itself to immuno-engineering or genome editing. Participants also considered important challenges, such as hosting the chip technology in-house, the high variability of cell batches and the resulting regulatory concerns, as well as the financial risk associated with the new technology. To make progress in this area and increase confidence with the use of tissue chips, the re-purposing of approved drugs ought to be the very first step. Impact statement Designing and conducting clinical trials are extremely difficult in rare diseases. Adapting tissue chips for rare disease therapy development is pivotal in assuring that treatments are available, especially for severe diseases that are difficult to treat. Thus far, the NCATS-led National Institutes of Health (NIH) Tissue Chip program has focused on deploying the technology towards in vitro tools for safety and efficacy assessments of therapeutics. However, exploring the feasibility and best possible approach to expanding this focus towards the development phase of therapeutics is critical to moving the field of CToCs forward and increasing confidence with the use of tissue chips. The working group of stakeholders and experts convened by NCATS and the Drug Information Association (DIA) addresses important questions related to disease setting, test agents, study design, data collection, benefit/risk, and stakeholder engagement—exploring both current and future best use cases and important prerequisites for progress in this area.

Factors Affecting Workload of Cancer Clinical Trials: Results of a Multicenter Study of the National Cancer Institute of Canada Clinical Trials Group

2002 ◽  
Vol 20 (2) ◽  
pp. 545-556 ◽  
Author(s):  
Kathyrn Roche ◽  
Nancy Paul ◽  
Bobbi Smuck ◽  
Marlo Whitehead ◽  
Benny Zee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Collection ◽  
Cancer Treatment ◽  
Multicenter Study ◽  
National Cancer Institute ◽  
Phase Iii ◽  
Study Phase ◽  
Factors Affecting ◽  
Clinical Research Associates

PURPOSE: Increasingly, cancer treatment centers need to be able to estimate specific costs and resources associated with clinical trials. Because the time requirements of trial coordination and data collection are not well known, the Clinical Research Associates (CRA) Committee of the National Cancer Institute of Canada Clinical Trials Group carried out a multicenter study to measure trials’ task times and evaluate the effects of certain factors. METHODS: A data collection instrument was designed and validated before its implementation in the study. Eighty-three CRAs from 24 cancer treatment institutions across Canada collected timing observations of 41 tasks (156 subtasks). Information from all stages of trials activity (protocol management, eligibility and entry, treatment, and follow-up and final stage) was obtained, from initial negotiations to follow-up after study closure. RESULTS: After controlling for stage, phase and sponsor were found to be significant independent factors. Analysis within the stages showed similar patterns. New drug inclusion as a factor was confounded with phase. Industry-sponsored studies had significantly higher overall mean times than did local and cooperative group studies. Early-phase studies required more time than did phase III trials. External sponsorship of any kind increased CRA time more than that necessary for locally coordinated studies, except during the protocol management stage. The burden of a phase I study increased to greater than average once underway and accruing patients. CONCLUSION: Our data demonstrated that sponsor and study phase are important factors to be taken into consideration when estimating clinical trial costs and resource use.

Improving data collection procedures in multi-center clinical trials: Evaluation of an electronic system in the URCC CCOP research base

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 6084-6084
Author(s):  
S. L. Ranson ◽  
G. R. Morrow ◽  
S. Dakhil ◽  
M. Good ◽  
P. J. Kuebler ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Collection ◽  
Electronic System

A multidisciplinary-guided digital solution to data capture in early-phase clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18063-e18063
Author(s):  
Donna M. Graham ◽  
Joanna Clarke ◽  
Gemma Wickert ◽  
Leanna Goodwin ◽  
Carla Timmins ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Focus Group ◽  
Data Collection ◽  
Early Phase ◽  
Patient Data ◽  
Simulated Patient ◽  
Data Capture ◽  
Health Staff ◽  
Case Report Form ◽  
Acceptance Test

e18063 Background: Data capture in early phase cancer clinical trials (EPCCT) is usually via paper records with manual transcription to the sponsor’s case report form. Capturing real time trial data directly to computer (eSource) may reduce errors and increase completeness and timeliness of data entry. A simulated system pilot took place between Oct 2018 and Jan 2019 at an EPCCT facility to appraise Foundry Health’s eSource system “ClinSpark”. Aims were to assess consistency and effectiveness of creating electronic templates for source data capture and live data collection compliance. Methods: A multidisciplinary focus group (2 research nurses, 1 doctor, 3 data managers) was created to collaborate with Foundry Health staff. The focus group agreed on a 52 item user acceptance test listing ideal features for a data collection tool, classifying items as high, medium or low priority. Specialised features of the eSource system were adapted to handle the complex needs of EPCCT. The pilot incorporated a 5 day boot camp for familiarisation to the digital platform; a conference room test using simulated patient data; construction of a trial template including contingency planning; and a clinic floor test with live simulated patient data collection using digital tablets. Results: During the 3 month pilot, templates for 2 EPCCT were planned and created. Using eSource, 43 items (83%) of the acceptance test were passed compared with 27 items (52%) for the current (paper-based) system. The paper system did not pass any of the 9 items for which eSource failed. For the 30 high priority items, eSource passed 30 (100%) compared with 22 for the paper system (73%). Time saving and potential error reduction were noted as additional benefits. Conclusions: This process demonstrates that a multidisciplinary approach can be used to successfully integrate a customised eSource system working with previously untrained staff. Improved performance across pre-specified domains and potential additional benefits were noted. As FDA encourages the use of digital solutions in clinical trials, using eSource provides a potential solution for compliant and efficient capture of data from protocol assessments at investigator sites and rapid data transfer to sponsors.

scholarly journals Usability testing of a Digital Assessment Routing Tool: An Iterative Convergent Mixed Methods Study Protocol (Preprint)

2021 ◽  
Author(s):  
Cabella Lowe ◽  
Harry Hanuman-Sing ◽  
Mitchell Browne ◽  
Meshari F. Alwashmi ◽  
William Marsh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Mixed Methods ◽  
Data Collection ◽  
Quantitative Data ◽  
Usability Testing ◽  
Manuscript Submission ◽  
Digital Assessment ◽  
Usability Problems ◽  
System Usability Scale ◽  
System Usability

BACKGROUND Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing burden on healthcare utilization. Digital technologies to improve health care outcomes and efficiency are considered a priority; however, innovations are often inadequately developed and poorly adopted. Further, they are rarely tested with sufficient rigor in clinical trials, the gold standard for clinical proof of efficacy. We have developed a new musculoskeletal Digital Assessment Routing Tool (DART) that allows users to self-assess and be directed to the right care. DART requires usability testing in preparation for clinical trials. OBJECTIVE This study will use the iterative-convergent mixed methods design to assess and mitigate all serious usability issues to optimize user experience and adoption. This will provide justifiable confidence to progress to full-scale randomized controlled trials when DART is integrated into clinical management pathways. METHODS We will collect qualitative and quantitative data from between 20-30 participants aged 18 and over four months. The exact number of participants recruited will be dependent on the number of iterative cycles required to reach the study end points. Building on previous internal testing and stakeholder involvement, quantitative data collection is defined by the constructs within the ISO 9241-210-2019 Standard and the System Usability Scale (SUS), providing a benchmark usability score for DART. Guided by the participant responses to quantitative questioning, the researcher will focus the qualitative data collection on specific usability problems. These will then be graded to provide the rationale for further DART system improvements throughout the iterative cycles. RESULTS This study received approval from Queen Mary University of London Ethics of Research Committee (QMREC2018/48/048) in June 2020. At manuscript submission, the first round of individual interviews has been completed, with data collection to be completed and results published in 2021. CONCLUSIONS This study will provide evidence concerning mHealth DART system usability and acceptance determining system improvements required to support user adoption and minimize sub-optimal system usability as a potential confounder within subsequent non-inferiority clinical trials. This deliberately rigorous approach to mHealth innovation could be used as a guide for other developers of similar applications. Success should produce a safe, effective system with excellent usability, facilitating quicker and easier patient access to appropriate care while reducing the burden on primary and secondary care musculoskeletal services.

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