A novel patient-centric approach between sites, CRO, and sponsor to accelerate FPI and drive more patients into oncology protocols.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6573-6573
Author(s):  
Krystyna Kowalczyk ◽  
Rhonda U. Henry ◽  
Bellinda Conte
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Field Research ◽  
Just In Time ◽  
On Demand ◽  
Oncology Clinical Trial ◽  
Local Access ◽  
Oncology Clinical Trials ◽  
A Site ◽  
New Compounds

6573 Background: According to the Journal of Clinical Oncology, 50% of sites performing clinical trials never enroll a patient. And on top of that, it can take several months to activate a site for an oncology clinical trial; precious time that patients cannot afford when they’ve had a cancer diagnosis and precious time sponsors need when developing new compounds for market. While many patients are interested in participating in trials, they are limited in their opportunities because they do not live near a research site or work with a physician performing clinical trials. So with this crisis in the oncology field, research needs to be more efficient and inclusive. Methods: A combined partnership of sites, physicians, CRO and sponsor leveraging Just-in-Time enrollment methodology helped expedite clinical trial enrollment and diversify trial access driving faster first patient enrolled and expanding the potential patient denominator. Results: This on-demand methodology augmented existing sites that had access to oncology patients by providing broader access, faster, and with no quality loss. Strong partnerships between CRO and sponsor then facilitated two-week site activation allowing every identified patient to be converted to a study subject. This methodology was repeated across seven protocols driving patents on trials within six weeks of trial available. Conclusions: The benefits of this Just-in-Time methodology touch all areas of clinical trials: Patients have greater clinical trial access: A larger denominator of patients across broader geographies have local access to portfolios of clinical trials; Trials start to enroll faster: Patients can be randomized into oncology clinical trials within two weeks of study start up driving trial time to completion; Sites have more trial options to consider: Sites have a broader portfolio of trials to access on demand without added administrative burden; Trials complete faster: Sponsors accrue patients faster driving expedited timelines and accelerating drug development.

scholarly journals Who Needs What? Perceptions of Patients and Caregivers in Oncology Phase 1 Trials

2019 ◽  
Vol 7 (1) ◽  
pp. 27-33 ◽  
Author(s):  
Victoria Rezash ◽  
Janice Reed ◽  
Barbara Gedeon ◽  
Eric Parsons ◽  
Sandra Siedlecki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase 1 ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Oncology Clinical Trial ◽  
Oncology Clinical Trials ◽  
Vulnerable Patient ◽  
Additional Support

Background: The study design and nature of oncology phase 1 clinical trials create a uniquely vulnerable patient population yet little research has been conducted to identify the added burden these trials create for both cancer patients and their caregiver(s). Objective: Examining the perceptions and needs of patients and their caregivers participating in phase 1 oncology clinical trials, the investigators tested the hypothesis that the caregiver will exhibit a higher level of burden and/or distress than the patient. Method: A mixed-methods exploratory process utilizing patient and caregiver interviews and quality-of-life questionnaires was used to assess the psychosocial burdens associated with oncology clinical trial participation. A qualitative and quantitative analysis of the responses were 8 performed. Result: Both patients and caregivers reported similar themes identifying the burdens and benefits related to phase 1 clinical trial participation. However, the caregivers’ expressed burden exceeded that of the patients’ validating the study’s hypothesis. Conclusion: The need for ongoing additional support services for not only the patient but also the caregiver was identified.

scholarly journals OCTANE: Oncology Clinical Trial Annotation Engine

2019 ◽  
pp. 1-11 ◽  
Author(s):  
Jia Zeng ◽  
Md Abu Shufean ◽  
Yekaterina Khotskaya ◽  
Dong Yang ◽  
Michael Kahle ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
False Positive Rate ◽  
False Negative ◽  
False Negative Rate ◽  
Cancer Center ◽  
Precision Oncology ◽  
Expert Review ◽  
Oncology Clinical Trial ◽  
Oncology Clinical Trials

PURPOSE Many targeted therapies are currently available only via clinical trials. Therefore, routine precision oncology using biomarker-based assignment to drug depends on matching patients to clinical trials. A comprehensive and up-to-date trial database is necessary for optimal patient-trial matching. METHODS We describe processes for establishing and maintaining a clinical trial database, focusing on genomically informed trials. Furthermore, we present OCTANE (Oncology Clinical Trial Annotation Engine), an informatics framework supporting these processes in a scalable fashion. To illustrate how the framework can be applied at an institution, we describe how we implemented an instance of OCTANE at a large cancer center. OCTANE consists of three modules. The data aggregation module automates retrieval, aggregation, and update of trial information. The annotation module establishes the database schema, implements data integration necessary for automation, and provides an annotation interface. The update module monitors trial change logs, identifies critical change events, and alerts the annotators when manual intervention may be needed. RESULTS Using OCTANE, we annotated 5,439 oncology clinical trials (4,438 genomically informed trials) that collectively were associated with 1,453 drugs, 779 genes, and 252 cancer types. To date, we have used the database to screen 4,220 patients for trial eligibility. We compared the update module with expert review, and the module achieved 98.5% accuracy, 0% false-negative rate, and 2.3% false-positive rate. CONCLUSION OCTANE is a general informatics framework that can be helpful for establishing and maintaining a comprehensive database necessary for automating patient-trial matching, which facilitates the successful delivery of personalized cancer care on a routine basis. Several OCTANE components are publically available and may be useful to other precision oncology programs.

Dedicated clinical trial tissue tracking database to improve turn-around time at high-volume center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1543-1543
Author(s):  
Peter Blankenship ◽  
David DeLaRosa ◽  
Marc Burris ◽  
Steven Cusson ◽  
Kayla Hendricks ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Tissue Sample ◽  
High Volume ◽  
Trial Participation ◽  
Fresh Tissue ◽  
Oncology Clinical Trials ◽  
The Status ◽  
Unique Source

1543 Background: Tissue requirements in oncology clinical trials are increasingly complex due to prescreening protocols for patient selection and serial biopsies to understand molecular-level treatment effects. Novel solutions for tissue processing are necessary for timely tissue procurement. Based on these needs, we developed a Tissue Tracker (TT), a comprehensive database for study-related tissue tasks at our high-volume clinical trial center. Methods: In this Microsoft Access database, patients are assigned an ID within the TT that is associated with their name, medical record number, and study that follows their request to external users: pathology departments, clinical trial coordinators and data team members. To complete tasks in the TT, relevant information is required to update the status. Due to the high number of archival tissue requests from unique pathology labs, the TT has a “Follow-Up Dashboard” that organizes information needed to conduct follow-up on all archival samples with the status “Requested”. This results in an autogenerated email and pdf report sent to necessary teams. The TT also includes a kit inventory system and a real-time read only version formatted for interdepartmental communication, metric reporting, and other data-driven efforts. The primary outcome in this study was to evaluate our average turnaround time (ATAT: average time from request to shipment) for archival and fresh tissue samples before and after TT development. Results: Before implementing the TT, between March 2016 and March 2018, we processed 2676 archival requests from 235 unique source labs resulting in 2040 shipments with an ATAT of 19.29 days. We also processed 1099 fresh biopsies resulting in 944 shipments with an ATAT of 7.72 days. After TT implementation, between April 2018 and April 2020, we processed 2664 archival requests from 204 unique source labs resulting in 2506 shipments (+28.0%) with an ATAT of 14.78 days (-23.4%). During that same period, we processed 1795 fresh biopsies (+63.3%) resulting in 2006 shipments (+112.5%) with an ATAT of 6.85 days (-11.3%). Conclusions: Oncology clinical trials continue to evolve toward more extensive tissue requirements for prescreening and scientific exploration of on-treatment molecular profiling. Timely results are required to optimize patient trial participation. During the intervention period, our tissue sample volume and shipments increased, but the development and implementation of an automated tracking system allowed improvement in ATAT of both archival and fresh tissue. This automation not only improves end-user expectations and experiences for patients and trial sponsors but this allows our team to adapt to the increasing interest in tissue exploration.

scholarly journals Prospective analysis of 895 patients on a UK Genomics Review Board

ESMO Open ◽  
2019 ◽  
Vol 4 (2) ◽  
pp. e000469 ◽  
Author(s):  
David Allan Moore ◽  
Marina Kushnir ◽  
Gabriel Mak ◽  
Helen Winter ◽  
Teresa Curiel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Genetics ◽  
Routine Practice ◽  
Prospective Data ◽  
Expert Review ◽  
Molecular Oncology ◽  
Oncology Clinical Trials ◽  
Uncertain Significance ◽  
Generation Sequencing

BackgroundThe increasing frequency and complexity of cancer genomic profiling represents a challenge for the oncology community. Results from next-generation sequencing–based clinical tests require expert review to determine their clinical relevance and to ensure patients are stratified appropriately to established therapies or clinical trials.MethodsThe Sarah Cannon Research Institute UK/UCL Genomics Review Board (GRB) was established in 2014 and represents a multidisciplinary team with expertise in molecular oncology, clinical trials, clinical cancer genetics and molecular pathology. Prospective data from this board were collated.ResultsTo date, 895 patients have been reviewed by the GRB, of whom 180 (20%) were referred for clinical trial screening and 62 (7%) received trial therapy. For a further 106, a clinical trial recommendation was given.ConclusionsNumerous challenges are faced in implementing a GRB, including the identification of potential germline variants, the interpretation of variants of uncertain significance and consideration of the technical limitations of pathology material when interpreting results. These challenges are likely to be encountered with increasing frequency in routine practice. This GRB experience provides a model for the multidisciplinary review of molecular profiling data and for the linking of molecular analysis to clinical trial networks.

Trifluoperazine (“Stelazine”) a Controlled Clinical Trial in Chronic Schizophrenia

1961 ◽  
Vol 107 (447) ◽  
pp. 250-257 ◽  
Author(s):  
W. J. Stanley ◽  
D. Walton
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Controlled Trial ◽  
Pernicious Anaemia ◽  
Chronic Schizophrenia ◽  
Mental Illnesses ◽  
Controlled Clinical Trial ◽  
Vitamin B ◽  
Uncontrolled Trial ◽  
New Compounds

So many new compounds are now being introduced for the treatment of psychiatric disorders that it is difficult for the clinician to assess the accuracy of the claims made for them. If a form of therapy is one hundred per cent. effective in a disease which was previously one hundred per cent. fatal, for example vitamin B12 in pernicious anaemia, the question of a controlled trial does not arise. But even the manufacturers do not claim such a degree of effectiveness for drugs advocated for the treatment of mental illnesses, and in addition the natural course of such illnesses is very variable, so that it is essential that clinical trials of these drugs should be controlled. Foulds (1958) has reviewed British and American clinical trials of drugs in psychiatry during the years 1951 to 1956, and has shown that the less controlled a trial, the more likely it is to result in a favourable report on the drug being tested, presumably because of bias on the part of the clinician. Forrester (1958), however, on the basis of a completely uncontrolled trial of Stelazine on only twenty-five patients, concluded that “the amount of improvement in a few cases was not sufficient to encourage the further use of the drug”.

scholarly journals Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical Oncology Survey

2020 ◽  
Vol 16 (7) ◽  
pp. 417-421 ◽  
Author(s):  
David M. Waterhouse ◽  
R. Donald Harvey ◽  
Patricia Hurley ◽  
Laura A. Levit ◽  
Edward S. Kim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Care ◽  
Research Committee ◽  
Community Based Programs ◽  
Oncology Clinical Trials ◽  
Community Forum ◽  
American Society ◽  
Remote Patient

The coronavirus disease 2019 (COVID-19) pandemic has disrupted all aspects of clinical care, including cancer clinical trials. In March 2020, ASCO launched a survey of clinical programs represented on its Cancer Research Committee and Research Community Forum Steering Group and taskforces to learn about the types of changes and challenges that clinical trial programs were experiencing early in the pandemic. There were 32 survey respondents; 14 represented academic programs, and 18 represented community-based programs. Respondents indicated that COVID-19 is leading programs to halt or prioritize screening and/or enrollment for certain clinical trials and cease research-only visits. Most reported conducting remote patient care where possible and remote visits and monitoring with sponsors and/or contract research organizations (CROs); respondents viewed this shift positively. Numerous challenges with conducting clinical trials were reported, including enrollment and protocol adherence difficulties with decreased patient visits, staffing constraints, and limited availability of ancillary services. Interactions with sponsors and CROs about modifying trial procedures were also challenging. The changes in clinical trial procedures identified by the survey could serve as strategies for other programs attempting to maintain their clinical trial portfolios during the COVID-19 pandemic. Additionally, many of the adaptations to trials made during the pandemic provide a long-term opportunity to improve and transform the clinical trial system. Specific improvements could be expanded use of more pragmatic or streamlined trial designs, fewer clinical trial–related patient visits, and minimized sponsor and CRO visits to trial programs.

Accelerating clinical trial enrollment with comprehensive genomic profiling (CGP) and just-in-time clinical trial sites: An index case of a paradigm shift.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6539-6539
Author(s):  
Gaurav Singal ◽  
Deepu Madduri ◽  
Lara Yuan ◽  
David Luo ◽  
Aparna Upadhyay ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Therapeutic Option ◽  
Just In Time ◽  
Trial Participation ◽  
Community Settings ◽  
Patient Identification ◽  
Access Methods ◽  
Comprehensive Genomic Profiling

6539 Background: In many instances, trials may offer the best or only therapeutic option for patients with rare findings. However, conducting clinical trials of novel therapeutics targeting rare molecular variants is challenging. Patient populations are small, distributed, and predominantly in community settings where trial access remains limited by awareness and site availability. These challenges increase costs of drug development and approval, delaying widespread patient access. Methods: Foundation Medicine deployed a trial education and access program, “Precision Enrollment,” with Ignyta (a trial sponsor) and Pharmatech (a site management organization, or SMO, enabling “Just-In-Time” clinical trials) (Wiener, JCO 2007). Infrastructure and algorithms developed at Foundation Medicine (“SmartTrials Engine”) matched sequenced patients (avg n = 800/wk) with activating NTRK, ROS1, or ALK fusions to the phase II study of Entrectinib (NCT02568267). Oncologists at Foundation Medicine, through peer-to-peer outreach, facilitated trial access by providing trial and nearest site information to treating providers of matched patients. Results: 107 treatment-eligible patients with NTRK, ROS1, or ALK fusions were matched by the SmartTrials Engine; 36 (33%) expressed interest in trial participation. One such patient with NSCLC and a CD74-ROS1 fusion was unable to participate at an open trial site due to inability to travel. The patient’s site was part of the “Just-In-Time” network, with IRB and contract pre-approval, and was activated in only 3 days. Total time from patient identification to initiation of therapy was 7 days. Conclusions: We demonstrate a novel methodology for patient matching to trials targeting rare genomic findings, including in community settings. If extended, such innovative partnerships combined with computational matching infrastructure, could improve drug development and therapeutic access.

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