scholarly journals The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute

2020 ◽  
Author(s):  
Sara M Tolaney ◽  
Christine A Lydon ◽  
Tianyu Li ◽  
Jiale Dai ◽  
Andrea Standring ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Statistical Significance ◽  
Median Number ◽  
Lessons Learned ◽  
Interventional Treatment ◽  
Serious Adverse Events ◽  
Drug Dosing ◽  
Dana Farber Cancer Institute ◽  
The Impact

Abstract Interventions designed to limit the spread of coronavirus disease 2019 (COVID-19) are having profound effects on the delivery of health care, but data showing the impact on oncology clinical trial enrollment, treatment, and monitoring are limited. We prospectively tracked relevant data from oncology clinical trials at Dana-Farber Cancer Institute from January 1, 2018, to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed or shipped oral investigational agents, research biopsies, and blood samples. We ascertained why patients came off trials and determined on-site clinical research staffing levels. We used 2-sided Wilcoxon rank sum tests to assess the statistical significance of the reported changes. Nearly all patients on interventional treatment trials were maintained, and new enrollments continued at just under one-half the prepandemic rate. The median number of investigational prescriptions shipped to patients increased from 0 to 74 (range = 22-107) per week from March to June 2020. The median number of telemedicine appointments increased from 0 to 107 (range = 33-267) per week from March to June 2020. Research biopsies and blood collections decreased dramatically after Dana-Farber Cancer Institute implemented COVID-19–related policies in March 2020. The number of research nurses and clinical research coordinators on site also decreased after March 2020. Substantial changes were required to safely continue clinical research during the pandemic, yet we observed no increases in serious adverse events or major violations related to drug dosing. Lessons learned from adapting research practices during COVID-19 can inform industry sponsors and governmental agencies to consider altering practices to increase operational efficiency and convenience for patients.

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 Pivoting during a pandemic: lessons learned from transitioning a multisite randomized controlled trial to a remote protocol in response to COVID-19

2021 ◽  
Author(s):  
Hailey Inverso ◽  
Fayo Abadula ◽  
Troy Morrow ◽  
Lauren LeStourgeon ◽  
Angelee Parmar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Controlled Trial ◽  
Clinical Care ◽  
Lessons Learned ◽  
Diabetes Distress ◽  
Randomized Controlled ◽  
Testing Strategies ◽  
Glycemic Outcomes

Abstract THR1VE! is an ongoing multisite randomized clinical trial of a positive psychology intervention designed to treat diabetes distress and improve glycemic outcomes in teens with type 1 diabetes. Due to the COVID-19 pandemic restrictions on clinical research and changes in diabetes clinical care, THR1VE! was adapted from an in-person enrollment protocol to a remote protocol through a series of development and testing strategies. We discuss the process of transitioning the protocol and the demonstrated feasibility of ongoing recruitment, enrollment, and retention outcomes. These findings offer support for a remotely transitioned protocol that has larger applications for ongoing and future clinical research.

scholarly journals Density strips: visualisation of uncertainty in clinical data summaries and research findings

2021 ◽  
pp. bmjebm-2021-111746
Author(s):  
Christopher J Weir ◽  
Adrian W Bowman
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Selective Reporting ◽  
Advantages And Disadvantages ◽  
Secondary Progressive ◽  
Complementary Approach ◽  
Trial Outcomes ◽  
Research Findings

The disproportionate focus on statistical significance in reporting and interpreting clinical research studies contributes to publication bias and encourages selective reporting. This highlights a need for alternative approaches that clearly communicate the uncertainty in the data, enabling researchers to provide a more nuanced interpretation of clinical research findings.Our purpose in this article is to introduce the density strip method as one potential approach that might act as a bridge between data visualisation for descriptive purposes and formal statistical inference. We build on existing theory, translating it to the applied research context to illustrate its utility to clinical researchers.We achieve this by considering an exemplar clinical trial, Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART). MS-SMART was a multiarm randomised placebo-controlled trial of three potentially neuroprotective drugs in secondary progressive MS. We illustrate through MS-SMART the potential of the density strip as an effective visualisation of the distribution of clinical trial outcomes and as a complementary approach to aid the interpretation of formal, inferential, statistical analysis.We conclude by summarising the advantages and disadvantages of the density strip methodology and provide suggestions for its potential extensions and possible further uses.

The impact of immunotherapy education on GI cancers.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 479-479
Author(s):  
Kinjal Parikh ◽  
Katie Lucero ◽  
Charlotte Warren ◽  
Emily Sherene Van Laar ◽  
Patrick Kugel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Checkpoint Inhibitors ◽  
Statistical Significance ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Educational Activities ◽  
Cancer Subtypes ◽  
Gi Cancers ◽  
The Impact

479 Background: Gastrointestinal (GI) cancers are a heterogeneous group of cancers with varying underlying pathophysiology and distinct treatment paradigms. Immunotherapy (IO) is unique in each of the subtypes and biomarkers utility varies. With the expansion of IO in each cancer subtypes, education remains essential to optimize patient outcomes through integration of the latest evidence-based data at point of care. Through the partnership between Medscape Oncology and the Society for Immunotherapy of Cancer, 2 educational activities were designed to increase the knowledge and competence of oncologists surrounding the role of IO in patients with advanced GI cancers. Methods: The 2 educational activities included a text based online activity with 3 chapters focused on gastroesophageal cancers, colorectal cancers, and hepatocellular carcinoma (HCC) and a 30-minute online, video discussion with 3 faculty and synchronized slides on HCC. Educational effectiveness was assessed with repeated paired pre/post assessment where learners served as their own controls. A chi-square test was used to identify statistical significance in proportion of correct responses. The first activity launched 11/27/2019 and the second activity launched on 5/8/20. Data were collected and reported through 8/25/2020. Results: A total of 8433 learners, including 1543 oncologists, participated from 11/2019 through 8/2020. Participation in education resulted in significant relative improvements among oncologist learners on IO in GI cancers in (n = 641): 110%: role or eligibility of immune checkpoint inhibitors (ICIs) (p < .001) 38%: clinical trial data of ICIs (p < .001) Subsequent education on unresectable HCC demonstrated a significant relative improvement in both knowledge and competence for oncologist learners (n = 902): 19%: regarding clinical trial data in unresectable HCC (p = .073) 19%; competence identifying role of ICIs in unresectable HCC (p < .05) 59%: competence managing irAEs in unresectable HCC (p < .001). Conclusions: These 2 online CME-certified educational activities resulted in statistically significant gains in oncologist knowledge surrounding the use of IO in advanced GI cancers Follow-up education on HCC demonstrated the value and benefit of multi-modal and sequential activities on improving competence among oncologists caring for patients with unresectable HCC There remains a need for continuous education as more oncologists utilize IO in their practice while the understanding and availability of clinical data continues to expand and evolve in the varying GI cancer subtypes. More than 50% of learners continued to demonstrate a need in understanding the clinical trial data or role of IO in metastatic GI cancers with more than 40% of the learners demonstrating continued need on clinical trial data or role of IO in HCC specifically.

A Prognostic Model Using ZAP- 70, CD38 and Cytogenetics To Better Predict Need for Early Therapy and Response to Treatment in Chronic Lymphocytic Leukemia (CLL).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2114-2114 ◽  
Author(s):  
Peter Acs ◽  
Blanche Mavromatis ◽  
Metin Ozdemirly ◽  
Daniel Hartmann ◽  
Jean Meck ◽  
...  
Keyword(s):  
Early Treatment ◽  
Statistical Significance ◽  
Univariate Analysis ◽  
Median Number ◽  
Response To Therapy ◽  
Fish Analysis ◽  
Refractory Disease ◽  
Early Therapy ◽  
The Impact ◽  
13Q Deletion

Abstract Introduction. New prognostic markers such as ZAP-70, CD38, and cytogenetics have proven to be highly predictive of outcome in CLL. However, their role in the management and treatment of CLL patients (pts) has yet to be determined. Furthermore, the impact of each marker in the context of other markers has also not been identified. Of 70 CLL pts seen at our institution 54 pts were enrolled on an ongoing prospective CLL trial, with data also available on an additional 16 pts. ZAP-70 was measured by immunohistochemistry using a monoclonal antibody (clone 2F3.2). CD38 was detected by flow cytometry on peripheral blood lymphocytes, and cytogenetic abnormalities were tested by FISH analysis. We correlated results of the marker studies with the need for early treatment compared to those who were managed by a continued watch and wait approach, and, if treatment was instituted the prediction of these markers on response. Using a linear regression model, the markers were analyzed by univariate analysis as they pertained to the above. Data. The median pt age was 61 years (yrs) (range 26-83), median number of yrs with CLL was 5 (range 0–27 yrs), and the median Rai stage was 2. 20/34 pts who required therapy because of rapidly progressive or symptomatic disease were previously untreated, and the median number of prior therapies for the other 14 pts was 1.6 (range 1–4). Pts were otherwise followed by a watch and waited approach until therapy was indicated according to the NCI-WG guidelines (Cheson et al. Blood87:4990, 1996). Treatments included chemotherapy-rituximab combinations, e.g. rituximab with fludarabine (+/− oblimerson), or CHOP, and 8 pts received fludarabine alone, alemtuzumab, chlorambucil, or radiation. ZAP-70 was positive in 26/51 pts. CD38 was positive in 24/65 CLL pts. 19 pts were positive for ZAP-70 and CD38. FISH data were available for 64 pts; 28 had del 13q abnormality, 2 del 11, 1 del 17, 23 normal cytogenetics, and 2 complex abnormalities. 22/26 (85%) ZAP-70 + pts required early treatment, compared to 14/25 (56%) ZAP-70 - pts (p=0.034). 20/24 (83%) CD38 + pts required early treatment, compared to 18/41 (44%) in CD38 - pts (p=0.036). ¾ (75%) pts with refractory disease were positive for ZAP-70 and CD38. 7/14 pts with 13q deletion requiring therapy had a CR with 13/14 (93%) ORR and 1/14 (7%) SD. 6/13 pts (46%) with nl FISH had a CR with ORR of 11/13 (84%), and 1 pt with refractory disease. Conclusions. ZAP-70 and CD38 were strong independent equally predictive markers of need for treatment.13q deletion was predictive of treatment not being indicated at the time of study, only when ZAP-70 expression and CD38 expression were negative. ZAP-70 negativity was highly predictive of overall response to therapy, whereas CD38 negativity was more predictive of achieving a CR. The simultaneous presence of ZAP-70 and CD38 was suggestive of refractory disease, although the numbers were too small for statistical significance. The presence of 13q deletion was equally predictive of CR and ORR when compared to pts with a normal karyotype. These results need to be incorporated into a CLL treatment model to better delineate pts who may require earlier intervention.

scholarly journals Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial

Cytotherapy ◽  
2015 ◽  
Vol 17 (4) ◽  
pp. 339-343 ◽  
Author(s):  
Stacy Ouseph ◽  
Darah Tappitake ◽  
Myriam Armant ◽  
Robin Wesselschmidt ◽  
Ivy Derecho ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Cellular Therapy ◽  
Lessons Learned ◽  
Cellular Therapies

scholarly journals The COVID-19 pandemic and new clinical trial activations

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Joseph M. Unger ◽  
Hong Xiao
Keyword(s):  
Clinical Trial ◽  
Relative Risk ◽  
Clinical Research ◽  
Risk Ratio ◽  
Negative Impact ◽  
Interrupted Time Series ◽  
Relative Risk Ratio ◽  
Negative Consequences ◽  
Interrupted Time Series Analysis ◽  
The Impact

Abstract Background The COVID-19 pandemic has caused severe disruptions in care for many patients. A key question is whether the landscape of clinical research has also changed. Methods In a retrospective cohort study, we examined the association of the COVID-19 outbreak with new clinical trial activations. Trial data for all interventional and observational oncology, cardiovascular, and mental health studies from January 2015 through September 2020 were obtained from ClinicalTrials.gov. An interrupted time-series analysis with Poisson regression was used. Results We examined 62,252 trial activations. During the initial COVID-19 outbreak (February 2020 through May 2020), model-estimated monthly trial activations for US-based studies were only 57% of the expected estimate had the pandemic not occurred (relative risk = 0.57, 95% CI 0.52 to 0.61, p < .001). For non-US-based studies, the impact of the pandemic was less dramatic (relative risk = 0.77, 95% CI 0.73 to 0.82, p < .001), resulting in an overall 27% reduction in the relative risk of new trial activations for US-based trials compared to non-US-based trials (relative risk ratio = 0.73, 95% CI 0.67 to 0.81, p < .001). Although a rebound occurred in the initial reopening phase (June 2020 through September 2020), the rebound was weaker for US-based studies compared to non-US-based studies (relative risk ratio = 0.87, 95% CI 0.80 to 0.95, p < .001). Conclusions These findings are consistent with the disproportionate burden of COVID-19 diagnoses and deaths during the initial phase of the pandemic in the USA. Reduced activation of cancer clinical trials will likely slow the pace of clinical research and new drug discovery, with long-term negative consequences for cancer patients. An important question is whether the renewed outbreak period of winter 2020/2021 will have a similarly negative impact on the initiation of new clinical research studies for non-COVID-19 diseases.

scholarly journals Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers

2020 ◽  
pp. OP.20.00501
Author(s):  
Carrie Lee ◽  
Theresa L. Werner ◽  
Allison M. Deal ◽  
Cassandra J. Krise-Confair ◽  
Tricia Adrales Bentz ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
North America ◽  
Clinical Research ◽  
The United States ◽  
Median Number ◽  
Steering Committee ◽  
Full Time ◽  
Cancer Centers

PURPOSE: Cancer clinical trials offices (CTOs) support the investigation of cancer prevention, early detection, and treatment at cancer centers across North America. CTOs are a centralized resource for clinical trial conduct and typically use research staff with expertise in four functional areas of clinical research: finance, regulatory, clinical, and data operations. To our knowledge, there are no publicly available benchmark data sets that characterize the size, cost, volume, and efficiency of these offices, nor whether the metrics differ by National Cancer Institute (NCI) designation. The Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) steering committee developed a survey to address this knowledge gap. METHODS: An 11-question survey that addressed CTO budget, accrual and trial volume, full-time equivalents (FTEs), staff turnover, and activation timelines was developed by the AACI CRI steering committee and sent to 92 academic cancer research centers in North America (n = 90 in the United States; n = 2 in Canada), with 79 respondents completing the survey (86% completion rate). RESULTS: The number of FTE employees working in the CTOs ranged from 4.5 to 811 (median, 104). The median number of analytic cases (ie, newly diagnosed or received first course of treatment) reported by the main center was 3,856. Annual CTO budgets ranged from $250,000 to $23,900,000 (median, $8.2 million). The median trial activation time, based on 61 centers, was 167 days. The median number of accruals per center was 480 (range, 5-6,271) and median number of trials per center was 282 (range, 31-1,833). Budget and FTE ranges varied by NCI designation. CONCLUSION: The response rate to the survey was high. These data will allow cancer centers to evaluate their CTO infrastructure, funding, portfolio, and/or accrual goals as compared with peers. A wide range in each of the outcomes was noted, in keeping with the wide variation in size and scope of cancer center CTOs across the United States and Canada. These variations may warrant additional investigation.

OPTIMISATION OF PHARMACY CONTENT IN PAEDIATRIC ONCOLOGY AND HAEMATOLOGY CLINICAL TRIAL PROTOCOLS. EXPERIENCE OF CHEMOTHERAPY PHARMACY ADVISORY SERVICE (CPAS) FROM 2011 TO PRESENT

2016 ◽  
Vol 101 (9) ◽  
pp. e2.67-e2
Author(s):  
Rachel Greer ◽  
Sally Harvey
Keyword(s):  
Clinical Trial ◽  
Patient Safety ◽  
Clinical Research ◽  
Paediatric Oncology ◽  
Cancer Clinical Trial ◽  
Research Network ◽  
Advisory Service ◽  
Trial Protocols ◽  
The Impact ◽  
Protocol Review

AimClarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in protocols have the potential to delay research and jeopardise both patient safety and the collection of credible data. The Chemotherapy and Pharmacy Advisory Service (CPAS) was established in 2007 by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical trial protocols. This abstract describes the scope of CPAS, its methodology of mandated protocol review and an analysis of the issues found and reported in paediatric oncology and haematology trials.MethodAll paediatric oncology and haematology clinical trial protocols from 2011 to present were included in this study. A review checklist was developed by CPAS and used by the review panel, consisting of pharmacists, doctors and nurses, to standardise the evaluation of all protocols. Once completed, all reviews were collated and any queries and inconsistencies were fed back to Chief Investigators and study sponsors. The most common remarks made at protocol review were summarised and categorised through retrospective analysis. It is at the discretion of the study Sponsor and Chief Investigator to accept any recommendations or amendments based on the findings. In order to evaluate the impact of the service, Chief Investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from Chief Investigators have been collated and acceptance rates determined.ResultsA total of 13 paediatric protocols were reviewed during this period. The mean number of comments per protocol was 32 and these mainly concerned the drug regimen, support medication, dose calculation, drug information and administration. Eleven of the Chief investigators returned responses to their protocols reviews. All responses were positive with an overall acceptance rate of 82% of the proposed protocol changes.ConclusionReview by CPAS of pharmacy content of paediatric oncology and haematology clinical trial protocols prior to final approval is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct and/or patient safety. This analysis has highlighted that the majority of suggestions were deemed clinically significant and effectively incorporated into the final protocols. The refinement of existing and development of further pharmacy-related guidance documents by CPAS might support more effective and safer clinical research.

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