Late Phase Clinical Trials

2018 ◽  
Author(s):  
Karla V. Ballman
Keyword(s):  
Clinical Trials ◽  
Late Phase

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials

2018 ◽  
Vol 15 (6) ◽  
pp. 616-623 ◽  
Author(s):  
Peter C Trask ◽  
Amylou C Dueck ◽  
Elisabeth Piault ◽  
Alicyn Campbell
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Selection Process ◽  
Late Phase ◽  
Relevant Information ◽  
Specific Patient ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
The Common

As new cancer treatment regimens demonstrate increased potential to improve patients’ survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment’s tolerability. The U.S. Food and Drug Administration has recommended using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in clinical trials. A practical guideline is needed to inform a priori selection of specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items for use in any given industry-sponsored oncology clinical trial. Standardizing this selection process will foster systematic and consistent data collection as part of drug development and enhance our knowledge on how to use patient-relevant information as part of a treatment’s risk/benefit assessment. This article presents methods and consensus recommendations for selecting specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items to include in early-phase and late-phase oncology clinical trials.

scholarly journals The LIFE CYCLE OF COVID-19 STAGES AND TREATMENT

2020 ◽  
Vol 9 (3) ◽  
Author(s):  
Ripu Daman M. Singh ◽  
Nida Malim ◽  
Aves Raza Khan ◽  
Huda Khan ◽  
Nauman Khatib ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Life Cycle ◽  
Severe Acute Respiratory Syndrome ◽  
Late Phase ◽  
Antiviral Drug ◽  
Cytokine Storm ◽  
Clinical Recovery ◽  
The World ◽  
Autoimmune Conditions ◽  
Viral Outbreak

The coronavirus disease 19 (COVID-19) is a highly transmittable and pathogenic viral infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)bat viruses, therefore bats could be the possible primary reservoir , which emerged in Wuhan, China and spread around the world. The intermediate source of origin and transfer to humans is not known, however, the rapid human to human transfer has been confirmed widely. There is no clinically approved antiviral drug or vaccine available to be used against COVID-19. However, few broad-spectrum antiviral drugs have been evaluated against COVID-19 in clinical trials, resulted in clinical recovery. We also discuss the approaches for  therapeutic combinations to cope with this viral outbreak. Chloroquine has been sporadically used in treating SARS-CoV-2 infection. Hydroxychloroquine shares the same mechanism of action as chloroquine, but its more tolerable safety profile makes it the preferred drug to treat malaria and autoimmune conditions. We propose that the immunomodulatory effect of hydroxychloroquine also may be useful in controlling the cytokine storm that occurs late-phase in critically ill SARS-CoV-2 infected patients.

National Cancer Institute (NCI) implementation of the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) broadening clinical trials eligibility criteria.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6518-6518
Author(s):  
Andrea M. Denicoff ◽  
S. Percy Ivy ◽  
Katherine H. Worthington ◽  
Jinxiu Zhao ◽  
Nita Seibel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Brain Metastases ◽  
Hiv Infection ◽  
National Cancer Institute ◽  
Late Phase ◽  
Eligibility Criteria ◽  
Minimum Age ◽  
Liver And Kidney ◽  
Localized Disease ◽  
American Society

6518 Background: The 2017 ASCO/Friends eligibility criteria guidelines recommend inclusiveness to promote generalizable trial results and clear rationale for necessary exclusion. These guidelines focused on brain metastases, minimum age for enrollment, HIV infection, and organ dysfunction and prior and concurrent malignancies. In September 2018, the NCI Cancer Therapy Evaluation Program (CTEP) implemented modernized protocol template language to operationalize these criteria. We evaluated utilization of the new language among CTEP-sponsored treatment trials. Methods: We evaluated protocols first approved by CTEP between 11/01/2018 and 4/30/2020. The most recent approved protocol version was evaluated for consistency with the new template language for brain metastases, HIV infection, prior or concurrent malignancies, minimum age, and cardiac, liver and kidney function. If a particular criterion was not relevant for a trial, it was not included in the analysis. We did not score age in pediatric or adult-specific trials (e.g. prostate). Results: 122 trials (71% early and 29% late phase) were identified and included in the analysis. Compliance with the new criteria language ranged from a high of 87.7% for liver function to a low of 11.5% for “new or progressive brain metastases” (table). Modernized criteria language was lacking in nearly 46% of trials in the use of concurrent or prior malignancy criteria and 31% of trials for the cardiac criteria. Of the 87 trials for non-localized disease or non-brain tumor trials, 64.4% did not address brain metastases, leaving it to investigator discretion. Thus, 75.9% of trials could theoretically enroll patients with brain metastases. Only 6 trials were considered relevant for patients < 18 years old; 50% were consistent with the age criterion (not shown in table). Conclusions: Implementing ASCO/Friends eligibility criteria requires focused reviews during protocol development to ensure compliance. CTEP is using these findings to continue to improve its protocol review processes to broaden eligibility in clinical trials. Maximizing opportunities for diverse populations to participate in trials is a priority for the National Cancer Institute and CTEP will continue efforts to achieve this goal.[Table: see text]

Repurposing of Metformin for Cancer Therapy: Updated Patent and Literature Review

2021 ◽  
Vol 16 ◽  
Author(s):  
Zainab Sabry Othman Ahmed ◽  
Matthew Golovoy ◽  
Yassen Abdullah ◽  
Reda Saber Ibrahim Ahmed ◽  
Q. Ping Dou
Keyword(s):  
Clinical Trials ◽  
Cancer Therapy ◽  
Late Phase ◽  
Drug Dosage ◽  
Great Promise ◽  
Cancer Therapies ◽  
Anticancer Properties ◽  
Anticancer Effects ◽  
Pubmed Database ◽  
Early Phase Clinical Trials

Background: Over recent years, there has been an increasing focus on the repurposing of existing, well-known medications for new, novel usage. One such drug is metformin, typically utilized in the management of diabetes, which demonstrates a positive relationship between its administration and lower cancer morbidity and mortality. Based on this finding, numerous studies and clinical trials have been conducted to examine the potential usage of metformin as an anticancer agent. Objective: This article aims to summarize metformin’s anticancer effects through reviewing its literature and patents, with a focus on its potential to be repurposed for cancer therapy. Methods: Various databases were examined using keywords, ‘Metformin’ and ‘Cancer’. Research articles were collected through the PubMed database, clinical trials were obtained from the Clinical Trials database, and patents were collected through the Google Patents database. Results: Metformin shows antineoplastic activity in various models. These anticancer properties appear to synergize with existing chemotherapeutics, which allows for a reduction in drug dosage without losing potency while minimizing adverse effects. Numerous patents on metformin have been filed which claim various combination therapies, delivery methods, and uses for cancer therapy, displaying an increasing interest in metformin’s anticancer potential. Conclusion: Preclinical studies, along with early phase clinical trials, have examined antitumor properties of metformin on a variety of cancers. Metformin’s anticancer effects are well documented, demonstrating a great promise in improving current cancer therapies. However, there is a significant lack of late phase clinical trials, specifically those involving non-diabetic cancer patients, and therefore further research in this area is required.

Criteria of Evidence to Move Potential Chemopreventive Agents into Late Phase Clinical Trials

2011 ◽  
Vol 12 (13) ◽  
pp. 1983-1988 ◽  
Author(s):  
Ronan J. Kelly ◽  
Ariel Lopez-Chavez ◽  
Eva Szabo
Keyword(s):  
Clinical Trials ◽  
Late Phase ◽  
Chemopreventive Agents

scholarly journals Experiences of establishing an academic early phase clinical trials unit

2017 ◽  
Vol 14 (4) ◽  
pp. 349-356 ◽  
Author(s):  
Sarah R Brown ◽  
Debbie Sherratt ◽  
Gill Booth ◽  
Julia Brown ◽  
Fiona Collinson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Late Phase ◽  
Knowledge Retention ◽  
Lessons Learned ◽  
Phase Iii ◽  
Trial Management ◽  
Early Phase Trials ◽  
Early Phase Trial ◽  
Phase Trial

Background: Early phase trials are essential in drug development, determining appropriate dose levels and assessing preliminary activity. These trials are undertaken by industry and academia, with increasing collaborations between the two. There is pressure to perform these trials quickly, safely, and robustly. However, there are inherent differences between developing and managing early phase, compared to late phase, drug trials. This article describes an approach to establishing an academically led early phase trial portfolio, highlighting lessons learned and sharing experiences. Methods: In 2009, the University of Leeds Clinical Trials Research Unit became the Clinical Trials Coordinating Office for Myeloma UK’s phase I and II trials. We embarked on a transition from working extensively in phase III to early phase trials development and conduct. This involved evaluating and revising our well-established standard operating procedures, visiting other academic early phase units, and developing essential new documentation and processes. Results: A core team of trial and data managers and statisticians was established to facilitate expertise and knowledge retention. A detailed training plan was implemented focussing on essential standard practices for early phase. These included pharmacovigilance, recruitment, trial design and set-up, data and site monitoring, and oversight committees. Training in statistical methods for early phase trials was incorporated. Conclusion: Initial scoping of early phase trial management and conduct was essential in establishing this early phase portfolio. Many of the processes developed were successful. However, regular review and evaluation were implemented to enable changes and ensure efficiencies. It is recommended that others embarking on this venture build on the experiences described in this article.

scholarly journals regCOVID: Tracking publications of registered COVID-19 studies

2021 ◽  
Author(s):  
Craig Mayer ◽  
Vojtech Huser
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Late Phase ◽  
Phase 3 ◽  
Multiple Study ◽  
Vaccine Trials ◽  
Study Results ◽  
Phase Phase ◽  
Trial Phase

Abstract In response to the COVID-19 pandemic many clinical studies have been initiated leading to the need for efficient ways to track and analyze study results. We expanded our previous project that tracked registered COVID-19 clinical studies to also track result articles generated from these studies. We conducted searches of ClinicalTrials.gov and PubMed to identify articles linked to COVID-19 studies, and developed criteria based on the trial phase, intervention, location, and record recency to develop a prioritized list of result publications. We found 760 articles linked to 419 interventional trials (15.7% of all 2 669 COVID-19 interventional trials as of 15 August 2021), with 418 identified via abstract-link in PubMed and 342 via registry-link in ClinicalTrials.gov. Of the 419 trials publishing at least one article, 123 (29.4%) have multiple linked publications. We used an attention score to develop a prioritized list of all publications linked to COVID-19 trials and identified 58 publications that are result articles from late phase (Phase 3) trials with at least one US site and multiple study record updates. For COVID-19 vaccine trials, we found 69 linked result articles for 40 trials (13.9% of 290 total COVID-19 vaccine trials). Our method allows for the efficient identification of important COVID-19 articles that report results of registered clinical trials and are connected via a structured article-trial link.

NCI’s national treatment trial networks: Experience and adaptations during COVID-19.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1562-1562
Author(s):  
Margaret M. Mooney ◽  
Grace E. Mishkin ◽  
Matthew J Boron ◽  
Andrea M. Denicoff ◽  
Shanda Finnigan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase 1 ◽  
Late Phase ◽  
Opportunity To Learn ◽  
National Treatment ◽  
Phase 3 ◽  
Clinical Cancer Research ◽  
Trial Conduct ◽  
Treatment Trials ◽  
Patient Concerns

1562 Background: The National Cancer Institute supports several national trial networks which responded rapidly to the COVID-19 pandemic to overcome operational barriers to clinical cancer research. The National Clinical Trials Network (NCTN) focuses on late phase treatment trials, while the Experimental Therapeutics Clinical Trials Network (ETCTN) conducts early phase treatment trials. We report findings on the experience and adaptations of these networks during COVID-19. Methods: Using 2019 and 2020 accrual data, we analyzed changes in accrual levels and demographics. We also evaluated changes in trial activation numbers and timelines. In July 2020, we surveyed 255 investigators from academic and community sites to assess changes in research practices and get feedback on modified processes implemented by NCI to address trial conduct during the pandemic. Results: Accrual across the NCTN and ETCTN fell significantly in mid-March 2020, dropping from a weekly average of 307 patients in February to 169 the week of March 23-29. Accrual began to recover in June and July but did not return to pre-pandemic levels until September. Accrual in November and December 2020 followed the patterns seen in 2019, with short-term drops around major holidays. Non-White participants were enrolled to NCTN and ETCTN trials at similar monthly rates throughout 2019 and 2020, with slightly higher overall enrollment in 2020 (23.7% vs. 22.7%). New trials continued to be developed and activated throughout 2020. Between 2017 and 2019, an average of 71 trials were activated per year (NCTN = 46, ETCTN = 25), compared to 84 activated in 2020 (NCTN = 58, ETCTN = 26). The average time to trial activation was similar or slightly longer in 2020 compared to 2019. The investigator survey yielded 111 responses (43.5% response rate). 43% of respondents’ sites paused enrollment to phase 1 trials during the pandemic, compared to 18% for phase 3 trials. Many sites temporarily stopped opening new trials and processing specimens. Sites were more likely to keep enrolling to trials offering clear potential benefit and pause complex trials that required more patient contact. Respondents attributed some of the decline in accrual to a reduction in overall patient volume, increased patient concerns, and reduced research staff on site. Respondents were asked to rate the usefulness of modified trial processes NCI put in place during the pandemic. Telehealth was rated most useful (avg. 4.6/5), followed by shipping oral IND agents to enrolled patients (4.5/5), remote informed consent (4.2/5), coordinating care with local providers (3.9/5), and remote auditing (3.7/5). Conclusions: The cancer trials community has an opportunity to learn from working through the challenges of COVID-19. NCI will seek to continue and expand on modifications to clinical trial processes that have the potential to improve operational efficiency, reduce cost, and help bring trials to more patients.

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