scholarly journals Clinical Trial Principal Investigator License

2020 ◽  
Author(s):  
Keyword(s):  
Clinical Trial ◽  
Principal Investigator

The role of experience and clinical decision support in clinical trial accrual within oncology.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1527-1527
Author(s):  
Waqas Haque ◽  
Ann M. Geiger ◽  
Celette Sugg Skinner ◽  
Rasmi Nair ◽  
Simon Craddock Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Decision Support ◽  
Clinical Decision Support ◽  
Clinical Decision ◽  
Principal Investigator ◽  
Physician Practices ◽  
The Past ◽  
The Future ◽  
Clinical Trial Accrual

1527 Background: Patient accrual for cancer clinical trials is suboptimal. The complexity of applying eligibility criteria and enrolling patients may deter oncologists from recommending patients for a trial. As such, there is a need to understand how experience, training, and clinical decision support impact physician practices and intentions related to trial accrual. Methods: From May to September 2017, we conducted a survey on clinical trial accrual in a national sample of medical, surgical, and radiation oncologists. The 20-minute survey assessed barriers and facilitators to clinical trial accrual, including experience (e.g., “In the past 5 years, have you been a study or site PI of a trial?”), training (e.g., “Did you receive training about trial design and recruitment as part of medical school, residency, or fellowship? After fellowship?”), and clinical decision support (e.g., “What kind of clinical decision support has your practice implemented?). We used logistic regression to identify factors associated with frequency of discussing trials (with ≥25% of patients) and likelihood of recommending a trial to a patient (likely or very likely) in the future. Results: Survey respondents (n = 1,030) were mostly medical oncologists (59%), age 35-54 years (67%), male (74%), and not in academic practice (58%). About 18% of respondents (n = 183) reported discussing trials with ≥25% of their patients, and 80% reported being likely or very likely to recommend a trial to a patient in the future. Prior experience as principal investigator of a trial was associated with both frequency of discussing trials (OR 3.27, 95% CI 2.25, 4.75) and likelihood of recommending a trial in the future (OR 5.22, 95% CI 3.71, 7.34), as was receiving additional training in clinical trials after fellowship (discussion with patients: OR 2.48, 95% CI 1.80, 3.42; recommend in future: OR 1.92, 95% CI 1.37, 2.69). Implementing clinical decision support was not associated with discussing trials with ≥25% of patients (OR 1.12, 95% CI 0.76, 1.67), but was associated with being likely to recommend a trial in the future (OR 1.73, 95% CI 1.11, 2.71). Conclusions: In a national survey of oncologists, we observed differences in physician practices and intention related to clinical trial accrual. Whereas the vast majority (80%) reported being likely or very likely to recommend trials in the future, far fewer (20%) reported discussing trials with their patients within the past 5 years. Implementation of clinical decision support – electronic tools intended to optimize patient care and identification of patient eligibility – was not associated with frequency of past discussion of clinical trials but was associated with recommending a trial in the future. Given the stronger association between experience as a site Principal Investigator and recommending a trial, future research should explore how improving opportunities to lead a clinical trial impact trial accrual.

An analysis of safety in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) receiving chemotherapy (CT) with or without panitumumab (pmab) in a phase III clinical trial (SPECTRUM)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6050-6050 ◽  
Author(s):  
J. B. Vermorken ◽  
J. Stöhlmacher ◽  
I. Davidenko ◽  
E. Winquist ◽  
L. Licitra ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clin Oncol ◽  
Disease Progression ◽  
Annual Meeting ◽  
Conflict Of Interest ◽  
Principal Investigator ◽  
Phase Iii ◽  
Therapeutic Area ◽  
Oncology Research ◽  
Interest Policy

6050^ Background: The epidermal growth factor receptor (EGFR) is an important target for treatment of patients with SCCHN. Pmab is a fully human monoclonal antibody against EGFR. This study is planned to assess the safety and efficacy of pmab in combination with a standard platinum-based CT regimen for patients with R/M disease. Methods: This ongoing, global, phase III, open-label, randomized (1:1) study is enrolling pts with R/M SCCHN. Pts receive cisplatin 100 mg/m2 IV on day 1 plus 5-FU (1,000 mg/m2) continuous IV daily on days 1–4 ± pmab (9 mg/kg on day 1) every 21 days for up to 6 cycles. Changes to carboplatin (AUC 5) are allowed for specific cisplatin-related toxicities. Pts in the pmab arm without disease progression after 6 cycles may remain on pmab monotherapy until disease progression or intolerability. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, response rate, duration of response, and safety. This study includes multiple planned safety interim analyses conducted by an independent Data Monitoring Committee (DMC). The latest analysis included the first 300 of approximately 650 planned patients. Results: Of 300 pts enrolled, 88% are male; median age is 59 years (range 31–82); ECOG PS 0: 32%, PS 1: 68%. Of the 300 patients, 99% received any study treatment and 76% had ended all CT. Median follow-up time is 13.9 weeks. The rate of any grade 5 treatment-related AE was 3.4%. Adverse events of interest are shown in the Table. Conclusions: After the interim safety analysis of the first 300 pts conducted by the independent DMC, SPECTRUM continues per protocol. Enrollment is estimated to be completed in Feb 2009. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

Randomized clinical trial of LigasureTM versus open haemorrhoidectomy

2002 ◽  
Vol 89 (2) ◽  
pp. 154-157 ◽  
Author(s):  
F. F Palazzo ◽  
D. L Francis ◽  
M. A Clifton
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial

Ciprofloxacin is more effective in treating acute pouchitis than metronidazole: A randomized clinical trial

2001 ◽  
Vol 120 (5) ◽  
pp. A453-A453 ◽  
Author(s):  
B SHEN ◽  
J ACHKAR ◽  
B LASHNER ◽  
A ORMSBY ◽  
F REMZI ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial
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