A timing and process flow analysis of opening clinical trials within an oncology cooperative group setting: The case of the CALGB

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6015-6015
Author(s):  
D. M. Dilts ◽  
A. B. Sandler ◽  
M. Baker ◽  
S. Cheng ◽  
S. McGuire ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Group Setting ◽  
Calendar Time ◽  
Time Step ◽  
Center Staff ◽  
Regulatory Affairs ◽  
Decision Points ◽  
Phase Iii Study ◽  
Phase Iii Studies

6015 Background: Cooperative oncology groups are major sponsors of Phase III clinical trials, yet the number of steps and times required to setup and open such a trial have yet to be studied. This study assesses these items in the Cancer and Leukemia Group B (CALGB) for all Phase III studies opened in a 3 year period. Methods: Step 1: headquarters and statistical center staff were interviewed to discover the detailed steps required for a study to transit from initial concept submission by a potential study chair to final activation of the study. The formal procedures manuals were also reviewed. All study records and draft protocol documents were inspected to verify and identify additional setup steps. Finally, data was collected through direct contact with study chairs and disease committee chairs. Step 2: timing data for each of the major functions or processes were collected. All times are from initial initiation of the function to the final completion of the task. Times represent calendar time. Step 3: creation of stream-lined process flows, currently underway. Members from the CALGB and the Vanderbilt Center for Management Research in Healthcare (cmrhc.org) will spend 2 days creating a process to significantly reduce the time and the number of steps to opening a trial. Results: A total of 13 Phase III studies were activated during the 3 years study period. 372 processes are required to open a Phase III at CALGB, which include 314 work steps, 43 major decision points. Interesting, most of the decision points (63%) are external to CALGB. There are 23 processing loops that require repeating processes. The process map, which lists all processes, is a chart 243.5” × 41 in 8 pt font (or about the length of a 20 passenger bus). Median calendar days to activate a Phase III study at CALGB is 767 days (min = 488, max = 1,441). The three functions requiring the greatest median days are protocol development (477), forms development (434), and regulatory affairs (350). Conclusion: It can require years to open a Phase III study at a major cooperative oncology group. Using process redesign techniques, we expect to be able to significantly streamline the process. Support provided by the NCI. No significant financial relationships to disclose.

Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B

2006 ◽  
Vol 24 (28) ◽  
pp. 4553-4557 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler ◽  
Matthew Baker ◽  
Steven K. Cheng ◽  
Stephen L. George ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Activation Process ◽  
Oncology Group ◽  
Calendar Time ◽  
Phase Iii Clinical Trials ◽  
Decision Points ◽  
Phase Iii Study ◽  
Group B ◽  
Leukemia Group

Purpose National Cancer Institute–sponsored cooperative oncology groups are major sponsors of phase III clinical trials, yet the time and steps required to design and activate such studies has not been well studied. We examine the processes and document the calendar time required to activate such studies opened by the Cancer and Leukemia Group B (CALGB). Methods Setup steps were documented by (1) interviewing CALGB headquarters and statistical center staff and committee chairs to discover the steps required to transit from concept development to final study activation, (2) reviewing procedure manuals, and (3) inspecting all study records, documents, and e-mails to identify any additional steps. Calendar time was collected for each major process. Results Thirteen phase III studies were activated by CALGB during the study period of May 2002 to May 2005. More than 370 distinct processes were required for study activation: 317 work steps, 42 decision points, and 29 processing loops. Sixty-three percent of the decision points were outside CALGB. The complete process map measures 243.5” × 41” in 8-point font. Median calendar days to activate a phase III study at CALGB was 580 days (range, 295 to 1,248 days) from concept approval and 784 days (range, 537 to 1,130 days) from initial conception of the study. Conclusion Setup of a phase III study at a major cooperative oncology group is a complex and lengthy process, with the majority of decision points external to the cooperative group. To improve the activation process, research should to be directed toward both internal and external groups and processes.

scholarly journals Dutch Breast Cancer Trialists' Group (BOOG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 61-79
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Metastatic Breast ◽  
Phase Iii ◽  
List Type ◽  
First Line ◽  
Open Label ◽  
Phase Iii Study

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Dutch breast cancer trialists' group (BOOG). Clinical trials include:An open label randomized (inter)national multicenter comparative trial of 5 years adjuvant endocrine therapy with an LHRH agonist plus an aromatase inhibitor (goserelin + anastrozole) versus five courses FE90C chemotherapy followed by the same endocrine therapy in pre- or perimenopausal patients with hormone receptor-positive primary breast cancer (PRemenopausal Optimal Management IS Endocrine therapy). BOOG 2002-01/PROMISE. ISRCTN23561723Open label, comparative, randomized, multicenter, study of trastuzumab (Herceptin) given with docetaxel (Taxotere) versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for metastatic breast cancer (MBC) patients with HER2neu overexpression. BOOG 2002-02/HERTAX ISRCTN13770586Micro-metastases and Isolated tumour cells: Robust and Relevant Or Rubbish? The MIRROR study in BREAST CANCER. BOOG 2003-03/ZonMW 3214Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed. BOOG 2004-01/Young Boost SRCTN45066831Microarray analysis in breast cancer to Tailor Adjuvant Drugs Or Regimens, a randomized phase III study. MATADOR, BOOG 2005-02, CKTO 2004-04 ISRCTN61893718A prospective randomised, open, multicentre, phase III study to assess different Durations of Anastrozole therapy after 2–3 years Tamoxifen as Adjuvant therapy in postmenopausal women with breast cancer. 2006-01/DATAA randomized, open-label phase III study of first line chemotherapy in elderly metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a complete geriatric assessment. 2006-02/OMEGABOOG participation in International studies:. BOOG 2001-01/TEAM trial. BOOG 2001-02/AMAROS (EORTC 10981/22023). BOOG 2002-04/HERA (BIG 1-01/EORTC 10011/BO16348B). BOOG 2003-02 (BIG 1-02/IBCSG 27-02). BOOG 2003-04 (GBG 29). BOOG 2004-02/TBP (GBG 26, BIG 3-05). BOOG 2005-01/CASA (IBCSG 32-05/BIG 1-05). BOOG 2005-03/MINDACT (EORTC 10041, BIG 3-04). BOOG 2006-03/SUPREMO (BIG 2-04). BOOG 2006-04/Adjuvant lapatinib study (BIG 2-06/EGF106708)

scholarly journals Trends in clinical trials for stroke by cell therapy: data mining ClinicalTrials.gov and the ICTRP portal site

2019 ◽  
Vol 4 (1) ◽  
Author(s):  
Takaharu Negoro ◽  
Hanayuki Okura ◽  
Midori Maehata ◽  
Shigekazu Hayashi ◽  
Satoru Yoshida ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cell Therapy ◽  
Chronic Phase ◽  
Cell Types ◽  
Phase Iii ◽  
Definitive Treatment ◽  
Stroke Treatment ◽  
Portal Site ◽  
Therapy Studies ◽  
Phase Iii Studies

Abstract Definitive treatment of stroke constitutes an important thesis of regenerative medicine in the cerebrovascular field. However, to date, no cell therapy products for stroke are yet on the market. In this study, we examined the clinical research trends related to cell therapy products in the stroke field based on data obtained from the ClinicalTrials.gov website and International Clinical Trials Research Platform (ICTRP) portal site. These data do not offer results of clinical trials comprehensively but provide information regarding various attributes of planned clinical trials including work in progress. We selected 78 cell therapy studies related to the field of stroke treatment from ClinicalTrial.gov and ICTRP. These were analyzed according to, e.g., the reporting countries, origin (autologous or allogeneic), of cell used, cell types and source organs, the progress of translational phases, target phase of the disease (acute or chronic stroke), and route of administration. This analysis revealed a trend whereby in the acute phase, mesenchymal stem cells were administered intravenously at a relatively higher dose, whereas in the chronic phase a small number of cells were administered intracranially. Only two randomized controlled Phase III studies with over 100 patients are registered, but none of them has been completed. Thus, cell therapy against stroke appears to constitute a premature area compared with cartilage repair as assessed in our previous report. In addition, tracking by means of the ID number of each trial via PubMed revealed that 44% of clinical studies in this field have corresponding published results, which was also discussed.

scholarly journals An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic

2019 ◽  
Vol 69 (Supplement_1) ◽  
pp. S40-S47 ◽  
Author(s):  
Steven Opal ◽  
Thomas M File ◽  
Tom van der Poll ◽  
Evan Tzanis ◽  
Surya Chitra ◽  
...  
Keyword(s):  
Bacterial Pneumonia ◽  
Bone Growth ◽  
Package Insert ◽  
Late Pregnancy ◽  
Phase Iii ◽  
Tooth Discoloration ◽  
Phase Iii Study ◽  
Clinical Trial Results ◽  
Muscarinic M2 Receptors ◽  
Phase Iii Studies

AbstractOmadacycline is a semisynthetic tetracycline antibiotic. Phase III clinical trial results have shown that omadacycline has an acceptable safety profile in the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Similar to most tetracyclines, transient nausea and vomiting and low-magnitude increases in liver aminotransferases were the most frequent treatment-emergent adverse events in phase III studies but were not treatment limiting. Package insert warnings and precautions for omadacycline include tooth discoloration; enamel hypoplasia; inhibition of bone growth following use in late pregnancy, infancy, or childhood up to 8 years of age; an imbalance in mortality (2%, compared with 1% in moxifloxacin-treated patients) was observed in the phase III study in patients with community-acquired bacterial pneumonia. Omadacycline has no effect on the QT interval, and its affinity for muscarinic M2 receptors resulted in transient heart rate increases following dosing.

Use of placebo in cancer medicine: The experience of a National Clinical Trials organization

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6104-6104
Author(s):  
J. L. Pater ◽  
W. Parulekar
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Study Design ◽  
Standard Of Care ◽  
Phase Iii ◽  
Design Data ◽  
Standard Of Care Treatment ◽  
Prevention Trials ◽  
The Impact ◽  
Phase Iii Studies

6104 Background: The use of placebos in cancer clinical trials requires careful evaluation. Factors that must be considered include the impact of placebo on endpoint measurement, the efficacy of placebo relative to standard of care treatment, patient altruism/acceptance of a non-active intervention and the resulting increase in complexity of study conduct with respect to randomization, drug supply, data management, analysis and the unblinding process. Methods: We reviewed the experience of the National Cancer Institute of Canada Clinical Trials Group with the use of placebo in the randomized phase III setting from 1982–2005. Results: Since 1982, 34 studies were identified that utilized a placebo as part of study design. Data is presented below according to the type of study and date of study activation. The numbers in brackets represent those studies in which placebo was used alone in the control arm. Supportive care studies were the most common type of study employing a placebo as part of study design and constituted almost 50% of our Group’s experience. Therapeutic studies involving placebo were conducted in multiple sites including breast (4), lung (6), myeloma (1), melanoma (1), ovary (1) and pancreas (1). Conclusion: Phase III studies involving a placebo constitute an important part of our clinical trial activity and cross the spectrum of supportive care, therapeutic and prevention trials. The use of placebo in cancer studies may increase due to the relative ease of blinding in studies that evaluate targeted, oral therapies with minimal toxicities as well as the need for unbiased assessment of increasingly used endpoints such as time to progression. [Table: see text] No significant financial relationships to disclose.

Evolution of statistical methodology and design of phase II/III clinical trials in non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7108-7108 ◽  
Author(s):  
R. K. Bagai ◽  
A. Dowlati
Keyword(s):  
Clinical Trials ◽  
Survival Time ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Iii ◽  
Type I ◽  
Phase Ii Trials ◽  
Improvement In Survival ◽  
Phase Ii And Iii ◽  
Phase Iii Studies

7108 Background: A significant heterogeneity exists in the design and reporting of phase II and III therapeutic clinical trials in NSCLC. This has led to difficulty in interpretation of these trials leading to over- or underestimation of therapeutic efficacy. We set out to investigate the statistical methodology and design reporting of chemotherapeutic trials in NSCLC published in the Journal of Clinical Oncology (JCO) over 20 years. Methods: We identified all phase II and III NSCLC chemotherapy trials published in the JCO from January 1983 to August 2005. All manuscripts were reviewed to evaluate components of statistical design that were reported, including: sample size calculation, power, type I error, single or multiple drug trials, relative response sought in phase II trials and improvement in survival time or response rate sought in phase III trials. Results: One hundred forty eight trials were identified. 52% of studies were phase III and 48% were phase II. The majority (78%) were conducted in advanced stage NSCLC. Sample size calculations were reported for only 58% of phase III studies and 31% of phase II studies. Power was reported in 66% of phase III studies and 13% of phase II trials. Type I error was reported in 47% of phase III studies and 17% in phase II studies. 60% of phase III trials defined endpoints (percentage improvement in survival time, improvement in survival time in months or increase in response rate). 41% of phase II trails defined the target response rate, ranging from response rates of 15% to 70%. The frequency of adequate reporting of statistical design was shown to increase from 31% in 1990–1995 to 64% in 2000–2005 ( table ). Conclusions: Significant heterogeneity exists in trial design and reporting of phase II and III trials in NSCLC. This impacts the ability to adequately interpret these studies. More widespread application of statistical methods in planning and reporting of lung cancer clinical trials are necessary to increase reliability of data. [Table: see text] No significant financial relationships to disclose.

A randomized phase III study of duration of anti-PD-1 therapy in metastatic melanoma (STOP-GAP): Canadian Clinical Trials Group study (CCTG) ME.13.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. TPS9600-TPS9600
Author(s):  
Tara D. Baetz ◽  
Xinni Song ◽  
D. Scott Ernst ◽  
Elaine McWhirter ◽  
Teresa M. Petrella ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Metastatic Melanoma ◽  
Phase Iii ◽  
Phase Iii Study
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