Uncategorized

Download PDF Oncology Clinical Trials: Successful Design, Conduct and Analysis

Free download. Book file PDF easily for everyone and every device. You can download and read online Oncology Clinical Trials: Successful Design, Conduct and Analysis file PDF Book only if you are registered here. And also you can download or read online all Book PDF file that related with Oncology Clinical Trials: Successful Design, Conduct and Analysis book. Happy reading Oncology Clinical Trials: Successful Design, Conduct and Analysis Bookeveryone. Download file Free Book PDF Oncology Clinical Trials: Successful Design, Conduct and Analysis at Complete PDF Library. This Book have some digital formats such us :paperbook, ebook, kindle, epub, fb2 and another formats. Here is The CompletePDF Book Library. It's free to register here to get Book file PDF Oncology Clinical Trials: Successful Design, Conduct and Analysis Pocket Guide.

These data, if updated and aggregated in a timely fashion, could be used to identify trial factors and strategies that produce successful achievement of recruitment goals. For example, prior studies have shown that streamlining the trial design process would increase successful accrual [ 1 ], and that development of a model for predicting accrual success would enable the early identification of trials unlikely to achieve sufficient accrual, allowing for trial redesign and saving scarce research resources [ 2 ].

Oncology Clinical Trials Therapeutic Expertise

For CTG to succeed as a public repository, facilitating research transparency, and for it to be useful in the secondary analysis of clinical trials, it is necessary that data reported on CTG be accurate, complete, and up-to-date. The purpose of our research effort was to determine whether publicly available clinical trial data are sufficient to develop a comprehensive understanding of accrual. We tested the hypothesis that incomplete and delayed reporting of clinical trials would result in low availability of accrual data through public channels.

As a proof of concept, we selected a manageable cohort of trials for thorough analysis. Renal cell carcinoma RCC was chosen, owing to the rapid evolution of treatments in the field and the number of trials supporting novel agents seven new drugs from through [ 11 ]. Detailed methods describing the creation of the AACT, including the oncology specific dataset, have been reported previously [ 12 ]. The final oncology dataset included 8, trials registered on CTG between and We used CTG as the initial data source, since accrual data are supposed to be available there by public mandate. These data were abstracted in June Owing to low rates of reporting on CTG, additional efforts were made to extract accrual data from other publicly available sources.

This led to the implementation of a supplemental structured survey of clinical trial teams and a review of resulting publications for accrual data see Additional file 1. Approval from the institutional review board was obtained before beginning the survey. For the majority of trials registered on CTG, one or more persons are listed as the principal investigators or trial coordinators; email addresses for each of these persons were obtained either directly from CTG or from institutional websites or other publications authored by the same persons.

In March of , a survey was sent via email to the contacts, as described, requesting information about accrual rates, trial sponsor, and completion status. For each trial, the survey was sent to each available email address, whether this was only one or more than one. For no trial did we receive more than one survey response. If the survey was not completed within two weeks, a reminder email was sent and then an attempt at telephone contact was made.

PubMed and Google Scholar were used to search for resulting publications. For each trial, separate searches, including 1 the ClincalTrials. Resulting abstracts or papers were searched for reported accrual figures. The date of the last abstraction was 23 June 23 Data presently available via CTG are inadequate, as they are often incomplete and difficult to obtain.

After expanding our data acquisition to include surveys, phone calls, and publication searches, accrual data for RCC trials remained largely unavailable. Factors contributing to the low response rate included a reluctance to release this information to unknown parties and possible time constraints among research teams.

Participant accrual remains a challenge to clinical research.

Without adequate data, we will struggle to improve the completion of trials, devise, and implement new strategies to enhance accrual, and monitor impact. Detailed clinical trial data need to be available, in order to support our societal investment in research. To facilitate trial completion, we must better understand drivers of accrual by developing systems to monitor ongoing accrual success. Accrual statistics are available within research networks, such as the cancer cooperative groups, but they are not comprehensive or publicly available.

Some regionalized efforts have made impressive progress in systematically monitoring accrual [ 8 ], and have begun to identify systemic drivers of accrual rates and clinical trial success [ 7 , 15 ]. However, this work has been limited to trials under US National Cancer Institute sponsorship, and therefore does not describe the full breadth of the clinical trial infrastructure.

For a comprehensive understanding, such research must have access to and include accurate data on all clinical trials.


  • Oncology Clinical Trials.
  • Lanalisi funzionale dello stress. Dalla clinica alla psicologia applicata: Dalla clinica alla psicologia applicata (Strum. lavoro psico-sociale e educativo) (Italian Edition).
  • Oncology Clinical Trials: Successful Design, Conduct and Analysis - كتب Google.
  • Boy in Chains?
  • I poemi epici - Eneide (Riassunti) (Italian Edition).
  • Introduction;
  • Arnold Clark Home.

Although greater transparency in recruitment may allow for improvement in accrual over the long term, there may also be drawbacks. Early public availability of accrual figures for ongoing trials might lead to withdrawal of funding for those trials with slower-than-expected recruitment. While this might help to funnel resources towards trials more likely to produce meaningful results, it could also result in financial stress at the institutional level.

It is also possible that patients might decide to enroll in trials based upon publicly reported accrual rates, potentially further depressing accrual in trials that are already accruing poorly; we 1anticipate that this is an unlikely scenario. Efforts to increase the timeliness and completeness of reporting will help CTG meet its full potential as a central clearing house of clinical trial data, capable of supporting vital analysis of our research priorities and conduct.

A requirement that clinical trial data be updated at predefined intervals would significantly increase the quality of data available in CTG. As clinical researchers, study sponsors, and a community at large, it is important that we share this information, recognizing its importance in advancing the conduct of clinical trials.

Abernethy had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Clin Cancer Res. Clin Trials. J Clin Oncol. Cooperative Oncology Groups. A review of trials funded by two UK funding agencies. Med Care. Hutson TE: Targeted therapies for the treatment of metastatic renal cell carcinoma: clinical evidence.

Oncology Clinical Trials: Successful Design Conduct And Analysis

Contemp Clin Trials. Download references. Correspondence to Amy P Abernethy.


  • Customer Reviews?
  • Reverse Angle;
  • 2ND EARTH!
  • Exploring a ‘Rescue’ Strategy for Your Oncology Clinical Trial - Clinical Trials Arena;
  • Law School: Getting In, Getting Out, Getting On?
  • Clinical Trials in Oncology, Third Edition - CRC Press Book!
  • Public Investment, the Rate of Return, and Optimal Fiscal Policy (RFF Environmental and Resource Economics Set)?

This work was unfunded. No other party was involved in the design and conduct of the study, data analysis, or preparation or review of the manuscript. Owing to low rates of reporting on CTG, additional efforts were made to extract accrual data from other publicly available sources.

Advanced Oncology Medical Imaging

This led to the implementation of a supplemental structured survey of clinical trial teams and a review of resulting publications for accrual data see Additional file 1. Approval from the institutional review board was obtained before beginning the survey. For the majority of trials registered on CTG, one or more persons are listed as the principal investigators or trial coordinators; email addresses for each of these persons were obtained either directly from CTG or from institutional websites or other publications authored by the same persons.

In March of , a survey was sent via email to the contacts, as described, requesting information about accrual rates, trial sponsor, and completion status.

For each trial, the survey was sent to each available email address, whether this was only one or more than one. For no trial did we receive more than one survey response.

Oncology survey

If the survey was not completed within two weeks, a reminder email was sent and then an attempt at telephone contact was made. PubMed and Google Scholar were used to search for resulting publications. For each trial, separate searches, including 1 the ClincalTrials. Resulting abstracts or papers were searched for reported accrual figures. The date of the last abstraction was 23 June 23 Data presently available via CTG are inadequate, as they are often incomplete and difficult to obtain. After expanding our data acquisition to include surveys, phone calls, and publication searches, accrual data for RCC trials remained largely unavailable.

Factors contributing to the low response rate included a reluctance to release this information to unknown parties and possible time constraints among research teams. Participant accrual remains a challenge to clinical research.

Clinical trial

Without adequate data, we will struggle to improve the completion of trials, devise, and implement new strategies to enhance accrual, and monitor impact. Detailed clinical trial data need to be available, in order to support our societal investment in research. To facilitate trial completion, we must better understand drivers of accrual by developing systems to monitor ongoing accrual success.

Accrual statistics are available within research networks, such as the cancer cooperative groups, but they are not comprehensive or publicly available. Some regionalized efforts have made impressive progress in systematically monitoring accrual [ 8 ], and have begun to identify systemic drivers of accrual rates and clinical trial success [ 7 , 15 ].

However, this work has been limited to trials under US National Cancer Institute sponsorship, and therefore does not describe the full breadth of the clinical trial infrastructure.

TRACO 2017 - Clinical trials and Precision Medicine

For a comprehensive understanding, such research must have access to and include accurate data on all clinical trials. Although greater transparency in recruitment may allow for improvement in accrual over the long term, there may also be drawbacks. Early public availability of accrual figures for ongoing trials might lead to withdrawal of funding for those trials with slower-than-expected recruitment.

While this might help to funnel resources towards trials more likely to produce meaningful results, it could also result in financial stress at the institutional level. It is also possible that patients might decide to enroll in trials based upon publicly reported accrual rates, potentially further depressing accrual in trials that are already accruing poorly; we 1anticipate that this is an unlikely scenario.

Efforts to increase the timeliness and completeness of reporting will help CTG meet its full potential as a central clearing house of clinical trial data, capable of supporting vital analysis of our research priorities and conduct. A requirement that clinical trial data be updated at predefined intervals would significantly increase the quality of data available in CTG. As clinical researchers, study sponsors, and a community at large, it is important that we share this information, recognizing its importance in advancing the conduct of clinical trials.

Abernethy had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Clin Cancer Res. Clin Trials.