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GCP Announces RAPS Approved Webinar on Addressing Common Causes of Late-Stage Clinical Trial Failures
This Webinar is over| Date | Apr 10, 2014 |
| Time | 12:00 PM EDT |
| Cost | $195.00 |
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Online
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Overview:
Clinical operations professionals are held responsible for ensuring successful completion of clinical trials. However, there are many more specialists within a company that must also employ best practices to help ensure trial success. There are a wide array of best practice methods that should be routinely used to maximize clinical trial success rate, and these become more critical in late-stage clinical trials, specifically Phase 2 pivotal trials and Phase 3 trials, and in many cases can also be applicable for Phase 1b trials in areas such as oncology.
Best practices begin with the trial design phase, incorporating protocol design methods and inclusion and exclusion criteria of the study population that meets the primary efficacy outcome and maximizes the number of evaluable study subjects. Best practices also involve the methods for site selection, as the sites drive enrollment which drives overall study timelines and therefore costs, a leading reason causing trial design shortcuts and negative regulatory review findings.
Another item driving overall study timelines and a leading cause of 483 and other adverse audit findings deals with creation and maintenance of the Trial Master File. Although Clinical Operations usually maintains the file, many departments throughout the company share responsibility for providing and updating documentation. More importantly, close-out of the TMF is one of the main causes of NDA or 510(k) submission delays. Learning how to set this up and maintain it in a real-time manner with a continual quality assurance program to have documentation audit-ready at all times not only greatly decreases study close-out time and associated costs but also decreases your risk of adverse audit findings. Good documentation practices also enable potential partner or purchasing companies to readily review work quality and investigational product progress.
Why should you attend: During this webinar the instructor will present a list of the most common issues that need to be addressed during study start-up and study conduct, along with real-world examples of their application, and procedures to follow during the study start-up and conduct phases to help maximize the probability of late-stage clinical trial success. Common, actual examples are presented to demonstrate the prevalence of issues that regularly occur leading to clinical trial failures and how they can be prevented so that your trial runs smoothly, increasing your chances of trial success.
Areas Covered in the Session:
Clinical operations professionals are held responsible for ensuring successful completion of clinical trials. However, there are many more specialists within a company that must also employ best practices to help ensure trial success. There are a wide array of best practice methods that should be routinely used to maximize clinical trial success rate, and these become more critical in late-stage clinical trials, specifically Phase 2 pivotal trials and Phase 3 trials, and in many cases can also be applicable for Phase 1b trials in areas such as oncology.
Best practices begin with the trial design phase, incorporating protocol design methods and inclusion and exclusion criteria of the study population that meets the primary efficacy outcome and maximizes the number of evaluable study subjects. Best practices also involve the methods for site selection, as the sites drive enrollment which drives overall study timelines and therefore costs, a leading reason causing trial design shortcuts and negative regulatory review findings.
Another item driving overall study timelines and a leading cause of 483 and other adverse audit findings deals with creation and maintenance of the Trial Master File. Although Clinical Operations usually maintains the file, many departments throughout the company share responsibility for providing and updating documentation. More importantly, close-out of the TMF is one of the main causes of NDA or 510(k) submission delays. Learning how to set this up and maintain it in a real-time manner with a continual quality assurance program to have documentation audit-ready at all times not only greatly decreases study close-out time and associated costs but also decreases your risk of adverse audit findings. Good documentation practices also enable potential partner or purchasing companies to readily review work quality and investigational product progress.
Why should you attend: During this webinar the instructor will present a list of the most common issues that need to be addressed during study start-up and study conduct, along with real-world examples of their application, and procedures to follow during the study start-up and conduct phases to help maximize the probability of late-stage clinical trial success. Common, actual examples are presented to demonstrate the prevalence of issues that regularly occur leading to clinical trial failures and how they can be prevented so that your trial runs smoothly, increasing your chances of trial success.
Areas Covered in the Session:
- The most commonly overlooked items that drive late-stage clinical trial success or failure
- Methods to address each of the critically overlooked items prior to and during study conduct
- Effects of various preventive and corrective action methods on minimizing risk of late-stage clinical trial failure
- Relative costs of implementing various preventive and corrective action procedures
- Technologies and processes that are available to help minimize trial risk
- Real-world examples in a variety of therapeutic areas before and after these processes are applied
- Methods to rescue studies using the discussed processes
- Clinical Operations and Clinical Development personnel
- Business Development personnel
- All personnel within the pharmaceutical, biotechnology, medical device, and diagnostics companies who have a stake in ensuring clinical trial success
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