Optimizing early phase trials key to success of novel cytotoxics & targeted therapies

According to the IMS Institute for Healthcare Informatics oncology products should reach around $75 billion in global spending by 2015. This depends on the success rate of novel cytotoxics and targeted therapies which are now in development. There are many challenges facing Phase I oncology trials including finding suitable patients, complex FDA or EMA regulations and data collection issues surrounding the trials. However with the right strategy these problems can be overcome.

I recently read an article on Applied Clinical Trials where the suggested the following ways to ensure your drug is taking to the next stages

Polishing protocols

Protocol design is important to a successful trial mainly because amendments cost time and money. This article suggests that sponsors must anticipate and eliminate protocol errors and flaws as early as possible. For example, check that all of the protocol-defined procedures are appropriate for collecting data that will support a new drug application or investigational medicinal product dossier? The protocol for a new agent—such as monoclonal antibodies, signal transduction pathway inhibitors, or antisense molecules—needs to define how to determine the recommended Phase II dose and to describe new assays or procedures to measure biologic endpoints as well as capture safety assessments.

Enabling enrollment

When choosing a site selection ensure the are capable of enrolling appropriate patients, have good clinical practice facilities and procedures, and employ sufficient and available qualified staff.

Operational excellence

Regulations. Make sure you research your chosen site's standard operating procedures so you are good to get your trial up and running asap. Also ensure you are compliant with federal, local and institutional regulations regarding protecting and caring for patients.

Infrastructure. Sponsors are held accountable for the quality and analysis of the data so data management and validation is key to get right. Applied Clinical Trials Online states that because of similarities across Phase I oncology trials, template-reporting mechanisms that summarize holistic patient results can simplify and expedite dose-escalation decisions. Using eClinical technologies will help control the data management process capturing data from enrollment through to ongoing analysis.

Cohort management

Tracking participants and assignments requires near constant communication between trial and on-site managers, and the assignment plan must be deemed fair by all sites to succeed.

Let me know if you have any other suggestions on how to optimise your early phase trials?

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