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How to Combine Clinical Trial Agreement

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well good afternoon everyone im david glaser and im just here to do a quick introductions and announcements uh and well turn it over to uh bob and katherine in a moment so our webinar our next webinar is on august 12th and the topic is going to be lessons from recent data bdocHubes and there have been some expensive lessons lots of seven figure lessons so this theyre going to talk about hipaa and otherwise katie ilton briar andreessen and lad will be doing it and theyre going to be talking so youre going to want to get your privacy and security people in on this so this is things like um you know uh how do you when you do it with how do you hire a vendor if theres been a data bdocHub what due diligence should you do on vendors to try to prevent data bdocHubes tips for dealing with bit data bdocHubes tips for dealing with the ocr on audits and settlement and having a good security policy so thats on august 12th same time a couple quick news announcements some of you may have heard

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What is a combined Phase 2 3 trial?

A study that tests how well a new treatment works for a certain type of cancer or other disease and compares the new treatment with a standard treatment. Phase 2/phase 3 clinical trials may also provide more information about the safety and side effects of the new treatment.

What does Phase 2 clinical trial mean?

Phase II clinical trials. A phase II clinical trial tells doctors more about how safe the treatment is and how well it works. Doctors also test whether a new treatment works for a specific cancer. They might measure the tumor, take blood samples, or check how well you can do certain activities.

What is a combination trial?

A combination trial is defined as a trial in which at least two drugs are administered to a group of patients. Without specific note, a drug can be a small molecule or a biological agent in our study.

What is the difference between Phase 2 and Phase 3 study?

Larger numbers of patients get the treatment in phase II trials, so less common side effects may be seen. If enough patients benefit from the treatment, and the side effects arent too bad, phase III clinical trials are begun.

What is a collaborative research agreement?

Research Collaboration Agreements (RCAs) Outlines materials or expertise each party brings to the research project, and what their anticipated contribution of each.

What is a clinical trial consortium?

It organizes, plans, and implements strategies and initiatives designed to grow the regions clinical research community, give access increased access to cutting edge medicine, engage local physicians in research, and provide high quality job opportunities.

What are the components of a clinical trial agreement?

A clinical trials agreement should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract

What is the main purpose of Phase 2 and 3 testing?

Phase 2 trials aim to find out: if the new treatment works well enough to be tested in a larger phase 3 trial. which types of cancer the treatment works for. more about side effects and how to manage them.

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