Clinipace Blog

New Webcast: Opportunities and Challenges Using Biomarkers in Oncology Drug Development

by Emily Nichols

With the promise of personalized medicine through targeted agents, the need for new approaches in the design and conduct of early phase oncology trials has become more evident. A putative biomarker should be validated as early as possible in development for both ethical and practical reasons. Additionally, biomarkers can be used to make early go/no-go decisions for compounds in development.

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Ron Marks and Mark Shapiro Pen ICT Adaptive Trial Article

by Emily Nichols

Recently, our chief scientific officer, Ron Marks, and our vice president of clinical development, Mark Shapiro, wrote an article on adaptive trial design for International Clinical Trials. They discussed the expansion of adaptive trial designs, as well as their potential benefits and industry concerns.

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Putting To Rest Data Quality & Consistency Concerns From Sites in Asia

by Barb Geiger

In a recent follow-up blog post to our webcast, “Demystifying Asia: Best Practices for Conducting Multinational Oncology Trials,” we shared one of the main advantages of taking clinical trials to Asia: Patient availability. However, we wanted to address a potential concern we heard from our webinar attendees—data quality. One question in particular that was raised in regards to quality: Can we be guaranteed comparable training and GCP compliance from Asian sites?

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Improving Compliance Through the Use of Electronic Diaries

by Darcy Forman

One form of technology that is gaining popularity and acceptance in a variety of clinical trials, but particularly in women’s contraception trials, is the electronic diary, also referred to as electronic patient reported outcomes (ePRO). To gauge the potential interest and current use of electronic diaries across our webinar audience, we asked attendees: Have you used, or would you consider using, ePRO for your contraception studies?

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Recruiting and Enrolling Patients in Multinational Trials for Highly Prevalent Diseases in Asia

by Barb Geiger

Last month, we discussed how Asian countries have proven to be an exciting and rapidly growing region in which to conduct trials during our webcast, Demystifying Asia: Best Practices for Conducting Multinational Oncology Trials. One of the biggest perceived advantages is the availability of patients. Asia, as a whole, represents 60 percent of the world's population. In particular, there are groups of patients who are treatment-naive, particularly for the increasing western patterns of diseases and those diseases that are more prevalent in Asia.

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The Acceptance of Foreign Data in Oncology Trials for US Product Registration

by Clara Li

My colleagues, Barb Geiger and Chris Wang, recently held a webinar, “Demystifying Asia: Best Practices For Conducting Multinational Clinical Trials,” which took a deep dive into the why, what, and how of enrolling patients in Asia. After the webinar, they were asked: What percentage of patients can be enrolled from Asia for oncology studies where the primary focus is for registration of the product in the US? Is there a precedent in a multinational study where data from Asian patients have contributed to US product registration? What percentage of patients was registered in the Asia?

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Expanding the Conversation around Surrogate Endpoints in Oncology Clinical Trials

by Lee Schacter

The gold standard for marketing approval of any cancer treatment has been—and continues to be—improved overall survival. However, FDA has defined a number of clinical measurements that are potential “surrogates” for that gold standard. FDA’s definition of a surrogate endpoint is “a laboratory measure or physical sign that is intended to be used as a substitute for a clinically meaningful endpoint.”

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Saving Time and Costs Through Patient Profile Development

by Darcy Forman

Owing to the wide range of choices, contraception is not just efficacy driven, but involves a high degree of personal preference. These same preferences influence a woman’s decision to enroll, comply, and complete a contraception clinical trial. Time spent developing a patient profile before trial commencement will save time and costs later.

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