Studying Dogs Alongside Humans, to Develop Cancer Drugs for Both

National Cancer Institute researchers are undertaking a project to conduct comparative oncology drug trials in humans and dogs, with the hopes of providing an improved perspective upon how clinical drugs will perform in later-stage trials. An offshoot of the project is to accelerate the development of efficacious cancer drugs for dogs. The Comparative Oncology Trials Consortium maps out its mission in the Public Library of Science online. Here is some of the rationale behind their work:

Current drug development pathways are frequently unidirectional. Novel agents are assessed in conventional preclinical models of efficacy and toxicity before moving into human clinical trials where they either fail or succeed. Particularly with novel targeted therapies the conventional paradigms of toxicity studies conducted in healthy animals followed by Phase I and Phase II human trials leave unanswered many important questions on the “best use” of these drugs [6]. Translational drug development studies in pet dogs with cancer provide an opportunity to answer these questions by serving as an intermediary between conventional preclinical models and human clinical trials [7]–[9]. In these dogs, cancers develop naturally in the context of an intact immune system and with a syngeneic host and tumor microenvironment. Similar environmental, nutrition, age, sex, and reproductive factors lead to tumor development and progression in human and canine cancers. They share similar features such as histologic appearance, tumor genetics, biological behavior, molecular targets, therapeutic response, and unfortunately, acquired resistance, recurrence, and metastasis.

--Paul Thomas

Global Outsourcing of Clinical Trials: Patient Concerns and Hope for Change

I've seen a number of news items come across my desk of late about Western companies forging partnerships to outsource clinical trials around the globe, particularly to India. Today's OpEd piece from UK's Guardian looks at some of the growing concern over fair treatment of patients as this trend plays out. The primary concern: "informed consent" can look good on paper but not necessarily be honored and practiced in situations in which trial patients are severely economically disadvantaged.

There are positives about the continued trend towards outsourcing trials overseas, of course. It's an opportunity to speed drug development, and to increase the availability of medications for "local diseases" around the world.

--Paul Thomas

FDA, EMEA Harmonize Around Clinical Practices

FDA and EMEA announced today a broad collaborative effort in the area of Good Clinical Practices. The joint effort bodes well for continued cooperation between the agencies on many fronts, and in the sharing of resources that is imperative if global regulatory authorities are to get the most out of their limited resources. The agreement also represents a significant step toward the agencies' recognizing each other's inspections as valid and binding, and toward reducing the regulatory burden upon drug companies who operate trials worldwide and must satisfy the requirements of multiple regulatory authorities.

--Paul Thomas

ADAPT Agenda Set; Throckmorton to Speak

The final agenda is available for September's ADAPT (Accelerating Development and Advancing Personalized Therapy) congress in Washington, D.C.

A quick summary of the tracks:

Track 1: Optimizing Clinical Trials
Track 2: Implementing Personalized Medicine
Track 3: Advancing Cancer Therapy
Track 4: Bridging Silos in Biomarker Development

Featured speakers include FDA Deputy Director Douglas Throckmorton; J. Carl Barrett, VP, Global Head Oncology Translational
Medicine, Novartis; Nicholas C. Dracopoli, VP, Biomarkers, Centocor R&D, Johnson & Johnson; and Giora Feuerstein, AVP, Head,Discovery Translational Medicine, Wyeth Research.

--Paul Thomas

Mulling Adaptive Clinical Trial Design, and Hula Hoops

Can accumulating clinical trial data be used to adapt trials in their earlier stages to either optimize them or suggest that they ought to be terminated? That's the premise of adaptive clinical design; this article from Applied Clinical Trials ponders the question of whether adaptive trials are here to stay or will go the route of the hula hoop.

Thanks to the Agile Clinical Development blog from Health Decisions for passing this one along.

--Paul Thomas

Biosensors in Clinical Trials: More from John Lowry in Ireland

I blogged a few weeks ago about the potential of biosensors to be used to monitor neurochemical brain activities in clinical trial patients in real time, from the work of Irish researcher John Lowry. Yesterday, I spoke with Lowry to dig further into why companies like Lilly are interested in his technology, and what obstacles exist before biosensors might be used in human trial subjects. Here is the summary of that interview.

--Paul Thomas

White Paper: Operational Efficiency in Clinical Trial Management

Good reading: A multi-article white paper from Oracle, including Accenture’s Henry Levy on enabling technology, Genzyme’s Jennifer Hunt on implementing a trial management system, and several leading consultants on clinical trials management of the future. While the paper promotes clinical trial management systems such as Oracle’s Siebel offering, it’s a strong overview of the current data management climate in general.

--Paul Thomas