Managing Clinical Trials

Transforming Oncology Drug Development with Adaptive Trials

Complimentary Webinar

Thursday, April 7^th at 11:00 AM Eastern Daylight Time

Please join us! Reserve your seat:

Register here >>>

Why should those engaged in oncology research be interested in adaptive trials?

Over 50% of confirmatory studies today end in failure – an especially distressing reality for oncologists and developers of cancer treatments.  But now, new adaptive study designs with a greater probability for successful outcome are helping reverse this discouraging trend.

The FDA’s 2010 Adaptive Trials Guidance document gives study sponsors confidence to utilize new study methods.  But how are adaptive designs changing oncology research today? 

Join biostatistical pioneer Cyrus Mehta of Cytel and noted oncology advisor Dr. John Grous (our VP of Medical Affairs) for a live examination of the increase of adaptive oncology studies.

Using actual adaptive study examples, you will learn:

• Definition and regulatory outlook – adaptations the FDA and EMA allow for both earlier and confirmatory stages
• Who benefits and why? Impact on sponsor companies, their investors, medical community and trial patients
• Oncology trial example – making the most of interim analysis: determining optimal adaptive changes with a “Promising Zone”
• Harnessing “conditional power” to effectively de-risk oncology development
• Ethical considerations: what do patients gain from participating in an adaptive study?

 Who should register?

Anyone with a stake in oncology clinical R&D, including:

Oncology medical leadership, advisors, R&D management, clinical researchers, biostatisticians, consultants and the biopharmaceutical investment community.

We hope to see you!

Register here >>>

 

Medelis co-founder Daniel Von Hoff receives prestigious ASCO scientific honor

We are pleased to share the news that Medelis co-founder and Medical Advisory Board member Daniel D. Von Hoff, M.D. was recently awarded the 2010 David A. Karnofsky Memorial Award by the American Society of Clinical Oncologists during their 26th annual meeting in Chicago. One of ASCO’s highest scientific honors, the award honors pioneering oncologists who, through clinical research, have changed the way oncologists think about the practice of oncology. 

In his award lecture, “The Last 12 Weeks,” Dr. Von Hoff discussed a model for helping patients whose solid tumors are refractory to standard therapies and are searching for help in their last 12 weeks. The key is, as described by ASCO, “to look deep into the tumor genome in search of its Achilles’ heel, a mutation that defines the tumor’s vulnerability and provides a therapeutic target.” 

“Rather than reach for the next agent to come along,” select one that is thought to have selectivity for the target on the basis of either preclinical studies or activity in other cancers containing the same vulnerability, Dr. Von Hoff said. The result is an initial phase I trial with one patient. “I believe that if we can work smarter, phase I trials can be more therapeutic,” he explained. 

Dr. Von Hoff also discussed his preference for the term “precision medicine” rather than “personalized medicine.” He told ASCO, “I don’t like the term ‘personalized medicine.’ Most nurses and doctors already try to deliver personalized medicine. We don’t always achieve it, but that’s why we got into medicine in the first place — to listen and engage with the patient,” he said. Instead, Dr. Von Hoff prefers the phrase “precision medicine” to describe the ongoing efforts to characterize individual patients and the tumors they have, to discover new genetic markers, and to develop targeted therapies with the maximum potential for disease response. “My primary goal is to optimize the care of the patient sitting in front of me.”

Congratulations, Dan, on this prestigious honor and your deep dedication to your patients and our field.

Links:  ASCO article about the Karnofsky award  |  Highlights from Dan’s lecture, “The Last 12 Weeks” |  Full list of 2010 ASCO awards

Adaptive Trial Design for Phase I, Phase II

Adaptive trial design is a hot issue in the drug development community. Adaptive conferences and web seminars abound, and suddenly, every consultant or vendor to the industry has become an adaptive expert. The FDA and EMEA are also much more receptive to adaptive trials than they were a few years ago. 

However, the picture is a shade different from what the industry had expected. Originally, much of the focus was on adaptive phase III trials as well as on seamless phase II/III trials. Those are, indeed, successfully being implemented today. But the real action is in phase II dose-finding trials and even in phase I trials for safety.

In today’s new issue of Peer Perspectives in Oncology, Medelis talks with Ranganath Nayak, Ph.D., the CEO of Cytel, Inc., about the benefits, opportunities, and challenges presented by adaptive trial design in phase I and phase II studies. Cytel has designed more adaptive trials for industry sponsors than any other service provider and in virtually every therapeutic area, including medical devices.

Dr. Nayak begins by discussing why adaptive trial design is gaining so much momentum in early stage studies. "First, adaptive trials are most helpful when you do not know enough at the beginning of a trial to design it with confidence," he says. "This is much more likely to be true in phases I and II than in phase III.  

"Second, the best way to make expensive phase III trials more successful is to do more thorough work in phases I and II," he continues. "Getting the dose right through well-designed phase I and phase II trials is the best way to maximize success in phase III, which then leads to a higher rate of NDAs. “

Dr. Nayak offers insight and expertise on a variety of issues surrounding adaptive trial design, including:

• Commercial, ethical, and budgetary benefits of the adaptive trial model;
• Statistical and data issues;
• Changing to the adaptive model across multiple sites;
• Safety issues to consider;
• Budgeting for an adaptive trial;
• Dealing with independent decision-making bodies;
• Patient consent and communication issues;
• Medical supply logistics;
• Other best practices and planning issues.

Download the abstract here; you’ll also gain access to the other issues in the series, and we’ll notify you of future publications as well.  

ASU launches new Master of Science, Clinical Research Management program

Innovative online program provides convenient specialty training for nurses, physicians & health care professionals

Medelis President and CEO Bob Bosserman serves on the advisory board for Arizona State University's Center for Healthcare Innovation & Clinical Trials, and we're pleased to share this information about their Master of Science in Clinical Research Management, a new online 33-credit degree program for working professionals around the globe.

The field of clinical research is changing dramatically, and this program prepares students to be innovative industry leaders in specialized positions including regulatory affairs, clinical research operations, auditing, and monitoring. The curriculum includes

• Emerging technologies and methodologies
• Clinical research project management
• Study design
• Trends in global trial operations
• Regulatory requirements for healthcare-related product development
• Clinical research process improvement techniques

Students can complete the degree online in 17, 24, or 42 months, and the program culminates in a 6-credit capstone project designed to advance the field of clinical research.

ASU is currently accepting applications for Fall 2010. To learn more and apply, please visit the ASU College of Nursing & Health Innovation web site.

Mouse Hematology: A Laboratory Manual

Mike McGarry, Ph.D., our Vice President of Preclinical Studies, along with his Arizona Mayo Clinic colleagues Cheryl A. Protheroe and James J. Lee, has just authored a new book, Mouse Hematology: A Laboratory Manual, now available for pre-order from Cold Spring Harbor Laboratory Press (ships in December):

http://tinyurl.com/mousehematology

Dr. McGarry, a preclinical research scientist with over 35 years of experience generating animal-based data, leads preclinical program design, management and execution on behalf of Medelis’ biotech clients around the world.

Here’s the description from CSH Press:  

The mouse has become a standard laboratory model organism, particularly for the study of hematopoiesis, the immune system, and inflammation. Although laboratories studying stem cells, blood, and blood-forming tissues have assimilated many new molecular diagnostic methods, the identification of cell lineages through classical light microscopic techniques is often poorly understood and practiced. Mouse Hematology presents a concise review of conventional methods for the preparation, enumeration, and microscopic examination of blood and blood-forming tissues of the laboratory mouse. Along with a short laboratory manual featuring detailed protocols, Mouse Hematology includes a DVD of short video demonstrations of the techniques and a poster of blood cell types for easy identification at the microscope. These rapid, inexpensive assessments can save valuable time and resources essential to the design, development, and interpretation of experiments.     

Contents include:

1. Collection of Peripheral Blood
2. Counting Red Blood Cells, Platelets, and Viable Nucleated White Blood Cells
3. Peripheral Blood Films and Cytospin Preparations
4. Cell Differential Assessments of Peripheral Blood Films
5. Preparation of Bone Marrow for Microscopic Examination
6. Cell Differential Assessments of Bone Marrow

The book also includes 8 videos on an accompanying DVD:

1. Venous Access for Blood Film Using Lateral Tail Vein
2. Venous Access for Blood Film Using Tip of Tail
3. Blood Film
4. Staining with Coplin Jar or Carriages
5. Coverslip
6. Cytocentrifuge Procedures
7. Surgical Exposure of Femur
8. Brush Smear of Marrow

To preorder, visit the CSH Press website: http://tinyurl.com/mousehematology.

Dr. Alan Sandler, Dr. James Cassidy Join Medelis' Medical Advisory Board

We’re pleased to announce more company news today:  Two leading oncology researchers, Dr. Alan Sandler of Portland, Oregon and Dr. James Cassidy of Glasgow, Scotland, have joined our Medical Advisory Board.  

Alan Sandler, M.D. is a Professor of Medicine in the Division of Hematology & Medical Oncology, Department of Medicine, at Oregon Health & Science University in Portland, Oregon. Board-certified in Medical Oncology and Internal Medicine, he serves as the Division Chief of the Hematology & Medical Oncology Division and holds the DeArmond Chair for Clinical Cancer Research. He specializes in cancer and blood disorders with a special interest in lung cancer, and he is widely considered a key opinion leader in the development of targeted therapies in the treatment of thoracic malignancies.

Dr. Sandler is a member of the American Society of Clinical Oncology and the Eastern Cooperative Oncology Group, where he serves as the Co-Chair of the Thoracic Committee. 

James Cassidy, MBChB, MD, MSc, FRCP is a leading researcher in anti-sickness compounds and innovative approaches to drug-resistant tumors. Dr. Cassidy is a Professor of Oncology and heads the Medical Oncology Department and the Division of Cancer Sciences & Molecular Pathology at the University of Glasgow, Scotland. He heads the Centre for Oncology and Applied Pharmacology (COAP) and has his own Cancer Research UK (CRUK) lab based program exploring methods for gene and drug delivery. He also heads the Glasgow Experimental Cancer Medicine Centre (ECMC) which is focused on Good Laboratory Practice (GLP) quality assured assessments of molecular markers, pharmacodynamics and pharmacokinetics of novel agents at the clinical/lab translational interface.

On the clinical side, Dr. Cassidy runs a service for colorectal cancer patients and has a major commitment to early phase clinical studies of innovative therapies. 

In our formal news release, Medelis president and CEO Bob Bosserman says, “Medelis is very privileged to add Dr. Cassidy and Dr. Sandler to our distinguished group of expert advisors. They strengthen our ability to provide clients with cutting-edge expertise and assistance in the development and advancement of personalized therapies, which will ultimately help improve the treatment options for clinicians.  They also further strengthen our relationship with the clinical research community that directly cares for cancer patients and closely understands their needs.”

“Both of these physician/researchers can now bring their clinical experience to bear on the unique study design and management issues that our biotechnology and pharmaceutical clients face in the oncology drug development process,” Bosserman adds.

You can find Dr. Sandler’s full bio here and Dr. Cassidy’s bio here.

Medelis expands CRO services to medical devices, welcomes Dr. Inder Makin

Today we’re pleased to announce that we're expanding our CRO services to the medical device industry under the guidance of Inder Makin, M.D., Ph.D., who is joining us as Vice President, Devices & Radiological Health. 

Dr. Makin has more than 20 years of experience developing "concept to clinic" healthcare technologies in both academia and industry.  He has developed medical ultrasound-based research programs at various institutes, taking concepts (including catheter-based devices for intravascular thrombolysis, transdermal drug delivery devices and non-invasive and intracorporeal tissue ablation devices) through feasibility and launch. 

Dr. Makin’s unique combination of medical and biomedical engineering expertise enables him to assist our clients in effectively developing and refining new device solutions for patients.  He will also provide invaluable guidance in helping obtain marketing approvals for successful commercialization. 

Medelis will support device manufacturers throughout the product life cycle including early design and prototyping, simulation, preclinical and phase I-III clinical studies, and regulatory/marketing approval. 

You can read Dr. Makin’s full bio here. If you'd like to learn more about our services for the medical device industry, please contact us today.

Big pharma tackles patient recruitment challenges, but we have a long way to go

Yesterday, Pfizer and Private Access, a search technology firm, announced that they’re joining forces to create an online community aimed at increasing awareness and participation in clinical trials.

According to this Fierce Biotech article, "Nearly 85 percent of patients in a recent survey stated they were unaware that clinical trials were a possible treatment option, and 31 percent of physicians surveyed did not refer patients to trials due to, among other things, lack of information."

The statistics for cancer clinical trials are even more dismal.  Earlier this month, the New York Times’ "Lack of Study Volunteers Hobbles Cancer Fight" reported the well-known statistic that only 3 percent of cancer patients participate in trials for new treatments.  As the article explains, “There are more than 6,500 cancer clinical trials seeking adult patients, according to clinicaltrials.gov … but many will be abandoned along the way.”

In fact, only half of the trials sponsored by the National Cancer Institute fail to reach the minimum needed for a meaningful result, according to cancer researcher and health economist Dr. Scott Ramsey and his colleague John Scoggins in an editorial in the September 2008 issue of The Oncologist. Furthermore, more than one in five NCI trials failed to enroll a single subject.

Their conclusion:  “Research sponsors, researchers, and journal editors should redouble their efforts to encourage publication of registered clinical trials in oncology.”

As patient recruitment costs continue to skyrocket as enrollment statistics decline, we couldn’t agree more.  Rapid, efficient patient recruitment is, without a doubt, a major barrier preventing our industry from successfully delivering promising new treatments to patients.

Links to the stories:

• Fierce Biotech article about Pfizer and Private Access
• Editorial in The Oncologist
• Lack of Study Volunteers Hobbles Cancer Fight (New York Times)