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BRITI and the International Center for Postgraduate Medical Education (ICPME) successfully hosted the first CME course on Imaging in Cancer Clinical Trials on April 16th, 2011 at the Doubletree Hotel in Philadelphia. Speakers included various pharmaceutical industry and academic experts such as Wendy Hayes, DO (Bristol-Myers Squibb), David Raunig, PhD (Pfizer), Sanjay Saini, MD, MBA (Massachusetts General Hospital), James Conklin, MD (Pharma Imaging Group Consortium), and Andrew Buckler, MS (Buckler Biomedical, LLC). Those in attendance ranged from pharmaceutical clinical trial personnel, to imaging core laboratories and independent radiologists.

"We were extremely pleased with the greater than anticipated turnout for our first live CME course, due in large part to the distinguished faculty that we assembled. We're looking forward to future courses in the US, and also in Europe and Asia." said Dr. Rick Patt, Principal of BRITI/Course Co-Director.

The full day course included 7 lectures by industry and academic experts in addition to a panel discussion, where several of the key speakers discussed current topics in clinical trial imaging and answered additional questions from the audience. The course was certified for up to 8.0 AMA PRA Category 1 Credits™ and 8.0 hours for ARRT Category A continuing education credit.

Dr. James Burke, Vice President of Clinical Research at Jennerex Biotherapeutics said the following, "The BRITI seminar helped me better understand the technical aspects and limitations of clinical trial imaging as well as the critical role played by a central radiology review. The seminar will be invaluable in determining clinical trial design with respect to radiographic endpoints."

The Blinded Reader and Investigator Training Institute (BRITI) offers comprehensive education and training through a broad range of accredited CME courses in the area of medical imaging for pharmaceutical, medical device and biotech clinical trials. For the last few years, BRITI has partnered with ICPME to develop high-quality, well-balanced educational programs of scientific rigor and integrity that are free from commercial bias.

For additional information about BRITI courses, contact Cindy Harris at charris@rad-md.net or 215-348-5644.

RadMD, LLC announced today that Douglas Stefanelli has joined the RadMD Senior Management team as COO and Executive VP. Mr. Stefanelli will take over responsibility for the company’s day-to-day operating activities, and will direct the short-term and long-range planning and development to support the company’s strategic business goals. He brings with him more than twenty-seven years of experience in the pharmaceutical industry managing businesses in both therapeutic and diagnostic areas.

“Doug joins RadMD as an experienced, senior level Healthcare Executive with a track record of success. Specializing in creating new markets, developing large brands and overall business development,” said Rick Patt, M.D., one of RadMD’s Principals. “Doug will help us further build our organization and lead our commercial operations in the United States and abroad.”

Prior to joining RadMD, Mr. Stefanelli held the position of Vice President and General Manager for Bayer Healthcare where he was responsible for managing the Diagnostic Imaging business in the US. He began his career in Sales for Berlex Laboratories and later moved through increasing responsibilities in Marketing, holding positions as Director and Vice President of Marketing for both Specialized Therapeutics and Diagnostic Imaging. He has significant experience in both medical imaging and neurology therapeutics. In addition to his Marketing experience Mr. Stefanelli also managed the Business Analytics Department at Berlex as Vice President and Executive Committee member. He received his BS in Chemistry from St. John’s University.

BIO International Convention: Drs. Shamsi leads session with Dwayne Reives, MD (FDA), Larry Schwartz MD, and Erik Pulkstenis PhD (HGS) on the Use of Imaging in Clinical Trials and Risk Management Strategies. Please see details below for more information.

Session Details
Track: Biomarkers
Session ID/Title: 87 - Use of Imaging in Clinical Development: Risk Management Strategies for Site and Independent Image Evaluations
Date: Monday, June 27, 2011
Time: 2:00 PM - 3:15 PM
Location: Walter E. Washington Convention Center, Mt. Vernon Place, NW, Washington D.C., 20001
Room: 152 A
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MAGI Clinical Research Convention
May 22-25, 2011
Philadelphia, PA
Attending

ASCO
June 3-7, 2011
Chicago, IL
Attending

Bio International Convention
June 27-30
Washington DC
Presenting

RSNA
November-Dec 2
Chicago, IL
Attending

Imaging in Cancer Clinical Trials: A One-Day Comprehensive Course – April 16th, 2011

BRITI and the International Center for Postgraduate Medical Education (ICPME) will jointly host the first CME course on Imaging in Cancer Clinical Trials. The seminar will be held on April 16th, 2011 at the Doubletree Hotel in Philadelphia and will be presented by pharmaceutical industry and academic experts. Speakers include: Wendy Hayes, DO (Bristol-Myers Squibb), David Raunig, PhD (Pfizer), Sanjay Saini, MD, MBA (Massachusetts General Hospital), James Conklin, MD (Pharma Imaging Group Consortium), and Andrew Buckler, MS (Buckler Biomedical, LLC). Additional speakers will be announced.

“We’ve designed this course for decision-makers in oncology drug development, clinical researchers and study personnel, as well as radiologists and oncologists using medical imaging to assess radiographic endpoints in the evaluation of drug efficacy. It provides attendees with a broad overview of imaging in cancer drug trials” said Dr. Rick Patt, Principal of BRITI/Course Co-Director.

Some of the topics to be covered include:
• An Introduction to Using Imaging in Cancer Trials
• Risk Management Strategies When Using Imaging in Cancer Trials
• Biostatistical Considerations and Reader Performance
• The Blinded and Site Read Processes
• Quantitative Imaging Biomarkers
• Imaging Efficacy Evaluation Criteria
• Imaging Standardization Processes

“With the increasing utilization of imaging in oncology trials has come a greater demand for formal training of pharmaceutical personnel on current concepts for applying imaging in drug trials. Regulatory agencies have also been placing greater emphasis on documented training of trial personnel. This course will provide attendees with practical and useable tools for using imaging in cancer drug trials” said Dr. Kohkan Shamsi, BRITI Principal/Course Co-Director.

The Blinded Reader and Investigator Training Institute (BRITI) offers comprehensive education and training through a broad range of accredited CME courses in the area of medical imaging for pharmaceutical, medical device and biotech clinical trials. For the last few years, BRITI has partnered with ICPME to develop high-quality, well-balanced educational programs of scientific rigor and integrity that are free from commercial bias.

For more information contact Jennifer Brennan at jbrennan@rad-md.net or 215-348-5644 or to register for this course, go to: http://courses.icpme.us/course_calendar.

Dr. Patt presents "Site & Central Reads in Oncology Trials: Controversies and Risk Management Strategies"
at ACRP Greater Philadelphia monthly meeting, to be held at ECRI, Plymouth Meeting, PA
16 Sept 10 6pm

Contact ACRP for details.

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Medical imaging in trials has been used as a measure of efficacy for more than 20 years. While the clinical practice of radiology provides sufficient information for managing individual patients, this practice varies geographically within the United States and globally. It was recognized by FDA that variability in evaluating trial images at the sites necessitated a more standardized and controlled review process, which was described in the agency's 1994 "Points to Consider for Developing Medical Imaging Drug and Biologic Products."

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By Ann Neuer

December 14, 2009 | As clinical trial protocols call for more imaging of all types, a big controversy is brewing as to whether efficacy can be based on site evaluation of images, or if the images should be read centrally, by trained and independent professionals. Much of the brouhaha centers on oncology trials and whether sites are able to adequately identify “progression-free survival (PFS)”, an image-based surrogate endpoint that indicates whether a patient’s disease has progressed.

“Making this kind of determination requires training and consistent methodology in acquiring and interpreting the images,” says radiologist Rick Patt, principal of RadMD, a provider of “blinded reader services” and consultants for implementing medical imaging endpoints in clinical trials. Blinded read is shorthand for blinded independent central review (BICR), the form of review advocated by the Food and Drug Administration for radiographic exams used in oncology studies when PFS is the primary endpoint.

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DOYLESTOWN, Penn., Oct. 27, 2009 – Lengthier cancer trials and new regulations have forced pharmaceutical companies to look for new ways to minimize costs and increase efficiency. As a result, the use of medical imaging, which is currently being used in 3000 clinical trials (†), has come to the forefront. Since imaging is a very specialized field, focused training of clinical trial personnel must be conducted in a standardized fashion to optimize imaging data. RadMD LLC (www.rad-md.net), provider of consulting, training, and blinded reader services for the pharmaceutical and biotech industries, offers the following tips on making more efficient use of medical imaging during the clinical trial process.

1. No add-ons. The FDA and regional regulatory agencies require documentation of extensive standardized training for clinical trial personnel, and efficacy and safety raters. In order for training to be effective, it needs to be part of a clinical trial plan from the beginning.


2. Standardize – Train both onsite readers and independent reviewers. All clinical trial evaluators should be trained radiologists experienced in the clinical trial process. The on-site methodology for controlling training, testing, and ongoing reader performance monitoring should be pre-defined and well-documented.


3. Identify site readers prospectively. When forming clinical teams for a specific site, it’s essential to identify the radiologist performing the image evaluations, particularly if imaging is an important efficacy or safety endpoint. This provides more consistent results within and across sites and less noise/variability in the results.


4. Train enrollment readers. Radiologists reviewing images to confirm whether patients qualify for study enrollment play a critical role in assuring that each subject enrolled is appropriate to the trial. Inappropriate enrollment based on poor image evaluations affects sample size calculations, number of evaluable patients, costs, and can create ethical and legal issues. A dedicated training program and ongoing oversight of enrollment readers can maximize reader performance and ensure appropriate enrollment.


5. Train readers for disease progression confirmation. It should be emphasized that central confirmation is not the remote practice of medicine, but is analogous to the manner in which central ECG and lab data are used. Currently, technology exists for 24-48 hour turnaround on these reads, providing an additional data point to the principal investigator when making decisions on disease progression. Readers for progression confirmation can also be the same readers as those for enrollment, but never the same as efficacy readers.


6. Ongoing training. Reader drift happens during a trial. Re-training during a clinical trial is crucial to obtaining quality data, particularly for lengthy or concurrent trials. Training must be ongoing throughout the trial to capture new site personnel and update those that who are participating.


7. Accept help from experts. Most companies do not have broad in-house imaging expertise or in-house imaging training programs. Seek out targeted experience to supplement your existing study-specific training and incorporate imaging training for all study personnel. A better understanding of trial imaging by study personnel (data and project managers, etc.) improves the ability to better assess imaging data quality.

DOYLESTOWN, Penn., Oct. 5, 2009 – Completing a major milestone in its three years of operation, RadMD LLC (www.rad-md.net) announced that it has sourced readers for 150 clinical trials.

The most recent trial, conducted by ICON Medical Imaging for a leading pharmaceutical company, was designed to test the efficacy of a new treatment for metastatic kidney cancer. The trial used medical imaging to support the primary analysis of Progression Free Survival based on an independent central radiological review.

“The results of the reads showed that the drug delayed tumor growth by five months, with patients living twice as long without tumor growth as other cancer victims in the study's control arm. Ultimately, this provided the FDA with the information it needed to approve the drug,” said Ted Gastineau, president and co-founder, ICON Medical Imaging. “Quality reads are critical and delays cost money and keep drugs from getting to the people who need it most. We are confident that RadMD’s blinded readers have the skills and experience necessary to help us support our clients through the drug development process.”

RadMD sourced five radiologists with a specialty in oncology within one week of the request and helped with resources and scheduling – allowing completion of the analysis ahead of schedule. Each radiologist received formalized training and extensive testing on a variety of topics related to the use of medical imaging in clinical trials from the company’s Blinded Reader and Investigator Training Institute (BRITI)TM. All CT scans, MRIs and bone scans obtained at baseline during the treatment period and the follow-up period were sent to the independent imaging core lab at ICON Medical Imaging. 

Founded by medical imaging experts Kohkan Shamsi, MD, PhD, and Richard Patt, MD, RadMD sources clinical experts and provides consulting services for pharmaceutical, biotech and medical device trials and offers both CME-certified and non-CME courses on medical imaging in clinical trials for both on-site and offsite readers. The company’s database of 600 readers come from multiple specialties including radiologists, pathologists, oncologists, cardiologists, medical physicists, medical technologists and others. RadMD has sourced readers for trials in cardiovascular, oncology, neurology, musculoskeletal, endocrinology and sports medicine.
“CRO’s and pharmaceutical companies usually manage many concurrent trials and the availability of quality blinded readers saves money, decreases variability and expedites the trial process,” said Dr. Shamsi. “By facilitating a key component of the clinical trial process, RadMD helps pharmaceutical, biotech and medical device companies reduce clinical development time, thus getting important anti-cancer and other treatments to the market more quickly.” 

For more information about RadMD, please visit www.rad-md.net or call 267-247-5544 ext. 500.

BRITI Accredited Courses Designed to Improve Quality and Accuracy of Results

DOYLESTOWN, Pa., July 28 /PRNewswire/ -- RadMD LLC (www.rad-md.net) has become the first company to offer a broad range of accredited CME courses in the area of medical imaging for pharmaceutical, medical device and biotech clinical trials.

The comprehensive education and training is offered through the company's Blinded Reader and Investigator Training Institute (BRITI)(TM). RadMD is partnering with International Center for Postgraduate Medical Education (ICPME) to obtain the CME certification.

"A huge number of clinical trials use medical imaging to demonstrate effectiveness," said Lisa Schleelein, MEd, ICPME's director of CME. "The primary goal of CME activities is to improve practice performance and patient care. RadMD is contributing to the overall quality of this process with educational activities that improve the utilization, acquisition and interpretation of medical images."

Founded by medical imaging experts Kohkan Shamsi, MD, PhD, and Richard Patt, MD, RadMD will offer both CME-certified and non-CME course modules providing clinical trial personnel with formalized training and testing on a variety of topics related to the use of medical imaging in clinical trials. The curricula were developed to reduce bias, increase data reliability and improve the accuracy of the results.

"The FDA emphasizes the role of training trial personnel but there are no standards in place to govern the use of medical imaging for this purpose," said Dr. Richard Patt, co-founder of RadMD. "Other companies in our industry use education as a marketing tool to sell their services; we recognize the crucial importance of independent, peer-reviewed validation for education and training."

The BRITI training program will offer both introductory and advanced courses on the use of medical imaging in trials, including specific evaluation methods. Customized modules for specific trials can also be developed to train pharmaceutical personnel, on-site investigators and blinded readers.

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Medical imaging experts Kohkan Shamsi, MD, PhD, and Richard Patt, MD, recently launched the Blinded Reader and Investigator Training Institute (BRITI) to facilitate training for medical imaging in clinical trials. BRITI will provide... Read More

Medical imaging in trials has been used as a measure of efficacy for more than 20 years. While the clinical practice of radiology provides sufficient information for managing individual patients, this practice varies geographically within the United States and globally. It was recognized by FDA that variability in evaluating trial images at the sites necessitated a more standardized and controlled review process, which was described in the agency's 1994 "Points to Consider for Developing Medical Imaging Drug and Biologic Products."

Read More