Dr. Patt presents "Site & Central Reads in Oncology Trials: Controversies and Risk Management Strategies"
July 22, 2010
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.
at ACRP Greater Philadelphia monthly meeting, to be held at ECRI, Plymouth Meeting, PA
16 Sept 10 6pm
Contact ACRP for details.
RadMD attends Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices:
July 14, 2010: Rockville, MD
July 14, 2010: Rockville, MD
July 22, 2010
RadMD presenting at FDA/Industry Statistics Workshop
21 September 2010, Washington, DC
21 September 2010, Washington, DC
July 21, 2010
RadMD to Attend:
ASCO June 4-8 2010, Chicago, IL
DIA June 13-17 2010; Washington, DC
ASCO June 4-8 2010, Chicago, IL
DIA June 13-17 2010; Washington, DC
May 05, 2010
On and Offsite Image Reads
Is basing drug efficacy on the site read risky business?
Excerpted from Applied Clinical Trials Online
Is basing drug efficacy on the site read risky business?
Excerpted from Applied Clinical Trials Online
January 01, 2010
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 MoreImages: Read On Site or Centrally and Independently?
Excerpted from eCliniqua
Excerpted from eCliniqua
December 14, 2009
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.
Read More
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.
Read More
RadMD Offers Tips on Optimizing Clinical Trial Efficiency
November 11, 2009
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
† According to ClinicalTrials.gov, a U.S. government database of clinical trials, as of October 27, 2009
RadMD reaches 150th clinical trial
October 05, 2009
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.
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.
RadMD First to Offer CME-Certified Education and Training For Medical Imaging in Clinical Trials
July 28, 2009
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.
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.
Read Drs. Patt and Shamsi's correspondence article in JCO
March 30, 2009
Pharma Veterans Launch Blinded Reader And Investigator Training Institute
Excerpted from Pharmaceutical Online
Excerpted from Pharmaceutical Online
July 09, 2008
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
On and Offsite Image Reads
Is basing drug efficacy on the site read risky business?
Is basing drug efficacy on the site read risky business?
December 31, 1969
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
