Anton Usala, MD, CTMG’s President and CEO, and members of the CTMG executive team were invited to meet with representatives of all three branches of the FDA (CDER, CBER, and CDRH), representatives from the FDA Commissioner’s Office on GCPs, FDA Enforcement, FDA veterinary medicine, and FDA Office of Scientific Research/Integrity to present CTMG’s successful approach to clinical trial conduct, on May 16, 2012 at FDA Headquarters in Silver Spring, MD.
CTMG is the world’s first Site Specific CRO, that develops and implements protocol-specific, design-reviewed processes, to conduct clinical trials with its Business Associate Physician Investigators. Dr. Usala explained that by implementing these processes under point-of-process completion layered quality systems at the Investigative Site, CTMG sites have 1) been the first to recognize test article related adverse events, 2) been the top enrolling sites with the highest retention rates in nearly all studies conducted between 2008-12, that enables recognition of both safety and efficacy trends by the Investigators, 3) reduces the time to bring a product through clinical trials by up to 3 years, and 4) cuts the cost of conducting the clinical trial by tens of millions of dollars.
CTMG also presented for FDA consideration two options to accelerate FDA review of Sponsor clinical trial data—1) if Sponsors conduct studies at clinical investigative sites that have onsite quality systems (such as those done at CTMG network sites), the FDA will place those study data in the established FDA accelerated review track, and 2) provide the option for Principal Investigators to check responsibility for medical procedures, medical review of data, medical decision making, and medical data interpretation, but delegate to other subject matter experts (such as CTMG) the operational and on site quality system conduct of the study at their site [the rationale being that physicians are NOT subject matter experts in clinical trial operations or quality systems, and only subject matter experts in the medical aspects of the clinical trials].
CTMG is the world’s first Site Specific CRO (SS-CRO) with, to the best of our knowledge, the highest clinical study enrollment and retention metrics in the world. Our trial management service utilizes our experienced personnel to implement design-reviewed cGMP-like processes, under proprietary layered Quality Systems, at our Business Associate Physician Investigator sites.
Thursday, June 7, 2012
Tuesday, April 24, 2012
CTMG, Inc. President and CEO at FDA Public Hearing
On Monday, April 23rd, Dr. Anton Usala, President and CEO of CTMG, Inc, spoke at the “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice” FDA public hearing. Dr. Usala discussed how CTMG’s designed reviewed processes, implemented under layered quality systems at the point of service delivery, ensure the most expedient path to acquire high quality data for Sponsors. Dr. Usala proposed an accelerated FDA review path for Sponsor that utilizes Physician Investigative Sites with internal, point of service quality systems. In addition, Dr. Usala’s presentation touched on the potential benefits of amending the Form 1572 in order to better allow the subject matter experts to be responsible for the organization and logistics of a study, while also making certain that the PI is aware and involved in all medical decision making.
When made available, the transcript can be viewed at the following link: http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm
When made available, the transcript can be viewed at the following link: http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm
Tuesday, September 6, 2011
CTMG Process Controls Effectively Address New FDA Guidance for Oversight of Clinical Trials
The FDA has recently released a new guidance regarding how Sponsor/ Sponsor side CROs should be monitoring their clinical trial sites. The guidance primarily notes that the main focus for Sponsors and Sponsor side CROs should be on taking measures which protect human subjects, while maintaining data integrity and compliance with regulations.
Many Sponsors are currently under the belief that frequent on-site monitoring visits in order to verify all data is the method most preferred by the FDA. In fact, the agency states in the recent guidance that centralized monitoring can, and should be considered. The reasoning behind their position is that typical problems with data, such as fraud, can be more easily and consistently detected by centralized monitoring techniques.
The FDA does not however, believe that Sponsors and CROs should completely abandon the on-site monitoring visit. In fact, the agency urges them to conduct at least one on-site visit, preferably in the early stages of the study, in order to evaluate the sites processes and controls for handling source documents. Additionally, the agency recommends more on-site visits in cases where the PI lacks significant experience or when there are significant safety concerns due to a product for which there is no prior experience in human clinical trials.
The aforementioned aspects of the FDA’s recent guidance can all be addressed through CTMG processes, which provide the type of constant oversight and centralized monitoring which the agency heavily favors in comparison to intermittent on-site monitoring. In addition to daily review of subject pre-screening, patient visit scheduling and study enrollment - with the application of corrective and/or preventative actions as indicated – internal source document quality assessment and correction are all managed for the investigator by CTMG personnel as part of the study. This constant vigilance provided by CTMG clinical coordinators, regulatory personnel, QA personnel, as well as executive management, creates the type of centralized monitoring infrastructure requested by the FDA in their recent guidance.
For additional information on CTMG services and processes, please visit http://www.ctmginc.com. For Business Development inquires, please contact David Holland, Business Development Manager, at dholland@ctmginc.com.
Many Sponsors are currently under the belief that frequent on-site monitoring visits in order to verify all data is the method most preferred by the FDA. In fact, the agency states in the recent guidance that centralized monitoring can, and should be considered. The reasoning behind their position is that typical problems with data, such as fraud, can be more easily and consistently detected by centralized monitoring techniques.
The FDA does not however, believe that Sponsors and CROs should completely abandon the on-site monitoring visit. In fact, the agency urges them to conduct at least one on-site visit, preferably in the early stages of the study, in order to evaluate the sites processes and controls for handling source documents. Additionally, the agency recommends more on-site visits in cases where the PI lacks significant experience or when there are significant safety concerns due to a product for which there is no prior experience in human clinical trials.
The aforementioned aspects of the FDA’s recent guidance can all be addressed through CTMG processes, which provide the type of constant oversight and centralized monitoring which the agency heavily favors in comparison to intermittent on-site monitoring. In addition to daily review of subject pre-screening, patient visit scheduling and study enrollment - with the application of corrective and/or preventative actions as indicated – internal source document quality assessment and correction are all managed for the investigator by CTMG personnel as part of the study. This constant vigilance provided by CTMG clinical coordinators, regulatory personnel, QA personnel, as well as executive management, creates the type of centralized monitoring infrastructure requested by the FDA in their recent guidance.
For additional information on CTMG services and processes, please visit http://www.ctmginc.com. For Business Development inquires, please contact David Holland, Business Development Manager, at dholland@ctmginc.com.
Monday, July 25, 2011
CTMG Inc. announces the creation of 8 new positions following their recent infrastructure expansion
Please join CTMG, Inc. in welcoming the following professionals to our elite team:
2 Quality Clinical Research Coordinators
1 Quality Clinical Research Coordinator Assistant
2 Data Management Associates
2 Clinical Support Associates
1 Regulatory Assistant
2 Quality Clinical Research Coordinators
1 Quality Clinical Research Coordinator Assistant
2 Data Management Associates
2 Clinical Support Associates
1 Regulatory Assistant
Friday, July 15, 2011
CTMG increases its presence in the Raleigh/Durham area
CTMG is proud to announce the opening of their Durham, NC office. The office is located in the CATO Research Building on S. Alston Ave. With this most recent expansion, CTMG now has two offices in the RTP.
CTMG welcomes any business development inquiries from local pharmaceutical companies, private practice physicians, or full service CROs.
Business Development Contact:
David Holland (Business Development Manager)
dholland@ctmginc.com
CTMG welcomes any business development inquiries from local pharmaceutical companies, private practice physicians, or full service CROs.
Business Development Contact:
David Holland (Business Development Manager)
dholland@ctmginc.com
Wednesday, July 6, 2011
CTMG opens new office!
CTMG is proud to announce the opening of a new office!
The new office is located in Raleigh, NC. With this expansion, CTMG will be closing its Wilson, NC office, but retaining the Greenville, NC office as its HQ.
CTMG is excited to be joining the RTP family and is looking forward to meeting with other CROs, pharmaceutical companies, as well as local physicians who are interested in being a study Investigator.
The new office is located in Raleigh, NC. With this expansion, CTMG will be closing its Wilson, NC office, but retaining the Greenville, NC office as its HQ.
CTMG is excited to be joining the RTP family and is looking forward to meeting with other CROs, pharmaceutical companies, as well as local physicians who are interested in being a study Investigator.
Friday, May 6, 2011
The Problem is not with the FDA….
Anton Lewis Usala, MD
President and CEO
CTMG, Inc.
Recently, a colleague sent me a link to an article about the Venture Capital lobby pressuring the FDA to speed up their review process.
http://www.xconomy.com/national/2011/04/25/vcs-turn-up-the-heat-on-fda-to-get-faster-more-predictable-to-save-u-s-jobs/
This is one of many such pieces to appear online. As the above article points out, Venture Capital has pulled back from investing in start-up biotechnology/pharmaceutical/medical device companies because of the risk that the FDA will delay evaluating their new test article, require additional expensive studies, or endlessly require re-work of the data.
There is plenty of reason for Venture Capital to be hesitant, as they need to get a return on their investment at least some of the time. Given that the number of new drugs approved by the FDA was only 21 last year (http://www.drugs.com/news/fda-s-approval-down-2010-28669.html), and the much cited cost of bringing a new drug to market exceeds $1 billion (NOTE: This figure is hotly debated), it is rational for the Venture Capital community to seek more predictability into what has become an unpredictable, highly expensive investment.
However, in my experience, the FDA is a consistent, steady regulatory body that has a design-reviewed system for conducting its evaluation process. The apparent inconsistencies do not result from the FDA changing its personnel, focus, or systems, but rather with the steady decline in the evaluability of clinical research data.
I believe the reasons for this decline are many, but one cause stands out from all the other peripheral factors—a total lack of design-reviewed, controlled processes linked to required Quality Systems at the point of Physician Investigator data acquisition when conducting clinical trial visits.
All other aspects of drug development require design-reviewed, GxP processes to be administered under layered Quality Systems. The most frequent cause for an FDA 483 for Sponsors is a lack of well described Corrective and Preventative Action (CAPA) Systems. These CAPAs describe what a Sponsor will do IF a variance or out of specification event is detected by their Quality System review of their GxP processes. These processes are required of the Sponsor during their pre-clinical testing, discovery, and manufacturing. However, once a test article enters testing in human clinical trials, neither the code of Federal Regulations nor ICH Good Clinical Practices require design-reviewed procedures or Quality System review at the point of Physician Investigator protocol execution.
It is really quite stunning that this is the only part of the drug development process that has no such requirements. ICH GCPs list what should be done, but as there are no design-reviewed processes nor quality systems to ensure what is intended in a protocol is actually done, each clinical site conducts the study differently.
On an operational level, the lack of these processes and Quality Systems results in the staggeringly poor enrollment metrics at nearly all Investigative Sites. A well designed system is a missing necessity needed to make all the uncontrolled events converge, resulting in robust patient enrollment. Quality Systems, and most importantly CAPA Systems, are required to assure that what is intended in the protocol is in fact done, and done on time. When operational timelines are not met, effective CAPA systems and Quality Review are required to provide on-site solutions.
The FDA utilizes these systems to evaluate data, and reviewers are able to pick up data inconsistencies as a result. Without these systems, it is no wonder that the FDA requires additional testing and credible evidence that new test articles are both safe and effective.
Imagine if the FDA were to receive data sets from Investigative Sites that had validated, design-reviewed processes, administered under layered Quality Systems with CAPAs.
The cost of doing studies in this manner would be significantly cheaper, as fewer investigative sites and fewer patients would be required. The time to market would in many cases be halved.
And for the Venture Capital Investors, that halving of the time to market means sales revenues in half the time.
The problem does not lie with the FDA. The Regulations need to be strengthened to require design-reviewed processes, administered under layered Quality Systems, at the Investigative Sites.
President and CEO
CTMG, Inc.
Recently, a colleague sent me a link to an article about the Venture Capital lobby pressuring the FDA to speed up their review process.
http://www.xconomy.com/national/2011/04/25/vcs-turn-up-the-heat-on-fda-to-get-faster-more-predictable-to-save-u-s-jobs/
This is one of many such pieces to appear online. As the above article points out, Venture Capital has pulled back from investing in start-up biotechnology/pharmaceutical/medical device companies because of the risk that the FDA will delay evaluating their new test article, require additional expensive studies, or endlessly require re-work of the data.
There is plenty of reason for Venture Capital to be hesitant, as they need to get a return on their investment at least some of the time. Given that the number of new drugs approved by the FDA was only 21 last year (http://www.drugs.com/news/fda-s-approval-down-2010-28669.html), and the much cited cost of bringing a new drug to market exceeds $1 billion (NOTE: This figure is hotly debated), it is rational for the Venture Capital community to seek more predictability into what has become an unpredictable, highly expensive investment.
However, in my experience, the FDA is a consistent, steady regulatory body that has a design-reviewed system for conducting its evaluation process. The apparent inconsistencies do not result from the FDA changing its personnel, focus, or systems, but rather with the steady decline in the evaluability of clinical research data.
I believe the reasons for this decline are many, but one cause stands out from all the other peripheral factors—a total lack of design-reviewed, controlled processes linked to required Quality Systems at the point of Physician Investigator data acquisition when conducting clinical trial visits.
All other aspects of drug development require design-reviewed, GxP processes to be administered under layered Quality Systems. The most frequent cause for an FDA 483 for Sponsors is a lack of well described Corrective and Preventative Action (CAPA) Systems. These CAPAs describe what a Sponsor will do IF a variance or out of specification event is detected by their Quality System review of their GxP processes. These processes are required of the Sponsor during their pre-clinical testing, discovery, and manufacturing. However, once a test article enters testing in human clinical trials, neither the code of Federal Regulations nor ICH Good Clinical Practices require design-reviewed procedures or Quality System review at the point of Physician Investigator protocol execution.
It is really quite stunning that this is the only part of the drug development process that has no such requirements. ICH GCPs list what should be done, but as there are no design-reviewed processes nor quality systems to ensure what is intended in a protocol is actually done, each clinical site conducts the study differently.
On an operational level, the lack of these processes and Quality Systems results in the staggeringly poor enrollment metrics at nearly all Investigative Sites. A well designed system is a missing necessity needed to make all the uncontrolled events converge, resulting in robust patient enrollment. Quality Systems, and most importantly CAPA Systems, are required to assure that what is intended in the protocol is in fact done, and done on time. When operational timelines are not met, effective CAPA systems and Quality Review are required to provide on-site solutions.
The FDA utilizes these systems to evaluate data, and reviewers are able to pick up data inconsistencies as a result. Without these systems, it is no wonder that the FDA requires additional testing and credible evidence that new test articles are both safe and effective.
Imagine if the FDA were to receive data sets from Investigative Sites that had validated, design-reviewed processes, administered under layered Quality Systems with CAPAs.
The cost of doing studies in this manner would be significantly cheaper, as fewer investigative sites and fewer patients would be required. The time to market would in many cases be halved.
And for the Venture Capital Investors, that halving of the time to market means sales revenues in half the time.
The problem does not lie with the FDA. The Regulations need to be strengthened to require design-reviewed processes, administered under layered Quality Systems, at the Investigative Sites.
Subscribe to:
Posts (Atom)