Navigation Links
Researchers query FDA about updating requirements for drug approval
Date:1/31/2008

Rockville, MD Scientists and the Food and Drug Administration (FDA) are discussing how new technologies in ophthalmology, which make it possible to collect better data about experimental treatments, might affect FDA clinical trials requirements.

Researchers from the National Institutes of Healths National Eye Institute (NEI) and major US universities and research centers met in a roundtable discussion with FDA representatives before an audience of their peers on November 28-29, 2006 in Washington DC.

The discussion among the 30 participants focused on endpoints and clinical trial strategies for evaluating new treatments for age-related macular degeneration (AMD), diabetic retinopathy and other severe retinal disorders.

The exchange is the subject of Report from the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium, an article in the February 2008 issue of ARVOs peer-reviewed journal, Investigative Ophthalmology and Visual Science (http://www.iovs.org/cgi/content/full/49/2/479). The authors are Karl G. Csaky of Duke University Medical Center, Elaine A. Richman of Richman Associates and Frederick L. Ferris III, of NEI.

The FDA currently recommends that clinical study sponsors compare changes in visual function (measured on a visual acuity chart of letters and numbers) as a primary endpoint in assessing the effect of a new compound for treating a disorder of the eye.

Many scientists feel that the FDA parameters may not be sensitive enough for studying diseases that progress very slowly or for studying the effect of new anti-VEGF agents for treating AMD. They query whether new technologies could more efficiently detect a treatments effectiveness, thereby hastening the translation of clinical trials into better treatments in the doctors office.

Such new technologies include optical coherence tomography (OCT), a scanning technology that maps, in 3-D, the minute hills and valleys of the retina.

Scientists suggested the FDA consider other endpoints, like OCT-detected changes in the thickness of the retina or the disappearance of problem blood vessels.

The FDA position is firm yet open. FDA representatives reminded researchers that the FDA sets a high bar for new drug approvals.

The agency might consider a lower bar and different endpoints for clinical trials, provided the degree of risk to the patient is correspondingly smaller and the trial sponsor is able to justify the clinical relevance of the new endpoints.

The FDA representatives also explained several new standards for drugs when two products are used in combination (called combination products or multi-agent products).

The report also reflects discussions about drug safety, post-marketing drug surveillance between eye study designs, mechanisms for obtaining and substantiating data for retinal disease post-marketing, and whether statistically significant differences in visual function outcomes are clinically important.


'/>"/>

Contact: Joanne Olson
jolson@arvo.org
240-221-2923
Association for Research in Vision and Ophthalmology
Source:Eurekalert

Related medicine news :

1. MITs McGovern Institute researchers awarded $8.5M to study brain basis of autism and dyslexia
2. U of M researchers discover a pathway to turn off immune system cells
3. Oregon researchers find trigger gene for muscle development
4. Researchers uncover more about how poxviruses evade the immune system
5. UCLA researchers discover biomarkers that predict lung cancer patient response to therapy
6. Penn researchers discover new target for preventing and treating flu
7. Researchers investigate links between prostate, cadmium, zinc
8. New nanotube findings by Stanford researchers give boost to potential biomedical applications
9. Researchers Map Paths Governing Neuron Function
10. Cold Spring Harbor Laboratory researchers race against time to save Tasmanian devils
11. Researchers at Peoria Pulmonary Associates to study airway bypass procedure for emphysema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
(Date:10/12/2017)... ... 12, 2017 , ... Dr. Parsa Mohebi, the Los Angeles ... to the newly revamped Cosmetic Town journal section, featuring articles written ... known as Follicular Unit Extraction (FUE). , Dr. Mohebi says “I ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... for the 49th Congress of the International Society of Paediatric Oncology (SIOP) ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. ...
(Date:10/12/2017)... GRAND RAPIDS, Mich. (PRWEB) , ... October 12, ... ... OnSite Wellness, has been named one of Michigan’s 2017 Best and Brightest in ... Best and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... COPENHAGEN, Denmark , Oct. 2, 2017 The ... tool in the struggle to reverse the tide of prescription ... plan for regulating their medicine intake and stepping down their ... is set to launch in December 2017; the first 100,000 ... access. Learn more at http://www.rebound-solution.com/ ...
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., a ... design, and immune-engineering today announced the launch of ... development of personalized therapeutic cancer vaccines. EpiVax has ... exclusive access to enabling technologies to the new ... will lead EpiVax Oncology as Chief Executive Officer. ...
Breaking Medicine Technology: