Clinical Trial Recruitment | Retention

Anxiety lurks among manufacturers of type 2 diabetes drugs, especially those manufacturers who have drugs in late clinical development. 

Recent FDA advisory committee recommendations have created an ongoing debate over whether Investigational diabetes agents should be subject to long-term cardiovascular safety. ¹   A firm consensus has not been reached,  however, several manufacturers are already scurrying to develop plans and design studies addressing impending implications of a confirmative study requirement.

There are 131 diabetes pipeline drugs, including 80 in phase 2 and phase 3 development.  Obvious consequences relating to study conduct will be increased competition among the many sponsors to recruit the appropriate patient type for safety assessment-subsequently retaining these patients in the study long-term and preventing lost to follow-up. 

For those agents in late stage development, slow recruitment, poor retention and ultimate study delay could potentially cause loss of a first-to-market position.  This could cost a drug manufacturer millions in revenue over the lifestyle of the drug.

Background

Several drugs in this therapeutic area raised cardiovascular safety concerns (rosiglitazone [Avandia, GalaxoSmithKline] and muraglitizar are recent examples). ¹ Compounding these concerns are:

• The recent results of the ACCORD trial-patients had increased mortality when patients underwent intensive glucose lowering. ³ 
• Unexpected results from ADVANCE, VADT and HEART2D-no CV benefit shown with intensive glucose lowering. ⁴-6

This apprehensive setting has led to FDA committee recommendations to increase the level of evidence of cardiovascular safety of new therapies for type 2 diabetes based on the requirement to conduct long-term trials or provision of equivalent evidence to rule out an unacceptable cardiovascular risk. ¹

There are several specific issues still under discussion:  (1) whether these cardiovascular assessments should occur pre- or post- approval and (2) several design considerations. ¹  However, there is no doubt that the clinical development process, approval time and cost of developing and marketing type 2 diabetes agents will dramatically increase. 

1, FDA Advisory Committee Recommends Cardiovascular Safety Studies for Diabetes Drugs [press release]. July 3, 2008. Available at: www.theheart.org.

2. Pipeline Insight: Non-insulin antidiabetics Incretin mimetics - leaders in a diverse pipeline.  Datamonitor [Reference Code: DMHC2395]. May, 2008.

3. Gerstein HC, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545-2559.

4. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes.  N Engl J Med. 2008;358:2560-2572.

5. The Veterans Affairs Diabetes Trial (VADT). Panel discussion at the American Diabetes Association 68th Scientific Sessions; June 6-10, 2008; San Francisco, CA.

Large, long-term Veterans Affairs diabetes trial (VADT) reveals important cardiovascular safety news on Avandia [press release]. PharmaLive. June 8, 2008.

6. HEART2D Study Produces No Cardiovascular Benefit by Targeting Postprandial Glucose Levels [press release]. Medscape Medical News. June 11, 2008.

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Please share your thoughts regarding our post on clinical trial recruitment / retention issues for manufacturers of diabetes agents.  Also, please email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

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