 |
||||
 |
|
|
 |
 |
Clinical Research Support
Clinical Trials - Minority Recruitment and Inclusion
Pharmaceutical and biotech companies are facing more stringent requirements surrounding efficacy and safety on new drug applications, particularly as they relate to minority populations and women. African Americans and Hispanics represent the largest minority subgroups in the United States, and are disproportionately and more severely affected by disorders such as cardiovascular disease, diabetes, hyperlipidemia, HIV/AIDS, asthma, obesity and cerebrovascular disease. Complying with the FDA guidelines regarding proportional inclusion of minorities and women in clinical trials has the potential for significant financial gain to pharmaceutical companies as new products receive quicker approval and are brought to market sooner. Further, the Center of Drug Evaluation & Research (CDER) notes that 4% or less of the participants in 2500 clinical trials conducted between 1995 and 1999 were African American. This trend continues today, even though it has been well established that certain drugs are metabolized differently in African Americans and women. Thus, minority inclusion in clinical trials also serves to improve healthcare for all Americans.
It has also been determined that a major barrier to successful drug development has been finding appropriately trained and experienced clinical investigators who have access to specific patient populations required to adequately test a drug’s efficacy and safety. In this regard, African-American and Hispanic physicians represent an important source of new clinical investigators that have ready access to this highly valued clinical population. HOV Clinical Research has established a network of local clinical research alliances which provide training and support to investigators as they successfully deliver patients to drug company sponsors in clinical trials.