Clinical trials in Alzheimer’s disease, depression, and schizophrenia: challenges of patient recruitment
Lisa Sipe, BA l Director, Clinical Operations l ICON Clinical Research
Mental illness is a significant healthcare problem worldwide and represents a major economic burden. In 2002, the World Health Organization (WHO) estimated that globally there were 24 million people with Alzheimer’s disease (AD) and other dementias, 154 million people with depression and 25 million with schizophrenia. (1) AD represents a major public health problem in many countries because it has a significant impact not only on the individual but also their families, the healthcare system, and society. In the U.S., it is estimated that up to 4 million people have AD and by 2050 that number is expected to increase to 14 million.(2) The cost of caring for people with AD is estimated to be U.S. $100 billion per year.2 Depression and schizophrenia are also significant public health problems. The economic burden of depression in the U.S. in 2000 was estimated to be U.S. $83.1 billion.(3) Of this total, U.S. $26.1 billion (31%) were direct medical costs, U.S. $5.4 billion (7%) were suicide-related mortality costs, and U.S. $51.5 billion (62%) were workplace costs.3 The cost of schizophrenia to the U.S. in 2002 was estimated to be U.S. $62.7 billion, of which U.S. $22.7 billion were direct healthcare costs, U.S. $7.6 billion were total direct non-healthcare costs, and U.S. $32.4 billion were indirect costs. (4).
Challenges of patient recruitment
Alzheimer’s disease (AD) • The normal channels used for advertising for patients, e.g. websites, radio and newspapers/magazines, are generally not productive for recruiting patients for clinical trials in AD so alternative methods have to be utilized. Perhaps the most important is to identify potential trial sites that have a robust database of AD patients and have established connections with day-care centers and local chapters of national support organizations. National and local organizations for patients and caregivers provide good community resources that trial sites can utilize as a recruiting base. Once a trial site has been identified, the company/sponsor needs to develop good working relationships with the investigators and site staff, who in turn must develop a rapport with patients and caregivers to ensure the smooth running of a trial.