Recruiting patients through sometimes dozens of study sites is among the most expensive parts of clinical research. The cost of bringing a new product to market is estimated at $1 billion, with much of that related to trials. Efforts to recruit patients more quickly could help drive down some of these costs.
Informed Eldercare Decisions, Inc. (IED) managed a 20 city pilot program using a collaborative team of geriatric care managers and home care agencies to raise awareness of clinical trials and to provide caregiver support services to trial participants and family caregivers to improve the retention rate of those families involved in the important work of finding more effective treatments for diseases of old age.
We have now developed a more extensive clinical trial awareness and supportive services program for clinical trials related to diseases of aging that will be available nationwide soon. Call us at 1-800-375-0595 or send an e-mail to Bob O'Toole at email@example.com
The Powerful Synergy of Principal Investigators and Eldercare Providers
In 2009, eldercare professionals from Informed Eldercare Decisions, (IED) working collaboratively with a team of clinical trial professionals, develpoed an experimental program to determine the value of using a national network of eldercare professionals to raise awareness of the opportunity for patients diagnosed with Alzheimer's disease to participate in clinical trials for promising new drugs to treat and possibly cure one of the most dreaded diseases known to man.
The project began when Bob O'Toole,president of IED and a nationally known social worker and geriatric care manager, was contacted by a major pharmaceutical reserach company and asked to consult with them around the difficult challenge of identifying enough qualified clinical trial candidates to participate in a large research effort on a promising new treatment for Alzheimer's diseases . During these discussions, Bob and his team at IED learned that the third stage of Alzheimer’s clinical research requires a large number of subjects to get FDA approval for new drug therapies to treat this disease.
To identify the large number of qualified participants needed, the pharmaceutical company spent a small fortune on expensive media advertising and public relations efforts using including newspapers, radio, television and the internet. Despite the large investment made to support these efforts, they were not sufficiently successful in attracting the number of qualified research subjects needed to complete the trials.
After several months of research into the problem of enrolling a sufficient number of clinical trial subjects, and retaining these patents and their family caregivers for the duration of the 24 month trial IED was asked to design a prototype that would improve the way in which those at risk of, or suffering from, Alzheimer’s disease could learn about current research and the opportunities available for participation in clinical trials that may result in significant progress in the treatment of these diseases
We proposed that those in charge of this large scale study consider using eldercare professionals, including geriatric social workers and nurses, who work with Alzheimer's patients and their caregivers every day, to screen and educate the families they worked with, as well as thier professional collegaues involved in the delivery of such services as home health care and adult day care about clinical trial opportunities instead of spending millions of dollars on radio, TV, newspaper ads and expensive public relations and "special event companies"
If you're disappointed with the costly "media shotgun" approach to making your clinical trials successful it's worth a phone call to learn more about how you can use this
highly cost effective method of identifying and retaining qualified clinical trial subjects and their family caregivers.
Call us at 1-800-375-0595 or send an e-mail to Bob O'Toole firstname.lastname@example.org
After months of teleconferences, due diligence visits to IED’s Massachusetts offices from senior management and research personnel from the pharmaceutical company, IED was retained to conduct a 6 month pilot program using a collaborative model that partnered experienced eldercare service providers with principal investigators at research sites in 20 American cities. The goal was to determine if such an effort could generate more qualified prospective candidates to be referred to clinical trial sites for screening for AD trials.
The Design, Goals and Objectives of the CARE-PAC Program
The name chosen for this pilot project was Community Alzheimer’s Research Exchange for Patients and Caregivers (CARE-PAC)
Clear goals and objectives for the project were delineated before the work got underway: Those goals and objectives were as follows:
1. IED woul develop and staff a central recruitment program office to recruit, screen and oversee the work of a nationwide network of professional geriatric care managers (PGCM’s) and home care agencies (HCA’s) located near the selected clinical trial sites.
2. IED would develop training curriculum in collaboration with a leading University based research center. Training sessions for PGCM’s and home care agencies (HCA’s) would be conducted with pre-approved training materials.
3. IED agreed to develop all aspects of the recruitment program concept in detail in under close review by research and management personnel from the pharmaceutical sponsor of all external documents
4. IED would contract with 20 experienced and highly trained nurses and social workers who were also PGCM's from a pre-screened professional resource network designed and developed by IED to work with up to 60 research sites nationwide.
5. IED's network of PGCM coordinators would be expected to identify home care agencies (HCA’s) in their region who were most likely to serve a significant number of AD patients. These HCA's were contracted with IED to identify Alzheimer’s patients and family caregivers most likely to be good candidates for inclusion in the study.
6. The PGCMs woul provide pre-screening services for referred trial candidates and also provide family case management services when requested by a site for the purposes of assisting the completion of the screening process.
7. The HCA’s provided trial candidate identification and educational services for those candidates passing the pre-screen. HCA’s would then be available to provide caregiver services when requested by a site for the purposes of assisting the completion of the screening process.
8. The PGCM’s and HCA’s would be under contract to and compensated by IED from funds provided by the CARE-PAC sponsor on a fee for service basis at normal market rates. At no time will they be compensated based on the number of subjects that became participants as this was forbidden by FDA guidelines..
If you're disappointed with the "media shotgun" approach to making your clinical trials successful it's worth a phone call to learn more about how you can use this highly cost effective method of identifying and retaining qualified clinical trial subjects and their family caregivers.
Call us at 1-800-375-0595 or send an e-mail to Bob O'Toole at email@example.com