“Redesigning trials may also help recruit patients with more severe Alzheimer’s disease, shorten recruitment periods and increase retention rates may offset costs of these changes”
Timely recruiting and retaining participants into Alzheimer’s disease and other clinical trials focused on the diseases of aging is one of the biggest challenges facing the clinical trials industry. Complicating this already demanding challenge is the fact that an Alzheimer’s disease clinical trial requires not only the commitment of the person with the disease, but a study partner as well, usually a family caregiver or other knowledgeable informant such as a home health aide that is in the patients’ home daily and has enough knowledge to report to researchers any change in behavior or other Alzheimer’s symptoms throughout the clinical trial.
Personal care providers are also needed to ensure compliance with the protocols of the study drug making sure that it is taken in a timely and precise manner.
THE “BUCKSHOT” APPROACH TO ATTRACTING QUALIFIED TRIAL PARTICIPANTS IS BOTH EXPENSIVE AND INCREASINGLY INEFFECTIVE
Desperate to attract a large number of qualified participants for each trial, pharmaceutical research firms as well as neurological clinics involved in these trials, collectively spend millions of dollars on radio advertising, television advertising, underwriting promotions on public radio, adds in local newspapers, and of course the Internet. While this “buckshot” mass media campaign can generate hundreds and even thousands of calls to toll-free number many of the callers are simply not qualified for a variety of reasons to participate in the trial being advertised.
Those answering these phone calls are often poorly trained call center personnel with insufficient skills to properly screen qualified trial candidates.
In a study published in 2008 entitled “How redesigning AD clinical trials might increase study partners’ willingness to participate” several researchers from the University of Pennsylvania concluded that providing supportive home visits was a far more effective recruitment and retention tool than providing transportation services. The authors concluded that “clinical trials that reduce travel inconvenience may offset the disincentive of study features such as the risk of intervention and may also increase willingness to participate. Redesigning trials may also help recruit patients with more severe Alzheimer’s disease, shorten recruitment periods and increase retention rates (which)may offset costs of these changes. (Neurology 2008; 71:1883 – 1888)
In the spring of 2009, Informed Eldercare Decisions, Inc, (IED), a well established and nationally prominent geriatric care management firm, was approached by a pharmaceutical research firm and asked to design a model that would improve the way in which those at risk of, or suffering from, Alzheimer’s disease can learn of current research and the opportunities available for participation in clinical trials that may result in significant progress in the treatment of these diseases
They expalined to us that expensive advertising and public relations efforts using such media as newspapers, radio, television and the internet were not sufficiently successful in attracting the number of qualified research subjects needed to complete the trials.
IED proposed that by using eldercare professionals, who work with Alzheimer’s patients and caregivers every day, to screen and educate these families about clinical trial opportunities instead of spending millions of dollars on mass marketing and public relations would be both a more effective, faster, and less costly approach to achieving the goal of enrolling and retaining the number of clinical trial participants needed to complete the study.
After conducting extensive research on the problems faced by those conducting clinical trials, IED designed a program that used a carefully screened network of eldercare professionals in 20 major metropolitan areas in the U.S. to train, coordinate and collaborate with other sectors of the eldercare services network such as private duty home care agencies, to identify prospective clinical trial participants that met specific criteria to be eligible for this particular clinical trial.
After several months of research into the problem of enrolling a sufficient number of clinical trial subjects, IED was asked to design a model that would improve the way in which those at risk of, or suffering from, Alzheimer’s disease can learn of 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 the sponsor of this large AD clinical trial consider using eldercare professionals who work with Alzheimer’s patients and caregivers every day. Training and paying these professionals at their standard rate to screen and educate these families about clinical trial opportunities instead of spending millions of dollars on advertising, PR and “special event” companies would be significantly more cost effective and help to speed up the completion of the trial.
IED was first retained to develop an initial concept paper elaborating on the idea of a collaboration model between the clinical trials professionals and those who worked daily providing a range of services for frail elders and their caregivers. Professional “cultures’, we discovered, that knew very little about each other.
After reviewing the concept paper, the funding source for this particular AD clinical trial asked IED to expand our ideas into a prototype that would illustrate how such a program would be administered and executed.
Finally IED was retained by the trial sponsor to develop a pilot program to partner private geriatric care managers (PGCM’s), who have extensive training and experience with a broad range of eldercare issues with local home care agencies in 20 major metropolitan areas around the country to provide a service to generate more qualified prospective candidates to be referred to clinical trial sites for screening for AD trials.
Assembling the personnel best qualified to conduct such an effort proved to be a daunting challenge. Professional social workers, nurses and home care providers were initially skeptical. Such a cross disciplinary effort to connect the research and provider communities had never been tried before. Eldercare providers were concerned with issues such as liability if any adverse reactions occurred with patients they referred, and there were also ethical considerations such as conflict of interest if the providers were being paid by the pharmaceutical company for their efforts.
PGCMs needed to understand that they were not expected to be “headhunters” or to identify patients for specific trials. To avoid conflict of interest concerns and to be in compliance with FDA guidelines about attracting clinical trial subjects, these professionals would work directly under contract with IED and not be paid directly by a pharmaceutical company.
All of these issues needed to be addressed and satisfactorily resolved prior to the GCM’s involvement in the program.
After a long and challenging process, and additional work to connect the two very different social and professional cultures of the research and provider professional communities, we then developed a two-day training curriculum for the coordinators and others who would be conducting this pilot program.
The pilot project was operational for three months and showed steady growth in the number of prospective trial candidates identified, until it was prematurely terminated due to the acquisition of the prime sponsor by a larger pharmaceutical company.
Following the termination of the pilot program, IED performed an extensive analysis of the program with input from all of the GCM coordinators, to identify strengths and weaknesses in our original model. After months of modifying and fine tuning the concept of using eldercare professionals, who work with Alzheimer’s patients and caregivers every day, to screen and educate families about clinical trial opportunities, we have now developed a more extensive awareness and supportive services program for AD clinical trials as well as other trials related to diseases of aging.
The revised program is now available nationwide.
If you are involved in conducting or promoting efforts to raise awareness of clinical trials and to provide a faster and more cost effective alternative to the “buckshot” approach of enrolling clinical trial participants. If you agree with the growing body of research that cites the value of providing caregiver support services to trial participants and family caregivers, and want to improve the retention rate of those involved in the important work of finding more effective treatments for diseases of old age contact Bob O’Toole at Informed Eldercare Decisions, by phone toll free at 1-800-375-0595 or by e-mail bob@elderlifeplanning.com for more information.
founded as a nationwide program to help raise awareness of Alzheimer’s Patients and Caregivers and to assist them in partnering with local memory disorder centers and to determine if they could participate in clinical trials for investigative new drugs for the treatment of Alzheimer’s Disease.
