How to Identify And Enroll Alzheimer's Patients In Clinical Trials
Medically reviewed by Dr Helen C Ly.
There are more than 750 listed clinical trials for nervous systems disorders in various stages, and in various stages of recruitment, as of this writing. 2,500 of them are for Alzheimer’s patients. But many neurologists, geriatricians, and PCPs perceive the effort to enroll their patients in these trials as onerous, even if the patient is asking for additional or alternative treatment options.
And patients do ask for them. In fact, research from the Global Alzheimer’s Platform Foundation finds that 59% of afflicted Americans would sign up for a trial. Getting these patients to a trial can result in improved patient outcomes, better engagement and participation, and ancillary revenue to the practice. Plus it advances medicine for future patients. Without participation in neurologic clinical trials, our society cannot progress against some of the most vexing diseases affecting tens of millions of aging Americans.
So how can providers connect patients with clinical trials without too much paperwork, time, and even investment? Fortunately, today there is a simple way to do so, and you can read more about that in our recent article Do I Have to be a PI to Refer Patients to Clinical Trials?
Consider these statistics:
- Only 10% of patients with Alzheimer’s end up eligible for clinical trials - to admit 100 eligible volunteers into a trial, you would need to screen a minimum of 1,000 potential volunteers)
- 80% of drug development programs are delayed due to unfulfilled enrollment numbers
- 15-20% of all clinical trials fail to enroll just one patient, and 66% fail due to being unable to meet their initial enrollment goals
So how can this issue be solved? What will improve the poor enrollment rates of Alzheimer's patients into clinical trials?
NOTE: This article will not focus on factors related to study design that act as barriers towards patient enrollment (ex. Study length, visit frequency, risks of side effects associated with the drug/procedure, etc.)
Increase Awareness of Clinical Trials Among Physicians & Patients
Without question, the most pressing reason behind poor enrollment involves a lack of awareness with physicians and patients.
Recent research statistics back this assertion up:
- There is a high degree of positive correlation between a physician’s knowledge of clinical trials currently enrolling in their field, and the number of their patients who end up enrolling (Source)
- Despite an overall high willingness to refer patients to clinical trials, the actual awareness levels of said opportunities among physicians are low (Source)
- Over 50% of patients are unaware of the active clinical trials pertaining to their disease state (Source)
- An interesting fact to note here is that just three years ago, SiteRx did not exist. SiteRx was established to address this very issue. Our sole mission is to bridge the gap between clinical research and clinical care.
Fortunately, researchers have several reliable mediums to increase awareness of the clinical trials where Alzheimer's patients are eligible to join.
Clear, Concise, Comprehensive Communication of Clinical Trial Facts
In the book Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary, communication is cited as one of the primary challenges behind recruitment for clinical trials:
“Emphasize effective communication, taking into account literacy levels, vision (especially with elderly patients), and language, and ensure that information given is no more complicated, jargon-laden, or legalistic than it absolutely needs to be.7
Effective communication requires recognition of the gap in subject-matter knowledge between researchers and prospective participants and appreciation of attitudes toward research, clinical trials, and health care providers.”
And as later noted in the book, having a “win-win” approach to communication ensures that patients will better see how the trials are important for their own health.
Details that are crucial to be transparent about for higher patient enrollment rates can include the following:
- Emphasize the benefits patients will experience as a result of their participation - receiving expert medical care, contributing towards the progression of available Alzheimer’s drug therapies, gaining access to life-saving treatments before they are available to the public, etc.
- Be honest about all of the risks involved with the clinical trial - receiving a placebo instead of the experimental treatment, potential side effects, the possibility of the drug being ineffective, travel costs, study duration, etc.
- Inform the patient of how they will be able to give consent, whether by themselves or through their caregiver.
Local Health Community
According to research published at the International Conference on Alzheimer’s Disease hosted in 2009:
“Partnering with local physicians, working with local clinics, and conducting educational seminars and health fairs were found to be the most effective tools in recruiting people for Alzheimer's clinical studies.”
“Surprisingly, patient registries and Internet recruiting were found to be much less successful recruitment strategies.”
While online advertising may provide a level of convenience to researchers, traditional forms of networking are still useful for increasing patient and physician awareness.
Direct communication with physicians specializing in the treatment of AD, especially those frequently involved in “on-the-ground” community events with other patients, will likely improve enrollment rates among patients with AD.
Research data from marketing company Hootsuite reveals that 65% of US adults ages 50-64 are active on Facebook, and it is the #1 platform used by seniors (ages 65 and up). Additionally, some older adults spend as much as 20 hours per week on the Internet!
Whether a company chooses to engage through organic social media or paid online advertisements, there are numerous ways to target very specific demographics by filtering for multiple requirements: Age, location, disease state, interests, and so on.
As PatientCentra notes, “These social media ads should speak directly to the ways in which clinical trials can address Alzheimer’s patients’ pain points, touching on treatment goals and factors that may improve their quality of life.”
However, please do note that you will be responsible for following FDA guidelines in your advertisement and complying with the Terms of Service for your chosen advertising platform.
Patient Matching Software
Another avenue to identify and enroll Alzheimer's patients in clinical trials is to take advantage of SiteRx's patient matching software. As noted earlier, the core of what we do is make it easy for doctors to connect the right patients to the right clinical trials.
SiteRx's value includes:
- Seamlessly enrolling patients in clinical trials via a HIPAA-compliant database
- A higher participation success rate as patients are more likely to volunteer when referred by their trusted doctors
- No special training or project managing is required to ensure your patient can access a potentially life-saving clinical trial
At the time of this publication, SiteRx is the only known solution which provides clinical neurologists and geriatricians matching software to offer clinical research as a care option for their neurodegenerative patients.
Clinical trials for Alzheimer’s Disease are among the best scientific methods of inquiry we have for helping patients get access to quality improving and potential life-saving therapies.
However, without ongoing efforts to increase the awareness of patients and physicians about ongoing trials, enrollment rates will suffer, and new treatments will not be able to reach the stage of FDA approval.
If you want to learn how our AI-based platform automatically solves the burden of low enrollment by matching eligible AD patients directly to local clinical trials, schedule your FREE demo today by calling (213) 797-7520.
Under-enrollment in Alzheimer's Disease Clinical Trials
Do I Have to be a PI to Refer Patients to Clinical Trials?
Top 7 Reasons to Refer Patients to Neurology Clinical Trials
Guide to Participating in Clinical Trials