Pat Stricker, RN, MEd
Senior Vice President
TCS Healthcare Technologies
I recently read an article about a man who took part in an Alzheimer’s genetic early onset clinical trial, and it made me think about how hard it is for patients or their support system to try to find a trial that might be right for them. If they are lucky enough to have a case manager, the process is much easier. However, it is still a long, arduous process for the case manager to sift through hundreds of available clinical trials to find one that meets their patient’s specific needs.
A clinical trial, or interventional study, is a research study that uses human volunteers (participants) who receive specific interventions according to a research plan or protocol. The trial may include medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. A trial may compare already available interventions to each other, or compare a new medical product or approach to one that is already available or to a placebo that contains no active ingredients. The goal is to measure certain outcomes to determine the safety and efficacy of the interventions and whether the new product or approach will be helpful, harmful or no different than the available alternatives.
Why are clinical trials important? Interventional studies are a key research tool for advancing medical knowledge and patient care and offer new ways to prevent, detect and treat disease, as well as improve the quality of life. For the patient, the trials offer the opportunity to obtain the newest, most advanced treatments not yet available to the general public. But there is another, often forgotten, benefit of clinical trials — cost-savings.
Let’s look at how clinical trials could affect Alzheimer’s disease. According to the Alzheimer’s Association, there are about 5.4 million Americans diagnosed with Alzheimer’s today, with that number expected to grow to over 13.8 million by 2050. According to the National Institutes of Health (NIH), Alzheimer costs have roughly doubled in the last five years to $991 million. By 2050 the costs of care for Alzheimer’s and other dementia patients are expected to be $1.1 trillion. However, if clinical trials could find ways to slow the progression of Alzheimer’s by five years, experts estimate we could reduce the number of Alzheimer’s cases and the overall cost of Alzheimer’s almost in half. That is a dramatic cost reduction, not to mention a terrific opportunity to delay the pain and suffering for millions of Alzheimer’s patients and their families.
Finding a clinical trial. If your patient is a candidate for a clinical trial, where do you start? Finding an appropriate clinical trial is usually too difficult for a patient or his or her family to feel comfortable taking on. So it may be up to you, as the case manager, to manage this process. There are certain steps that should be followed to assure the process progresses smoothly and you are able to find the trial that best meets your patient’s needs. These steps include:
1. Discussing the possibility of a clinical trial with the patient and with the attending physician to make sure everyone agrees that this is the right treatment option at this point in time. Be sure to discuss the benefits and ask the physician to explain the potential risks of each type of trial. The physician may be aware of clinical trials that would meet the patient’s needs, but if not, you may need to start searching yourself.
2. Looking for clinical trials using large, searchable databases that are valid research sites. Check credentials to be sure they are legitimate, trustworthy sites. Governmental or national non-profit sites like NIH, National Cancer Institute (NCI), ClincalTrials.gov, academic medical centers, and research universities may be more trustworthy than for-profit sites.
3. Documenting details about the diagnosis, condition, treatments and specific patient needs. The clinical trial coordinator will ask for specific information when you talk with them. Many of the sites contain a checklist or questionnaire that helps gather the needed information. You may also need to get some of the information from the physician or the patient’s record. An example of a cancer checklist includes 13 questions.
4. Reviewing the potential clinical trials closely to find the trial that seems to be the most appropriate. Look at the summary that describes the trial and check the objectives to make sure they match the patient’s goals. Check the eligibility requirements, the specifics for the treatment protocols, the length of the study and the location of the study sites.
5.When you have narrowed the trials to those that seem most appropriate, contact the trial coordinator to inquire about the trial in more detail and to determine if the patient may be an appropriate candidate. Be sure to have the clinical information checklist completed and write down a list of questions and/or topics that you want to discuss with them. Some sites offer an option that allows a patient to indicate that they are interested in a certain type of trial. If they register for this option, the coordinator will call the patient when they have a new trial that meets their needs.
6.When you find the trial that seems most appropriate, talk with the physician again to make sure he or she agrees. Then explain the trial to the patient and make sure he or she understands the process and is in agreement.
7.Make an appointment with the patient and trial coordinator to begin the trial registration process.
Trying to find an appropriate clinical trial is not a quick, easy task. This type of research usually involves looking at numerous sites for trials by "type" that may include: diagnosis or condition, sub-type, stage, supportive care, screening, prevention, treatment, genetics, biomarker or laboratory analysis, tissue collection, education/counseling/training, behavioral, epidemiology, or health services. It may also include searching for specific types of drug, treatment or alternative medicine trials. In addition, patients may be interested in learning about trials provided by public or privately held organizations, pharmaceutical companies, specific hospitals or healthcare systems or academic research institutions. Lastly patients may want to search for trials close to them (by zip, city, or state). Finding and researching each of these options is a very daunting and time-consuming process. How can you find and research each of them? How do you determine if they meet the specific goals and needs of your patient? Is there a way to streamline this search process, while still assuring the trials are credible, clinically sound, and trustworthy?
General Trial Sites: Rather than searching numerous individual websites, you should begin by looking for general websites that offer all types of clinical trials and have large-scale, searchable databases that make it quicker and easier to find the trials. These include governmental and private organizations, commercial and non-profit entities, academic universities, healthcare organizations and hospital systems, and pharmaceutical companies. These typically include the ability to search by all of the types noted above, plus by: age, gender, eligibility, study phase, study results, outcomes, sponsors, funder, and safety issues. Examples of these sites include:
These sites also typically contain educational information about how to search for clinical trials; current, up-to-date trial information; questionnaires to gather necessary data before contacting a trial coordinator; results of current and past trials; and contact numbers that allow direct access to someone to answer questions or help with searches.
Specialty Trial Sites: In addition to the general clinical trial websites, specialty association websites often include trials based on a specific clinical diagnosis or condition. For example, the following are sites showing trials for Alzheimer’s and cancer:
Academic Trials: Information about clinical trials conducted at specific academic institutions is also available on their website. While it can be more time-consuming to search these individual websites, it may be beneficial to check academic institutions near the patient to see if they are conducting trials that may be appropriate. Examples include:
Pharmaceutical/Drug Trials:Finding pharmaceutical trials is a little more complicated and time-consuming, as there is no combined database with that data. CenterWatch does include the top 10 pharmaceutical companies, but you may also need to search by individual pharmaceutical company name or by the name of drug. The following "Top 5 Pharma Companies for Clinical Trials" typically provide clinical trials:
The process of finding the "right" clinical trial can be tedious, but it can make a big difference in the life of your patient and his or her family. It may be able to provide them with a cure, a better quality of life or an extended remission. How much more rewarding can it get?
As for Alzheimer’s disease, remarkable progress has been made in the last three decades. Alzheimer’s has gone from obscurity to the forefront of neuroscience, thanks to research and clinical trials. A few years ago, Alzheimer’s was only able to be diagnosed at autopsy. Now, with the use of PET scans, Alzheimer’s can be diagnosed 10-15 years before symptoms begin to show, providing individuals with the opportunity to receive early treatment to prolong their quality of life. This is exactly what happened in the clinical trial I mentioned at the beginning of this article. The early onset Alzheimer’s patient has experienced less severe symptoms and his daily functioning has improved. The trial has slowed the progression of his disease for the past three years. Not only has that provided an improved quality of life for him and his family, it has also resulted in cost savings related to his care needs.
While there still is no cure for Alzheimer’s, there are promising therapies being worked on. Hopefully, it is only a matter of time before these clinical trials identify a successful cure.
Pat Stricker, RN, MEd, is senior vice president of Clinical Services at TCS Healthcare Technologies. She can be reached at pstricker@tcshealthcare.com.