If you or someone you know has a disease that’s not responding to traditional treatment protocols, you may want to consider taking part in a clinical trial.
Susan Locke
The first step is to ask your physician if he or she is aware of any clinical trials where you would meet the qualifications for the study. Be aware that clinical trials have very specific inclusion and exclusion criteria: the stage of your disease, age, previous treatments, medical illnesses, etc. It’s also important to understand the phases of clinical trials.
Phase 1: Researchers test a new drug or treatment in a small group (10-20) of subjects for the first time to evaluate its safety and safe dosage — and to identify side effects.
Phase 2: The drug is given to a larger group (100-300) to see if it’s effective and to further evaluate its safety.
Phase 3: The drug is given to an even large group (1,000-3,000) to confirm its effectiveness, monitor side effects and compare it to commonly used treatment.
Phase 4: Studies are done after the drug or treatment has been marketed to gather further information about the effect in various populations and side effects of long-term use. After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits and optimal use.
The most comprehensive site to find clinical trials for all medical conditions is clinicaltrials.gov. Search for studies under “advanced search.” The “search terms” have to be filled out to get results. But the key is to try to get the most relevant studies for your condition.
Here are a few hints for the specific sections to make your search more specific. Recruitment: choose “open studies.” Study Results: choose “all.” Study type: choose “interventional studies.” Skip “Targeted Search” unless you’re only looking for a specific intervention. Locations: if location is an issue, you can specify. The most important section in “Additional Criteria” is to specify the phase of the study. I recommend limiting your choice to Phase 3 or 4.
Hit “search” and you’ll be see all the trials that meet the criteria you specified. However, you need to look at each study individually. It’s important to understand what treatments are being given and also to look at the inclusion and exclusion criteria.
Confer with your physician if you find a likely match. He will need to be involved with your application for the trial. Clinical trial investigators will want to get specific medical information and history from your physician.
For clinical trials specific to a cancer treatment, another excellent source is on the American Cancer Society website: cancer.org. This site lists National Cancer Institute-supported trials.
Healthnetwork can help with your search, but understand that we’re limited by not knowing all the medical details of your specific condition and previous treatments. The list we generate may include many studies for which you do not qualify.
If you would like more information about Healthnetwork Foundation and how we can advocate for you, please call or email us today.
SUSAN LOCKE,MD, is Healthnetwork Foundation’s medical director.
HEALTHNETWORK is a Legatus membership benefit, a healthcare “concierge service” that provides members and their families access to some of the most respected hospitals in the world. One Call Starts It All: (866) 968-2467 or (440) 893-0830. Email: [email protected]
HEALTHNETWORK FOUNDATION is a non-profit whose mission is to improve medicine for all by connecting CEOs with leading hospitals and their doctors to provide the best access to world-class care and increase philanthropic funding for medical research.