Medical institutions, federal agencies, pharmaceutical corporations, and patient advocacy organizations conduct thousands of clinical trials annually, and according to John Schall, CEO of the Caregiver Action Network, family caregivers are the backbone of the clinical trial experience. Learning about the world of clinical trials, however, is akin to learning to speak a new language, and it can be overwhelming to both caregiver and care recipient — especially in the middle of a health crisis. So here is a simple breakdown of the top 10 facts you need to know about clinical trials:
- What are Clinical Trials? Clinical trials are a combination of interventional studies and observational studies conducted on volunteer patients.
- Why Conduct Clinical Trials? The purpose of clinical trials is to develop and bring to the market new and effective treatments for disease.
- How Common are Clinical Trials? In 2006 alone, there were about 15,000 drugs in the research and development (R&D) pipeline (1) and about 2.5 million clinical trial volunteers(2).
- Who are the Players in a Clinical Trials? Key players are the trial sponsor, who pays for the study; the principle investigator, who oversees the research; medical staff including doctors, nurses and social workers, who work directly with patients and collect data; the caregivers, who oversee patient compliance with clinical trial protocol; and the patients, who are the subject of study.
- Why Might My Loved One Choose to Participate in a Clinical Trial? According to Ken Getz, founder and board chair of the Center for Information and Study on Clinical Research Participation (CISCRP), there are numerous reasons to participate in a clinical trial — from access to new and alternative treatments, to personalized and expert medical attention, to free medicines and procedures, to the desire to leave a legacy by helping the advancement of medicine.
- Where Do I Find Out about Clinical Trials for My Loved One’s Health Condition? First, contact a patient advocacy organization that is ailment-specific to the condition affecting your loved one, and ask about clinical trial options. For example, if your loved one has Alzheimer’s, contact the Alzheimer’s Association. A simple internet search using the formula of “[disease name]” + “association” should pull up some of the top national advocacy groups. Second, visit the National Institutes of Health website on clinical trials, to find a list of upcoming research studies looking for volunteers. Third, contact CISCRP for information about, plus the added bonus of support throughout, upcoming clinical trials.
- Does Participants in a Clinical Trial Mean Stopping Other Medical Therapies? In some cases, there may be contraindications between therapies already being used and the therapies that will be used in a clinical trial. It is imperative to let the clinical trial medical team know exactly what therapies a loved one is receiving, whether prescribed or over the counter.
- How Risky Are Clinical Trials? To determine the exact risks associated with a particular clinical trial, experts agree, it is important to speak directly with the principle investigator and medical team of the trial your loved one is considering.
- What steps are involved in evaluating the safety and efficacy of drugs used in clinical trials? Pharmaceutical trials begin with years of pre-clinical research in laboratories, followed by testing on animals and concluding with several phases of testing on people. When a study begins working with people, it starts off with a small group in Phase I and steadily increases the number of people involved, until Phase IV — where the research team begins exploring additional indications for that drug. After completing Phase IV, the clinical trial team submits a New Drug Application (NDA) for approval to go on the market.
- How involved should I be in my loved one’s decision to participate in a clinical trial? To ensure the safety and quality of life for your loved one, get actively involved in evaluating the pros and cons of participating in a clinical trial.
If you or someone you know is interested in a alternative treatment option, consider learning more about Segal’s clinical study opportunities. Fill out the prescreen form below or call (877) 734-2588 for more information.