Crushing 8 Myths About Clinical Trials
Did you know it can take an average of 10 years to develop a new medicine at a cost of $2.6 billion dollars?
To develop a new medicine, researchers have to prove that the medicine is safe and effective through clinical trials before gaining approval from federal regulatory agencies. Finding enough volunteer participants to participate in the clinical trials is one of the biggest obstacles facing researchers.
- Myth: Clinical volunteers are merely human guinea pigs. FACT: Strict guidelines ensure clinical trial volunteers are treated fairly and ethically. Before volunteers can participate in clinical trials, researchers must complete a rigorous screening and preclinical testing process that can take up to six years. Also, every clinical trial has a thorough informed consent process to protect a volunteer’s rights, including the right to leave the trial at any time.
- Myth: Clinical trials are dangerous because they use new practices and medicines. FACT: The new medicine (investigational drug) is only given to clinical trial volunteers after it has been rigorously tested and scientific evidence indicates the drug is likely effective and safe for use in humans. Clinical trials are research-based and there may be some level of risk involved. However, all clinical trials are reviewed before they start by an institutional review board comprised of doctors, scientists and community members who are responsible for protecting clinical trial volunteer participants.
- Myth: Informed consent is just reading and signing a piece of paper. FACT: Informed consent is an ongoing, interactive process – not a one-time session. The process involves two essential parts: a document and a process. The informed consent document includes all the information a volunteer patient needs to help make a decision about participating in a clinical trial. The document describes the purpose of the clinical trial, explains the visits and procedures and includes the possible risks and benefits of participating – all in a way that is easy to understand. The informed consent process provides participants with ongoing explanations to help them make educated decisions about beginning or continuing in a clinical trial.
- Myth: Even after joining a clinical trial, a volunteer might get a “sugar pill” or placebo instead of a real drug. FACT: The decision to use a placebo in a clinical trial is based on how serious the illness is, whether an existing treatment is available and other factors that ensure a high ethical standard. When conducting research on a serious or life-threatening disease, the best available treatment or standard of care is used instead of a placebo.
- Myth: Some people who volunteer for a clinical trial are told by the research team they are not eligible to be in the trial. The process seems unfair. FACT: Every clinical trial has a protocol, a plan that describes the process, how the trial is conducted, why each part of the trial is necessary, eligibility criteria and guidelines on who can participate in the trial. Common eligibility criteria include age, gender, medicine and medical history and current health status. These criteria are used to identify the volunteers who are most likely to benefit from the clinical trial. Volunteers are not personally rejected. The criteria is also necessary to help researchers answer research questions about the investigational drug they plan to study.
- Myth: Being in a clinical trial will be painful or unpleasant. FACT: Processes and procedures can be different for each clinical trial. Research providers talk to participants in advance of the trial about what to expect and the informed consent document contains the procedures and risks of each trial. Clinical trials have potential benefits and risks such as side effects or pain. The institutional review board also ensures the benefits and risks are carefully weighed and the trial is reviewed for unnecessary harm or discomfort before it starts.
- Myth: Being in a clinical trial won’t help. FACT: It’s important to speak with a doctor or the research team about the clinical trial protocol and the risks and the benefits of participating in the trial in advance of making a decision. A potential benefit of participating is volunteers may have an opportunity to receive an investigational drug that is not available to people outside the trial. Also, the clinical trial research team closely monitors participants and with the trial protocol, additional tests and lab work may be part of the care provided. Some trial volunteers also report great personal satisfaction that they have played a key role in advancing medical science and helping find new treatments that will help people live longer, healthier lives.
- Myth: Providers will make their patients aware of clinical trials that might help them. FACT: Your doctor may not know about all available clinical trials that might benefit a patient. The National Institutes of Health has an online database that consumers and providers can use to search for appropriate trials, www.clinicaltrials.gov. Patient advocacy organizations can be good contacts to help navigate the process. Many have tailored services that can help patients with their search and understanding options.
The National Council for Behavioral Health is pleased to partner with the Vanguard Research Group (VRG) Network, an academic organization specializing in behavioral health research and clinical trials. The mission is to improve the circumstances of people with mental illness by partnering with community mental health centers across the US and providing them opportunities to be involved in research programs and clinical trials. VRG conducts many types of research projects such as evaluating new technologies, implementing new types of psychosocial treatments and testing new medications or medication algorithms.
By joining the VRG network, your site will be provided information about future research projects. As a research opportunity becomes available, VRG staff will inform all sites in the network about the upcoming project. If you think your organization would be a good fit and are interested in learning more about the project, please view the Vanguard Research Group Network Summary or contact Vivianne Dillon at firstname.lastname@example.org or 347-738-2449.