Guides Cover Photos_Clinical Trials
Last Updated: April, 2020

Clinical trials offer an opportunity for people with medical conditions or people who are interested in new approaches to healthcare to test the latest medical treatments or personal health. If you or someone you know is interested in or considering joining a clinical trial, this free guide will help you better understand how to find a trial, the risks and benefits of joining, the types of trials, and the stages of research you might participate in, patient protections, and how insurance coverage interacts with healthcare during a clinical trial.

What is a Clinical Trial?

Clinical trials are research studies that test new methods of prevention, detection, treatment, and care. The purpose of a clinical trial is to examine the effectiveness of a new intervention and compare it to existing ones. The main questions being asked by researchers are: “Does this work?”, “Is it better than the current standard treatmentStandard treatment – The form of treatment that is normally used and widely accepted. ?Standard treatment - The form of treatment that is normally used and widely accepted. ”, and “What are the harmful side effects?”

Types of Clinical Trials

Clinical trials take on several different forms depending on the information researchers hope to gather. A treatment trial is one of the more popular types of clinical trials among patient volunteersPatient volunteers – clinical trial volunteers with a specific disease or condition that is being studied.. The goal of a treatment trial is to find a better way to treat a condition or disease or broaden effective treatment options. This could include new behavioral interventions, vaccines, drugs, devices, surgical procedures, or a combination of those previously listed. Sometimes new modalities are not tested, rather, an altered sequence or combination of existing therapies is explored. Trials offer some patient volunteers the opportunity to test the efficacy of new medications that might extend or improve their quality of life with disease. In treatment trials, patients may be able to receive access to the most advanced treatment strategies for their disease. Patient participation also increases the knowledge that exists about specific conditions and how best to treat them. Participating trial volunteers value the role they play in advancing medical knowledge. Types of studies include: 

  • Natural history: investigate diseases, and collect information in order to better describe the disease. Tracks the disease and its progression. Natural history studies are mainly used for rare diseases because there is still a lot to learn about them.
  • Quality of life/supportive care: new ways of reducing end of life pain and symptoms associated with disease (drug, device)
  • Treatment: finding new ways to treat diseases. What is the best form of intervention? (drug, vaccine, device, behavioral, surgical, or combination treatment)
  • Screening: finding new ways to screen for and detect diseases. Which tests work better? How early should/can patients be screened?
  • Diagnostic: finding new ways to diagnose diseases. Which test is the most accurate and safe?
  • Prevention: finding new ways to prevent diseases. What actions prevent disease? What supplements prevent disease?
​
Safeguards for Patient Volunteers 

An area of concern for many patients who are considering treatment in a clinical trial is “being treated like a Guinea pig.” Historical events can certainly reinforce that perception, but they have also fueled the push for comprehensive safeguards in clinical trials. The central tenet of all clinical investigative trials is that the patient remains in control of all decision-making throughout trial participation. The Institutional Review Board (IRB), sometimes known as the Ethical Review Board, is the premier safeguard for research study participants. Any organization that is conducting a study must have an IRB. An IRB can be composed of researchers, health professionals, clergy members, bioethicists, community members, lawyers, and anyone with expertise in the topic of study. Its board members monitor a study from the beginning to the end. They enforce three ethical principles – beneficence, justice, and respect for persons – to ensure the safety and wellbeing of participants. The principle of beneficence requires that the treatment being tested does not harm the participant, and if possible, benefits them as well. Justice promotes equality in the processes of recruitment and treatment distribution. Respect for persons safeguards a participant’s autonomy Autonomy – a patient’s right to make their own health care decisions if they are capable. The patient’s doctor is not allowed to decide for them.. The application of this principle can be seen through the participant’s right to informed consent, to agree to participate, as well as the decision to leave a trial.


Patient Advocate/Representative

A patient advocate is someone who helps a patient navigate the healthcare system. An advocate may have personal experience with being a caregiver or a patient volunteer. Advocates are trained to support and campaign for the patient volunteer. Trust between a patient and their advocate is extremely important because the advocate acts as a liaison between the patient and the patient’s physician, insurer or employer. The advocate can be a family member, friend, or a professional advocateProfessional Advocate - advocates who have been trained and certified to help patients navigate the health care system. Advocates may sometimes have experience as a person with a diagnoses in the health care system.Professional Advocate – Advocates who have been trained and certified to help patients navigate the health care system. Advocates may sometimes have experience as a person with a diagnoses in the health care system.. Most government institutions provide patient advocates (sometimes called a patient representative) for study participants. This can be especially helpful in large institutions because it offers participants a personal contact who can answer their questions about the trial. However if you prefer a personal or Board Certified Patient Advocate (BCPA), one can be found here.


Informed Consent   

Simply because a volunteer qualifies to participate in a clinical trial does not automatically mean it is the best choice for that individual. Before participating in a clinical trial the participant must be given documents, verbal explanations and other information that allow them to clearly understand the purpose, protocols, potential risks, benefits, and processes of the study. Informed consent ensures that patients are knowledgeable about the trial they are participating in. Patients have the right to request information, ask questions, and withdraw from a study at any point. Patients should also be given enough time to discuss their possible participation with their family, friends, or patient advocate/representative.


254700  

04/20