Clinical Trials 101: What Patients Need to Know

Extensive media coverage around vaccine development in response to the COVID-19 pandemic has brought clinical trials top of mind for all of us. While there has been a lot of information shared about vaccines and the companies developing them, the clinical research process is still not widely understood. Here are five things to know about clinical trials and a list of key terms.

1. They look to answer a specific question to improve a health issue or increase understanding about human biology.

The purpose of a clinical trial, also called a clinical study, is to find a new way to treat, prevent, or detect a disease that is safe and effective. They may use study medications, treatments, therapies, surgeries, medical devices, or behavior changes to improve health. (1) Some clinical trials investigate how the human body works or how disease affects it. This deeper understanding helps develop medications.

2. They are regulated with patient safety at the forefront.

Clinical trials are designed to keep participants safe above all else. A protocol is written for the clinical trial; it outlines the objectives, design, methodology and data being sought. Before the clinical trial starts, the protocol is reviewed by an IRB (Institutional Review Board), a panel of medical experts, scientists and lay people, to ensure that the clinical trial follows the safety standards of the FDA, does not pose any unnecessary risks and is ethical. Potential participants receive a document called an ICF (Informed Consent Form) that clearly describes what is going to happen during the clinical trial, potential risks and potential benefits. It is important to have all your questions answered by the clinical research staff conducting the trial before signing the ICF and ensure you understand everything. (2)

3. You can leave a clinical trial at any time.

A participant in a clinical trial can leave the trial at any time, for any reason. They may share the reason with the clinical research staff conducting the trial – or not. Participants are not obligated to give a reason for withdrawing.

4. Not all clinical studies are looking to cure a disease.

There are different types of clinical trials. For example, prevention trials investigate ways to prevent a disease in participants who have never had the disease, or to stop it from recurring. Screening trials look for the early signs of a disease in the general population. Diagnostic trials look for new tests or procedures to diagnose a particular disease or condition. Quality of Life trials focus on improving the life and comfort of patients with chronic illnesses. (3)

5. Participant diversity in clinical trials is essential.

It is vital for clinical trial participants to represent all demographic backgrounds including race, gender, age, genetic background, weight, geographic location, socio-economic, etc. Different people can have vastly different responses to the same medication, treatment or therapy. Diversity in clinical trial participation ensures that treatments will be safe and effective for all. Some communities mistrust the clinical research process, based on unethical historical events, including the Tuskegee syphilis study of the mid-twentieth century. (4) The rules that are now in place in clinical research globally prevent these events from happening again and ensure patient safety.

Patients are the heart of clinical research, and without their participation, medications, treatments and therapies would not be developed. This includes medications that require a prescription from a medical professional, as well as over-the-counter treatments. Some clinical trials require patients to travel to a clinical site, but many others have a digital focus. Lightship has a virtual-first and hybrid approach to clinical research, where our nurses can meet with you at home, at work, or a third place. Learn more about the clinical trials that Lightship is conducting here. https://www.lightshipclinical.com/

Key terms to know

Protocol: the written description of a clinical trial that outlines the objectives, design and methods

IRB (Institutional Review Board): a panel of medical experts, scientists and lay people that review the protocol to ensure it follows safety standards outlined by the FDA, does not pose any unnecessary risks and is ethical

ICF (Informed Consent Form): the document presented to potential participants before the clinical trial starts that outlines what will happen during the clinical trial

PI (Principal Investigator): the physician in charge of managing the clinical trial

Placebo: an inactive substance or treatment that looks identical to the drug or treatment being studied and is given in the same way

Sources

1. (https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics)

2. (https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics)

3. (https://www.ciscrp.org/education-center/important-information/)

4. (https://www.cdc.gov/tuskegee/timeline.htm