Clinical trials are research studies that involve people. A study is intended to evaluate the safety and effectiveness of medications or medical devices by monitoring their effects on large groups of people. Volunteers are recruited, and in some cases research participants may be compensated for their time and travel. Clinical trials are key to developing new methods to prevent, find, and treat all types of diseases.
It is through clinical trials that scientists can find out if new treatments are safe and effective and work better than current treatments. For patients, clinical research trials represent an avenue for receiving promising new therapies that would not otherwise be available. Patients with difficult-to-treat or ‘incurable’ diseases may pursue participation in clinical research trials if standard therapies are not effective.
Clinical research plays a crucial role in advancing medical knowledge and improving patient care by exploring new treatments, therapies, and diagnostic procedures, as well as gaining insight into the underlying mechanisms of diseases.
Observational studies, in particular, are valuable in identifying potential risk factors for certain diseases, such as the connection between smoking and lung cancer.
Outcomes-based research helps healthcare providers determine the most effective treatments and therapies for various medical conditions. Additionally, clinical research plays a role in the development of innovative medical technologies.
Clinical research is conducted for the benefit of society, and the participation of volunteers is crucial in advancing medical knowledge. Many people choose to participate in clinical research with the goal of improving their own health and that of others. The opportunity to contribute to the advancement of medical science is a powerful motivator for many individuals.
There are two types of clinical research studies: Intervention and Non-intervention studies (clinical research).
Enroll patients and provide a specific treatment or intervention to the patients to study its impact and effectiveness on different illnesses. Examples of interventional clinical trials are:
Don’t provide treatment to patients, but instead study important factors that help advance our understanding of illnesses and thier impact. Non-intervention studies often lead to therapeutic studies.
Almost anyone can participate in a clinical trial. You can participate in clinical trials to advance medical research, regardless of your age, health, ethnicity or background. There is no-insurance required, nor any proof of legal status or citizenship.
Many trials are for healthy volunteers. These include most vaccine trials. Others are looking for people with specific illnesses or medical conditions, such a type 2 diabetes. These potentially offer participants the chance to access new investigational therapies, well before they are approved for the general public.
Each trial has specific inclusion and exclusion criteria to determine the exact patient populations that may participate. Individuals who fit the predefined and pre-approved inclusion criteria for a trial may participate if the trial is currently accepting participants. Inclusion criteria are based on factors such as patient age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
The informed consent form outlines important information about a study, including its purpose, duration, compensation, risks, and expectations for participants. This information can help you decide whether or not to participate.
Our clinical staff can provide more details and answer any questions you have, and you're free to withdraw from the study at any time. It's important to note that each study will have its own unique informed consent form.
Clinical studies are conducted by a principal investigator, usually a medical doctor, along with a research team that may include doctors, nurses, social workers, and other health care professionals.
These studies can be sponsored or funded by various organizations, including pharmaceutical companies, academic medical centers, voluntary groups, and government agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Individuals and healthcare providers can also sponsor clinical research. The Guardian Angel Research Center is an example of an organization that may conduct clinical studies.
Clinical trials are designed to evaluate and test new interventions such as therapies or medications. Clinical trials are often conducted in 4 phases and each phase has a different purpose.
The researchers test an experimental study drug or treatment within a small group of people for the first time. The researchers evaluate the safety of the treatment, determine a safe dosage range, and identify side effects.
The experimental drug or treatment is then given to a larger group of people to determine its efficacy to further assess its safety.
The experimental drug or treatment is given to large groups of people. The researchers confirm its efficacy, keep track of side effects, compare it to the most commonly used treatments, and collect information that will let the experimental drug or treatment be used safely.
Post-marketing studies, which are performed after a treatment is approved for use by the FDA, provide additional information, such as the treatment or drug's risks, advantages, and best use.
A placebo is an inactive substance that looks and tastes like the drug on trial but has no effect on the disease. The term “placebo-controlled” indicates that this study includes a placebo.
In other words, there is a chance that the medication you receive is inactive and not an actual treatment. It is used as a control group to compare the real study’s drug effects. Your symptoms may come from the actual drug, or your perception of what you received if you got the placebo. Therefore, “placebo controlled” maintains integrity of the study.
Placebos are a very important part of clinical studies as they provide researchers with a comparison point for new therapies, to prove their safety and effectivity. They can provide the evidence required to apply to regulatory bodies for approval of a new drug.
Yes. Most trials offer compensation for your time and effort, which could be anywhere from a few hundred to a thousand dollars. The amount of payment often has to do with the phase of the trial.
Every study is a little bit different, the compensation you receive is approved by an independent ethics board, and is relative to what is required of you in that trial, including the length and number of study visits. The compensation is detailed in the informed consent document.
When you speak with our specialists, please feel free to discuss the compensation with them. We appreciate the sacrifice of your time and effort entailed in study participation, and will be upfront with you about compensation.
At Guardian Angel Research Center, we are dedicated to providing patients with the best medical research services possible. Our clinic is dedicated to conducting and closely monitoring Clinical Research in an effort to improve disease prevention, diagnosis, and treatment methods.