Clinical trials are a common form of clinical research. They are conducted with the help of participant volunteers, and they play a vital role in the advancement of new treatments for diseases and medical conditions.

Before an investigational drug or device can be studied in humans, it must go through intensive testing in a laboratory by pharmaceutical companies (usually known as sponsors). The laboratory phase can last many years and only a few promising candidates make it through this phase and are allowed into the next stage of development. In this next phase, pre-clinical/animal trials are conducted and any drugs showing significant toxicity are excluded from further study. In the end, only a few are selected by the sponsor for a clinical trial involving humans, but only if sanctioned by the Food and Drug Administration (FDA).

The sponsor then chooses a qualified and reputable clinical trial site, such as Mills Clinical Research, to carry out the study. Clinical trials are conducted to establish the safety and efficacy of new drugs in humans so that the FDA can approve them for the public market. Research is a step into the unknown and there is a small possibility of harm but every step of the way, safety, and the well-being of those who participate is prioritized.

Before a medication is approved for the public, it must go through 3 stages of clinical trials, which are known as ‘phases’ of research. The trials at each phase have a slightly different goal and help researchers answer different questions. All of them are designed to monitor the safety of all those involved.

• Phase I trial – The first evaluation of an experimental drug or treatment in a small group of people (10– 90 participants usually). The purpose of this phase is to evaluate its safety and identify side effects.

• Phase II trial – The experimental drug or treatment is administered to a larger group of people (usually 100 – 300) to determine its effectiveness and to further evaluate its safety and the way it is works in the body.

• Phase III trial – This is usually the most important phase in research. The experimental drug or treatment is administered to large groups of people (usually 1,000 – 3,000) to confirm its effectiveness, monitor side effects and compare it with standard or equivalent treatments. Vaccine trials like COVID-19 enroll much larger numbers of participants.

• Phase IV trial – After a drug is licensed and approved by the FDA for broader use, researchers track its safety, seeking more information about its risks, benefits, and optimal use.

At nearly every step of the process, clinical research is meticulously monitored, audited, and regulated. The pharmaceutical sponsor provides Mills Clinical Research with a ‘protocol,’ which is a comprehensive guideline that dictates how to conduct the study. Before a clinical trial can begin, the Food and Drug Administration (FDA) and an Institutional Review Board (IRB) must review and approve the protocol.

The Food and Drug Administration (FDA) is the government agency that reviews all clinical research conducted in the United States. They are responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs and biological products. It is the FDA who determines whether a new drug is safe enough for subjects and promising enough to be studied in a clinical trial.

An Institutional Review Board (IRB) is an independent organization that is appointed to examine, approve, and monitor research involving human subjects. IRBs are used to ensure that subjects are properly informed about the trial; that the risks to subjects are minimized and reasonable in relation to the predicted benefits; that conflicts of interest are mitigated and reviewed; that there are provisions for protecting the privacy and confidentiality of subjects’ collected data; and that subjects are selected equitably and that no classes of patients are unfairly discriminated.

The physician responsible for supervising the trial at a research site is called the principal investigator (PI). At Mills Clinical Research, Dr. Anthony Mills is the PI. The most significant role of the PI is to monitor participant health and safety and provide supervision to the staff who work on those trials. Every protocol has strict inclusion and exclusion health criteria that determine who can enroll in the study. Following these criteria strictly is one of the many ways that the PI prioritizes participant safety.

Good Clinical Practice (GCP) guidelines are an additional precaution protecting the subject safety. These guidelines are made up of industry-accepted standards and federal regulations that direct human clinical trials. These standards and regulations apply to the conduct of studies, informed consent of subjects, risk-benefit assessments, conflict of interest, collection of scientific data, record keeping, and the submission of information to the FDA.

People choose to voluntarily participate in clinical trials for many reasons:

• To make a difference in the scientific community and to help improve the lives of others

• To receive first access to cutting-edge treatments and therapies

• To gain access to free medications that would otherwise be expensive once commercially available

• To collect monetary compensation for study participation

• To receive free health exams and blood tests

What goes on in clinical research can vary greatly depending on the type of clinical trial in which you are participating. Prior to enrolling in the study, the visit timeline and all trial expectations will be discussed with you. Over the course of the trial, the Principal Investigator, or a delegate, and the Study Coordinator will facilitate your participation and answer any questions that you have. The investigator and coordinator will evaluate your health at the start of trial, carefully monitor your health throughout the study, and follow up with you even after you have completed treatment.

Clinical trials often will have more tests and doctor visits than you would normally have for your illness or condition, all at no cost to you. Also, trials can range from lasting 6 months to up to six 6 years.

The United States National Library of Medicine at the National Institutes of Health maintains a registry of clinical trials at clinicaltrials.gov.

The website provides patients, family members, healthcare professionals, and the public with information on publicly and privately supported clinical studies on a wide range of diseases and conditions. Clinical trials which meet a certain definition must be registered on that website. You can find a glossary of common clinical research terms on this NIH website.