What is a Clinical Trial?

Clinical trials are a type of controlled research studies performed with the help of healthy volunteers or people with a specific disease or condition. They are conducted by doctors and clinical researchers to evaluate the safety of a treatment (i.e. investigational medicine or device) or vaccine, and how well it works.

These treatments have already passed initial safety assessments and have the potential to improve people`s health and their quality of life.

The clinical research methods used in any individual trial are designed with care to follow strict protocols. These methods receive approval from regulatory agencies and ethics committees around the world.

Clinical Trials aim to answer important medical questions such as:

Does the treatment or vaccine work?

Does it have a better effect than other treatments or vaccines already on the market?

What is the treatment or vaccine safety profile?

How does it affect certain diseases or conditions?

If you or your loved ones are living with a specific disease or condition, taking part in a clinical trial could be a good option to consider.

However, understanding the details of clinical trials is essential before making a decision.

Understanding Clinical Trials

The discovery and development of new medicines or treatment options is a long and complex process.

Clinical trials are an important part of the research process before a new treatment can be assessed by independent regulators for use in patients. Clinical trials are an option for all patients to consider and play an important role in improving healthcare. Results from clinical trials help to develop new medicines, new medical devices, new diagnostic tools, and new clinical procedures. These results can also inspire researchers to raise new questions, which lead to new findings over time and ultimately help us better understand the diseases and conditions people are currently living with.

Types of Clinical Trials

If you decide to participate in a clinical trial, it will be one of the following two options:

Interventional

Interventional clinical trials are the type of research that is needed before an investigational medicine, vaccine, device, or procedure is approved, marketed, and made available for use to patients. In this type of research, participants are provided a treatment that follows a carefully designed clinical research methods. Using these procedures, doctors and researchers typically compare at least two groups of participants: One group that has received the treatment, and one that has not received the treatment and is given an inactive placebo, or the standard of care. In some clinical trials, such as those testing dosages, all participants receive the treatment but are given different amounts. The data obtained from clinical trials are then analyzed and sent to regulatory agencies for review and approval.

Interventional

Clinical Trial Phases

It takes a lot of research before an investigational medicine can be approved by health authorities to be marketed and made available to patients. The entire clinical research process for an approved treatment takes around a decade, though some could take 15 years or more. The whole process can be divided into a series of steps called “Phases.”

Each phase has a specific purpose and is designed to evaluate different levels of safety and effectiveness of the investigational treatment and is conducted with the involvement of more participants at each phase.

All new treatments must first go through extensive studies in laboratories before being given to patients. Pre-clinical studies are conducted using animal models to provide sufficient evidence around the safety, efficacy, and appropriate dosage levels to be evaluated in humans.

If initial results of pre-clinical studies are promising, researchers seek permission from regulatory authorities and independent ethics committees to study the investigational treatment in human participants during clinical phases.