Learn About Clinical Trials | Otsuka Clinical Trials

What is a Clinical Trial?

Clinical trials, also known as clinical studies, are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device is safe and effective in people.

Other goals of clinical research include:

Testing ways to diagnose a disease early, sometimes before there are symptoms
Finding approaches to possibly prevent a health problem, including in people who are healthy but at increased risk of developing a disease
Potentially improving quality of life for people living with a life-threatening disease or chronic health problem
Learning the role of caregivers or support groups

Living with a disease or condition impacting your health, or the health of a loved one, can be stressful or even life-altering. But new investigational interventions are constantly in development for hundreds of diseases – many of which are being tested today in patients and healthy volunteers through clinical trials.

What are the potential benefits of participating in a clinical trial?

Participating in a clinical trial provides the opportunity to play a critical role in medical research leading to potentially better healthcare outcomes for yourself or others in the future.

Some benefits of participating in a clinical trial can include:

Playing a more active role in your own health care.
Receiving additional study-related check-ups by researchers.
Possible early access to an investigational treatment before it is available to the general public.
Having the chance to help others by identifying treatment options for others who are affected by disease or condition.

What are the potential risks of participating in a clinical trial?

Clinical trials are designed with the highest ethical and safety standards and require the review and approval of numerous review boards, such as an Institutional Review Board (IRB) that ensures the risks are minimal compared to the potential benefit. Clinical Trials conducted in the United States must also adhere to all FDA regulations and Good Clinical Practice standards to ensure clinical trials are safe and ethical.

Participants are valued and treated with quality care and closely monitored throughout the trial to ensure a patient’s health and safety. Participation is always voluntary, and participants can choose to stop participation in the trial at any time. With this said, participating in a clinical trial, may still carry risks, including:

The inability to choose the intervention you receive, including the dosage level or if you get a placebo, which contains no active drug.
The investigation intervention might not be better than available interventions.
There is a chance of experiencing unwanted side effects.
Participation in a clinical trial may require you to manage complex medication doses, to have additional or longer medical appointments, more procedures, or hospital stays.

Anyone thinking about joining a clinical trial must weigh the risks and benefits. It’s important to discuss participation with your doctor so you are fully aware of all considerations.

View this infographic to see suggested questions to help you start the conversation.

Types of Clinical Trials

There are two types of clinical trials researchers use:

Interventional:

This is the most common and widely known type of clinical trial. It is used to determine if an investigational intervention, such as a medication, diet, or medical device, is safe and effective. In these studies, the investigational intervention is typically compared to those receiving no treatment, an inactive placebo, or the standard of care.

Observational:

In this type of study, investigators observe participants throughout their existing, ongoing treatment – or regular daily lives – and track their specific health outcomes over time. Unlike interventional trials, observational trial participants are not provided an investigational intervention, but instead continue their regular treatment as part of their routine medical care.

Clinical Trials Phases

Clinical trials of investigational treatments and therapeutics are conducted in phases, with each phase building on the information learned in the previous phase. Each phase of a trial has a different purpose and helps researchers answer different questions. At each phase, potential participants are provided with information gained from previous research to help them make an informed decision about joining a study.

For more information about the phases of clinical research, please view this infographic.

Doctor holding and showing a bottle of medicine to a patient

Phase 1

The main focus of Phase 1 studies is to examine an intervention’s safety and see how it interacts with the body, typically with healthy volunteers who do not have the condition being studied. If the test is for a drug, it can include researching the effects of different dosages. This phase takes several months to complete, but each participant is not in the trial for the whole duration of the phase.

Phase 2

Phase 2 studies focus on intervention effectiveness of providing treatment or therapy to those with the condition being researched while also collecting data about safety and side effects. This phase takes an average of 3 years to complete, but each participant is not in the trial for the whole duration of the phase.

Phase 3

Phase 3 studies determine the effectiveness and safety of investigational treatments and therapeutics as compared to the current standard of care. This is the last stage of research before an intervention can be approved for use in the condition it treats and takes on average about 3 years to complete, but each participant is not in the trial for the whole duration of the phase.

Phase 4

Testing continues after an intervention is approved. Phase 4 studies determine the effectiveness and safety of interventions when used by the public in daily life, and collect additional data on benefits, risks, and quality of life.

Diversity in Clinical Trials

Diversity in clinical trials is an important aspect to health equity, which promotes equal access to healthcare resources for everybody. The data from clinical research studies is used to determine how well a product works and how safe it is, so it is important that the product is tested in the populations that are affected by the disease or condition. However, in the history of clinical research, people of different races and socioeconomic status were often not included. Otsuka is committed to improving diversity in our clinical trials and addressing health disparities. We aim to enroll diverse patient populations in our clinical trials including people from different races and ethnicities, gender, sexual orientation, age, disability, and socioeconomics.

For more information about diversity in clinical trials, please view this infographic.