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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.
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.
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:
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:
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.
There are two types of clinical trials researchers use:
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.
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. 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.
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.
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 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 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.
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.
What is a Plain Language Summary?
A Plain Language Summary gives the results of clinical trials in a way that is scientifically accurate but easier to understand. It includes information about the purpose, treatment, side effects, results and other facts about the trial. These summaries are translated into all the languages of the participants who were in the trial.
When will the Plain Language Summary be available?
After a clinical trial is completed, it will take about a year or more before plain language summaries from that trial are available for download. Only Trials with at least one European site will have a plain language summary available.
Where can I find Plain Language Summaries?
Otsuka currently has two Plain Language Summaries available for your viewing:
1. Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients with Dementia of the Alzheimer's Type.
2. Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients with Dementia of the Alzheimer's Type
We hope this helps the participants understand and feel proud of their important role in medical research. If you participated in the trial and have questions about the results, please speak with a doctor or staff at trial site.
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.