Our Clinical Trials

Clinical trials play a critical role in research and in making discoveries in healthcare. It’s these breakthroughs in science that help people defy the limitations of their disease. This would not be possible without the participation of patients, who are at the heart of everything we do.

Image
Clinical Trials, Research & Development

What Are Clinical Trials

Clinical trials are research studies performed on people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way to understand if a new treatment, such as a drug, diet, or medical device (such as a pacemaker) is safe and effective for people. A clinical trial may learn if a new treatment is more effective and/or has fewer side effects than the standard or current treatment(s).​

Benefits of Participating in Clinical Trials

  • You play a more active role in your own health care​​
  • Researchers may add more frequent health check-ups as part of your treatment.​​
  • Possible early access to a new treatment before it is available to the general public​​
  • You have the chance to help others get a better treatment for their health problems​

What happens in a clinical trial?​

The specifics of the clinical trial depend on the study protocol, a detailed plan explaining the purpose of the trial and what activities the trial will include. Before participating in a clinical trial, potential participants will review the informed consent form. This informed consent will include:​

  • The purpose of the trial​
  • The length of the trial​
  • The medicines, procedures, and tests in the trial
  • A schedule of activities
  • Potential side effects

Who can join a clinical trial?

Everyone is encouraged to consider participating in a clinical trial. It is important clinical trials include a diverse participant pool, including, but not limited to, diversity of age, race, ethnicity, gender, education level, and socioeconomic status.

Each clinical trial has its own criteria of who can participate in a clinical trial, known as eligibility criteria. Eligibility criteria could include whether you have been diagnosed with the illness of interest, current medications you take, or if you have other illnesses.

To learn more about clinical trials and how you can participate in a clinical trial, please refer to the following resources:

The Importance of Diversity In Clinical Trials

Diversity in clinical trials is an important aspect to health equity. The data from clinical research studies are used to determine how well a product works and how safe it is. 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.

 

Our Commitment To DE&I

Image
Otsuka DEI, Diversity, Equity, & Inclusion Office

It is Otsuka’s research and development vision to actively address health disparities through diversity, equity, and inclusion. By leveraging our diverse people and thought, Otsuka will put all patients and their communities at the heart of what we do.

Clinical Trial Access

If you are a clinical researcher and would like more information on the clinical trial data–sharing program, please visit the Otsuka Clinical Trial Data Transparency website.

For patients who may want to participate in a clinical trial, but may not be able to, there is still a possibility to access an investigational drug through the Expanded Access program. 

Expanded access, also known as compassionate use, allows for an investigational medical product that has not yet been approved by the FDA to be used outside of a clinical trial. Otsuka accepts requests for expanded access from physicians currently treating patients for whom there are no other treatment options available. 

To be eligible for access to an investigational product, the applying physician must certify that the patient for whom the application is being submitted meets the following criteria*:

Is suffering from a serious or life-threatening disease or condition

Is not able to participate in any ongoing clinical study of the drug related to the treatment of the patient’s condition

Has undergone appropriate standard treatments without success and there is no alternative treatment available, or no standard treatment exists for the disease or condition

The potential benefits for the patient must outweigh the potential risks

The provision of the drug will not interfere with the development of the product

Note that meeting these criteria does not guarantee access to any investigational product. 

Contact us at expandedaccess@otsuka-us.com with any questions, or to request an application form or submit a completed application form.

Otsuka will confirm receipt of an application within one week and will advise of any additionally required information after the initial review of the application.