Clinical Development in Partnership with Patients　Collaborating with Patients in Drug Development

This website provides easy-to-understand explanations using illustrations and videos about the path to conducting clinical trials and collaboration with patients in the process of drug development.

A “clinical trial” is a type of clinical study involving humans, conducted to obtain official approval to manufacture and sell a drug.

The Path to Conducting Clinical Trials

Learn about the path pharmaceutical companies take before conducting a clinical trial.

Collaborating with Patients
in Drug Development

Chugai Pharmaceutical considers patients to be partners in drug development. This section presents specific examples of collaboration based on this philosophy.

Making Clinical Trials Easier to Understand for Patients

Chugai Pharmaceutical aims to make clinical trials easier to understand for patients by introducing them through videos.

Drug Development Collaboration Guide［PDF 1.1MB］

This guide was created to help those on the drug development team gain a deeper understanding of the overall drug development process and general knowledge about clinical trials. We hope it will demonstrate how your experience can provide valuable insights and further enrich collaboration with pharmaceutical companies.

Q&A: From Planning to Conducting a Clinical Trial

  • Clinical trials must follow various regulations such as the Declaration of Helsinki, Good Clinical Practice (GCP), and the Pharmaceuticals and Medical Devices (PMD) Act.

    See also: The Path to Conducting Clinical Trials – Planning

  • Scientists and various specialists from pharmaceutical companies collaborate and discuss to create a clinical trial protocol.

    See also: The Path to Conducting Clinical Trials – Planning

  • To begin a clinical trial, pharmaceutical companies must undergo investigations by the Ministry of Health, Labour and Welfare and reviews by medical institutions.

    See also: The Path to Conducting Clinical Trials – Review

  • They examine the clinical trial protocol to ensure the rights and safety of participants are protected.

    See also: The Path to Conducting Clinical Trials – Review

  • Medical institutions request an Institutional Review Board (IRB) to evaluate whether the clinical trial can be conducted, and make decisions based on the outcome of the review.

    See also: The Path to Conducting Clinical Trials – Review

  • The IRB reviews whether participation is ethically and scientifically safe, whether there are disadvantages for patients, and whether conducting the clinical trial is appropriate.

    See also: The Path to Conducting Clinical Trials – Review

  • Members include healthcare professionals like physicians, nurses, and pharmacists, as well as lawyers and members of the general public from diverse backgrounds.

    See also: The Path to Conducting Clinical Trials – Review

  • There are two ways to participate in a clinical trial: being referred by a physician if you meet the criteria outlined in the protocol, or seeking out trial information on your own. However, participation in a clinical trial is entirely voluntary and based on your own decision.

    See also: The Path to Conducting Clinical Trials – Implementation

  • Eligibility criteria are established to protect clinical trial participants and to properly evaluate the safety and efficacy of candidate drug or medical device.

    See also: The Path to Conducting Clinical Trials – Implementation

  • Participants have the right to withdraw from a clinical trial at any time and may be entitled to reimbursement and compensation systems.

    See also: The Path to Conducting Clinical Trials – Implementation

    This is also explained in the clinical trial explanation video.

    See also: Making Clinical Trials Easier to Understand for Patients.

    This aims to make clinical trials easier to understand for patients.

  • Pharmaceutical companies continuously monitor to ensure that the rights and safety of participants are protected and that the clinical trial is conducted in accordance with the protocol and GCP guidelines.

    See also: Roles of People Involved in Clinical Trials

  • Medical institutions are responsible for informing clinical trial participants, monitoring their safety, and evaluating the drug or medical device candidates.

    See also: Roles of People Involved in Clinical Trials

  • For information on clinical trials currently conducted by Chugai Pharmaceutical, please refer to the Clinical Trial Information page (opens in a new window).

  • Information collected from clinical trial participants is handled with utmost care to ensure safety and is managed and utilized appropriately.

    See also: Chugai's Approach to Clinical Trials and Clinical Trial Data Sharing (opens in a new window).

For information on Chugai Pharmaceutical’s clinical trials, click here

Chugai Pharmaceutical’s Clinical Trial Information