The Path to Conducting Clinical Trials

Planning

Clinical trial plans are created in compliance with various regulations to ensure that the trials are conducted ethically and scientifically, while protecting the rights and safety of participants.

What Rules Must Be Followed When Conducting a Clinical Trial?
Why Are They Necessary?

Since clinical trials have a research aspect, they are governed by regulations such as the Declaration of Helsinki*1, Good Clinical Practice (GCP*2), and the PMD Act*3 to protect the rights and safety of participants. All clinical trials are planned and conducted based on these rules. Complying with these rules ensures clinical trial participants’ rights, safety, and privacy are protected.

Who Plans Clinical Trials and How?

Based on candidate medicine data obtained from non-clinical studies (using animals rather than humans), clinical development staff and various specialists from pharmaceutical companies come together to discuss and develop the clinical trial protocol. This includes determining the target patient population, dosage, frequency of use, and the type and frequency of tests needed to evaluate safety and efficacy.

Key considerations during protocol development include ensuring clinical trial participant safety, minimizing the burden on participants, and collecting appropriate data to understand the characteristics of the candidate drug.

In addition to opinions from physicians and experts specialized in the treatment being investigated, in recent years, pharmaceutical companies have also begun incorporating feedback directly from patients and their families into protocol design.

See also: “Drug Development in Partnership with Patients”

Terminology Explanations

  • *1 Declaration of Helsinki:

    Ethical principles for medical research involving human subjects, adopted at the World Medical Association’s General Assembly in 1964.

  • *2 GCP (Good Clinical Practice):

    Standards for Conducting Clinical Trials* of Pharmaceuticals.This is a legal regulation that stipulates the ethical and scientific conduct of clinical trials involving human participants, with an emphasis on respecting the rights of trial subjects (individuals participating in clinical trials). All parties involved in clinical trials—such as pharmaceutical companies and medical institutions—are required to comply with these standards.
    *Clinical trials are studies conducted on humans to evaluate the safety and efficacy of candidate drugs. Among these, trials conducted for the purpose of obtaining manufacturing and marketing approval from the Ministry of Health, Labour and Welfare are referred to as “clinical trials.”

  • *3 PMD Act (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics)

    This law, established by the national government (Ministry of Health, Labour and Welfare), ensures the quality, efficacy, and safety of pharmaceuticals and medical devices. It also provides regulations regarding their manufacturing, labeling, sales, distribution, and advertising.

The Path to Conducting Clinical Trials