What is Clinical Trial?

Clinical trial is a process where the results of scientific studies are converted to medical science useful to improving human health and prolonging life span. Clinical trial is an indispensable step during the process of new drug development. The stages of new drug development are as follows:

• Drug Discovery

The work in this stage includes new drug discovery and the evaluation of its potential treatment value. Modern drug development mostly includes small molecules, peptide/protein drugs, biological drugs, and herbal drugs (including Chinese herbs and Chinese over-the-counter medicine). Researchers select or synthesize effective ingredients based on literature review, data collection, and analysis to produce active pharmaceutical ingredient for further studies.

• Pre-clinical Tests

The work in this stage majorly includes active pharmaceutical ingredient development, effect tests, drug toxicity test, and dose type. The primary data of drug effect and safety is very crucial before using the drug on human body. Therefore, researchers conduct tests on cells (including human cells or animal cells) and on animals to understand the drug effect on biological bodies before human clinical trials. If the test results are ideal, the research team or drug manufacturer can submit application to the supervising organizations (such as Food and Drug Administration). Once approved, the research team can start clinical tests on human bodies.

• Phase I Trials

About ten healthy subjects are recruited with the goals of evaluating the safety of the new drug, pharmacology, and the tolerance on human body. The safety of the new drug is evaluated through observing the subjects’ conditions, testing blood/urine samples, and tracking the absorption, distribution, metabolism, and excretion process (pharmacokinetics) in human bodies to establish basic knowledge on doses for the following clinical trials.

• Phase II Trials

Tens to hundreds of patients (small scale) are selected as subjects with a goal of evaluating the drug effect and safety on patients with different doses, which will be used as reference for the doses in phase III trials. The foundation of phase II trials is proof of concept, which is compared with control group on the patients who has taken standard medication or placebo to explore the differences of the new drug effect and safety between experimental group and control group.

• Phase III Trials

The scale of trials is expanded based on phase II trials. Hundreds to thousands of patients are recruited as subjects who are divided into experimental group and control group using randomized-controlled design. Double-blind design is applied to conduct the trials (neither the doctors nor the patients know who is in experimental group or control group). The data in phase III trials will be strictly statistically analyzed to determine the drug effect and safety to clarify if the new drug is superior to or better than the current drugs. Moreover, some phase III trials also collect data regarding to the effect the new drug has on the patients’ quality of life. If the supervising organization accepts the data of the clinical trials, the new drug can be officially registered and used clinically.

• Phase IV Trials

Phase IV trials are also known as post-marketing surveillance studies. The major goal of phase IV trials is to monitor any serious adverse reactions not discovered in the previous phases after the new drug is in the market under large scale application (usually thousands to tens of thousands of patients). Besides tracking the safety of the new drug, phase IV trials sometimes also evaluate the effect the new drug has on health economics.

• Bioavailability & Bioequivalence Trials

The drug manufacturer that develops the new drug will possess the patent (called “patented drug”). When the patent period is due (about 20 years), other drug manufacturers are allowed to sell drugs with ingredients equivalent to the patented drugs (called “generic drugs”). Before the registration of generic drugs, the drug manufacturer need to recruit about tens of subjects to conduct bioavailability and bioequivalence trials, which is control experiment of generic and patented drugs, comparing human body absorption and metabolism of generic and patented drugs to provide pharmacokinetics data to prove the ingredients and effect of the generic drug are equivalent to the patented drug.

Responsibilities of Researchers

Physicians in charge of the clinical trials are responsible for providing sufficient information and discussing with you to make an informed decision as to whether or not participate in the research. This process is called Informed Consent. All researches require the subjects to sign written “Informed Consent Form” except for the research exempted by the supervising organization. Physicians in charge of the clinical trials are obligated to know and comply with the following ethical and legal regulations in terms of obtaining Informed Consent Form:

• The consent must be made by the patient who is capable of making such decision under no pressure.
• The principal investigator should provide the following information to the subjects with proper steps and methods to help the subjects understand the crucial contents of the research involved:

1. Name of the trial organization and the sources of the budget
2. Name, position title, and responsibilities of the principal investigator
3. Name and contact information of the contact person of the trial
4. The purpose, methods, procedures and duration of the trial
5. Inclusion/exclusion criteria and the estimated number of subjects
6. The risks on the subjects, fetus, babies, or nursing babies
7. Possible discomfort, inconvenience, or damage and treatment available during the trials
8. Reasonable expected clinical benefits. Should inform the subjects if there are no expected benefits.
9. Other alternative treatments or therapies and their possible benefits and risks
10. The responsibilities of the subjects, including the dos and don'ts, contraindications, prohibitions, and cautions during the trials
11. The rights of the subjects and the confidentiality of personal information
12. The compensation, reimbursement, or insurance the subject will obtain when damage occurs during the trials
13. The possible commercial benefits from the trials and the agreement of their application
14. The expiration date and utilization plans for the biological specimen, personal data, or research materials of the subjects
15. The expected possible scenarios and reasons for the subjects to terminate the participation of trials
16. Subjects, who participate in the trials voluntarily, can disagree or withdraw at any time without penalty or undermining their deserved benefits, and the way to withdraw their consent
17. The subjects or legal representatives will be informed immediately when new information could potentially influence the subjects’ decision on continuing to participate in the researches
18. The contact person and contact methods regarding the further trial information and subjects’ rights, and the contact person and contact methods in case of damages that occur during the trials

• If the trials involve aboriginals, consultation and consents of the aboriginal tribe are needed besides the consents of the subjects, legal representatives, or others who have the right of consent.

What is Human Research Protection Program?

The mission of Human Research Protection Program (HRPP) is to ensure that the rights, safety, and welfare of the subjects are protected and to provide timely and high quality clinical trial education, review and monitoring to accomplish excellent clinical trial program. China Medical University Hospital Human Research Protection Program is operated by our Human Research Protection Center, Research Ethics Committee, and Clinical Trial Center. If you have any question regarding the rights of subjects and our trial programs, please feel free to contact us: