Patients

4 messages about clinical research

１．What is the purpose of clinical research?

In cancer treatment, medical professionals strive to develop more effective and safety (side-effects-reduced) treatment to improve survival and patients’ quality of life.
The aim of clinical research is to establish the best treatment for patients in the future. Clinical trials are also conducted to verify the safety of newly-developed medicine and dosage.

２．What is clinical research for?

How do medical professionals decide a method of treatment?
We cannot tell the true efficacy to each patient until we actually start treating. Therefore, the most important thing for medical professionals is to decide which treatment is most expected to be effective.
Medical professionals exam their patients’ condition and decide on a treatment plan by referring the past data obtained from patients who had similar medical conditions.
Clinical trials are liberally the research to collect data. Medication and methods of treatment used today are based on an accumulation of data provided by many patients in earlier treatment. Thus, without patients’ cooperation, establishment of new treatment is unattainable.

３．What is clinical research?

In clinical research, data of efficacy and adverse-effect of new medication or treatment are collected. The data become more probable when it is compared with others. Collected data are analyzed either within the research or with data in earlier research. Clinical research are classified into phase I to phase IV, depending on the objects being compared in an analysis.
JORTC mostly conduct phase I,II, and III research.
Each patient must receive his/her best treatment. However, therapeutic effect is indeterminate when each patient is treated differently. This is because treatment outcome could be attributed to each patient’s health condition or predisposition, and not to the treatment itself. Hence, in clinical research, participants will receive their best treatment according to pre-determined schedule and they all will be examined synchronously unless it inflicts disadvantages in the treatment.

４．What is a randomized controlled trial?

A randomized controlled trial is a clinical experiment designed to evaluate the comparative efficacy of two or more therapies and decide which one is better.
It is very likely that individuals’ (either physicians or patients) evaluation is biased. These biases compromise the reliability of the data. Randomization is the method to prevent this bias. Patients are randomly decided to be treated with the procedure by the third-party.
You may question the reliability of a third-party decision. However, both treatment (procedure) at issue have been equally qualified by medical professionals, thus, neither of them will cause damage to patients. Participation in the trial is arbitrary, i.e., should patients feel anxious or insecure about the trial, they can choose not to join in and receive their ordinary treatment.

Explanation： Dr. Yasushi Goto, Department of Respiratory Medicine, National Cancer Center Hospital

Published：2012.12.03
Last updated：2015.05.18