Many patients are being asked to participate in a research study. A clinical trial is one of the final stages of a long and careful cancer research process. If it becomes clear from a laboratory research study that a new drug may be effective, investigators will test the drug in animals to see whether it is effective and safe. Only if animal studies show that a new drug is effective and safe, the drug will be investigated in humans. This means that a lot of research is being done, before humans participate in a clinical research study.
Research in humans is conducted in different phases. In the early phases investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment.
During a research study investigators often compare a new treatment with an existing treatment. Therefore subjects are assigned to different treatment groups by randomization. Subjects are randomized in clinical trials so that bias does not weaken the study results.
In a randomized trial, investigators use a computer program or a table of random numbers to assign each study participant to a group.
Sometimes an investigator would like to know if the effect of a new treatment only depends on the new treatment itself since several factors can play a role.Therefore the new treatment is being compared with 'no treatment'. This means that one patient group receives the new treatment and the other patient group not. In order to compare the new treatment with 'no treatment', investigators use a placebo-treatment. The placebo looks exactly like the new treatment, but has no active substances.
The Medical Research Involving Human Subjects Act (wmo) requires that research proposals may only be carried out if a recognized review committee has approved it. Many hospitals in the Netherlands have such a review committee. The VU University Medical Center also. The committee reviewes among others:
- if the clinical trial is relevant;
- if there are not too many risks and/or disadvantages for the patients;
- if the written information for patients is sufficient.
If the committee believes that the potential risks of a research study are not in proportion to the potential value of the research, the research study will not be approved. This means that an investigator cannot conduct the study; the study should be amended first.