Trial Sponsors/Supporter: Pharmaceutical companies, nonprofit organizations, or other institutes – the National Cancer Institute for example, may sponsor clinical trials. Pharmaceutical companies fund studies because they must prove their new medication or treatment is safe and effective via success in a clinical trial, in order for it to become available to the public.
Protocol: A protocol is a detailed plan that explains what will be done in a clinical trial and why. It outlines things like the trial objectives, the PI's name and affiliated institution, how many patients will take part in the clinical trial, inclusion and exclusion criteria for participation, what medical tests patients will need to complete and how often, and the overall treatment plan. Before a protocol can be made available to patients, an institutional review board (IRB) must review and approve the study.
The Institutional Review Board (IRB): These boards consist of a committee of people, such as scientists, doctors, social workers, nurses, attorneys and patients, who are responsible for making sure that the trials follow federal laws to protect the rights of the clinical trial's participants.
Before a trial begins, the IRB reviews and approves the protocol (sometimes altering or amending it) to make certain it is based on reliable scientific evidence and will not be harmful to the patient.
After a clinical trial begins, the IRB monitors the trials - and reviews its progress, usually at least once a year. If any concerns about the saftey of participating patients arise throughout the process, the board can and will call a hault to the trial.
The Office for Human Resources Protections (OHRP), is part of the US Department of Health and Human Services. The primary objective of the office is to ensure patient safety and welfare in federally funded clinical trials. The OHRP guides the IRBs and helps enforce protective regulations.
Response to treatment in a clinical trial can be described in the following terms:
Stable disease: A doctor may use the term “controlled” or “stable disease” if your tests or scans show a situation that remains unchanged over time. These terms mean that the tumor is showing no significant growth or decrease in size (that is, there maybe some growth or reduction but not enough to be categorized as a partial response or progressive disease). Some tumors can stay the same for a long period of time due to treatment, but some remain stable without any treatment.
Progressive disease: In clinical trials if the cancer does grow, it is deemed “progressive disease.” Most clinical trials define a tumor as a progressive tumor when there is a 20-25% measured growth in the tumor (although this also is specific to the clinical trial you are participating in). Tumor growth means that the tumor is getting bigger, but it may also mean that the tumor is spreading. Progression generally indicates that treatment has stopped working. The bottom line is that your cancer is not getting better.
Refractory cancer: For many reasons, cancer may not respond (or is thought to be resistant) to treatment. Some cancer cells have ways of defending themselves against many different types of therapies, termed refractory disease. Refractory cancer may shrink, but not to the point where the treatment is determined to be effective. Most of the time, this type of tumor will remain stable or continue to grow despite the treatments administered.
Complete Response: Doctors describe a complete response to treatment as that which completely gets rid of all tumors that were able to be measured on various tests. It may also be referred to as remission. After your cancer has been treated, your doctor will do some tests to see if any cancer cells are still present in your body. If your doctor can't find any cancer cells over a specified amount of time, you are thought to be in remission.
Partial Response: A partial response means your cancer responded and there has been a decrease in tumor size to some extent, but not completely, to your cancer treatment. If you are in a clinical trial this usually is defined more precisely, according to the parameters set forth in the protocol. A partial response is usually defined as a less than 50% reduction in measurable tumor, but in other trials a reduction in tumor size of at least 30% may be defined as a partial response.