What is a clinical trial?
A clinical trial is a research study required for all new medicines to help us understand whether an experimental treatment is safe and effective for humans.
There are usually several phases of clinical trials; each designed to provide more information on the experimental treatment’s effects. When a study is in an early phase (often called Phase 1 or 1b), the clinical trial may involve very few subjects. As more is learned about the experimental treatment, the size of its studies will typically grow. Later-phase studies (often called Phase 2 and 3) may involve hundreds or thousands of participants.
All clinical trials must follow a strict set of rules that are outlined in the study's protocol. These rules set specific requirements on which types of patients can be included in the study and the procedures that must be followed. Because of these rules, it is important that subjects who participate carefully adhere to the visit schedule and the instructions of the research personnel who are conducting the trials.
Why are clinical trials conducted?
Clinical trials are conducted to answer research questions about new medicines and to learn if the experimental treatment is safe and effective for humans. The main questions the researchers want to answer are:
- Does this treatment work?
- Does it work better than current treatment options?
- Does the treatment cause side effects?
- Do the benefits of the treatment outweigh the side effects and risks?
- Which patients are most likely to find this treatment helpful?
Why should I participate in a clinical trial?
Participating in a clinical trial is a voluntary opportunity, so it is up to you to decide if you would like to become involved.
Many people with serious diseases participate in clinical trials for these reasons:
- There is no currently approved treatment for their disease;
- They have not experienced improvements in their condition after using the currently approved treatments;
- They want access to a new type of treatment, even if it is not guaranteed to be as good as or better than available treatments;
- They want to contribute to the development of a new treatment for others with a similar disease.
Am I guaranteed to receive the new research drug if I participate in a research study?
Some studies guarantee the experimental treatment to every subject, while other studies may use an approach where only some of the subjects receive the experimental treatment.
Many studies use a “placebo,” which is an inactive substance that matches the look of the experimental treatment. A placebo is used so subjects and doctors do not know which subjects received the real experimental treatment, and which received the inactive substance.
This helps researchers determine if the experimental treatment is as good as or better than the standard therapy. Patients will always be told if they are being asked to participate in a study with a placebo arm.
What is involved in G1's studies for SCLC?
We are evaluating an investigational medicine for the treatment of with SCLC. Study 03 is for patients diagnosed with SCLC who have already received chemotherapy and Study 05 is for patients diagnosed with SCLC who have not yet received chemotherapy or checkpoint inhibitors. If you have been diagnosed with SCLC, you may be eligible to participate.
Prior to enrolling in the study, it is important to talk to your doctor and the study's staff and to read the Informed Consent Form, so you are aware of what is involved. The Informed Consent Form outlines the investigational medicine's known safety information and provides background on what the study involves.
Once you have signed the informed consent, your study doctor will run tests to confirm that you are eligible to participate. Your doctor and study team should be available to answer questions throughout the process.
Will I receive the active drug or placebo in this SCLC study ?
All participants will receive standard chemotherapy. Participants in Study 03 study for SCLC will receive standard of care of chemotherapy as the control arm and those participating in the 05 study for SCLC will also receive standard of care of chemotherapy with the addition of a checkpoint inhibitor as the control arm. Some participants will receive the investigational drug in addition to the study described treatment; in Study 05, some participants will receive placebo in addition to the chemotherapy plus checkpoint inhibitor.
If I receive the active drug, what side effects should I expect?
The Informed Consent Form will provide details on the known safety information on the investigational drug. Please direct any additional questions to your doctor.
Do I have to pay to participate in a clinical study?
No. The investigational treatment and associated diagnostics are provided free of charge to clinical study participants.