A clinical trial is a voluntary human research study conducted in humans to determine the safety and effectiveness of an investigational drug in a particular disease.
Clovis Oncology is conducting clinical trials with the PARP inhibitor rucaparib to test it in men with metastatic castration-resistant prostate cancer (mCRPC).
Who can participate in clinical trials?
All clinical trials have criteria to determine who is, or is not, eligible to participate in the trial. These eligibility criteria ensure that investigational drugs are tested in a group of patients who are similar. Examples of eligibility criteria include age, sex, type and stage of disease, and whether a person has received certain prior treatments. Eligibility criteria also help to exclude patients for whom the known risks may outweigh the potential benefit of an investigational medicine.
What can you expect during a clinical trial?
Your doctor will give you information to read about the clinical trial and answer any questions you have. Before you participate in a clinical trial, you will need to read a description of the trial and what your participation will involve, and you will need to provide your signature indicating your understanding of the trial and your agreement to participate (this is called your ‘informed consent’).
During a clinical trial, several healthcare professionals may be part of your study team – including doctors, nurses, social workers and other healthcare professionals. Throughout the clinical trial, you will be followed by your study team who will monitor your disease and wellbeing. You will receive medical tests that are part of the clinical trial in addition to the medical tests that are part of standards of care that you normally would have received if you were not in a clinical trial. You may be asked to fill out forms, or provide additional information about how you are feeling. As part of some studies, samples of tumor tissue or blood may be required. You may choose at any time to stop your participation in a clinical trial.
What are the possible benefits and risks of participating in a clinical trial?
Clinical trials do have risks, potential upsides, and potential downsides.
The benefits associated with participating in a clinical trial include:
- Learning more about your health condition
- The potential to receive investigational medication before it may be available to the public
- Results from the study may help other people
The risks associated with participating in clinical trials include:
- Unknown side effects
- The investigational treatment benefits some participants, but not everyone
- The treatment being studied only works as well or works worse than ones in current use
- The treatment may not work at all and may be harmful to you
Clinical trials may also require more frequent trips to the healthcare center for testing. The federal government has safety rules in place for the conduct of clinical trials.
In clinical trials, the investigational agent may be studied in a single-arm or multi-arm trial.
In single-arm trials, all patients will receive the investigational agent. In multi-arm trials, the investigational agent may be compared to placebo (a sugar pill or other inactive substance) or a standard of care treatment; in multi-arm trials, patients may be randomly assigned to receive the investigational agent or another treatment (including placebo). In a randomized cancer clinical trial, participants are assigned by chance to separate groups, to either a standard treatment group (control group) or one or more investigational treatment groups. Neither the researchers nor the participants may choose which group the patient will be assigned to.
In cancer clinical trials, the control group often receives the standard treatment currently available. In some randomized trials, study doctors and patients are blinded to the treatment assignment, meaning neither the study doctor nor the patient knows which treatment they are receiving.
Federal law requires most health insurance plans to cover routine healthcare costs for patients who are participating in a clinical trial under certain conditions:
- You must be eligible for the trial
- The trial must be an approved clinical trial
- The trial must not involve out-of-network doctors or hospitals
You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your healthcare professional about specific trials you are interested in.
Ask your healthcare professionals for more information about clinical trials or read more about clinical trials at:
http://www.cancer.gov/clinicaltrials/
The American Society of Clinical Oncology also has a series of videos, Preparatory Education About Clinical Trials (PRE-ACT), addressing common questions about clinical trials: