Frequently Asked Questions & Answers
ABOUT CLINICAL TrIALS
WHAT IS A CLINICAL TRIAL?
A clinical trial is a research study designed to understand whether an investigational new drug is safe and effective for humans. There are usually several phases of studies, each designed to learn more about the experimental drug’s effects. When a trial is in an early phase, (often called Phase I or 1b) the clinical trial may involve very few patients. As more is learned about an experimental drug the size of the studies typically gets larger and later phase studies (2 and 3) may involve hundreds or thousands of patients.
All clinical trials must follow a strict set of rules that are outlined in the trial protocol. These rules set specific requirements on which types of patients can be included in the trial, procedures that must be done and the number of trial visits.
Because of these rules, it is important that patients who participate carefully adhere to the visit schedule and instructions of the research personnel conducting the trials. Clinical trials are required for all new medicines because a company needs to show that the medicine is safe and effective before it can be made available to the general population.
WHY ARE CLINICAL TRIALS CONDUCTED?
Clinical trials are conducted to answer research questions and to learn if a drug is safe and effective. The main questions the researchers want to answer are:
· Does this drug work?
· Does it work better than what we’re now using?
· What side effects does it cause?
· Do the benefits of the drug outweigh the risks?
· Which patients are most likely to find this drug helpful?
WHY SHOULD I PARTICIPATE IN A CLINICAL TRIAL?
Participating in a clinical trial is a voluntary opportunity, and thus, it is always up to you to decide if you’d like to do so. Many people with serious diseases participate in clinical trials for these reasons:
· There is no current approved drug for their disease
· They have not experienced improvement of the condition after using the currently approved drugs
· They want access to a new type of drug even if it is not guaranteed to be better or as good as available drugs
· They want to contribute to the development of a new drug for others with a similar disease
ABOUT THE Clinical Trial of tipifarnib in HRAS Positive advanced Squamous Cell Cancer
What ARE HRAS MUTATIONS?
The HRAS gene belongs to a class of genes known as oncogenes. When mutated, oncogenes have the potential to cause normal cells to become cancerous. Genetic testing for HRAS mutation is available at no cost to you.
What type of Clinical trial is this?
This clinical trial is being conducted as an open label trial, which means that all participants will receive the investigational new drug, tipifarnib.
What is the investigational new drug used in this trial?
The investigational new drug for this clinical trial is tipifarnib.
IF I RECEIVE THE INVESTIGATIONAL NEW DRUG, WHAT POTENTiAL SIDE EFFECTS MAY Occur?
The Informed Consent Form will review in detail all of the safety information known about the investigational new drug. After you read it, please direct any questions to your doctor.
DO I HAVE TO PAY TO PARTICIPATE IN A CLINICAL TRIAL?
No. The investigational new drug and associated diagnostics not considered standard of care are provided free of charge to clinical trial participants.
does this clinical trial offer travel reimbursement?
Yes, qualified participants in this clinical trial may be reimbursed for related travel, as applicable.
HOW DO I GET STARTED?
Please sign up to provide your contact information and answer a few questions.