What You Should Know
Our ability to bring new medicines to patients in need and to find new uses for our current products is dependent upon our demonstrating safety and efficacy and a favorable benefit-risk relationship through systematic testing in patients who volunteer to participate in our studies.
Since 2002, we've brought 13 new products to patients in need -- patients with cancer, HIV/AIDS, psychiatric disorders, rheumatoid arthritis, chronic hepatitis B virus infection and diabetes.
Approval of a new medicine for marketing often marks just the beginning of a continuing scientific effort to determine the full range of benefits for patients. Throughout the course of a medicine’s patent lifetime, Bristol-Myers Squibb continues investing its scientific talent and financial resources to further define the compound’s role in the management of serious disease.
The clinical research process is a long and expensive one. Industrywide, it may take an investment of more than $1 billion and 10 to 15 years for a drug to advance from benchtop to bedside.
In clinical trials, investigational drugs are often compared with approved drugs or placebo (inactive pill, liquid, or powder) to assess safety and effectiveness. Clinical trial participants may be assigned to take:
- Investigational drugs
- Approved drugs
- A combination of these drugs.
Phases of Clinical Trials
Clinical trials are classified under four phases:
Phase I: Researchers test an investigational drug for the first time in humans by giving it to a small number of healthy volunteers to evaluate its safety, determine a safe dosage range and identify side effects.
Phase II: The investigational drug is given to a larger number of people who have a particular disease or condition, to determine its effectiveness and to further evaluate its safety.
Phase III: Several hundred to several thousand people with the appropriate disease or condition participate in these trials. The investigational drug undergoes additional testing to further determine its safety and effectiveness, monitor side effects, and compare it to commonly used treatments.
Phase IV: After a drug is available by prescription, additional information is gathered to assess the drug’s risks, benefits and use.
Eligibility and Trial Participation
There are certain requirements which must be met to be eligible to participate in a clinical trial. These requirements are based on such factors as age, gender, the type and stage of disease, previous and current treatments, and other medical conditions. Medical insurance is not required to participate in clinical trials or to receive study-related medical care and services.
If you are eligible and decide to participate, an informed consent document will be presented to you. This document includes information about the clinical trial and what you can expect as a participant, as well as potential benefits and possible risks associated with the research.
You should take your time and read carefully through the informed consent document. When you are satisfied that all of your questions have been answered, you will be asked to sign the document.
As a participant, you may be asked to:
- Take investigational drugs as directed
- Come in for office visits
- Have laboratory and diagnostic tests
- Receive, at no cost, study-related medical care
Potential Risks and Benefits
According to the National Institutes of Health (www.clinicaltrials.gov), there are multiple benefits and risks associated with participating in a clinical trial.
Clinical trials that are well-designed and well-executed are an approach for eligible participants to:
- Play an active role in their own health care
- Gain access to new investigational compounds
- Help others by contributing to medical research
There are risks to clinical trials:
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The protocol may require more time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
A medical ethics group will oversee the clinical trial to ensure all participants are being appropriately treated. If you are dissatisfied at any time, you are free to leave the trial.
You should talk with your doctor and carefully consider both the potential benefits and risks of participation before enrolling in a clinical trial; however, if you qualify, the actual decision whether to participate is yours to make.
What Questions Should I Ask?
Here are some questions you may want to discuss with the study doctor:
What is the purpose of this clinical trial?
How long will I be in the trial?
How often will I need to go to my clinic/hospital?
What tests and procedures are involved?
Will my medical records remain confidential?
Is there a chance I will receive a placebo?
What are the benefits and risks associated with this trial?
How do those benefits and risks compare with those of my current treatment?
Is followup care part of this study?
How will my condition be monitored?
What safeguards will be in place for my protection?
Will results of the trial be provided to me?