Overseas Research Team: located in North America, responsible for developing new technologies and products.
Domestic Research Team: located in Beijing, responsible for new drugs production and commercialization.
Extramural Partners: The Academy of Military Medical Sciences, Shanghai Institute of Materia Medica Chinese Academy of Sciences.
Technology Advantages
Innovative technology and global patents granted by USA, Canada, etc.
Research Bases
Biotechnological Research and Development Center in North America
Protein Engineering Academy in Yizhuang Hi-tech Zone, Beijing
Overview of Clinical Trials
1.What are clinical trials? Why are they important?
In medical research, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product in the country where the trial is taking place. In general, investigators enroll patients or healthy volunteers into small pilot studies initially, followed by larger scale studies, aiming at comparing the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of participants is typically about to increase.
The people who participate in clinical trials are carefully treated by researchers and doctors. Meanwhile, they give a great support to the scientific research, which is highly appreciated.
2.Why do we need to carry out clinical trials?
Clinical trials are the primary methods for doctors to find out the safety and efficacy of the new drug products.
In the U.S, new drugs and medical devices (dietary supplements excluded) are compulsorily required to undertake the qualification test (clinical trials) by the U.S. Food and Drug Administration (FDA). Only the drug passing clinical trials is granted a drug license, which is the prerequisite of drug launch.
3.What are the phases of clinical trials?
A clinical trial is usually divided into the following phases:
Phase I: the first stage of testing in human subjects. Normally, a small group of patients or healthy volunteers will be selected. This phase includes trails designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject cab be observed by full-time staffs. Phase I trials also normally include dose-ranging, also called dose escalation trial, so that the appropriate dose for therapeutic use can be found.
Phase II: Once the initial safety of subject drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups and are designed to assess how well the drug works, as well as to continue Phase I study safety assessments in a larger group of volunteers and patients. In general, Phase II is specifically designed to assess dosing requirements (how much drug should be given) and to study efficacy (how well the drug works at the prescribed dose).
Phase III: Phase III studies are randomized controlled multicenter trials on larger patients groups and are aimed at being the definitive assessment of how effective the drug is, in comparison with current “gold standard” treatment. Because of its size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run. Once a drug has been proved satisfactory after Phase III trials, the trial results are usually combined into a larger document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life.
Phase IV: Phase IV trials are also known as Post Marketing Surveillance Trial. The trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than that of Phase I-III clinical trials.
4. Why do clinical trials attract attention?
People participate in a clinical trial for many reasons. Healthy people may join clinical trials to contribute to medical science and improve medical knowledge and care for others. Clinical trials also may provide free medical care during the trial, which appeals to some people.If you have a specific illness, clinical trials offer access to new approaches that are often not available otherwise.
5.What are the benefits of taking part in a clinical trial?
The benefits of participating in a clinical trial include the following:
Participants have access to promising new approaches that are often not available outside the clinical trial setting.
The approach being studied may be more effective than the standard approach.
Participants receive regular and careful medical attention from a research team that includes doctors and other professionals.
Participants may be the first to benefit from the new treatment method.
Results from the study may help others in the future.
6. What are some of the possible risks associated when taking part in a clinical trial?
You should understand that clinical trials are still experiments. They involve risks. Here are some of the risks the NIH urges you to consider before joining a clinical trial.
New drugs or procedures under study are not always better -- and could be worse -- than the standard care to which they are being compared.
New treatments may have side effects that doctors do not expect. Sometimes these side effects are permanent.
Participants in randomized trials will not be able to choose the approach they receive.
Health insurance and managed care providers may not cover all patient care costs in a study.
Participants may be required to make more visits and undergo more procedures than they would if they were not in the clinical trial.
7. How are participants protected?
Researchers must take several steps to make clinical trials as safe as possible.
These include:
A written examination about the content of clinical research and ethical responsibilities of researchers.
Preclinical studies that show that a new treatment is safe and effective in laboratory and animal tests.
Use of a strict protocol -- an outline prepared before the beginning of a study that describes exactly what will take place during the trial.
A written description of all the information that you will need to make an informed decision about joining a clinical trial. The process of giving you this information is called informed consent.
Approval of the trial by an Institutional Review Board (IRB) -- a committee of doctors, researchers, statistical experts, and selected nonmedical community members. An IRB must approve all clinical trials before they begin and periodically afterward. The IRB evaluates the merits of a trial and ensures that the clinical trial poses no unnecessary or inappropriate risks to protect the rights of study participants.
Before you make a decision about joining a clinical trial, make sure you understand every aspect of your participation in the experiment. This includes what side effects you might expect, how much time and effort the trial will take, and whom you should contact if you have any problems.
8. What is informed consent?
Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or nurse, people receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean people must stay in the study. People can leave the study at any time—either before the study starts or at any time during the study or the follow-up period.
The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.
At the present time, Genova Biotech has been approved by China SFDA to perform the first phrase of clinical trial.On the 31th day of May 2009, Novaferon was granted the Clinical Trial Approval by SFDA. The Phase¢ñtrial has been finished in October 2009. The safety, tolerability,pharmacokinetics and pharmacodynamics of Novaferon have been assessed and proved.
Novaferon was specially approved by SFDA for both phase 2 and 3 clinical trials for treatment of patient with advanced pancreatic cancer on March 28