Creating a new medicine is a long and rigorous process. Much of what we investigate never makes it to patients. In our search for new medicines, our primary responsibility is patient safety.
It can take up to 15 years to progress from a promising idea in the research laboratory to receiving approval from regulators that allow us to make a new medicine available to patients through their doctors. We may investigate 5,000 or more different chemicals to identify just one that can be tested in humans.
We begin the search for a new medicine by seeking to understand what processes in the body lead to a disease or create the symptoms. This starting point is based on both our own research and the learnings of the broader scientific community.
Developing a new treatment typically goes through seven stages from laboratory to patient.
From laboratory to patient
Research – identifying a possible new approach to treat a disease or condition
We use the growing understanding of biology to identify ‘targets’. A target is a structure – like an enzyme – in the body that contributes to the development of disease or the symptoms of that condition. It is important initially to know that the target we select is valid – that it does affect the disease process in the way that the science suggests.
Once such a target has been validated, the next step is to seek out chemicals or natural compounds that might inhibit or enhance the target’s activity.
Techniques like automated high through-put screening allow many hundreds of compounds to be screened for that sort of activity very quickly. Compounds that show the sort of effect we want are called 'hits'.
Discovery – developing and investigating compounds that can alter a disease process
Once we have identified our hits, we seek to narrow down the number of possible compounds by further testing to come up with lead compounds. Our lead compounds may need to be 'improved' - we may modify them using chemistry to enhance different properties. Ideally we look for compounds that can:
• selectively hit the target for the disease processes
• be absorbed by the body
• reach the appropriate point in the body to find the target
• remain in the system long enough to have an effect
• be manufactured to produce a stable preparation convenient to use
• has few side-effects (off target effect)
Pre-clinical testing – understanding how a compound works in a system and its effects
At this stage our researchers do more detailed investigation of the lead compounds. By testing 'in vitro' with living cells, bacteria or tissue cultures or 'in vivo' in animals, scientists can build an understanding of how the lead compounds behave.
If the work has been successful, the development team will have identified a candidate compound to consider testing in humans.
Clinical trials – carrying out tests in humans
Before any trial in humans can start, a protocol is developed that defines what the trial would involve. The protocol will be carefully considered by an ethical review committee made of experienced independent medical and scientific practitioners. This committee has the power to reject or stop a clinical trial at any time.
New medicine must go through three phases of human testing before it can be approved for use.
• Phase l is intended to confirm how the potential medicine is absorbed and moves through the body and is usually conducted with a small group of healthy volunteers.
• The larger group of volunteers in Phase ll will include patients with the condition the new preparation is intended to treat. This will establish whether it is going to have a beneficial effect on the particular disease process and what doses may be most appropriate.
• Successful outcomes from Phase ll will lead to a Phase lll trial. This is a much larger study likely to be conducted with many hundreds of patients in several different countries. Phase lll trials are designed to demonstrate the efficacy and the safety of the potential new medicine in a wide variety of patients.
These three phases of clinical trials may last six, seven years or longer and many candidate medicines will not advance through each stage.
Find out more about these critical phases in the development of a new medicine by visiting our section devoted to clinical trials.
The safety of those who take part in clinical trials is of paramount importance. All our clinical trials are conducted in accordance with guidelines developed by the International Conference on Harmonisation (ICH) and the principles contained in the World Medical Association Declaration of Helsinki on the Ethical Principles for Medical Research Involving Human Subjects (2008).
Regulatory approval – submitting our data and information to government regulators to gain approval for a new medicine
Once a medicine has successfully completed its studies based on its use in humans, the information gathered throughout the development process in the laboratory and its clinical trials is submitted to government regulators. This is the formal application to seek approval for the new medicine. The process must be followed in every territory in which we hope to offer the new treatment to doctors and patients.
Based on our research, we suggest to the regulators which patients may find our medicines helpful, but it is the regulators who make the final decisions. Their approval will include details of the diseases or conditions – known as indications – that this medicine has been cleared to treat. Regulators may also require restrictions or warnings to be placed on the use of new medicines.
Only after the regulators have given their approval to a medicine can we make it available to doctors to prescribe to patients.
Supplying – manufacturing and shipping the approved medicine so that doctors can prescribe it for patients
The approved new medicine is now manufactured and distributed. Doctors will be supplied with the information that will help them in deciding when to prescribe the new treatment.
Find out more about how we advise doctors on the availability of our treatments and the ethical standards that we have set ourselves as we conduct our relationships with medical professionals by visiting our section on How we work with doctors.
Monitoring – continuing to gain understanding from the use of new medicines in a real world setting
As new medicines are used more widely, we build a deeper understanding of their effectiveness in different circumstances. This can mean that our appreciation of a medicine changes over time.
Part of the remit of our Global Safety Board (GSB), chaired by our Chief Medical Officer and made up of senior physicians and scientists, is to review the information on the safety of GSK products as reports come in from patients and prescribers on the use of the medicines in a real world setting. All the Board's decisions are guided by the need to ensure that our medicines and vaccines always have a favourable benefit-risk profile.
We continue to monitor patients' responses to our medicines through reports and regulator reporting systems. We follow this information to understand fully a new medicine's efficacy and to seek out any very rare adverse effects that may only become apparent as more patients use a treatment.
Learn more about our commitment to patient safety by visiting our review of research practices.
Matéria em GSK
http://www.gsk.com/research/discover/index.htm
Acesso em 01 de novembro de 2011.
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