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The process that brings a new drug from the research laboratory to the marketplace is a long and careful one. Long, because it takes years to complete all the laboratory, animal and human tests; careful, because all those involved in bringing it to market must ensure patient safety and follow strict government regulations in evaluating the drug's safety and efficacy.
One of the most important steps in the development process is the clinical trial, which is a study with people who volunteer to receive the drug and be observed for its effects. It is through these trials that investigational drugs are tested to determine whether they can benefit human beings. But before this can happen, people must volunteer and participate - a choice that may benefit not only the individual but many, many others as well.
Whether or not you qualify for a clinical trial depends on a number of factors, including your medical condition. Your physician will discuss these factors with you and provide comprehensive information on the investigational drug and the trial itself.
Still, you may have questions. Participation in a clinical trial can be a great undertaking, and there are no guarantees that the investigational drug will work. This page, however, will help you understand some of the potential benefits and risks of participation, and give you some idea of what to expect if you decide to participate.
Making trials smaller, faster, more efficient and more accessible
Amgen is innovating new ways to get medicines to patients faster. To achieve that, our R&D strategy in clinical trials is focused on leveraging innovative clinical trials design, real world data and digital technologies to accelerate drug development. We are continuously working to achieve equitable access to clinical trials by improving the diversity of participants in a study and ensuring they are more characteristic of a broader patient population.
Amgen is innovating new ways to get medicines to patients faster. To achieve that, our R&D strategy in clinical trials is focused on leveraging innovative clinical trials Adaptive clinical trials allow continual learning as data is being collected, helping to find new solutions for those who are afflicted with the disease we seek to treat. We are now evolving the way we think and run clinical trials applying new approaches in design and execution to improve efficiency and flexibility and to increase speed.A clinical trial is carefully supervised research that is done in humans prior to the availability of an investigational drug to the public.
The term clinical refers to research performed in a hospital or clinic setting in which a physician and other healthcare professionals observe a participant. A trial is a study, whereby the drug is analysed for its effects on a group of participants.
However, before a drug enters the clinical trial phase, it is extensively tested through basic or preclinical research in the laboratory, both in lab experiments and in animals. The type of experiments depends on the disease being studied, and if animals also can have the same disease. This type of research is extremely important in gathering information on the drug's possible benefits and risks before it is tested in humans.
It is important to understand that both basic research and research done through clinical trials are carefully supervised, monitored and documented. Investigational drugs must demonstrate their safety and effectiveness to government regulators before they are approved. Clinical trial volunteers play a very big role in this process.
The reasons why people become involved in clinical trials are as varied as the individuals themselves.
Some people have an illness that currently has no treatment. A clinical trial may offer the opportunity to try an investigational medication, which may help.
Others may become involved because their current medication has too many side effects and they want to see if they can tolerate the investigational drug being tested.
And others volunteer because they want to help find answers to scientific or medical questions that will help others benefit in the future.
Only you can decide whether or not to participate in a clinical trial. That's why you should take plenty of time to think about the trial and ask all the questions you want. You may even consider asking a close friend or family member to help you in your decision—they may have questions or concerns that you may not have considered.
Above all, remember that there are risks associated with clinical trials. And yes, it's a tough decision. Have all the facts before you make up your mind.
"I decided to enter a clinical trial because I hoped that the research would be of help to future patients."—Clinical trial participant
Investigational drugs are tested in clinical trials because not everything is yet known about them. There may be risks to receiving the drug, which will not be uncovered until after a clinical trial begins. Your physician will discuss these potential risks with you. You should carefully weigh them against the possible benefits and ask as many questions as you need to. Keep the following in mind when evaluating risks:
A placebo is an inactive product used to compare results of the active drug being studied and to learn more about its actions. It is used in clinical trials as one of many possible treatment assignments. Because the participant and healthcare professionals usually do not know which individual has received the placebo and which has not, observations in the clinical trial can be conducted more fairly, without any bias towards a particular group of participants.
There are a number of potential benefits from participating in a clinical trial. In general, they include:
"I was always willing to try anything that was available to potentially help in finding new treatment options for the disease."—Matt, Clinical Trial Volunteer
Clinical trials can occur in a variety of places. Some are performed in a hospital and others in your local GP practice. They can also be done in special research centres.
If you decide to participate in a clinical trial, you will receive information regarding the study location.
You should not be asked to pay to be in a clinical trial. In most cases, study medication is provided free of charge.
If you are considering participation in a clinical trial, discuss the potential financial implications with your physician or other healthcare professional. They can tell you exactly what will be covered as part of the clinical trial and what will be considered part of your normal healthcare routine, including that which may be your responsibility. Remember to ask everything that's on your mind. It's your right.
People interested in clinical trial participation should discuss this with their physician. It's the best way to learn whether an appropriate trial is available, and where it is being conducted. Potential participants are screened to determine if they are eligible for a given trial. Sometimes screening involves nothing more than a series of questions and answers. Other times it may require laboratory tests. In any case, these tests are performed only with the participant’s consent.
Not every disease will have a clinical trial currently underway. But this situation is constantly changing. Consult your doctor or patient support group to learn if research is being planned which may be appropriate for you.
"I found an article on the bulletin board at the hospital...and they were eager to talk to people who were interested in potentially getting involved with a study."—Alfred, Clinical Trial Volunteer
Your responsibilities will be explained to you by your healthcare team. In general, however, you must see your study physician as scheduled and take the study medication as directed.
You may also be asked to keep a diary of your experience with the study medication; this may help give your study physician information on its safety and effectiveness. You should also contact your study doctor as soon as possible if you are hospitalised for any reason.
In addition, it is important to let all of your non-study doctors know that you are participating in a clinical trial. They will need the name and phone number of the study physician in order to let him or her know about any pertinent medical information that may affect your participation in the trial. It is advisable to keep the study doctor’s name and number with you at all times in case of emergency.
No. Clinical research is regulated by government and by the medical profession. You are protected from unauthorised research without your consent through a process known as informed consent.
Informed consent means that your physician and/or study nurse will thoroughly explain the clinical trial to you and may provide a package of information on the trial along with an informed consent form. The informed consent form provides information on the length of the study, potential side effects (if known) from the drug being tested, your rights to withdraw from the study, and how the study is considered completed.
The consent form will also explain how the study protocol is designed, whether or not a placebo is to be used, and what kind of tests will be required. If you don't understand any of the terms of an informed consent form, it is important that you ask your doctor Once you are satisfied that you have a full understanding of the nature and scope of the trial and decide to proceed, and if you qualify to participate, you may decide to sign the informed consent form. However, remember that you always have the right to say no. If you are uncomfortable with what you are being asked to do in the study, or if you don't fully understand it, or if you simply no longer want to participate, do not feel like you have to participate.
If anything changes, or new information becomes available during the course of the trial, you will receive an updated consent form for you to review and sign to ensure you are happy to continue to participate.