A study also described as a clinical trial is the routine but essential examination of how a new medicine is absorbed and handled by the body. Studies may be conducted for new medicines or may look at improvements to an existing treatment.
It’s only with the help of volunteers in our studies that the medicine in question can be tested for effectiveness and tolerance.
A clinical trial is designed by a sponsor. A sponsor is typically a pharmaceutical company with a new product or an existing product that they would like to test. The sponsor contracts with a principal investigator who is a doctor that actually runs the clinical trial. An investigator will have help from various people, including a study manager that manages the trial and clinicians who are medical personnel that perform the study procedures.
Subjects are people who volunteer to undergo the procedures in the trial. The rights of the subjects are protected by an independent review board (IRB). The IRB makes sure the clinical trial and the physician investigator are acting ethically and that the subjects are properly protected.
All of our studies are conducted under internationally agreed guidelines. For studies conducted in the US, these guidelines are set down by the US Food and Drug Administration (FDA). For studies conducted in the UK, the guidelines are set down by the UK Medicine and Healthcare Products Regulatory Agency (MHRA). In addition, each study is reviewed by an Independent Ethics Committee who are responsible for ensuring that your safety has been thoroughly considered, that the information provided to you is fair, balanced and accurate and that your rights as a volunteer are maintained.
Each clinical study is described by a document called a protocol. Protocols describe what type of subjects can and can’t be enrolled into the study. The protocol also includes information like the study schedule, a list of the procedures to perform, and any laboratory tests to be run. Each protocol is different. Before you enter a trial, the principal investigator will describe to you the procedures, risks and benefits during the informed consent process.
Even though every trial is different, most trials require you to have some blood and urine samples taken, your blood pressure and pulse monitored and ECG recordings. Depending on the trial, sometimes the meals you are provided with will be determined by the protocol. How often this happens depends on the study or visit schedule. The principal investigator will explain the visit schedule to you during the informed consent process. Studies last for varying periods anything from 24 hours to four weeks and usually require overnight stays in our research facility.
Before, during and after the trial, volunteers are carefully monitored by our highly qualified and experienced staff to ensure their safety and wellbeing is maintained at all times.
At ICBio, we always put the safety of our volunteers first. We, like other clinical research organisations, are governed by legal and ethical codes to ensure we comply with the guidelines on good clinical practice, good laboratory practice and good manufacturing practice.
Our team of medical staff, including Medical Directors, several Physicians and numerous nurses will be around to monitor you 24 hours a day. You will have regular checks to ensure you are healthy and safe.
All of our studies are conducted under internationally agreed guidelines. For studies conducted in the US, these guidelines are set down by the US Food and Drug Administration (FDA). For studies conducted in the UK, the guidelines are set down by the UK Medicine and Healthcare Products Regulatory Agency (MHRA). In addition, each study is reviewed by an Independent Ethics Committee who are responsible for ensuring that your safety has been thoroughly considered, that the information provided to you is fair, balanced and accurate and that your rights as a volunteer are maintained.
For your safety, there is a wash out period between studies to ensure the study drug is clear from your system.
As with any medicines, there are risks of side-effects this is one of the important reasons for carrying out clinical studies with us. Before your study starts you will be given information documents (notes) about the study you have chosen, which will give you all the available information on the study drug, the results of any previous studies, as well as a list of possible side effects.
The common short-term side effects are nausea, headaches, drowsiness and possibly a slight change in blood pressure. Any expected side effects will be explained by one of our physicians when you attend your medical screening visit.
Throughout the duration of the study, our team of medical staff, including Medical Directors, several physicians and numerous nurses will be around to monitor you 24 hours a day. You will have regular checks to ensure you are healthy and safe.
There are many reasons why our volunteers choose to take part in a clinical study at ICBio.
Payment: The study payment is calculated by the amount of time and commitment involved for our volunteers and will be explained in detail during the informed consent process. The payment schedule for your chosen study will be explained to you in the study information documents. Some studies that require a longer commitment may be given an interim payment.
Making friends: Volunteering for a study at ICBio is a great way to make new friends, who share a common interest in bringing new medicines to market.
Free Medical: At your pre-study medical visit you will meet one of our medical staff who will answer any questions you may have about the study, following which you will sign the consent form . You will be asked about your medical history and have certain procedures performed including urine and blood samples, blood pressure, height and weight, and ECG (Electrocardiogram a heart activity tracing). Each study is different, therefore you may also have additional tests performed or be required to attend for additional visits; details of which will be provided in your study information documents.
If you are a patient with a particular condition, you may participate in a trial to get early access to new treatments for your condition. Typically, trials for specific conditions are run by physician-investigators with advanced or specialised knowledge of the condition.
Helping to develop medicines: Without the time and commitment of our volunteers, we would not be able to help research and develop new, potentially life saving medicines. Any medication you buy at the pharmacy today has been researched by clinical research companies like ICBio.
Recreational Time: When taking part in one of our studies you will have lots of time to relax with a book, chat with other volunteers, have access to a range of digital games and TV and can surf the Internet. You will be involved in certain study procedures each day but the rest of the time is yours.
As a basic guide, if you’re fit and healthy and aged between 18 and 80 (18+ in Nebraska), you’re the kind of volunteer that ICBio needs.
General criteria stipulates that you:
On occasions, specific studies may require volunteers with particular characteristics for instance, we may need volunteers who have the medical condition a new medicine is intended to treat e.g. Asthma or Diabetes
Each study has its own unique set of qualification criteria. Please call us or visit our studies page to see which studies you may qualify for.
If you’ve had a procedure in a hospital, you may have had to sign a consent form. An informed consent for a clinical trial is a more specialised consent and it has a very distinct purpose: it is designed to protect you, not the research staff.
You will be given an informed consent document as part of a conversation you have with the research staff before you participate in a trial. The informed consent will explain:
Use the written informed consent as a basis for asking any questions you may have about the clinical trial process.
Signing an informed consent does not obligate you to participate in the clinical trial. Even though you sign the consent, you can change your mind and leave a study at any time.
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