YOU’VE ARRIVED AT SIMBEC ORION CLINICAL TRIALS JOIN BELOW

Most of us at some point in our lives have or will have been prescribed or taken some form of medication. These medications are developed using clinical trials, so each time we use a medication, we benefit directly from these clinical trials which have involved healthy volunteers and patients just like you.

Medicines we now take for granted were once new medicinal products and had to undergo a series of clinical trials and testing before being allowed onto the market. In fact, these medicines continue to be researched as pharmaceutical companies strive to improve their formulation and function.

Giving a medicine to a healthy volunteer or patient provides information on the safety and tolerance of new medicines and how the body absorbs and excretes these. This can be tested, for example, by taking blood and urine samples, measuring blood pressure, and performing an ECG (a trace of your heart rate) at various times in the day.

Have you ever considered how a doctor knows how frequently you need to take a medicine? Again, this information is obtained from measuring the medicine in participants’ blood. This is done by taking blood samples over a period and then measuring the amount of medicine in each sample.

Clinical trials are vital in combatting and preventing major diseases and conditions, that is why we need your help to ensure research can continue and we can aid in developing the medicines and treatments of tomorrow.

As a participant it is natural that you will be concerned about your safety. That is why here at Simbec the wellbeing of our participants is our top priority. Each and every trial we undertake is submitted to the South East Wales Research Ethics Committee, who as an independent group, review the information available and ensure that each trial maintains the highest levels of safety before allowing it to proceed.

Prior to any onsite screening assessments or procedures, you will be asked to sign an informed consent form to confirm you fully understand what is expected of you as a volunteer. This is completed with one of our Research Physicians/Doctors and gives you as the volunteer the opportunity to ask any detailed questions you may have about the trial, safety, and possible side effects.

All trials are different, and all require range of specific procedures and tests, but you will be fully informed of these prior to agreeing to screen or take part in the trial.

Before the start of every trial, you will be asked to attend a screening appointment involving a pre-trial medical examination and normally a blood and urine test to ensure that you are suitable to take part. Before any assessments take place, you will be provided with the full trial details and will be asked to sign an informed consent form.

By consenting and screening for a clinical trial, you will be under no obligation to take part in any trial and if you do take part and enrolled into one of our trials you are free to withdraw at any time.

During the actual trial, you will more than likely have blood and urine samples taken at set times throughout your stay. In addition, you may have your blood pressure and heart monitored periodically. Every trial follows a strict schedule of events. For example, you may need to fast overnight in preparation for the dosing of the trial medication, which usually occurs in the morning. Dosing is mostly in tablet form but may be in the form of an injection, liquid, patches, or infusion.

Before being discharged from any trial, it is mandatory that you attend post-trial blood test and a medical examination. Following discharge by one of our Research Physicians, each trial includes an inconvenience payment for your time and efforts for participating and this is only paid after full trial completion.

At Simbec, we aim to make your stay as comfortable as possible with a full range of free facilities available. Examples are satellite TV, books, daily newspapers, board games and pool tables for your use. If you want to study, work, or unwind, there is a quiet reading room with free Internet access on hand for you. We also have Wi-Fi access on each ward if you wish to bring your laptop or tablet.

We provide you with all your meals during your stay at Simbec, although there may be certain restrictions on what you can eat. We can, upon request, provide alternative dietary plans, such as vegetarian meals where the trial requirements allow it.

Each year, we have more than 1000 individuals who take part in our clinical trials, including healthy volunteers and patients from all ages and backgrounds. Every trial has its own individual inclusion and exclusion criteria, so even though you may not be eligible for any of our current trials now you may well be eligible for future trials.

We are continuously looking to recruit volunteers and patients to our database, once you become a member of our volunteer database you will be the first to know about any up and coming trials we have or are planning to conduct for which you are deemed eligible.