About MAC Clinical Research:
MAC has been successfully conducting medical research trials on behalf of the pharmaceutical industry since 1988. With many research sites across the UK including Greater Manchester, Yorkshire, Lancashire, Staffordshire and County Durham. MAC are leading the way in the development of new medicines for a wide range of conditions.
What is a “healthy volunteer”?
Someone with no known significant health problems who participates in research to test a new drug, device, or intervention is a “healthy volunteer” or “Clinical Research Volunteer”.
What are healthy volunteer clinical trials?
Healthy volunteer clinical trials are a large and vital part of the research industry. As with all aspects of clinical trials, the healthy volunteer segment of clinical trials is extremely highly regulated. For any medication, there has to be positive research in healthy volunteers before it is moved into testing in the target group of patients. To ensure safety, the dose used for the first stage of healthy volunteer clinical trials starts at a minuscule measure, which is too low to be expected to have any therapeutic effect. This dose is then slowly increased to the dosage required based on the clinical trial using the data collected during the trial to analyse the next potential dose.
Why do we need both healthy and patient volunteers?
Healthy volunteers have always played a vital role in medical research. When developing a new technique such as a blood test or imaging device, we need clinical research volunteers to help us define the limits of “normal.” In some studies, researchers need to compare healthy volunteers with people who have a specific disease or condition, in which case the healthy volunteer would serve as the control group. They are often matched to patients on characteristics such as age, gender, or family relationship. Healthy volunteers are then given the same test, procedure, or drug the patient group receives. Investigators learn about the effect of the drug by comparing the patient group to the clinical research volunteers. Research with healthy volunteers is designed to develop new knowledge, not to provide direct benefit to study participants.
How can I volunteer?
Almost all healthy volunteer studies in the UK are run in specially qualified private units knows as Phase 1 units or Early Phase Units. There are around 15 of these across the country including MAC’s Early Phase Unit. MAC’s healthy volunteer trials and further information can be found on our website.
What happens in a clinical trial?
If you are interested in taking part in a clinical trial then a patient advisor will take you through a brief medical research questionnaire over the telephone. Once this is completed then they will match you with a suitable study according to your requirements and availability. The patient advisor will send you the study information sheet in the post which gives much more detailed information about the study for you to read before you come in and a consent form for us to contact your GP to obtain your medical records. You will then be invited in for a screening visit at the unit and during this screening visit you will meet with a physician who will guide you through all the study information. You will be asked to give consent to take part in the study and then you will have a discussion about your medical history. You will also have a physical examination and then the nursing staff will perform some other tests like taking your blood pressure, doing an ECG (electrical recording of you heart rhythm), taking a small blood sample and doing alcohol and drugs of abuse tests. If you are considered suitable for the study after this visit you will be given an admission date.
Due to the scientific nature of a healthy volunteer study you generally have to stay in the unit for a certain amount of days and nights so that different tests can be done once you have taken the drug. During this time everyone is kept within the same environment and given the same food and drink so that the study is as controlled as possible. You check into the unit on a day we call Day -1, this is the day before we intend to give the study drug and on this day a lot of the assessments performed at screening are repeated just to ensure you are still suitable. Then on the next day you will be dosed with the drug usually early in the morning, then blood samples will be taken at set points during the day, along with blood pressure tests, ECGs and other tests required by the study. Meals and snacks will be provided throughout the day. This then continues for as many days as the study requires. Sometimes you can stay in the unit until Day 2, for some studies it could be longer.
Some studies may require you to come in for further outpatient visits or other types of studies you may be required to come in for another residential period. There are many different types of studies with different timetables. Once you have completed a study you will be asked to come in for a follow-up visit where assessments are repeated for a final time then you are discharged from the study.
Will it cost me to take part?
There is no cost to take part in our clinical trials. In fact, we pay for your time and commitment. We also pay all travel expenses incurred or we can arrange transport for you.
How do I learn more?
Our patient advisers are on hand to provide you with all the information you require. For your no obligation conversation call 0800 633 5507. To establish whether we have a research study suited to you we, will guide you through a brief medical questionnaire over the telephone. You could also find us on Facebook: MACClinicalResearch or follow us on Twitter @MAC_Research.