What happens if you contact P3 Research and want to participate in a study?
The studies we run at P3 Research are Phase 2 and Phase 3 trials, looking into new treatments, usually for a common conditions, for example asthma, type 2 diabetes, COPD, hypertension etc.
We actively advertise our studies in our local communities, so you’ll see or hear our ads in local newspapers, on the radio, and through Facebook and other online sites.
Our volunteering process explained
- Typically, first contact will be made by one of our Nurses or Study Co-ordinators, either by phone or email, to outline the study and make an initial assessment to see if you would be eligible to participate in the study. This is called a pre-screening call. You’ll be given an overview of the study, and be asked some questions about your condition, your general health and what medications you are taking.
- The Study Co-ordinator will send you a Patient Information Sheet (PIS), either by email or post, for you to read through. The PIS is a document that tells you what you need to know about the study, so that you can make an informed decision as to whether you want to participate in the study or not. Every clinical trial is required to have one. You might also want to use this opportunity to discuss the study with your friends, whanau, or your own doctor or specialist. The PIS will tell you:
- What drug/medication is being trialled
- How the medication will be administered
- Why the research is being done
- Who is the Sponsor company (the company that has contracted for the research to be done)
- The risks and possible benefits of participating
- What your rights are, such as being able to withdraw from a study at anytime
- Contact details for further information
- What is involved for you personally in participating in the study, such as
- how many visits there are
- what type of visits are required (e.g. visits to the clinic, phone visits)
- what is involved at each visit (e.g. physical examination, medical history, blood testing etc.)
- how long the study will run
- if there is anything you must do during the study (e.g. taking medication, completing diaries)
- if there is anything you must not do during the study (e.g. limiting or abstaining from certain drinks or medications)
- what payment or reimbursement you will receive for participating
- If you’re eligible to participate based on the pre-screening call, and have read through the PIS and are keen to be involved, you’ll be invited to one of our clinics for a screening visit and some screening assessments. These assessments are required to make sure it is safe for you to take part and to check that you are a suitable candidate.
- At the screening visit you will be asked to sign the Informed Consent form. This must be done before any other study procedures take place, to show that you understand what is involved and are willing to participate in the study. You can ask as many questions as you need to before deciding to take part in a study. It sometimes helps to write down any questions that you might think of prior to the screening visit.
- A doctor and study co-ordinator will ask you detailed questions about your health and the medicines you are taking and will explain the study to you. It is very helpful to the researchers if you can bring any prescribed medications or over the counter treatments to the screening visit. If you fit the criteria for the study you will be asked to return to the clinic at specific times for treatment and tests.
- Each study varies in how it is run and what is required. Some studies are fairly short and may run over the course of a few months, while others can run for 1-2 years or longer. The frequency and duration of study visits also varies, with some requiring weekly visits and others 1-2 monthly. Most studies will require you to have blood tests and blood pressure taken throughout the study. Some studies will ask for other assessments or tests, such as physical examinations, breathing tests, ECGs, x-rays, MRIs or other imaging. For some studies, the study medication might only be given to you to take when you are at the clinic, while for others you might be given medicine to take when you are at home. You might also be asked to record information about your health in between the study visits. How a study is run and what is required from you will be clearly outlined in the Patient Information Sheet.
- Studies usually have a strict timetable for visits to take place. It is important that you try to adhere to the scheduled visits as much as possible. The PIS will give details of when study visits are due, so you can plan ahead. The Study Co-ordinator will discuss with you possible study visit dates, holidays and other limitations of your availability during the study.
- If you enrol into a study, we will, with your consent, notify your GP so that we can make sure it that it is as safe as possible for you to take part in the study.
- All your personal information is kept by P3 Research and will remain confidential. We will ask for your permission to keep your information in a database, so that we can contact you later if you are interested in taking part in more trials. You can decline this request if you choose. Your study results, such as blood tests or results of other assessments will be sent to the sponsor company for analysis. The sponsor company will not be given your name and you will not be able to be identified in any of the study reports or publications.
- Your involvement in a study is entirely voluntary. If you change your mind at any stage, or if your circumstances change and you can no longer participate, you can decide to withdraw from the study, for any reason. However we would ask you to come to the clinic for a final visit so we can check your health and make sure you are getting the right treatments for your condition.
- Results of the study are made publicly available, although these can take some years to complete. You can request a copy of these by contacting us at any time.
Who can I talk to for more information?
For information about studies at P3 Research
Call us on 0800 737 883
The staff at P3 are very friendly and helpful and made the experience easy to cope with. I wouldn’t hesitate to volunteer for any similar trial at P3.
I was invited to take part in a study of a new medication for pancreatitis. The study was for 3 nights and the staff made me feel very comfortable and put my mind at ease. I would put my hand up to volunteer again.
I have secondary progressive MS and participated in a year long drug trial at P3. It was a great experience. I was really well informed, so cared for during the weekly infusions and assessments and I would join another trial with P3 like a shot. Thank you especially Mary and Dean.