The Patient Journey
What is it like to take part in research?
Deciding to take part in clinical research can feel daunting and scary. For many of us, it is an entirely new experience that is sometimes resorted to when traditional lines of treatment haven’t worked. For others who decide to take part, it might be because a clinical trial can provide treatment or medication that is more advanced than what is currently being offered,or because at the moment, there are no suitable treatment options. Some clinical trials assess medications that are disease-altering, rather than aiming to delay progression like with most possible treatment options.
More than anything, you will likely want to be reassured that what you’re about to take part in is safe, ethical, and puts your care first. We’re here to let you know that this is absolutely the case, and that you couldn’t be in better hands.
Step 1: Registering your interest with SPCR online
The first step of every study that we run will require you completing one of our patient questionnaires on our website. These forms give us a good indication of where you’re currently at in terms of treatment, the severity of the condition you have by using a scoring system, and whether or not you’ve been clinically diagnosed. These questions vary per study. Once your form is submitted, you will then be contacted by a member of our patient engagement team who will speak with you and ask you some questions about your medical history to determine whether you are eligible for the specific study.
If you don’t have access to a computer or would prefer assistance with your form, you can contact our Patient Engagement Team who can help you register your interest confidentially over the phone.
The information we would normally ask you for over the phone is as follows:
- Your medical history
- Your current medications and treatments
- Your medical condition, the inciting events and consequent diagnosis
- Your previous experience with certain medications, including allergies and failed treatments
- Other medical conditions and your general wellbeing, including upcoming procedures or conditions under investigation
- Your ability to take part in a clinical trial logistically, and what it would require of you in terms of time commitment
Step 2: Patient Information Visit (PIV)
Once you are successfully matched to one of our studies, a member of our team will contact you to talk to you about the study in more detail and to also ask further questions about your medical history. A Participant Information Sheet will be sent to you if you are interested in taking part in the study. It is a booklet that explains what the study entails; for example: how many visits are needed and specific tests or assessments that will be completed as part of the study process.
You will then be invited to our clinic for a Patient Information Visit (PIV), which usually lasts a couple of hours. Your PIV is a great opportunity to meet the doctors and the clinical staff running the studies who will be involved in your care if you decide you want to take part. You will be shown around our premises, and you will have the opportunity to ask the team any questions you may have.
If you are not suitable for a study, this is because unfortunately sometimes not everybody is suitable and this will be due to a specific criteria required to be fulfilled to take part. Our main goal is to ensure our participants are kept as safe as possible during the clinical study, and therefore, the strict criteria aims to ensure that your health and wellbeing is considered in all aspects. Just because you aren’t suitable for one of our studies, this doesn’t exclude you from other research in the future. If you are unable to take part at this time or the timing is not right for you, we’ll ask you if you consent to us keeping your information on our secure database so that we can contact you about any future trials you might be suitable for.
Step 2a: Screening Visit - Informed Consent Form
If your PIV goes well and you decide you would like to participate in a study, you will then be booked in for Screening Visit. A Screening Visit is the first part of a clinical trial – you will sign the informed consent and then become an active participant in the trial.
During the Informed Consent, your doctor will talk you through the trial in detail, and explain the informed consent form which is part of the Patient Information Sheet you received during your initial Patient Information Visit (PIV) to the clinic. A key part of the Informed Consent stage is ensuring your safety and checking your suitability for the study. Only when you are happy to proceed and have signed the consent form, are you officially a participant in the clinical trial. Remember, you can withdraw from the study at any point, and for any reason, during any stage of the clinical study.
Step 2b: Screening - Assessments
The Screening Visit will include a full MOT of sorts – you will have an extensive medical check-up that will include tests and assessments such as urine and blood tests, memory assessments for memory studies, pain scale ratings for pain studies, ECG’s, and neurological examinations amongst others. There may also be further tests required such as an MRI scan or X-ray, or additional memory assessments. Every aspect of the trial and the assessments included will be explained to you in detail at the Informed Consent stage of the Screening Visit.
Step 3: Randomisation Visit
After your eligibility is confirmed by the results of the Screening assessments, you will then proceed to the treatment part of the trial which is called Randomisation. The Randomisation visit is the first visit where you will receive the study medication – this could be placebo or active study drug in varying levels. Our trials are double-blinded meaning neither you nor our team know whether you are on placebo or active medication. The structure of each clinical trial varies and is dependent upon the kind of treatment and condition the trial is assessing. This will be explained in detail by your doctor prior to consenting to take part.
During the Randomisation visit, there may be additional tests to ensure safety and to check for consistency in your medical assessments. For example, you might be asked to fill in a questionnaire, to have blood samples taken, etc. The measurements in this stage are usually used as a record for researchers to compare the before and after effect on you from the treatment or medication you received. We will always inform you what kinds of tests are required.
Step 4: Ongoing Clinic Visits and Treatment
Following the Randomisation visit, you will attend multiple clinic visits and will receive follow up phone calls from our doctors and clinical team to monitor your safety for the treatment period duration. You will receive the study medication either as oral medication, or as an infusion or vaccine, and this will be given to you on site with continued treatment at home for oral medications. Your doctor will explain how and when to take your medication in detail.
On average, you will only need to come to our clinic once a month after you had attended the first few study visits. Some of our studies can run for a while, and some involve follow-up procedures to see whether the treatment can obtain a long-lasting effect such as further MRIs or x-rays. Some studies may also involve diary-style reporting of daily pain levels for the duration of the trial.
Study Do's and Don'ts
Please remember to follow the Dos and Don’ts of the study in order to avoid disqualification from the study – your doctor and study team will explain what you can and can’t do while participating in a study before you consent to take part and details of this can be found in the Participant Information Sheet.
Follow Up Visits and Trial Results
After the treatment period, there is a follow up period. The follow up visits and phone calls are used to assess your safety and the efficacy of the medication beyond the treatment period.
Once a clinical trial has finished, you won’t be unblinded for a while until the results from the study are ready. This is due to the fact that all data needs to be collated and analysed and it requires all participants to have finished the trial globally and most countries are set up on different time scales, hence the analysis can take some time.
