No, and your rights are protected by a rigorous set of guidelines, laws and regulations. You can read more about these regulatory boards here:
MHRA – Medicines and Healthcare Products Regulatory Agency
NIHR – National Institute for Health Research
NHS – National Health Service
MRC – Medical Research Council
At SPCR, we conduct phase II and III clinical trials. This means that researchers have proven the medicine to be safe in humans but need more data to prove that it is effective at treating the specific condition, and at which dose. This is known as drug efficacy.
Absolutely! We invite everyone interested in taking part in a clinical study to our clinic for a “Patient Information Visit” (PIV). This gives you a chance to get to know our team and clinic, learn about the study, and it gives you the opportunity to ask a doctor or one of our research team any questions you might have. This visit takes place before signing any consent forms.
You can withdraw your participation at any point during the trial, and you will never feel pressured to continue staying on the study if you decide not to continue. In some cases, we will need to withdraw a participant if it has been decided that a) the sponsor has found that the drug has no benefit over placebo, or b) if it has been decided that you are no longer able to take part.
Usually this is not required. We run an outpatient clinic, where those on studies come to us during the day and return home once their visit is complete. Sometimes to make travel easier, there is an option to stay overnight in a hotel nearby. The costs of which will be covered by the study sponsor. This is the pharmaceutical company who’s study you are enrolled in. If the study you are taking part in requires you to be given medicine as an inpatient, this will be explained to and clarified with you prior to consenting to a study.
We cover reasonable travel expenses back and forth to our clinic and also provide refreshments where necessary during your visits at the clinic . If you are attending a particularly long visit, we also can provide breakfast or lunch. All we ask is that you keep a hold of your travel receipts and hand them in when you visit us. Refunds are processed in 5-10 working days.
Having a study partner is not necessary for all studies but will be required for some of our memory and cognition studies. If you sign up for one of our studies in which study partners are needed, this will be discussed during your initial conversations with our team.
A study partner is someone who consents to the study with you. Your study partner will be involved in the study visits and will be required to attend as well. The visits the study partner has to attend varies per study.
They need to be someone who you spend around 7 hours per week, because they assist with the assessment of your cognition functionality by providing an insight for the period of time you are not with us at the clinic.
The answer to this question varies depending on the study and is determined by certain criteria set out in the study design by the pharmaceutical company responsible for the study. Some of our studies will have a requirement of a diagnosis within a specific timeframe, for example for at least 6 months before beginning the study, whereas other studies may allow SPCR to give a research diagnosis of Mild Cognitive Impairment or of a pain condition such as CRPS or small fibre neuropathy.
If you have any specific questions relating to this, you can always get in touch with a member of our Patient Engagement team who can answer any queries: [email protected].
Just because you haven’t been suitable for one study, does not mean you won’t ever be suitable for studies we have in the future.
When this happens, we will ask you if you consent to us keeping your contact information on our secure database so that if any different studies come up in the future that might help, you will be told about them.
Yes, we are paid by the pharmaceutical companies responsible for the studies we work on. There are a lot of costs involved in conducting clinical trials:
- Treatments, tests, assessments and procedures
- Research staff to run the trial and collect data
- Admin costs – paperwork, overseeing study protocol, analysing and inputting data and production of results
- External tests such as MRI’s, PET scans or hospital stays for patients taking part.
There are side effects to all treatments, irrespective of whether or not they are still in the clinical study phases.
Being given a study drug does not necessarily mean you are more likely to experience side effects than if you were to be prescribed a drug from your GP. If you are considering taking part in a study, the side effects would be explained in detail and you would have the opportunity to talk to one of our study doctors about any concerns you might have regarding side effects. If any side effects do occur, they will be monitored by our doctors and we operate a 24/7 medical emergency line for everyone on a study with us.
We would always recommend you bringing along people who will make you feel comfortable and at ease throughout your visit, as they can vary in length. However, we are not always able to cover travel and refreshments for additional persons due to the ethical obligations we have to ensure no one is persuaded to take part in a study.
We understand that you may need to cancel or rearrange a visit, and that things can happen out of the blue. Where possible, please give as much notice if you need to cancel or change your appointment with us. We send out reminder texts the day before your visit, with the time of your appointment and a phone number to call should anything change from your end. Our study teams will be in communication with you about your study visits and will give you information about what to do if you cannot make one once you are enrolled.
Our pharmacists and doctors will let you know if there is a risk of drug interaction between the medicine you are currently taking, and the study drug. If there is the potential of a bad interaction, you may be asked to stop taking your other medication. Questions like this would be covered extensively prior to consenting to a study in conjunction with our study team and doctors.
Yes, you can continue visiting your GP. We work very closely with your GP throughout the duration of the trial and will need to request medical history before we enrol you to make sure it is safe for you to take part. Certain tests completed as part of the study will be made available to your GP where possible as per the specific study requirements. If there are any medical concerns during your participation we communicate with your GP and inform them of any results from additional tests completed as part of our safety checks. Please do talk to your doctor/GP about taking part in research – we encourage you to consult your friends, family and GP because we know it is a big decision to take part in a clinical study.