After the success of our online Summer School, we’re sharing an activity that you can do at home with your family. It’s our mock clinical trial which gives an insight into how our researchers test new treatments in our Clinical Research Facility.
Clinical trials, compared to observational studies, are considered by many to be the gold standard method for evaluation of healthcare interventions. They contribute significantly to relevant research evidence developed by the National Institute for Health Research (NIHR) to support the NHS in England and other care providers (source NIHR website).
This exercise aims to demonstrate to you the process of taking part in clinical trials. We used two different types of orange juice as Investigational Medicinal Products to assess “efficacy” through a taste preference. If you don’t want to use orange juice, you can use any items you can find in your house to compare such as full fat vs skimmed milk or even tap water from the kitchen cold tap vs the bathroom cold tap.
Read the below instructions and carry out the experiment with the people you are living with (the instructions may need to be changed slightly if you are trialling a different product). You will be the Principal Investigator in this study and have full overall responsibility for its delivery. You will also find a Patient Information Sheet which you must get all of your participants to read and you must obtain their informed consent to be included in your mock trial.
If you want to do some further research you can find out more about clinical trials on the National Institute for Health Research website.
|Study type||Phase 3|
|Primary Objective||To evaluate the efficacy (taste) of a standard treatment (branded orange juice) versus the efficacy (taste) of a new treatment (supermarket own brand orange juice).|
|Secondary Objective||To explain the process of involvement in clinical trials to patients and the general public.|
|Study design||This is a one day double blind crossover study to evaluate the efficacy of a standard orange juice treatment (brand) versus the efficacy of a new orange juice treatment (Supermarket own brand). Participants will be given a dose of each treatment and will be asked to rate the efficacy (taste quality) of each treatment. Efficacy (taste) data will be recorded using a visual analogue scale (VAS) where 10 tastes best and 1 tastes worst.|
|Sample size||Dependent of those living in the same household as the Principal Investigator|
|Inclusion criteria||1. Participant lives in the same household as the Principal Investigator
2. Participant is able to swallow;
3. Participant likes orange juice;
4. Participant is willing to drink a cup of orange juice;
5. Participant consents to participation in the study.
|Exclusion criteria||1. Participant has a known allergy to any ingredients contained within the proposed treatments;
2. Participant does not like orange juice;
3. Participant is a diabetic;
4. Participant is not able to swallow.
|Criteria for withdrawal||1. Participant does not comply with, or is unable to complete, the procedure outlined in the protocol;
2. In the Principal Investigator’s (PI) professional opinion it is no longer appropriate for the participant to continue on the study.
|Investigational Medicinal Product (IMP)||· Standard treatment: branded orange juice (IMP A)
New treatment: Supermarket own brand orange juice (IMP B) Water : H2O
|Dosage||1 x unit of IMP A , 1x cup of water, 1x IMP B|
|Form of administration||Oral|
|Preparation||IMP is delivered to study site prepared and ready for administration|
|Storage||The IMP should be stored in the fridge.|
Information and instructions for the Principal Investigator
|Procedure||1. Explain study and purpose to participant and gauge interest and assign a participant no and enter this on the Case Report Form (CRF)
(no names to be used to protect confidentiality).
2. Each participant must have his/her own CRF. Check that each approached participant meets the inclusion criteria and does not meet the exclusion criteria. Confirm this in section 1 of their Case Report Form (CRF).
3. If person meets all the inclusion criteria obtain informed consent.
4. Each participant should be handed a cup IMP A and IMP B along with a cup of water.
5. Participant should consume IMP A and note down the efficacy using the VAS scale on the CRF. Participant should drink the supplied cup of water. Participant should consume IMP B and note down the efficacy using the VAS scale on the CRF.
6. At the end of the trial collate all results and calculate the efficacy of IMP A versus efficacy of IMP B. Treatment with a higher efficacy (taste) score will be deemed as most efficacious in satisfying thirst.