If you are thinking about joining a medical research study you may want to know that drug development is a lengthy process that calls for rigorous screening before it is evaluated in humans. In the early stages of research, drugs are screened for efficacy and risks using in vitro cell-based methods in laboratory settings. Further studies are then conducted to see if the drug works the same way in living animals as it did in the artificial environment. Only when potential drugs reliably pass the safety screening are they evaluated in humans. In addition to that, stringent ethical and regulatory rules apply to all trials to ensure that the risks are as low as possible and worth the potential benefits. Each clinical trial follows a detailed protocol that explains exactly how researchers must conduct the trial.
If clinical trial participation is your choice, you not only take control of your own healthcare solutions but give next generations the gift of medical innovations too; and if an ethical approach and excellent service are factors guiding your decision-making, Vx Pharma would like you to consider its vast expertise and facilities for conducting clinical trials at our two dedicated research centres. We work with many GPs and specialists who oversee our various clinical trials, and you can be assured that both our operations and clinical staff will give you all the support and care you need, every step of the way.
Clinical trial process
The following is a step-by-step explanation of what you can expect once you have indicated your decision to volunteer for participation in one of Vx Pharma’s clinical trials:
- First, you have to be identified as a suitable candidate for a specific trial by matching the ‘inclusion criteria:’ factors such as age, gender, the type and stage of a disease, previous treatment history and other medical conditions are usually considered.
- A screening visit is booked, either by your GP or a member of our clinical staff, for a medical examination in order to record your health at the start of the investigation process.
- Your next visit will be with a study coordinator to discuss the trial protocol and receive an informed consent document: an outline of the key facts about the trial that helps you to decide whether or not to participate. You have time to review the document and schedule a return visit for more questions, before giving your permission to be signed on.
- Inpatient or outpatient status is decided by the type of trial: early phase studies (phase 1 and 2) may require that you stay overnight for a few nights, whereas late phase studies (phase 3 and 4) may require you to only come in for appointments.
- Please know that you can expect ethical and professional conduct from both our operations and clinical staff throughout the trial. You will not be rushed to sign on, and you are at liberty to withdraw from a trial at any time.
- Once your application has been approved by our ethics committee, your GP will be informed that you are participating in the trial.
- If you are participating in an outpatient trial, every visit will be booked in advance. You can expect each visit to last about 1 to 2 hours. Our staff will always try to accommodate your needs and availability, provided those fall within the parameters of the trial protocol.
- If you are participating in an inpatient trial, you will need to stay overnight for a few nights. Once you have been discharged, some follow-up visits may be needed, depending the requirements of the study.
- Transport money for each visit is paid within a range of R150 to R300. Refreshment is usually provided, but if your treatment results in a missed meal, you will be compensated for that as well.
- In the event of required overnight inpatient stay, a significant stipend will compensate for any inconvenience and possible loss of income.