Clinical trials are vital for the development of new ways to diagnose, treat and manage myriad health conditions; however, the complexities and ramifications can be daunting for participants and caregivers alike. Here are five more key facts you need to know about clinical trials.
1. Discovering relevant clinical trials
Seek out a charity or advocacy that specialises in your loved one’s health condition. Try a simple internet search, check out the National Institute of Heath website, or contact CISCRP for information on future research and volunteer recruitment opportunities.
2. My loved one wants to take part, but how involved should I be?
Ensure you do your own research as to the risks and benefits so that you can openly discuss these. By understanding what is involved and recognising the potential implications, both large and small, you will both be better placed to appreciate what to expect.
3. Just how safe are trials?
There is no extra risk involved in observation-based studies; however, those involving intervention, such as drug administration, will carry an element of risk. Adverse effects from FDA approved drugs are still possible; however, the risk is contained, and the effects are generally known. The less a drug is known and tested, the more potentially risky they are. Various systematic reviews and processes are in place to protect participants, including the NHS Research Ethics Committee for NHS-based trials. Discuss all concerns and questions about safety with the medical team undertaking the trial.
4. How is drug safety assessed through clinical trials?
Human clinical trials are usually the last step of the assessment process, after years of laboratory research and then animal testing. The sample size is increased from a small starting selection of human participants; other indications are explored; and an application to the pharmaceutical market is finally made. This is a stringent procedure, with researchers submitting a New Drug application for regulatory bodies to review after each stage. Companies such as http://www.richmondpharmacology.com/specialist-services/bridging-studies that offer bridging studies and participant recruitment are therefore increasingly in demand.
5. Will other treatments need to be stopped?
It may be decided that current treatment could interfere with the treatment being tested, which would require the temporary suspension. Ensure the research team is aware of exactly what treatments are being taken, whether supplements, dietary changes, implants or drugs.