The World Health Organization (WHO) definition for a clinical trial is
‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’
Clinical trials are research studies involving humans that are undertaken to investigate new ways of treating, preventing, detecting or diagnosing disease or medical conditions. Clinical trials may also involve testing interventions already available on the market for further improvement.
Clinical trials may be interventional or observational.
Interventional trials can involve testing with new experimental drugs, behavioural therapies, educational interventions, medical devices or other preventative care strategies-eg diet and lifestyle modifications.
Observational trials observe and assess health outcomes in patients allocated to already approved interventions, based on clinical decisions.
Clinical trials help determine if treatments or interventions are safe and if they produce the intended and desired outcome/result.
Why are clinical trials important?
‘Absence of evidence is not evidence of absence’- Carl Sagan
Clinical trials are important because they are the only way to discover new treatments as well as new ways to prevent, detect, diagnose, and reduce the risk of disease.
Medicine of the Future
The medical care we receive today is built upon years of research by scientists, PhDs, and other medical and allied healthcare professionals investigating the causes of and potential treatments for disease. The future of medicine and healthcare is built on the research of today.
If more people are involved in clinical trials, it may reduce the time it takes to make new discoveries available. These discoveries may benefit you or someone you know, now and for generations to come.
Why participate in a clinical trial?
‘If you look at clinicaltrials.gov as of today we need somewhere in the region of 58 million patients just to fill current demand’ Clare Grace, Syneos Health 2016 .
People participate in clinical trials for a variety of reasons. Clinical trials require both healthy participants and people diagnosed with a disease or medical condition in order to help find new ways of treating, preventing, detecting and diagnosing disease and disability.
Who participates in clinical trials?
People with medical conditions that have utilised approved treatment options available to them, without success, may benefit from clinical trials by accessing potential treatments/interventions that would otherwise not be available to them. With some medical conditions and disease there may not even be any currently available treatment choices.
Healthy volunteers may participate because they want to help others or they may have a personal interest in helping support discoveries into a specific condition due to having a friend or family member afflicted with the disease or disability being investigated.
Awareness can lead to discoveries
‘‘Somewhere, something incredible is waiting to be known’’- Carl Sagan
If more people are aware of clinical trials then participation rates may increase and this means that the time taken to make new therapies and interventions available could be reduced.
Participating in a clinical trial also means that you are contributing to the advancement of scientific knowledge, and are able to gain early access to potential health solutions, at no cost. Clinical trials are often run by medical professionals considered experts in their field, so access to care from specialists is another key benefit.
All clinical trials are voluntary
Participating in research is voluntary. It is important that you never feel forced or coerced to take part in a trial. Researchers are required to obtain ‘Informed Consent’ from participants prior to undertaking any study related procedures. Clinical trials should not be viewed as treatments that guarantee improved health outcomes. You should have a clear understanding of the trial objectives and the potential benefits and risks associated with the trial intervention before signing and consenting to enrol.
You should feel free to discuss your involvement with family or your local GP, and should never feel as though your decision to not participate in a trial will compromise the quality of your future healthcare.
Never take part in anything that makes you feel uncomfortable or that you don’t understand.