To all those involved in Clinical Trials, the word ‘research’ can have numerous definitions and can hold significance to individuals for a variety of reasons. For some, Clinical research can mean exploration. Exploring possibilities, alternatives, causes and solutions; always prioritising the improvement of care for the public.
According to ICH GCP E6(R2), a Clinical Trial is defined as; ‘Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.’
Without clinical trials, healthcare would not be where it is today. Important questions would not be answered and any treatment available, if any, would be a box standard that would fail to be effective for all. The future of medicine is changing. More effort is being made to tailor treatment according to the unique characteristics specific to each condition; making treatment more personalised. It is becoming more evident that one size does not fit all. Clinical trials open doors to novel therapies which embrace the individuality of every condition, giving everyone a chance to fight back; not just those who respond well to the standard treatment available.
Each clinical trial carried out is a step closer to making great discoveries and advancements in the field of research. Clinical trials could be used to develop a cure to a currently untreatable disease or lessen the risk of unwanted side-effects caused by a pre-existing treatment. Some studies are carried out to test the reliability and validity of findings from previous studies. If more evidence is gathered to support a hypothesis, it aids the development and the likelihood of a potential drug reaching the market. If the evidence strongly contradicts the findings, the investigation can be stopped, and the skills, resources, money and time involved can be redirected towards a new investigation or finding a different approach.
Preventative measures and early diagnosis both play a crucial role in the outcome of public care and wellbeing. Clinical trials allow us to understand the way our bodies work and determine the key players and various mechanisms involved in the pathology of diseases; through processes such as detection and elimination. This enables more effective actions to be taken to prevent the progression or even the onset of diseases. Subsequently saving further resources, time and money and more importantly, saving the patient from undergoing avoidable and sometimes ineffective or detrimental treatment.
To many, Clinical Trials provide a sense of hope. Whether that may be in finding a cure or taking a small step forward in making a difference for future generations. The public are central to the success of a trial and without their contribution, healthcare would come to a halt. Research does not provide answers immediately. It is a long process that can, at times, last longer than the average lifespan.
There are no guarantees with trials and so, researchers must rely on the trust of the participants in order to carry out their investigations. It is a huge leap of faith, but one that can possibly affect countless individuals across the globe, now and in years to come.
We still have a long way to go in terms of ensuring the wellbeing of the population; there is always going to be room for improvement. Researchers are continuously discovering new information that could change the way healthcare is administered. Clinical trials are a necessity in fulfilling every person’s right to be cared for and helped.