Clinical trials are essential in the Healthcare industry to answer unanswered questions, discover possibilities, find missing pieces of a puzzle or even validate an existing hypothesis. Regardless of the outcome, clinical trials contribute towards the advancement of scientific knowledge, proving to be a valuable process in improving prevention, diagnosis and treatment of diseases for the public.
There are a range of members within the clinical trial team, including professionals such as Project Managers, Study Co-ordinators and Research Nurses; who all play a part to ensure the success of a trial. The members of whose contribution must not go unappreciated are the study participants. Their input and presence are equivalently crucial to the progress and outcome of a trial.
Patients are the heart and soul of clinical trials. Without them, clinical trials would come to a halt and research would be void. Every individual involved makes a difference, no matter what their reason is for participating. As clinical professionals, we should value the significance of their involvement and be accommodating and understanding when recruiting and engaging with patients. ‘The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society’ (ICH GCP 2.3)
Recruitment of patients requires trust, honesty, respect and a degree of transparency. Patients should be aware of their rights and should be assured that their safety is of the utmost priority. Any information provided to the participants must be comprehensible to them so that they are adequately informed and can come to a well-thought out decision, free from any external influence including any bias feelings the clinical professional may have towards the trial.
Obtaining the informed consent of a participant does not just occur once, it should be looked at as a process that continues throughout the trial. The participant should feel as though they are informed at all times and be comfortable enough to take part or withdraw at any time. For trials with very specific patient eligibility criteria, obtaining participants may be a challenge and might require team members to seek out potential subjects.
In these circumstances, it is important for professionals to make the effort to find the most appropriate way to raise awareness and communicate with the patient population. This could be through social media or direct interaction with communities to help educate those unaware of clinical trials.
The way patients are perceived is also an influencing factor in the way patients engage in a clinical trial. Patients don’t want to be just a number or feel like they are a guinea pig in an experiment. They shouldn’t be spoken down to and should be treated as an equal to all involved in the trial.
Researchers should be considerate of the circumstances, fears and doubts of the individual and appreciate the unselfish willingness of the patient to participate.
The success of a trial is substantially dependent on the engagement of patients with the trial. Should they fail to engage, the quality of the data can be left compromised, removing validity from any potential findings.
Patients could choose not to attend follow-up visits, fail to adhere to treatment regimens or fail to comply to instructions given to them. Whether they are hopeful for a cure of a certain disease, want to help to improve treatment for future generations or just want to make a difference, patients should be acknowledged for their effort.
Every individual participating in research is working towards the same goal but bringing something to the table that others involved wouldn't be able to. The unique contribution of each person should be regarded with the same level of respect and appreciation.