Today is International Clinical Trials Day, when we celebrate the day in 1747 when James Lind started what is widely considered to be the first randomized clinical trial, with a ‘fair test’ of treatments for scurvy in sailors.
Ever since then, clinical trials have been essential for new treatments, vaccines and medicines, and never have they been more vital than now during a pandemic.
There are more than 1500 commercial clinical trials of medicines to prevent or treat COVID-19 underway around the world – a figure which will be out of date very quickly in this fast moving situation.
COVID-19 impact on clinical trials
COVID-19 has brought about both negative and positive changes to clinical trials.
The process of prioritising COVID related trials helps to avoid duplicative research efforts, supports scientists in learning as much as possible about this disease and ensures research staff are redeployed where needed – on the frontline or on urgent COVID-19 research.
The knock-on effect is that some valuable non-COVID research has been halted.
The decision to halt a clinical trial is not one that is taken lightly and companies are doing everything they can to keep non-COVID trials going wherever possible, with patient safety the top priority.
We know that companies have introduced measures like direct to patient shipments of investigational medicinal products; supporting investigator led home or local laboratory study assessments and administration of treatment; and doing remote follow up and monitoring of study patients via video or telephone.
Clinical trials appreciation
Clinical Trials Day is a well-deserved ‘time out’ to recognize the people who conduct clinical trials and to say “thanks” for what they do every day to improve public health.
This day of celebration also provides our community with a unique opportunity to raise awareness of clinical trials – and of clinical research as a career option – among the greater public.
Internationally, public involvement is becoming embedded within the design and conduct of trials and is increasingly seen as usual practice. This reflects the many ethical, moral and political arguments for involving patients and members of the public in research, as well as the argument that such involvement can enhance the quality of the research.
Ensuring that the outcomes a trial measures are important to patients can help to develop the relevance of a trial, and so enhance the potential health benefits it will create for patients by ensuring the intervention is evaluated against what really matters for patients. Public involvement in trials can also help retention of participants, as recruitment strategies and the design of trials aligns with the reality of people’s’ lives, helping to ensure that participation is desired and feasible, and promoting the concept that a clinical trial is a treatment option for patients and is intended to benefit patients, whether now or in the future.
In developing our international approach to public involvement in trials, we view involvement as an area of evidence-based social practice. This means that when we plan and undertake public involvement in trials, we should draw on evidence of what works, for whom, why and in what context.
If we don’t use available evidence of what works in public involvement, it is a form of research waste, as it misses opportunities to create the highest quality clinical trials.
If we don’t have the evidence of what works best in public involvement in a specific aspect of clinical trial development, we need to actively develop and publish it, to ensure our international community can learn from it – including the public and patients.