The first known clinical study took place on a ship when navy surgeon James Lind investigated the effects of citrus fruit on a small group of sailors suffering from scurvy. Surprisingly, more than two and a half centuries later, Lind’s little study is still the model for the massive, sophisticated clinical trials that researchers do today. But of course, that is light years away from the technology such as a clinical trial management system that we use today.
Since then, randomised clinical trials have been the gold standard method of determining if a new pill, surgical technique, or other healthcare intervention is safe and valuable to those who receive it. The Covid pandemic has emphasized the significance of clinical studies. We would not have our current arsenal of vaccinations and therapies against the virus if volunteers for vaccine trials, patients with Covid engaging in randomised studies, or the scientists working tirelessly to provide this research did not exist.
In the face of the Covid pandemic, clinical trials in 2022 will most likely expand on the methods that were quickly adopted in the past 22 months. Over the last few years, unconventional trial designs have been increasingly examined to improve economies in clinical trial operations.
The single most significant challenge for clinical research is a lack of public trust generated by disconnects between the public health sector and the drug development industry. While there are several explanations for the growing gap, the result is that it has alarmed the public. For example, suppose patients are skeptical of regulatory authorities and clinical research. In that case, organisations must work to restore their faith by breaking down divisions and publicly demonstrating that all they do is for the benefit of patients. Trust is essential for the success of clinical trials. As a result, the drug development community must innovate to increase public trust in the clinical trial process.
Implementing decentralized and hybrid trial designs is the dominant trend for 2022. GlobalData predicts that roughly 1,300 trials with a decentralized or virtual component will begin in 2022. This is an exceptional quantity in this format, showing a 28% increase from 2021, which held the record for more than 1,000, and a 93% increase from the 673 in 2020.
Decentralised and hybrid trial designs have grown in popularity for various reasons, not the least of which is that they allowed clinical research to recover from the disruptions caused by Covid-related lockdowns, travel restrictions, and healthcare interruptions. According to the industry, one of the critical drivers of decentralized research in the future is that it allows for more patient-centric trials, reduces burdens such as travel on participants, and allows eligible patients located further away from study sites to participate.
In both the EU and the US, there is a growing interest in using real-world evidence and data to support the continuum of evidence production for regulatory decision-making for pharmacological and biological products. The FDA’s recent publishing of a new draft guideline in this area is noteworthy. The FDA reports that the use of computers, mobile devices, wearables, and other biosensors to collect and store massive volumes of health-related data is fast increasing. This data can improve the design and conduct of clinical trials and studies in the healthcare context to answer previously thought intractable questions.
Furthermore, when sophisticated new analytical skills are developed, we can better interpret these data and apply the outcomes of our analyses to medical product development, approval, and reimbursement. RWD, for example, is projected to facilitate the creation of further evidence post-launch, inform dynamic price-setting in connection to the value of medications, and optimize proper usage in daily practice.
In 2022, the clinical trial landscape has continued to diversify as we move past the COVID-19 pandemic. The number of new trials that began in 2022, is already up from 2021. The complexity of protocols has also expanded dramatically. For example, data from phase 2/3 studies reveal a 69% increase in the number of operations performed and three times the quantity of data points gathered.
Helen Baumeister did her degree in psychology at the University of Hertfordshire. She is interested in mental health, wellness, and lifestyle.