The relevance of clinical trials in the development and delivery of new drugs has been demonstrated through the years, especially during the ongoing pandemic. Clinical trials have not fundamentally changed over the last 20 years, however as technology is evolving, as well as patients’ needs, clinical trials need to reinvent along with them.
Recently, study sponsors have focused on small patient populations who have, for example, rare diseases, in order to present them with personalized medicine, boosted by the advances in genetics and the use of biomarkers. As a result, we have seen that DNA-based drugs and gene therapy are being implemented more and more in the market. To support the development of these types of medicines, several innovations are already being put into practice in clinical trials, such as risk-based monitoring, electronic patient screening, and online training of investigators.
Another focus of the innovations in clinical trials is the advancement in patient recruitment. Currently patients tend to join clinical trials that are relatively close to where they live, and therefore, more dispersed investigational sites do not recruit a representative cross-section of the patient population, hence, the results may be biased. Throughout the 2020s, it is expected that recruitment for clinical trials moves to incorporate outreach on platforms such as social media, targeting certain groups of people based on their social media profiles. Nevertheless, recruitment activities are not limited to generating interest in the trial, the sponsor must also assess if the potential patient is appropriate for participating in the trial. In this matter, genetic screening is an innovation that is already utilized in clinical trials to identify population groups with specific biomarkers, in order to establish genetic differences between ethnicities and groups of individuals, along with which group of people will benefit from the drug that is being evaluated in the trial.
One p[JABA1] rimordial aspect of clinical trials is consent, which ensures that the patient makes well-informed decisions. The future for clinical trials involves the implementation of e-consent, obtaining and archiving patients’ consent through an electronic method that relies on the use of multimedia such as images, audio, videos, and other resources. The main objective of implementing e-consent is to make the process less laborious and simpler for the patients, and ultimately lead to improved quality and efficiency of clinical trials, by reducing the time needed for recruiting patients and starting the trial. Emerging technology such as blockchain (mostly used for the managing of cryptocurrency), can be implemented in the recruitment and consent stages of the clinical trials in order to provide them with more security and reliability.
Another aspect of clinical trials that will be reinvented during the coming years will be accessibility. Currently clinical trials are conducted in large sites and hospitals, forcing participants to travel several times a week or month, and often long distances. Several transportation companies, such as Uber and Lyft, are developing services focused on patient transportation to clinical trials facilities, nevertheless, this still requires that the patient travels, investing time and money, and is particularly challenging if the patient has a significant health condition. Remote trials and hybrid approaches are a solution for accessibility issues, not only benefiting the patients but also the sponsors, since they will have an increased pool of patients. Remote trials can be supported by telemedicine, which has had substantial advancements in recent years. For example, the use of sensors and algorithms make home care easier and more accessible, including the use of remote technology for blood glucose, pressure, and mobility monitoring. Additionally, remote information collection facilitates the provision of anonymized data to pharmaceutical companies and CROs, such as Acceler8 Clinical Research. Nevertheless, there are still challenges to the complete implementation of virtual trials, since complex and rare diseases might still require the presence of doctors or nurses at a clinical trial site, but the industry is already focusing on how to overcome this issue.
There is also a growing focus on innovations in the management and analysis of clinical trial data. Virtual trials can provide datasets in real-time, giving an insight into how a drug works in the real world, compared with a more controlled and artificial clinical trial site. Also, outcomes research (which aims to understand the end results of specific practices and interventions) can be collected. Furthermore, electronic data capture makes analysis through technologies such as artificial intelligence and machine learning algorithms possible. And finally, a big data approach will decrease the dependance of the industry on paper recording, which will aid many companies’ commitments to environmental policies.
Undoubtedly, there are many aspects involved in the development and implementation of clinical trials. Innovations described above, such as the adoption of personalized medicine, accessible patient recruitment, e-consent, and data analysis, will only be possible thanks to the synergy of Biotechnology, Process and Systems Engineering, Medicine, and the collaborative work of organizations such as pharmaceutical and medical device companies, as well as CROs. The implementation of these innovations will allow the industry to conduct more efficient and safer clinical trials, and therefore better pharmaceutical products by the beginning of the 2030s.