2022 marks the third year of the worldwide COVID-19 pandemic, which continues to fuel the transformation of the clinical trial and the research industry. Understandably, a huge focus of the research and healthcare industry over the last few years have revolved around developing vaccines and cures for COVID-19. However, the pandemic has also accelerated specific trends, such as the use of technology in clinical trials. Here are some of the predicted clinical trends for the year ahead:
HYBRID/AGILE CLINICAL TRIALS
Hybrid or Agile clinical trials are currently one of the most important trends shaping clinical research. Hybrid clinical trials combine both elements of traditional on-site clinical trials and technological advances for at-home treatment/testing. This combination of both aspects allows for the most effective patient-centric design.
Traditional on-site clinical trials can be costly and time-consuming, with some participants needing to travel long distances. Hybrid clinical trials allow participants to take part from the comfort of their own homes, and with advances in online video conferencing and wearable technology, remote patient monitoring and telemedicine are more convenient and accessible than ever. As a bonus, clinical trial sites are still available for participants who want to go in for face to face contact.
REAL-WORLD EVIDENCE/REAL-WORLD DATA
There has been an increased interest in using real-world evidence/data since wearable technology, computers, mobile devices, and biosensors make it easy to collect and store. Real-world evidence/data is incredibly valuable as it has the potential to improve the design and conduct of clinical trials.
The development of sophisticated new analytics makes it possible for real-world evidence/data to be analysed more thoroughly and applied to medical product development, approvals and reimbursement.
CHANGES TO THE INFRASTRUCTURE OF CLINICAL RESEARCH SITES
The COVID-19 pandemic has impacted all aspects of clinical trials, including clinical trial sites. Traditional healthcare research sites struggle with staffing shortages and new protocols coming from sponsors. Although technology solutions are in place (clinical trial management systems, eRegulatory systems and automatic data capture), they haven't completely solved the problems plaguing clinical trial sites. This opens up the door for new models of research site organisation that would improve the efficiency, data quality and increased enrollment at clinical trial sites. It also creates the possibility for new players and redesigned models to get their foot in the door of sponsored clinical trials.
BETTER SUPPORT FOR CLINICAL TRIAL SITES
Community-based clinics and hospitals have the highest number of patients but have the lowest number of clinical trial opportunities making it an excellent chance for medical professionals to join clinical trials and have a more diverse patient demographic. In addition, participant-centric policies and sponsors' wanting to innovate means that there will be a fundamental shift for clinical trial access.
2022 will see experienced clinical trial sites push for better budgets and clinical trial agreement terms to ensure the sustainability of their programs. Sites will also continue to adapt to new business models to become more efficient and retain key staff.
INCREASING THE PUBLIC VISIBILITY OF CLINICAL TRIALS
Increasing drug development costs and lower returns mean clinical trial staff need to establish innovative ways to carry out clinical trials more efficiently and engage more participants.
Looking to the future of clinical trials means streamlining processes and integrating data to provide transparency in a clinical trial's conduct. Since the COVID-19 pandemic has begun, more people have been interested in how evidence-based therapies and medication are developed and have more investment in their own health and continued health advancements. As a result, clinical trials will become a more popular care option for patients.
Data analysis in clinical trials focuses on finding trends. Technological advances allow for more data to be collected in real-time. However, this causes challenges as some of the data is not valid. It can be time-consuming to sort out the valuable information gathered. Clinical and data scientists need to work together closely to gain valuable insights from data. The rising trend of human-enabled AI is powerful when used correctly. It has become vital to the world of clinical research.
In 2022, Subject Matter Experts (SMEs) will work with AI to convert data into valuable insights.
DIVERSITY AND INCLUSION
The trend of Diversity, Equity and Inclusion (DE&I) has steadily increased since 2021 and looks to continue in 2022.
A few key areas include:
- Informing a diverse group of patients and caregivers to an information session and including them throughout the trial.
- Listening with compassion and humility to the issues, questions and concerns of patients and their caregivers. Remain as flexible as possible to include their voices in any solutions.
- Ensuring diversity is practised by clinical trial staff and sites.
- Providing sites and staff with training on bias, cultural competence and health literacy.
FURTHER PROGRESS IN ONCOLOGY RESEARCH
Significant progress is continually being made in oncology due to oncology drugs remaining a dominant therapeutic focus. New oncology clinical trials will increase during 2022, with precision therapies at the forefront, like genomic testing and the identification of more predictive biomarkers.
The ongoing development of small molecule targeted medication will continue to be a significant part of cancer research in 2022, offering more options for oral drugs.
Extended Reality (XR) includes Virtual Reality (VR), Augmented Reality (AR) and Mixed Reality (MR). Extended reality devices are becoming more prevalent in the clinical setting, with VR headsets being used to train doctors and surgeons and Cognitive Behavioural Therapy (CBT) assisting patients who suffer from anxiety and chronic pain. This is a trend that we will see continue in 2022.
GENOMICS AND PERSONALISED MEDICATION
Modern technology allows for a more personalised approach to be taken with medication, with genomics and AI, which allows for treatments to be tailored to each patient. Genomics maps individual genomes, resulting in new effective treatments for diseases like cancer and Alzheimer's disease.
In conclusion, 2022 will continue to see the rising trend of decentralised and hybrid clinical trials as the COVID-19 pandemic continues. Advances in technology (AI, genomics, and augmented reality (AR) will see new effective treatment options for serious diseases like cancer, diabetes and Alzheimer's disease. Inclusivity and diversity will take centre stage in the clinical health field.