As we step into 2022, the clinical research landscape is rapidly evolving, shaped by the lessons learned from the COVID-19 pandemic and the accelerated adoption of new technologies. This year promises to bring significant changes in study designs, participant engagement, and the integration of decentralized clinical trial (DCT) technologies. Below are key predictions and trends for the clinical research industry in 2022.
Decentralized Clinical Trials Take Center Stage
One of the most anticipated trends in clinical research for 2022 is the continued expansion of decentralized clinical trials (DCTs). These trials, which allow patients to participate remotely, have become a critical component of modern study designs. Rather than requiring participants to visit research sites for each interaction, DCTs offer flexibility, enabling them to participate from their homes or local communities using digital tools.
This year, the focus will likely be on consolidating various trial designs—such as adaptive and decentralized approaches—into more cohesive and participant-friendly formats. This shift is not just about convenience; it significantly broadens the pool of eligible participants, particularly those from rural or underserved areas. For instance, patients living far from major academic centers may only need to travel for initial screenings, with follow-up visits and data collection happening remotely. These technologies make participation easier for a diverse range of people, enhancing inclusivity and diversity in clinical trials.
Advances in Real-world Evidence
The use of real-world evidence (RWE) in clinical research is gaining momentum, with regulatory bodies like the FDA issuing guidance on how to effectively integrate RWE into clinical trials. RWE allows researchers to collect data from everyday settings, offering a more accurate reflection of how treatments perform outside the controlled environment of traditional trials.
This trend aligns with the broader goal of making clinical trials more representative of real-world populations. Remote data collection tools, such as wearable devices, enable researchers to capture real-time data, offering insights that were previously hard to obtain. These technologies allow researchers to measure evidence out in the real world rather than in controlled clinical settings. However, the increased reliance on remote data collection also introduces challenges, particularly in ensuring the validity and integrity of the data.
Innovation in mRNA and Gene Therapy
Building on the success of mRNA vaccines during the COVID-19 pandemic, 2022 is expected to see continued innovation in mRNA technology and gene therapy. These fields are pushing the boundaries of what’s possible in clinical research, offering new therapeutic options for a range of diseases.
As mRNA and gene therapy technologies become more advanced, clinical trials in these areas will likely incorporate more adaptive and decentralized designs. This approach will enable trials to be more flexible, faster, and inclusive. The focus will be on bringing together various biotech innovations and trial designs, helping to push clinical research forward.
The Role of Local Pharmacies and Community Clinics
Another exciting development is the increasing role of local pharmacies and community clinics in clinical research. With decentralized technologies enabling remote participation, there’s a growing need for professionals in the community to support participants. Local pharmacies and minute clinics are well-positioned to assist in this process, providing services such as sample collection and basic health checks.
This integration not only brings clinical research closer to participants but also diversifies the types of clinical research sites. decentralized trials could soon involve locations rather than just traditional research offices. This shift will further facilitate participant access to trials, improving recruitment and retention.
Streamlining Data Collection in Clinical Trials
While the explosion of data from wearable devices and remote monitoring offers significant benefits, it also poses a challenge. The sheer volume of data can be overwhelming, and it’s crucial for researchers to focus on collecting only the most relevant information. This more targeted approach to data collection will help streamline the trial process, allowing for quicker and more efficient studies.
Resurgence of Clinical Research in North America
In 2022, there is optimism in a resurgence of clinical research in North America. The COVID-19 pandemic has brought clinical trials into the public eye, raising awareness and interest in research participation. With decentralized technologies making trials more accessible, the potential for growth in the North American market is high.
Consolidation of Clinical Research Sites
Consolidation of clinical research sites is another trend expected to accelerate in 2022. Similar to the consolidation seen in hospital systems over the past decade, clinical research sites are beginning to merge into larger networks. This trend allows for more consistent operations and improved data quality, ultimately benefiting sponsors and participants alike. Additionally, these larger networks can tap into more resources, enabling them to support decentralized trials more effectively.
