Modern clinical research is witnessing several fascinating trends that are reshaping the landscape of medical research. The focus on patient centricity, platform trials, advanced biomarkers, diversity and inclusion, as well as data interoperability are all contributing to the advancement of medical knowledge and the improvement of patient care. By embracing these trends, sponsors and contract research organizations (CROs) can enhance the efficacy, effectiveness, and patient relevance of their studies, ultimately leading to better healthcare outcomes for all. Here, we will explore the top five trends that are shaping modern clinical research, as well as take a look at their current use in clinical trials today.
1 | Welcoming the Patient’s Perspective
A notable trend in modern clinical research is the shift towards a patient-centric approach in clinical trial design. Recognizing the importance of incorporating the patient perspective, researchers are actively involving patients in trial design, conduct, and dissemination of results. Patient engagement initiatives aim to improve the overall participant experience, increase trial recruitment and retention rates, and ensure that research outcomes align with patient priorities. Patient engagement initiatives can take various forms, such as patient advisory boards (PABs), patient-reported outcome (PRO) measures, and patient-centered communication strategies.
These initiatives empower patients to actively participate in the decision-making process, providing valuable insights into their preferences, needs, and concerns. They also contribute to the ethical conduct of research by respecting the autonomy and dignity of participants. For example, recent research has supported the favorable use of PABs due to their low costs and ability to assess a clinical trial’s expected burden on its patient population. By actively engaging patients, researchers can not only improve trial recruitment and retention rates by enhancing the overall participant experience, but patients themselves are more likely to advocate for research participation and help increase awareness about enrollment in clinical trials.
2 | The Rise of Platform Trials in Modern Clinical Research
Since the COVID-19 pandemic, the platform clinical trial design gained a boost in attention for the advantages they offer, including increased efficiency, reduced costs, and enhanced collaboration among different stakeholders. In a platform trial, multiple companies test their drugs simultaneously within the same trial infrastructure, which then reduces the number of patients receiving placebos because more individuals can be assigned to active treatment arms. Because these trials also facilitate adaptive designs, fewer patients are required overall, which reduces the risk of patient failures and improves the chances of succeeding over traditional two-arm clinical trial designs.
One notable example of such a trial is the Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP), which was established long before the pandemic in 2014. As of September 2023, the REMAP-CAP includes about 325 active sites participating worldwide and has currently enrolled almost 13,000 patients. Although designing such a trial is a huge undertaking, as the leaders of REMAP-CAP have attested to, evaluating multiple therapies in parallel removes the inefficient gap between Phase II and Phase III studies and expedites the process of identifying effective treatments more quickly.
3 | Advanced Biomarker Trends in Clinical Research
Biomarkers are measurable indicators of biological processes or responses to treatment, such as blood pressure or cholesterol levels, and they have long been used in clinical trials. However, recent advancements in technology have led to the discovery of newer, more interesting biomarkers, including digital biomarkers and novel blood biomarkers. By incorporating both of these types of advanced biomarkers into clinical trials, researchers can enhance patient stratification, improve treatment monitoring, and accelerate the development of targeted therapies.
Digital biomarkers are interesting because they are made possible by wearables, which are estimated to be worn by nearly a quarter of Americans today. Including technology such as smartwatches, fitness trackers, virtual reality headsets, and more, the global market value for wearable devices is expected to skyrocket to US$111 billion by 2027 with a compound annual growth rate of 16.43% from 2022 through 2027. Digital biomarkers provide objective and continuous measurements of patients’ physiological and behavioral parameters, from sleep quality to even voice and speech patterns, throughout the day while requiring minimal input from the patient.
Sponsors and CROs can also incorporate novel blood biomarkers into their clinical trial endpoints to offer insights into specific disease mechanisms and enable personalized treatment approaches. Blood-based biomarkers have shown especially great promise in the diagnostic and prognostic work-up patients with Alzheimer’s Disease, a devastating neurodegenerative disease caused by abnormal protein aggregations. Currently, there are numerous blood biomarkers used in clinical practice to evaluate the load of amyloid-β and tau protein fibrils, such as positron emission tomography (PET) tracers and plasma-based plaque biomarkers.
4 | Prioritizing Diversity and Inclusion in Life Sciences
Traditionally, clinical trials have been conducted on a limited population, often excluding underrepresented groups such as racial and ethnic minorities, women, and the elderly. However, there is growing recognition that the results of clinical trials should be applicable to a diverse range of patients for several reasons, including the following:
1. Different populations may respond to treatments differently, and excluding certain groups may lead to biased or incomplete results. For example, a number of studies support the disproportionate risk of adverse drug reactions between different ethnic groups when using interventions such as angiotensin-converting enzyme (ACE) inhibitors, thrombolytic therapy, and hydrochlorothiazide.
2. By including individuals from different age groups, genders, and socioeconomic backgrounds, clinical trial results provide a more comprehensive understanding of how a treatment may impact different populations.
3. Diverse representation in clinical trials promotes equity and access to healthcare by ensuring that all populations have equal opportunities to participate in research. This not only helps in addressing health disparities but also improves the real-world generalizability of research findings.
Initiatives such as community engagement, targeted recruitment strategies, and culturally sensitive informed consent processes are being implemented to improve diversity and inclusion in clinical trial recruitment. The United States Food and Drug Administration (FDA) also released a draft guidance in April 2022 outlining requirements for sponsors conducting clinical trials to develop a Race and Ethnicity Diversity Plan. By prioritizing diversity and inclusion, the clinical trial industry will continue to contribute more robust and inclusive evidence that better reflects the realities of healthcare.
5 | Striving for Data Interoperability
Another significant trend in modern clinical research is the focus on data interoperability, an approach that connects data from various trial systems and vendors into a unified platform that manages and structures the information for easier oversight and adherence. This trend aims to streamline the data management process, ensuring that a sponsor’s and CRO’s researchers and other stakeholders have access to comprehensive and integrated data across different sources. Data interoperability also enables the use of advanced analytics techniques, such as machine learning and artificial intelligence, to derive valuable insights and patterns from large datasets. By designing seamless systems allowing input from multiple databases, researchers can develop predictive models that can aid in patient stratification, treatment selection, and outcome prediction.
Traditionally, clinical trial data has been fragmented and stored in various systems and formats, leading to data silos. Data silos hinder efficient data management and analysis, as well as limit the ability to derive meaningful insights from comprehensive and integrated data. Recognizing these challenges, Vial CRO has developed technology products that aim to move beyond the inefficient traditional approach and promote data interoperability in clinical trials. Vial CRO’s flagship product, Vial EDC (Electronic Data Capture), is a unified platform that integrates data from multiple sources, including input from Vial ePRO and Vial eSource (Electronic Source). This system streamlines data management and oversight by providing a unified interface to access, manage, and analyze trial data via centralized monitoring. Like other CRO leaders within the industry, Vial strives to push clinical trials into the future by harnessing the power of these technologies and promoting data interoperability.
Vial: The CRO for Biotech, Powered by Technology
Vial is a full-service CRO that recognizes the role of technology in the future of drug development and is paving the way for modernized clinical research through digital innovation. Trusted by leading sponsors, our specialized teams deliver shorter study timelines, quality affordable services, and a clinical trial experience that puts you first. Contact a Vial representative today to discover how we can help!
![A companion diagnostic (CDx) is “a medical device, often an in vitro diagnostic (IVD), which provides information that is essential for the safe and effective use of a corresponding drug or biological product”[1]. IVDs refer to lab tests on samples of bodily fluids, e.g., blood, urine, and saliva, to diagnose, monitor, and manage diseases and conditions.](https://vial.com/wp-content/uploads/2023/10/shutterstock_1826989610.jpg)
