Will Today's Clinical Trial Trends Become Tomorrow's Routine?

By S.S. Milovanov, Ph.D., independent auditor, clinical research specialist, entrepreneur

Clinical trials are not only the practical application of changes and discoveries in medicine — that is, they make changes in medical practice — but they themselves are subject to change. Changes in the clinical research industry are tendentious and develop gradually, which requires both study and forecasting. To understand where clinical trials have been and where they are headed, we studied open-source publications between 1930 and 2023 and analyzed them by clinical trial industry keywords in both Russian and English.

What we found is that clinical trial trends until the end of 2023 can be divided into two groups — those related to changes in the conduct of clinical trials and those related to the changes in the products of a given nosology. If in the first group the trends remain similar to those of 2022, the ongoing digitalization of operations, the shift of centralized research toward decentralization, and the shift in protocol design toward patient centricity will continue. For the second group, the trend of a decline in the number of expected drugs will continue, and there will continue to be a shift toward biologics and gene therapy drugs.

Then And Now — The Evolution of Trials

The first time the term “clinical trials” appears is in 1931^1,2, but another source dates the concept back as far as 1896⁴. Nonetheless, after 1946, prototypes of clinical trials appeared, consisting of a sponsor, a researcher, and a patient, which were then joined by an ethical component (the Nuremberg Code and the Declaration of Helsinki⁵). Until the end of the 20^th century, the scheme included a clinical center where patients were concentrated and underwent basic procedures; that is, centralized clinical trials were formed³.

With the development of technology, the need for centralization in research began to decrease, although I determined⁶ that the role of the clinical center remains. With the established classical centralized scheme for conducting clinical trials, the changes concerned the nosology and indications of the studied new medical substances of chemical synthesis. With the discovery of hybridoma technologies (those that support the production of monoclonal antibodies)⁷ in 1975, the era of clinical trials of biological preparations began, and the development of genomic and gene technologies in the early 1990s⁸ can be considered the beginning of gene and cell therapy trial preparations. As for the methods of conducting clinical trials, changes began to appear in recent decades, and by the end of 2022, the classical scheme underwent modifications associated with the introduction of new technologies. Those permutations of clinical trials now include^{9,10,11,12,13,14}:

• centralized clinical trials (CT) — conventional or routine
• decentralized clinical trials (DCTs)
• personalized clinical trials
• hybrid clinical trials
• virtual clinical trials
• clinical trials using Bayesian statistics
• clinical studies using real-world data (RWD) and real-world evidence (RWE)
• clinical trials based on AI

The therapeutic area of clinical trials is also tendentious in nature and is undoubtedly determined by the need for the treatment of diseases. For example, the emergence of new infectious diseases like COVID-19, Ebola, and others has significantly increased the number of clinical trials in the field of infections, and the clinicaltrial.gov database now contains more than 18,000 clinical trials in the field of infectious diseases, compared with 590 in the last decade of the 20^th century.

Trends That Will Continue Throughout 2024 And Beyond

After surveying the landscape of existing publications on clinical trials, two main groups of trends revealed themselves: trends in the organization and conduct of clinical trials and trends in the release of new drugs in a particular therapeutic area.

Emerging And Sustaining Trends In Trial Design

Digitalization

The trend of digitalization of clinical trials in 2023 will continue to accelerate as many of the activities related to conducting clinical trials have moved into the digital realm. In particular, electronic informed consent (eConsent) will see continued adoption, and this will likely increase patient awareness and participation in studies. The FDA in 2016^18,19 issued a regulatory document on the implementation of eConsent. In addition to maximizing the availability of research participants, eConsent may also attract patients from remote regions.

What’s more, paper originals and copies of study documents are also being transferred to digital formats, including primary documentation, and this is facilitated by the development of EMRs. Electronic signature technologies, such as DocuSign²⁰, and electronic payments to researchers, such as with Popsipay²¹, make it possible to solve the problem of payments in clinical trials. Blockchain, cloud technologies, and cybersecurity are also among the trends in the digitalization of clinical research²².

Decentralization

The tendency for centralized clinical trials is rooted in procedures^23,24 becoming more complicated and those that can only be performed at a clinical trial site. Yet, the trend toward decentralization has been made possible by the advent of new wearable technologies and the improvement of remote data transmission capabilities²⁵. The driver for the development of decentralized research is the fact that 70% of patients live more than two hours away from a clinical trial site²⁶. Mobile sites and smartphone applications also contribute to the development of decentralization. In turn, a propensity for decentralization has given impetus to the development of in-home nursing care services within CROs^27,28.

Tangentially, the rise in telemedicine in clinical research is related to the trend of decentralized clinical research, as is the trend of remote auditing, which originally gathered momentum during the pandemic⁴².

RWD/RWE

The trend to implement clinical research based on real clinical data, such as RWD and RWE, in which data generated by the patient’s own body is immediately recorded and transferred to the data center.²⁹ Currently, in particular, a HARPER (HARmonized Protocol template to Enhance Reproducibility for RWD/RWE) protocol template is being developed for such a study³⁰.

Risk-Based Trials

A risk-based approach calculates all risks that could occur during a particular clinical trial, and it’s an approach that continues to be relevant for 2023. It also remains relevant to finding effective ways to recruit patients^23,31.

Virtual Trials

The introduction of virtual trials is based on the rejection of preclinical studies in some cases. A law enacted at the end of 2022 gives the FDA the authority to approve clinical trials without requiring preclinical animal trials,³² and the issue of a unified platform for preclinical and clinical studies³³ is being considered; that is, a trend of connected studies is emerging. The trend of introducing AI into clinical trials has already borne fruit, and in 2023 the first drug discovered by AI passed Phase 1 clinical trials³⁴. Work is underway to improve the use of AI in medicine³⁵.

Personalized Trials

Personalized clinical trials, also known as patient-centric trials, allow the patient to actively participate in the design of the protocol and other activities¹⁴. This trend is closely intertwined with trends in patient diversity, RWD/RWE, telemedicine, and personalized medicine — when medicines are developed based on a patient's genetic profile³⁷.

Bayesian Trials

Incorporating Bayesian statistics into clinical trials allows one to continuously reassess generated data and results while moving forward on clinical trials, which could lead to "rearranging the cause and effect” and eventually, based on the known fact of the event,  speeding up and increasing the credibility of results in clinical trials concerning both efficacy and safety³⁸.

Gamification

Gaming elements and technologies^15,39 have been created to introduce augmented reality (AR), mixed reality (MR), virtual reality (VR)⁴⁰, and extended reality (XR) game technologies into clinical research.  Abhishek Sinha said, “With use of AR, MR, VR, and XR, scenario building becomes more manageable. Testing simulations save time and money, reduce risk, and provide additional benefits. Consider these examples:  XR in pharma allows scientists and engineers to review 3D assets and models at full scale by inspecting data in a spatial context.” Using the FDA Phase 2-3 pharmacotherapy model as guidance, VR has been used to assess and treat a wide variety of medical, surgical, psychiatric, and neurocognitive conditions.

Single Ethics Committee Approval

This trend refers to the approval of a clinical trial by a single ethics committee for all clinical sites in the study, and regulatory authorities have supported this trend⁴¹. This contrasts with the common practice of using many central and local ethics committees.  

Pharmacy Chains As Sites

Large pharmacy chains have begun to offer trials, in part, as a way to fulfill diversity initiatives. Walgreens and CVS, in 2022, launched their clinical trial plans on the heels of the decentralization trend⁴³.

Emerging And Sustaining Trends In Therapeutic Areas And Drug Types

Biologics

In 2023, heavy research into biological drugs for the treatment of oncologic and orphan diseases continued and in 2024 will continue to be supplemented by research into gene therapy drugs. Of the 10 most anticipated approvals^44,45 of new drugs, approximately 10% are gene therapy drugs, 20% are for the treatment of degenerative diseases of the elderly, and 70% are biological drugs, such as monoclonal antibodies (including 20% that are oncologic drugs).

Cannabinoids

A new trend is to conduct clinical trials on drugs, like cannabinoids¹⁷ and thalidomide,⁶⁰ that have restrictions on their use for new indications. This means that existing ready-to-use substances are inspiring new research into unmet needs. This trend is expected to be extended to other similar (often addictive) products.

Personalized Medicine

Almost all expected drugs in 2023 compared to the previous year are for personalized medicine^46,47,48 — either gene-based or marker-based^45,50. The development of personalized clinical research is closely related to the development of data from real clinical practice, telemedicine, and patient diversity.

Personalized medicine came to the fore for the first time; however, we believe that in the development of drugs, it is also necessary to focus on the development of new antimicrobial drugs, quite possibly including biologics⁵⁴.

Clinical Trial Trends For The Years Ahead

We can also anticipate several new trends in the coming years. An implicit trend is the search for ways to successfully recruit patients⁵⁵, which can be traced as the basis of some trends — a risk-based approach, decentralized research that requires clear algorithms. The outcome of a successful recruitment of patients may be the success or failure of a clinical trial, which may be the trend in subsequent years⁵⁶. Also continuing in the years ahead will be a vibrant M&A market⁵⁷.

Finally, I posit that perhaps a new trend is emerging — private clinical trials. These would comprise both patient-centered studies and new approaches in technology and imply unconditional and investigator-initiated clinical trials^58,59. More plainly, I see a future where trials are not only conducted by medical professionals but by enthusiasts as well.

 

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About The Author:

Svyatoslav Milovanov has more than 15 years of Phase 1-4 clinical research experience. Graduated in 2000 as a pediatrician, Dr. Milovanov has worked in large regional hospital settings and as a pediatrician. In 2003, Dr. Milovanov earned his Ph.D. Since 2006, Dr. Milovanov participated as a sub-investigator and since 2007 has fully dedicated himself to the clinical trial industry as medical monitor, CRA, auditor, and study physician. He has international certificates as both a doctor (AKH, CHOP) and clinical trial professional (CRP). In 2021, he became a certified as an oncologist. He is an active member of many professional societies, including ACRES, RQA, ESMO, and has published 80+ scientific articles.