Love is in the air this Valentine’s Day! What better way to celebrate with TFS HealthScience than by highlighting the heartwarming clinical research trends transforming patient care in 2025? As we fully embrace the new year, the clinical trial landscape for several therapeutic areas, from oncology to rare diseases, is blooming with exciting innovations that are making our hearts skip a beat. Sponsors, contract research organizations (CROs), and clinicians are continuing to work tirelessly to push the boundaries of clinical development, with a particular dedication to patient-focused trials, to make clinical trials more accessible than ever.  

From groundbreaking technologies to patient-centered approaches, there’s so much to love about where clinical research is heading this year. Read on as we look at the top clinical trends to follow in 2025! 

 

Personalized Medicine: Finding the Perfect Fit 

Every love story is unique, and in the same way, modern medicine is recognizing that each individual patient is unique, increasingly embracing novel personalized medicine approaches. The beauty of this concept, also known as precision medicine, lies in its ability to consider each patient’s unique genetic makeup, lifestyle factors, and environmental influences, creating a truly individualized healing journey. The marriage between advances in genetic profiling capabilities and the clinical development of targeted therapies is providing hope for previously untreatable diseases, particularly with precision oncology.  

With diagnostic tools becoming more sophisticated, researchers are often able to identify specific genetic markers in a patient to create tailored treatment plans that have significantly better response rates than general traditional treatments while still minimizing side effects. Here are three examples of exciting recent approvals from the United States (U.S.) Food and Drug Administration (FDA) for targeted therapies that have warmed our hearts! 

• Imfinzi (durvalumab) was approved in August 2024 as a presurgical and postsurgical treatment for patients with surgically removable non-small cell lung cancer (NSCLC). Read the full press release here. 
• Lazcluze (lazertinib) plus Rybrevant (amivantamab-vmj) was approved in August 2024 for patients with advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. Visit this page to learn more. 
• Lymphir (denileukin diftitox-cxdl) was also approved in August 2024 for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who have received at least one previous treatment. Learn more here.  

 

Immunotherapy Innovations: Uplifting the Body’s Natural Defenses 

The relationship between immunotherapy and patient care has been going strong since interferon-alpha 2 (IFN-a2) became the first approved immunotherapy in the US in 1986. In fact, the principles behind immunotherapy have been around since the time of the ancient Greeks! Today, this revolutionary approach still continues to capture the hearts of both researchers and patients alike by leveraging the body’s own immune system to fight diseases, particularly cancer, more effectively. The beauty of immunotherapy lies in its potential for long-lasting responses, sometimes leading to complete remission in cases that once seemed hopeless. 

Immunotherapy approaches present a promising future for oncology clinical development programs, boosted by the specialized expertise in clinical trials from experienced innovative CROs in cancer research. The therapeutic landscape now includes a variety of different types of immunotherapies, from chimeric antigen receptor (CAR) T cell therapy and immune checkpoint inhibitors (ICIs) to tumor-infiltrating lymphocytes (TIL) therapy and even cancer vaccines. These are providing several new opportunities for cancer patients and their families: 

• CAR T cell therapy is expanding its reach beyond blood cancers and is now showing promising clinical trial results in solid tumor types, such as neuroblastoma, glioblastoma, and gastrointestinal cancers. Read more here about the current landscape of CAR T cell therapy for solid tumors. 
• lifileucel (Amtagvi) became the first cell therapy approved by the FDA in February 2024 to treat a solid tumor. It was specifically approved for use in patients with metastatic melanoma whose cancer has not responded to other treatments. View the full press release here. 
• Tislelizumab (Tevimbra), a programmed death-ligand 1 inhibitor, is an ICI that received recommendations for expansion to several new indications in the past year:  
  • First- and second-line NSCLC from the European Medicines Agency (EMA) in April 2024. 
  • First-line gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC) from the EMA in November 2024. 
  • First-line G/GEJ adenocarcinoma from the FDA in December 2024.  

 

Patient-Centric Approaches in Clinical Trials: Putting Patient Hearts First 

In the spirit of true love for this upcoming Valentine’s Day, clinical research has embraced a patient-first mentality that is revolutionizing how modern trials are conducted. Sponsors, CROs, and patients are increasingly demonstrating their passion for promoting patient-centric clinical trials to reduce the heavy participation burden shouldered by patients. This involves attentively listening to feedback from real clinical trial patients and their loved ones, then making study-related decisions based on their needs and perspectives. After all, what is a clinical trial without the invaluable contributions of its participants? Even patient advocacy groups are playing an increasingly important role in trial design and implementation to ensure trials are truly serving the people they are meant for. 

The strongest relationships are based on active listening, teamwork, and compromise, which is why more sponsors are turning to decentralized or partially remote clinical trials that allow research opportunities to be brought directly into patients’ homes. The integration of wearable devices and remote monitoring technologies has made it easier for patients to participate while maintaining their daily routines. The added convenience of these digital tools not only help improve retention rates throughout the trial, but it allows potential patients from rural or remote communities who are underserved and underrepresented in clinical research. This result is increased accessibility, greater diversity in patient representation, and a more positive patient experience, all of which are key ingredients for a successful trial with strong adherence rates. 

Interested in learning more? Click here to read about the trend of patient-focused clinical trials.  

 

AI and Machine Learning in Clinical Development: A Smart Match Made in Heaven 

Although still fresh and new, the romance between artificial intelligence (AI) and clinical research is quickly blossoming into an unstoppable partnership. As technological advancements in AI and machine learning (ML) techniques emerge, they present several opportunities for clinical drug development, such as accelerating drug discovery, optimizing trial design, and improving patient recruitment and outcomes. For example, ML prediction models can accurately determine whether a patient is likely to respond to certain treatments before they even begin. In practice, these insights would allow for more efficient clinical trial designs and more targeted patient matching during recruitment.  

AI algorithms have come a long way in a short period of time; they can now analyze massive amounts of medical data in minutes, identifying patterns that would otherwise take humans years to understand. This is especially helpful in patient recruitment because these algorithms can quickly scan large patient databases like electronic health records (EHRs) to match eligible participants with appropriate trials more effectively than ever before. Like a symbiotic relationship, breakthroughs in AI technology have already begun to cause significant shifts in clinical trial development. Unique study designs like adaptive clinical trials are slowly becoming more popular because tools like deep learning models are making real-time data analysis more manageable, enabling researchers to pivot and make rapid study decisions as the data emerges.

Read more about the opportunities of AI in clinical trials here. 

 

Rare Cancer Research: Showing Appreciation for the Forgotten Few 

The commitment to researching rare diseases demonstrates that in clinical research, every patient deserves attention and care. The collaboration between sponsors and innovative CROs in cancer research with specialized rare disease expertise is helping drive greater interest in developing novel therapeutic approaches for patients with rare cancers, such as gene therapy. This has been made possible by recent advances in genetic sequencing technologies, innovations in immunotherapy, as well as more unique trial designs, such as basket trials and umbrella studies, which are suited to small patient populations. The international clinical research community has also shown their dedication to rare cancer research by promoting partnerships between researchers and organizations like the National Organization for Rare Disorders or the European Organization for Rare Diseases.  

The renewed interest in pushing forward the therapeutic landscape of rare cancer, and the recent promising treatments that have emerged as a result, prove that no disease is too rare to deserve our attention and innovation. 

• Tecelra® (afamitresgene autoleucel) is a T cell therapy approved by the US FDA in August 2024 for patients with surgically unremovable or metastatic synovial sarcoma who had previously received chemotherapy. For full details, visit the press release here. 
• Voranigo (vorasidenib) is a new post-surgical drug that was approved in August 2024 for adult and pediatric (≥12 years of age) patients with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1/2 (IDH1 or IDH2) mutation. Learn more here. 

 

Sustainability in Clinical Trials: Encouraging Long-Term Devotion and Stability 

The final clinical research trend that we are loving for 2025 is the clinical research community falling head over heels for sustainable practices in drug development, emphasizing the importance of protecting our planet while still prioritizing medical advancements. Notably, a 2024 sustainability report reported an average clinical research associate (CRA) visit in North America can have an approximate carbon footprint of 500 kg of CO2e. Based on this estimate, decentralized and digitized study designs can help sponsors decrease their study’s total greenhouse gas emissions by requiring fewer in-person evaluative site visits by CRAs. In fact, an analysis from Accenture and the World Economic Forum found that increasing the adoption of digital technologies across various industries, including the clinical research field, could reduce emissions by 20% by 2050.  

Several modern CROs like TFS HealthScience are setting new industry standards for sustainability in clinical trial development, encompassing environmental stewardship, social responsibility, and ethical governance. For example, TFS has secured a Silver Rating from EcoVadis, the world’s leading provider of business sustainability ratings, for five consecutive years and is among the top 15% of 1.6 million companies evaluated globally.

Access the full details from the 2023 TFS Sustainability Report here. 

 

Why These Trends Matter: Building a Bright Future We Love 

As we look ahead into 2025, the future of clinical research has never been brighter or more promising. These trends represent more than just technological advances – they symbolize a fundamental shift towards more effective, accessible, and sustainable healthcare solutions. Most importantly, the clinical research trends presented in this article are creating a world with new and better treatment options for millions of patients, giving them and their families hope. This is especially evident for the evolving field of oncology, which is seeing more and more patients being given their lives back thanks to the dedicated research being done by innovative sponsors, CROs, researchers, and clinicians.  

 

Conclusion 

This Valentine’s Day, join TFS as we celebrate these advances in clinical research that are transforming patient care and bringing hope to millions. Whether you are a healthcare professional, researcher, patient, or family member, there are countless ways to support and participate in this exciting evolution of medical innovation. From participating in clinical trials to advocating for research funding, every contribution helps advance new treatments. Together, we can continue to foster these loving relationships between innovation and patient care, creating a healthier future for all. 

 

About TFS HealthScience CRO 

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. As a trusted CRO partner throughout the entire clinical development journey, we understand the importance of providing essential and diverse services to streamline clinical trials for our clients. Visit our website to learn more about the solutions TFS can offer for your next clinical trial or connect with a TFS representative today!