Chronic Disease Clinical Trials and Studies

Chronic diseases are long-lasting conditions that arise from a combination of genetic, physiological, environmental, and behavioral factors.¹  

Chronic disease clinical trials play a critical role in advancing care for long-term conditions by evaluating new therapies, treatment strategies, and disease-modifying approaches that aim to improve patient outcomes. These trials require a collaborative effort that brings together investigators, pharmaceutical sponsors, clinical research organizations, and volunteers, each playing a vital role in the successful execution of a study. 

Sanofi is dedicated to advancing investigator-sponsored studies and supporting externally led scientific collaborations. 

According to the Centers for Disease Control and Prevention (CDC), an estimated 129 million people in the US live with at least one major chronic condition.²  

Current treatments for chronic diseases often focus on managing symptoms and may fail to work with the complexities of patients’ daily routines, living environments, and self-management abilities.³ 

As such, there is a growing need for ongoing chronic disease research that goes beyond biological outcomes to address long-term, biopsychosocial impacts on patients’ daily lives.⁴

Chronic disease trials and studies explore a range of treatment areas, such as next-generation biologics, small molecules, and combination therapies, which are highly targeted medicines designed to target specific molecular pathways.⁷

Sanofi is committed to transforming chronic disease care through clinical research, innovation, and strategic partnerships.⁸  

Sanofi recognizes the financial burden posed by chronic diseases and has invested in innovative digital health solutions which collect real-time clinical and behavioral data to enable personalized patient care.⁸ 

Sanofi also actively collaborates with pharmacy benefit managers (PBMs) such as MedOne, as well as with payers and healthcare providers, to integrate digital tools into broader treatment ecosystems.⁸ 

Despite advances in treatment, chronic diseases continue to pose a significant long-term burden, affecting the quality of life of individuals.⁹ That’s why clinical trials are essential for testing whether new treatments are safe and effective for these people.¹⁰ 

Learn more about why people volunteer for clinical trials. 

Recruitment for chronic disease clinical trials is a multistep rigorous process. Volunteers typically learn about clinical trials by suggestion from their healthcare provider or independent research from public sources, like the US Clinical Trials Registry.  

Once a volunteer expresses their interest to participate in a clinical trial, they are provided with a patient information sheet and an informed consent form. A member of the medical staff conducting the trials will explain the objectives of the clinical trial, the process and any potential risks.  

Not every volunteer interested in a clinical trial may be eligible for the study. Each clinical trial has specific inclusion criteria for participants based on factors like medical history, severity of condition, previous treatments used and more. When the prospective participant has signed the informed consent form, they undergo a process called clinical trial screening. The screening process involves a recommendation from a healthcare provider, medical history review, physical exams and diagnostic tests relevant to the clinical trial.  

If the volunteer is found to be eligible based on the screening results, they can move on to participating in the trial. All participants in a clinical trial are volunteers, and can withdraw at any point for any reason. Learn more about the clinical trial recruitment process at Sanofi. 

Sanofi conducts a range of clinical trials to advance treatment options for chronic diseases: 

• Phase 1 clinical trials: these are designed to test the best possible way to safely administer a drug, including dosage amounts, frequency and the mode of administration (i.e. injections, tablets etc.). Phase 1 trials usually contain 20–100 patients.  
• Phase 2 clinical trials: these are focused on finding the best dose for the medication and characterizing treatment effectiveness. Phase 2 clinical trials contain upwards of 100 participants. 
• Phase 3 clinical trials: these are full-scale trials designed to compare the effectiveness of the candidate treatment against the current standard treatment (Standard of Care/SoC) or a placebo. These trials involve large groups of hundreds to more than a thousand participants. 
• Phase 4 clinical trials: these sometimes occur after the approval of the drug by regulatory bodies like the FDA. The drugs are proven to be safe and effective, and Phase 4 trials are mainly concerned with long-term effectiveness and potential side effects. 

All of Sanofi’s clinical trials are conducted in compliance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. These trials receive oversight from independent ethics committees, such as Independent Ethics Committees (IECs) and Institutional Review Boards (IRBs), to protect participant rights, safety, and data integrity. Learn more about Sanofi’s bioethics in clinical trials. 

1: Sankiya M, Sunil BN, Varun R. Prevalence of Non-communicable Disease Risk Factors Among Adults in a Rural Field Practice Area of a Tertiary Care Medical Center in Karnataka. Cureus. Published August 22, 2024. doi:https://doi.org/10.7759/cureus.67474

‌2: Boersma P, Black LI, Ward BW. Prevalence of Multiple Chronic Conditions Among US Adults, 2018. Preventing Chronic Disease. 2020;17. doi:https://doi.org/10.5888/pcd17.200130

3: Mustafa Ozkaynak, Valdez R, Hannah K, Woodhouse G, Klem P. Understanding Gaps Between Daily Living and Clinical Settings in Chronic Disease Management: Qualitative Study. Journal of Medical Internet Research. 2021;23(2):e17590-e17590. doi:https://doi.org/10.2196/17590

4: Fayed N, de Camargo OK, Elahi I, et al. Patient-important activity and participation outcomes in clinical trials involving children with chronic conditions. Quality of Life Research. 2013;23(3):751-757. doi:https://doi.org/10.1007/s11136-013-0483-9

5: Turner JRick, Hoofwijk TJ. Clinical Trials in New Drug Development. The Journal of Clinical Hypertension. 2013;15(5):306-309. doi:https://doi.org/10.1111/jch.12085

6: Superchi C, Bouvier FB, Gerardi C, et al. Study designs for clinical trials applied to personalised medicine: a scoping review. BMJ Open. 2022;12(5):e052926-e052926. doi:https://doi.org/10.1136/bmjopen-2021-052926

7: Adami G, Saag KG, Chapurlat RD, et al. Balancing benefits and risks in the era of biologics. Therapeutic Advances in Musculoskeletal Disease. 2019;11. doi:https://doi.org/10.1177/1759720x19883973

8: MedOne: A PBM That Prioritizes Whole-Health Member Care. https://www.digitalhealthcaresanofi.com/dam/jcr:5b0cee43-a4b5-4eb9-ba02-0aab2ae88f18/Sanofi%20Dario%20White%20Paper.pdf

‌9: Ebenezer Afrifa‐Yamoah, Adua E, Peprah‐Yamoah E, et al. Pathways to chronic disease detection and prediction: Mapping the potential of machine learning to the pathophysiological processes while navigating ethical challenges. Chronic Diseases and Translational Medicine. 2024;11(1):1-21. doi:https://doi.org/10.1002/cdt3.137

10: What Are Clinical Trials and Studies? National Institute on Aging. Published March 22, 2023. https://www.nia.nih.gov/health/clinical-trials-and-studies/what-are-clinical-trials-and-studies

11: EbtesamMohammed Ba-Essa, Sahar Abdulrhman, Mayson Karkar, et al. Closing gaps in diabetes care: From evidence to practice. Saudi Journal of Medicine and Medical Sciences. 2018;6(2):68-68. doi:https://doi.org/10.4103/sjmms.sjmms_86_17

12: Spencer EA, Abbasi S, Kayal M. Barriers to optimizing inflammatory bowel disease care in the United States. Therapeutic Advances in Gastroenterology. 2023;16:175628482311696-175628482311696. doi:https://doi.org/10.1177/17562848231169652