Pharmacists Emerge as Central Players in Modern Clinical Trials

As clinical trials grow more complex and data-driven, the role of pharmacists has expanded far beyond investigational drug logistics. Today, pharmacists are increasingly embedded within multidisciplinary research teams, contributing to protocol design, patient safety, regulatory compliance, and trial efficiency. In this Q&A with Pharmacy Times®, Nan Limvorasak, PharmD, investigational drug services pharmacy program coordinator at Cedars-Sinai, discusses how pharmacists have become essential partners in clinical research—bridging pharmacology, patient care, and trial operations to support both scientific rigor and participant safety.

Pharmacy Times: How has the role of pharmacists evolved within clinical trial teams over the past decade?

Nan Limvorasak, PharmD: Historically, investigational drug pharmacists focused primarily on the logistics of drug management—receiving, storing, dispensing and compounding; maintaining records;

and ensuring protocol compliance. Over the past decade, our role has evolved significantly. Pharmacists are now integrated members of the clinical trial team, contributing to patient care and therapeutic drug management including supportive care, toxicity management and patient education. Today, investigational drug pharmacists participate in protocol scientific review and implementation, regulatory compliance, safety monitoring, and interdisciplinary collaboration with the investigators, sponsors and other clinical trial teams. What was once largely a “pharmacy-logistics” role has transformed into a specialized clinical research function—a bridge between pharmacology, patient care, regulatory oversight and trial operations.

Pharmacy Times: What unique expertise do pharmacists bring to the design and execution of clinical trials?

Limvorasak: Pharmacists bring a unique combination of clinical pharmacology expertise, patient-safety leadership and operational excellence in investigational drug management. With extensive knowledge of pharmacokinetics and pharmacodynamics, we evaluate protocol feasibility, identify drug-drug interactions and other safety risks that may affect participant outcomes or compromise study integrity, and provide guidance on dosing, toxicity management and supportive care strategies.

Investigational drug pharmacists are well positioned to design and implement practical drug handling procedures that comply with state and federal regulations, Good Clinical Practice (GCP) and sponsor requirements. We ensure adherence to all regulatory frameworks throughout the conduct of a clinical trial and maintain both paper and electronic records that are audit-ready and fully compliant with regulatory standards. This level of oversight is critical for protecting participant safety and generating reliable, reproducible clinical data. In my current role, there are tremendous opportunities to contribute a distinct set of scientific and operational competencies that are essential to the design and execution of contemporary clinical trials. Ultimately, our goal is to enhance the methodological integrity of clinical research and support the safe, compliant translation of investigational drugs from the research workbench to clinical practice.

Pharmacy Times: How do pharmacists support protocol development, particularly regarding dosing, drug–drug interactions, and safety considerations?

Limvorasak: Pharmacists play a critical role in protocol development by applying our expertise in pharmacology, clinical therapeutics and patient safety to ensure that investigational drugs are used safely and effectively. Our contributions typically focus on these key areas:

1. Dosing Strategy
2. Drug-Drug Interactions
3. Safety Considerations

Initially, we evaluate the proposed dosing regimen for safety, feasibility and scientific rationale based on pharmacokinetics, pharmacodynamics and prior clinical data. In early-phase trials, we advise on timing, titration schedule and dose escalation schemes as needed, with the goal of optimizing therapeutic effect while minimizing toxicity. More recently, we leverage AI driven platforms to analyze large datasets, predict patient-specific responses and guide precision dosing strategies.

Throughout the trial, pharmacists are involved in identifying potential drug-drug interactions between the investigational drug and concomitant medications, supplements and over-the-counter drugs. If an interaction may affect drug metabolism, efficacy or safety, we recommend mitigation strategies and, when appropriate, alternative substitutions. We also assist in determining participant eligibility for a clinical trial by ensuring that the interacting drugs are discontinued within an appropriate timeframe prior to initiating study treatment.

For safety considerations, we proactively assess known or anticipated adverse events from preclinical and clinical data and develop monitoring plans to protect participants. These include recommendations on laboratory tests, vital sign assessments and symptom tracking tailored to the investigational therapy. Pharmacists also provide guidance on supportive care strategies, toxicity management, and dose modifications to mitigate adverse events. By integrating clinical knowledge with predictive analytics, we help minimize risks, enhance safety monitoring and maintain the integrity of the trial.

Pharmacy Times: Can you share an example of how pharmacist involvement improved trial efficiency or patient outcomes?

Limvorasak: One quality improvement, pharmacist-led project I worked on involved conducting post-treatment follow up phone calls with participants after discharge. The outcomes were highly positive, including reduced treatment interruptions, timely identification ofadverse events and prompt management of these events. This approach also contributed to a reduction in emergency room visits and hospitalization related to adverse events and improve participant compliance to study treatment.

This example demonstrates that pharmacist involvement not only enhances patient safety but also improves operational efficiency, supports data integrity and contributes to more reliable clinical trial outcomes.

Pharmacy Times: What skills or training will be most important for future pharmacists entering clinical research roles?

Limvorasak: As clinical trials become increasingly complex, the next generation of pharmacists will need a combination of scientific expertise, technical skills and interpersonal competencies to succeed in this role. This requires a balance of advanced clinical and pharmacological knowledge, regulatory and compliance expertise, operational and investigational drug management skills, and data-driven decision-making skills. Proficiency in electronic data capture (EDC) systems, clinical trial management systems and electronic health records (EHR) is essential, as is the ability to leverage data for precision medicine, predictive modeling and trial optimization. Training programs that integrate advanced pharmacology, research methodology, regulatory education, and technological proficiency will be critical to preparing pharmacists to contribute effectively to the safe and efficient conduct of modern clinical trials.

Pharmacy Times: What are the biggest barriers that limit pharmacist involvement in clinical trials today?

Limvorasak: Although pharmacists bring significant expertise to clinical trials, infrastructure limitations, resource constraints, and insufficient investment in pharmacy personnel and technology often restrict our involvement. These barriers can compromise patient safety, reduce trial efficiency, increase staff burnout, and raise operational costs. Early integration of pharmacists, supported by dedicated staffing and extensive education and training, is essential to fully leverage pharmacist contributions and enhance both trial quality and outcomes

Pharmacy Times: How can health systems or sponsors better integrate pharmacists to maximize trial success?

Limvorasak: Health systems and sponsors can maximize clinical trial success by integrating pharmacists early in protocol design, leveraging their expertise in dosing, drug-drug interactions and safety monitoring, and embedding pharmacists as core members of multidisciplinary clinical trial teams participating in investigator meetings, safety reviews and patient care planning. Providing dedicated staffing, robust infrastructure, both resources and technology—such as computerized or electronic drug accountability systems—and extensive education and training can certainly ensure pharmacists manage investigational drugs efficiently. Supporting data-driven approaches, including AI tools, will further enhance recruitment, patient safety, trial efficiency, and overall clinical trial quality.