Clinical Research

What is Clinical Research?

Clinical Research is a branch of healthcare science that studies people to understand health and disease and to determine the safety and effectiveness of new medications, medical devices, diagnostic products, and treatment regimens. It is the fundamental process through which new medical interventions are evaluated and approved for human use.

Context & Strategic Role

Clinical Research is the bedrock of evidence-based medicine and the engine of pharmaceutical innovation. Its strategic role is to provide regulatory bodies, such as the Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMA), with the robust data required to approve new therapies. For a life sciences company, a successful clinical research program is the primary pathway to bringing a new product to market and the foundation upon which all commercial and medical activities are built.

Core Functions / The Phases of Clinical Research

The clinical research process is rigorously structured into distinct phases, each with a specific objective:

• Phase I: The first studies in humans, typically conducted in small groups of healthy volunteers (20-100), to evaluate a new drug's safety, determine a safe dosage range, and identify side effects.

• Phase II: The drug or treatment is given to a larger group of people with the target disease (100-300) to test for efficacy and further evaluate its safety.

• Phase III: Large-scale, pivotal trials conducted in diverse patient populations (300 to 3,000+) to confirm effectiveness, monitor side effects, compare it to standard treatments, and collect information that will allow the drug to be used safely. Successful Phase III trials are essential for regulatory approval.

• Phase IV: Post-marketing studies conducted after a treatment is approved and on the market. These trials gather additional information on the drug's risks, benefits, and optimal use in a real-world setting.

Lifecycle & Practical Impact

Clinical research spans the entire drug development lifecycle, from early discovery to post-market surveillance. The outcomes of these trials have a profound practical impact: they determine whether a promising molecule becomes a life-saving therapy or a costly failure. A single failed Phase III trial can cost a company hundreds of millions of dollars and prevent a needed treatment from reaching patients.

Success Metrics / KPIs

The success of a clinical research program is measured by several key performance indicators:

• Patient Enrollment & Retention Rate: The ability to recruit and retain the required number of participants for a trial.

• Trial Timelines: The speed at which a trial moves from startup to completion and data lock.

• Data Quality: The accuracy, completeness, and integrity of the data collected during the trial.

• Endpoint Achievement: Successfully meeting the trial's pre-defined primary and secondary endpoints.

• Regulatory Submission & Approval: The ultimate measure of success is the acceptance of a New Drug Application (NDA) or Biologics License Application (BLA) by regulatory authorities.

TikaMobile Relevance

While TikaMobile is not a Clinical Trial Management System (CTMS), it plays a crucial supporting role in the clinical research ecosystem. Medical Science Liaisons (MSLs) use TikaMobile’s Medical Affairs CRM to identify and build relationships with Key Opinion Leaders (KOLs) who may serve as principal investigators for future trials. Furthermore, after a trial is complete, MSLs rely on the platform to effectively and compliantly disseminate the published clinical research findings to the broader medical community, bridging the gap between clinical development and clinical practice.