We live in an exciting time. Breakthrough medical science is happening all around us at breakneck speed. To simplify the terminology, Trial AMPlify has compiled a list of the most commonly used clinical trial patient recruitment terminology, acronyms, and abbreviations to help define the landscape.

Understanding the terminology and definitions surrounding patient recruitment in clinical trials is crucial for anyone involved in or interested in medical research. Let’s dive into some of these key terms:

Clinical Trial:   A research study conducted to evaluate the safety and effectiveness of new treatments, drugs, or medical devices in humans. Clinical trials are essential for developing new medical interventions and understanding their impacts on various health conditions.

Decentralized Clinical Trials (DCTs):  A modern approach to performing clinical research that shifts traditional, site-based activities away from centralized physical locations (like hospitals or clinics) to subjects at home to collect data and manage trial research. Learn more and DCT's here >>

Patients: Individuals who participate in clinical trials. These participants are sometimes patients with specific health conditions that the trial aims to study or treat. In other cases, they might be healthy volunteers.

Recruitment: The process of identifying and attracting potential participants for a clinical trial. Effective recruitment strategies are essential to ensure that the trial has a sufficient number of participants who meet the study’s eligibility criteria.

Patient Recruitment Agency:   A patient recruitment agency specializes in identifying, attracting, and enrolling suitable participants for clinical trials. These agencies use various strategies and tools to streamline the recruitment process and ensure the enrollment of qualified subjects.

Investigator: A person, often a healthcare professional or researcher, who conducts the clinical trial. Investigators are responsible for ensuring the study is conducted ethically and in accordance with regulatory requirements, and for overseeing the care and monitoring of study participants.

Clinical Trial Marketing:   Refers to the methods and strategies used to promote clinical trials to potential participants. This includes the design and development of dedicated clinical trial websites, social media advertising, clinical trial digital marketing services, physician outreach marketing and other tactics aimed at raising awareness about a trial and attracting suitable subjects.

Protocol:   A protocol is defined as a detailed plan for a clinical study, medical experiment, treatment, or procedure. The goal of any protocol is to provide detailed structure for how to manage the patient and how to perform the procedure. It should provide precise instructions on what should be done, how, when, to whom, and why.

Clinical Trial Website /Landing Page:   A custom clinical trial site acts as the "home base"  for everything patients, physicians, family members, HCP's and advocacy groups need to know about your study. A clinical trial site should encompass a memorable trial branded logo, unique graphics, icons, imagery, messaging and include patient profile and visitor journey analysis as a best practices to optimize patient enrollment. Developing a site in WordPress should be avoided. WordPress is the most venerable to being hacked and requires plugins to run which are not HIPAA or GDPR compliant.

Amazon AWS:   AWS Cloud supports a patient-centric digital experience with cloud services so healthcare organizations can build websites, mobile applications and patient engagement portals. AWS provides a superior clinical trial website hosting platform to ensure study sites are safe and secure. 90% of the Top 10 global biopharma companies use Amazon AWS.

Enrollment:   The act of registering or signing up participants for a clinical trial. Enrollment occurs after potential participants are identified, screened, and have consented to participate in the study.

Subjects:   Another term often used interchangeably with “patients or volunteer” to refer to individuals participating in a clinical trial. Subjects can include both patients with the condition being studied and healthy volunteers, depending on the trial’s requirements.

Study: A term used to refer to the clinical trial itself. It encompasses the entire process from design to execution, including the recruitment and enrollment of subjects, data collection, and analysis.

Sponsor:   The organization or individual responsible for initiating, managing, and financing a clinical trial. Sponsors can be pharmaceutical companies, academic institutions, government agencies, or other organizations involved in medical research.

CRO (Contract Research Organization):   A company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. CROs often assist in various stages of clinical trials, including patient recruitment.

Patient Retention - Despite best efforts, a percentage of patients will abandon a clinical trial. The patient dropout rate averages around 30% but can vary from study to study. Clinical trial patients abandon clinical trials prematurely for a variety of reasons.

FIH: First in Human

CRA:   Clinical Research Associate is a person who performs activities related to medical research, particularly clinical studies.

ARM: A subgroup or group of participants in a clinical study who either receive treatment or no intervention at all, according to the trial's specific protocol

Blinded Study:   Both the sponsor and the patient do not know which treatment the patient is getting until the study has concluded.

IND: Investigational New Drug

Pl: Principal Investigator

CTMS: Clinical Trial Management System

IRB:   The committee of healthcare professionals that monitor all clinical research trials being conducted to ensure the  safety and rights of participants. Often, a sponsor or investor will need to clear certain stages of a trial  with  the IRB.

Understanding these terms provides a clearer picture of clinical trials' complex and multifaceted world. Effective patient recruitment is a critical component of successful clinical studies, ensuring that research can proceed efficiently and contribute valuable findings to the field of biopharma and life science companies.

Trial   AMPlify is a patient recruitment agency located in Boston, MA. We are solely focused on global clinical trial marketing, customized physician outreach campaigns, and world-class clinical trial website design for Biotech, Life Science, Pharma, and MedTech firms.