Clinical trial data glossary: real-world data, feasibility and site selection terms

16 termsThe data

Real-world data and where it comes from.

• Real-world data (RWD). Information about patients’ health and care collected during routine care rather than inside a clinical trial, such as health records, insurance claims, pharmacy and lab records, and registries. Also written real world data. More →
• Real-world evidence (RWE). The findings that come from analyzing real-world data, for example how many patients meet a protocol’s criteria or which institutions treat them.
• Patient-level data. Data kept as one de-identified record per patient, so individual patients can be counted against each of a protocol’s criteria rather than estimated from totals. More →
• Aggregate data. Totals and averages, such as how many people in a region have a diagnosis. Useful for sizing a disease, not for counting who meets a protocol.
• De-identified data. Data with names and other direct identifiers removed, so that no individual can be recognized. Trial planning works with counts, never identities.
• Tokenization. Replacing a patient’s identifying details with an irreversible code, called a token, so records about the same patient from different sources can be linked without revealing who the patient is.
• Linked data. Records from different sources, such as a hospital, a pharmacy and a lab, joined for the same de-identified patient so their care can be seen as a whole.
• Longitudinal data. Data that follows the same patient over time, so criteria that depend on history, such as prior treatment lines, can be checked.
• Electronic health record (EHR). The record a hospital or clinic keeps of a patient’s care: diagnoses, procedures, test results, medicines and clinical notes. Also called an electronic medical record (EMR).
• Claims data. Billing records of the care a patient received, submitted by providers to insurers. Claims show diagnoses, procedures and prescriptions across every provider that billed for them.
• Open claims. Claims captured as they pass from providers toward payers, before final payment. They arrive quickly and cover many payers, but a patient’s record can have gaps when some claims take another route.
• Closed claims. Claims taken from a payer after they are fully processed. They are complete for the time a patient is covered by that payer, but arrive more slowly and cover only that payer’s members.
• Lab data. Test results and their dates, used to check the thresholds written into inclusion and exclusion criteria.
• Pharmacy data. Records of prescriptions written and filled, used to check prior and current medicines.
• Disease registry. A database of patients with one condition, kept by a disease group, an institution or a government. Often an important source in rare disease.
• Data freshness (data lag). How recent the newest records are. Routine-care data takes time to arrive, so the latest weeks or months are usually the least complete.

11 termsPatients and protocols

Who can take part in a trial, and how that is decided.

• Protocol. The document that sets out how a clinical trial will be run, including who can take part, what is measured and for how long.
• Indication. The disease or condition a treatment is being studied for.
• Inclusion criteria. The conditions a patient must meet to enter a trial, such as a confirmed diagnosis, an age range or a lab value.
• Exclusion criteria. The conditions that rule a patient out, such as another illness, a prior treatment or a medicine they take.
• Eligibility criteria (I/E criteria). Inclusion and exclusion criteria taken together.
• Qualifying patients. Patients who meet a protocol’s inclusion and exclusion criteria, not just its diagnosis. Usually a small share of everyone with the condition. More →
• Patient pool. The number of patients who could take part in a trial in a given country, region or site.
• Screen failure. A patient who is screened for a trial but turns out not to meet its criteria. A high screen-failure rate costs sites time and budget.
• Diagnosis code (ICD-10). The standard code used in health records and billing to record a diagnosis. Codes are how a protocol’s conditions are matched to real-world records.
• Procedure code. A standard code, such as a CPT code in the US, that records a test or treatment a patient received.
• Protocol amendment. A change to a protocol after a trial has started, often to widen criteria when enrollment falls short. Amendments cost time and money.

15 termsSites and investigators

Who runs the trial, and where.

• Research site. A hospital, clinic or research center that runs a clinical trial and enrolls its patients.
• Principal investigator (PI). The physician responsible for running a trial at a site.
• Sub-investigator. A member of the site team who carries out trial tasks under the principal investigator.
• Key opinion leader (KOL). A physician whose expertise in a disease area is widely recognized. A well-known name, but not always the strongest enroller.
• Investigator track record. How an investigator has performed on past trials, especially trials like the one being planned.
• Verified site record. A site record whose identity has been confirmed, so one institution is not counted twice under different names or addresses and its trials and investigators are attached to the right place.
• Site dossier. A profile of a research site: its investigators, its past and active trials, the patients it treats and its capabilities.
• Site identification. Finding the candidate sites that could run a trial. The long list.
• Site selection. Choosing which candidate sites will run the trial. The shortlist. More →
• Site feasibility. Checking whether a particular site can run a trial: its patients, staff, equipment and timelines.
• Feasibility questionnaire. A survey sent to sites asking how many patients they could enroll. Answers are self-reported and often optimistic.
• Site activation. The steps that make a selected site ready to enroll: contracts, approvals, training and set-up.
• Non-enrolling site. A site that is activated but enrolls no patients. Tufts CSDD puts this at about 11% of sites. More →
• Rescue site. A site added after a trial starts because the original sites are not enrolling fast enough.
• Enrollment rate. How many patients a site or a trial enrolls per month.

8 termsFeasibility and the bid

How trials are planned, bid for and won.

• Clinical trial feasibility. The assessment of whether a study can realistically enroll, where and how fast. More →
• Protocol feasibility. Testing a protocol’s criteria against real patients before it is final, to see how many qualify and which criteria remove the most.
• Country feasibility. Assessing which countries can support a trial: patient numbers, sites, and regulatory and start-up timelines.
• RFP (request for proposal). A sponsor’s invitation to CROs to bid for a trial, usually asking for a budget, a timeline and a site plan.
• Bid defense. The meeting where a shortlisted CRO presents and defends its proposal to the sponsor before the award is decided. More →
• CRO (contract research organization). A company that runs clinical trials on behalf of a sponsor.
• Sponsor. The company or organization that funds a trial and owns the treatment being tested, often a pharmaceutical or biotech company.
• Full-service data company. A provider that supplies both the data and the analysis: it holds the records, and its team turns them into the answer a trial team needs instead of handing over raw data or software. Quantum Research Cloud is a full-service data company for clinical trials.