ACORI | Dictionary: $P

Pairing

Pairing is a method by which a pair of clinical study participants are selected with similar characteristics (for example, weight, smoking habits) but one receives treatment A and the other receives treatment B.

Parallel Assignment

Parallel assignment is when two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives medicine A, and the other group receives medicine B.

Parallel Trial

In a parallel trial, two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives medicine A, and the other group receives medicine B.

Parameter

In clinical studies, parameters (or variables) refer to factual information, such as personal data (age, height, weight), measurements, and clinical assessments.

Participant

A participant is a person who is enrolled in a clinical study.

Participant Flow

Participant flow is a summary of the progress of participants through each stage of a clinical study.

Parts

"The term ""parts"""" is used when a clinical study protocol includes more than one design. These designs can be independent of each other and have different objectives or different groups of volunteers. For example"

Patient Advocacy Group

Patient advocacy groups help patients, their families, and their caregivers navigate the entire scope of the cancer experience. These groups often provide services in cooperation with (and in addition to) standard medical care (e.g., education, financial assistance, counseling, transportation, lodging, and other types of support).

Patient Registry

A patient registry is a collection—for one or more purposes—of standardized information about a group of patients who share a condition or experience.

Patient Volunteer

A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition. (NIH)

Patient-reported Outcome

Patient-reported outcomes is where the clinical study participant directly reports his or her health condition in some form of questionnaire. These assessments are free from amendment or interpretation by a clinician or anyone else. These questionnaires might assess things like: pain level, quality of life, ability to perform daily tasks, mobility, etc.

Payment for Participation

Payment for participation refers to when those in charge of conducting a clinical study provide some form of compensation to participants. This may take the form of money, or the reimbursement of travel expenses, food, food vouchers, or other services.

Period Effect

"Period effect is something that occurs ""medically"""" to a participant in a clinical study during a period of the clinical study when the participant did not receive treatment."""

Personal Health Information (PHI)

Personal health information (PHI) is data that are created, received, stored, or transmitted by organizations that are bound by law to the Health Insurance Portability and Accountability Act. It refers to any personal information related to healthcare (e.g., healthcare operations, payment for healthcare services, treatments, disease, diagnoses, etc.). Electronic personal health information is often shortened to ePHI.

Personally Identifiable Information

Personally identifiable information is any information about an individual maintained by an agency (or group) which can be used to distinguish or trace an individual's identity, including (but not limited to): name, social security number, date and place of birth, mother's maiden name, education, financial transactions, medical history, criminal information, employment history, biometric records, or any other personal information that is linked or linkable to an individual.

Pharmaceutical Product

A pharmaceutical product is a medicinal product in a dose form (often referred to as a medicine) authorized by the Food and Drug Administration to be safe and effective to give to patients.

Pharmacogenetics

Pharmacogenetics is the study of the way medicines interact with genes.

Pharmacokinetics

Pharmacokinetics is how a living organism absorbs, distributes, metabolizes, and/or excretes medicines or vaccines.

Pharmacology

Pharmacology is the science that deals with the characteristics, effects, and uses of medicines and their interactions with living organisms. (CDISC)

Pharmacotherapy

Pharmacotherapy is using medicines to treat a disease or condition. (UMPLMD)

Pharmacovigilance

Pharmacovigilance is monitoring and reporting the safety and any possible adverse events associated with a medicine. It also involves taking action to reduce the risks and increase the benefits of medicines.

Phase 1/2

Phase 1/2 clinical trials tests the safety, side effects, and best dose of a new treatment. Phase I/II clinical trials also test how well a certain type of cancer or other disease responds to a new treatment. In the phase II part of the clinical trial, participants usually receive the highest dose of treatment that did not cause harmful side effects in the phase I part of the clinical trial. Combining phases I and II may allow research questions to be answered more quickly or with fewer participants. Also called phase 1/phase 2 clinical trial.

Phase 1a

Phase 1a clinical trials also test safety but also look at how the medicine is processed in the body (pharmacokinetics). These clinical trials involve slightly larger groups of participants (20-80).

Phase 1b

Phase 1b clinical trials also focus on safety, but are the first human clinical trials that also focus on treating a condition or disease. Like with Phase 1a clinical trials, participant numbers range from 20-80.

Phase 2

Phase 2 clinical trials administer the experimental medicine or treatment to a larger group of people (100–300). These clinical trials gather preliminary data on whether a medicine works in people who have a certain condition/disease. For example, participants receiving the medicine may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different medicine. Safety continues to be evaluated, and short-term adverse events are studied. (CTG)

Phase 3

Phase 3 clinical trials administer the experimental medicine or treatment to large groups of people (1,000–3,000) to further confirm its effectiveness, monitor side effects, and/or compare it with standard or equivalent treatments. If a medicine successfully passes a Phase 3 clinical trial, it can be approved by the Food and Drug Administration for public sale and use.

Phase 3 b

Phase 3 b is a subcategory of a Phase 3 clinical trial that is performed near the time of approval to elicit additional findings. (CDISC)

Phase 4

After a medicine is licensed and approved by the Food and Drug Administration, researchers use phase 4 clinical trials to track the treatment's safety, seeking more information about its risks, benefits, and optimal use. (NIH)

Phase not Applicable

"""Phase not applicable"" describes clinical trials without Food and Drug Administration-defined phases"

Phases of a Trial

Clinical trials are conducted in step-by-step phases that evaluate treatments to see if they are safe and effective for treating human health conditions.

Placebo

A placebo is a medication (pill, liquid, patch, etc.) that looks like the treatment being studied but does not contain any ingredients that have any effect on the disease or condition being tested in the clinical study. Placebos are often used in blinded studies to reduce the chance of bias, since it makes it difficult for participants (and sometimes the investigator) to know what medicine is being administered.

Placebo Comparator Arm

The placebo comparator arm is the group of participants that receives a placebo during a clinical study.

Placebo Comparator Branch

The placebo comparator branch is the group of participants that receives a placebo during a clinical study.

Placebo Comparator Group

The placebo comparator group consists of the participants that receive a placebo during a clinical study.

Placebo-controlled Study

In a placebo-controlled study one group is given the medicine being tested and the other group is given a placebo (a medication that has no ingredients that has any effect on the disease or condition being tested).

Plain Language Summary

A plain language summary of a clinical study is specifically designed so that those who do not have a medical or scientific background can easily understand all aspects of a clinical study (e.g., its design, execution, results, analysis, discussion, implications, etc.). The purpose of this is to make clinical studies more transparent to the lay public so that they might not only better understand clinical studies but also their significance and importance to medical research.

Plain Language Writing

In the medical setting, plain language writing is intended to use common words and sentence structures in a way that better communicates complex medical terms and concepts and makes them easier to understand for those with limited or no medical background.

Population

A population is any collection of people from which information is obtained for a clinical study to obtain estimates that might be applied to a larger collection of people.

Pragmatic Trial

A pragmatic trial is a study designed to examine the benefits of a medical product under real world conditions. (CDISC)

Pre-approval Access

Pre-approved access is a potential way for a patient with an immediately life-threatening condition or serious disease or condition to be permitted to use a medical product (medicine, biologic, or medical device) that has not yet been approved for public use. This is usually only granted when no other effective approved therapy is available.

Pre-clinical Trials

Pre-clinical trials are studies of medical treatments and devices that do not involve human participants.

Prevention Trials

Prevention trials are clinical studies that evaluate new methods, ways, or procedures to: prevent disease in people who have never had the disease or have been diagnosed early, prevent the disease from returning in those persons who have had the disease, and limit the negative effects of the disease and its treatments.

Primary Completion Data

The primary completion date is when investigators have examined, provided treatment, or collected information from the last participant in a clinical study. Whether the clinical study ended as planned or was prematurely terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures.

Primary Objective

The primary objective is the main purpose for the clinical study. Primary objectives include: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and others. (CTG)

Primary Outcome Measure

In a clinical study, the primary outcome measure is the most important measure for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one. (CTG)

Primary Outcome Variable

In a clinical study, the primary outcome variable is the is the most important measure for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome variable, but some have more than one. (CTG)

Primary Purpose

The primary purpose is the main reason for conducting the clinical study. Primary purposes include: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and others. (CTG)

Principal Investigator

The principle investigator is the clinician who leads the research team and, along with the other members of the research team, regularly monitors clinical study participants􏰦 health to determine the clinical study'􏰦s safety and effectiveness. (NIH)

Privacy Breach

A privacy breach is the loss of, unauthorized access to, or disclosure of, personal information. (CDISC)

Product Dose

Product dose is the amount of a medicine administered in a single dose at a point in time. It is usually expressed as a weight, volume, or a number of items administered.

Prophylaxis

Prophylaxis are practices or interventions that help people stay healthy and avoid disease. A face mask is an example of a prophylaxis against Covid 19.

Prospective Study

In a prospective study, investigators collect the bulk of the information about what they are clinical studying after the clinical study begins, and that's the information they will use to make their conclusions about the topic being studied

Prospectively Assigned

Prospectively assigned refers to when investigators assign different groups to different treatments after a clinical study has begun.

Protected Health Information

Personal health information is data that are created, received, stored, or transmitted by organizations that are bound by law to the Health Insurance Portability and Accountability Act. It refers to any personal information related to healthcare (e.g., healthcare operations, payment for healthcare services, treatments, disease, diagnoses, etc.)

Protected Personal Data (PPD)

Protected personal data (PPD) is any personal or medical information about a person that, by law, cannot be shared with anyone who does not have the legal and medical right to have access to that information. It also includes any information that could identify a participant in a clinical study. Examples of PPDs are: a person's medical condition, mental health status, economic status, cultural or social identity, etc.

Protocol

The protocol is a document that describes the objective(s), design, methodology, statistical consideration, and organization of a clinical study. (NIH)

Protocol Amendments

Protocol amendments are written descriptions of changes to or formal clarifications of a protocol. (NIH)

Protocol Deviation

Protocol deviations are the failure to conduct a clinical study in the manner outlined in the protocol. The failure may be accidental or due to negligence. In either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include: failure to obtain/maintain approval for research, failure to obtain informed consent when required, failure to file adverse event reports, performance of an unapproved clinical study procedure, performance of research at an unapproved site, failure to file protocol modifications and failure to adhere to an approved protocol. (NIH)

Protocol Deviation Report

A protocol deviation report is an internal document created as part of the ongoing quality control process. It summarizes compliance with the protocol and lists protocol deviations and/or violations. (NIH)

Protocol Violation

A protocol violation is the failure to conduct a clinical study in the manner outlined in the protocol. The failure may be accidental or due to negligence. In either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include: failure to obtain/maintain approval for research, failure to obtain informed consent when required, failure to file adverse event reports, performance of an unapproved clinical study procedure, performance of research at an unapproved site, failure to file protocol modifications and failure to adhere to an approved protocol. (NIH)

Proxy Outcome Data

Proxy outcome data are outcome data furnished by someone other than the patient and thus distinguish the origin of the outcome from a self-reports that come directly from the patient. NOTE: The term proxy helps qualify outcomes measures that record feelings and symptoms reported by the patient but not recorded directly. (CDISC)

Proxy Respondent

A proxy respondent is someone other than the patient who is responding about the patient on behalf of the patient. This person does not make any observations of their own, but only communicates exactly what the patient reports about his or her condition.

Pseudonymization

Pseudonymization is when a clinical study protects the identity of its participants by not listing their actual name but instead assigns each participant a number or other identifier.

Psychometrics

Psychometrics is the science of measuring mental capacities and processes.

Clinical Research Terms Glossary

Terms starting with P