Per protocol analysis is a statistical approach that includes only those participants who completed the study according to the predefined protocol without major protocol deviations or non-compliance. It aims to assess treatment efficacy among a subgroup of participants who adhered closely to the study procedures.
In an intention-to-treat analysis, participants are analyzed based on the group to which they were originally assigned, regardless of whether they received the intended treatment or fully complied with the study protocol. This approach aims to maintain the principle of randomization and preserve the benefits of random assignment, such as controlling for confounding factors and reducing bias.
The primary purpose of a Phase 1 study in clinical research is to evaluate the safety and dosage of a drug in humans. Phase 1 studies are typically the first stage of clinical trials and involve a small number of healthy volunteers or individuals with the target disease or condition.
According to the International Council for Harmonisation (ICH) guideline E6, section 1.33, the definition of an investigational drug is as follows: "A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use."
Source documents are the original records or materials that provide evidence or information about a subject's participation in a clinical study. These documents serve as the primary sources of data and play a crucial role in ensuring the accuracy, reliability, and integrity of the study data.
In the context of clinical trials, the term "sponsor" refers to the entity or organization that takes responsibility for the initiation, management, and funding of a clinical study. The sponsor can be any legal entity, including a pharmaceutical or biotechnology company, a contract research organization (CRO), an academic institution, a government agency, or even an individual researcher.
The Form FDA 1572 collects information about the investigator, the site, and the qualifications of the investigator to conduct the study. It also includes a statement of commitment to follow the protocol, comply with Good Clinical Practice (GCP) guidelines, and report any adverse events or safety concerns.
