Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 104

Here are some important definitions for the sponsor and investigator players involved in conducting a clinical trial. A clinical trial will have,

1 The Sponsor:A sponsor who is “an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial” (ICH E6(R2) 1.53). The sponsor will be interested in collecting data from a series of clinical trials to prove the safety and efficacy of an investigational product so that they may apply to the governing regulatory authority(ies) for approval to market the product. The sponsor will seek out investigators who have access to the study population, i.e., healthy volunteers or the patients who have the indication being studied in the trial.The sponsor for a clinical trial may contract with a Contract Research Organization(s) (CRO), which is a person or an organization (commercial, academic, or other) contracted to perform one or more of a sponsor's trial‐related duties and functions (ICH E6(R2) 1.20). The CRO will bear the GCP and regulatory responsibilities for the contracted tasks (Chapter 15 Trial Resourcing and Outsourcing).

2 The Investigator:The investigator is “a person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator” (ICH E6(R2) 1.34). The investigator, or a qualified designee, will administer the investigational product to the study subjects.The investigator may subcontract or delegate tasks to others; however, unlike the sponsor, the investigator maintains full GCP and regulatory responsibilities for the delegated tasks.

3  The Sponsor‐Investigator:An individual may decide to take responsibility for the supply of the investigational product and to test the investigational product on research volunteers as well. In this scenario, the individual or organization assumes the GCP and regulatory responsibilities as both sponsor and investigator. This sponsor‐investigator is therefore an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor–investigator include both those of a sponsor and those of an investigator (ICH E6(R2) 1.54). For example, an investigator at an academic medical research institution may be interested in testing an approved or investigational product for a new indication that the original sponsor may not pursue. The investigator will then procure the product, create the clinical trial protocol and conduct the trial as the sponsor as well as enroll the patients and administer the product to the patients.An example of an Investigator–CRO combination is that of what is known as a phase 1 facility, where typically first‐in‐human testing is performed to obtain pharmacokinetic information of an investigational product. The sponsor may select such a facility because these facilities are equipped with on‐site housing and hospital services and the phase 1 study is testing the investigational product on few individuals who must be constantly monitored for safety and pharmacokinetic results. This facility may not only perform investigator responsibilities, in that they will enroll and administer the product to the study subjects, but may also perform the pharmacokinetic testing and data analyses, and prepare the clinical study report for the sponsor. The facility has then also assumed sponsor responsibilities in that they are contracted as a central laboratory to perform the pharmacokinetic testing and as the writer of the clinical study report.