Small clinical trials, such as most open-label and uncontrolled trials, often have the organization shown in Fig. 80.2. These may or may not involve a pharmaceutical sponsor, and the figure does not show participation of a sponsor. No regulatory interactions are shown either, but these may be another component in these studies.

A moderate to large clinical trial, shown in Fig. 80.3, has additional groups participating in the trial but does not have a sponsor or need for regulatory assistance. The “clinical site staff” might include residents, fellows, nurses, trial coordinator, and pharmacists. In addition, there may be a need for medical specialists and teams to assist with specific tests such as eye examinations, electrocardiograms, and blood draws. Additional site staff might include data managers, data entry personnel, and statisticians if the site will be handling the data management function.

A simple sponsored clinical trial is shown in Fig. 80.4. This figure now adds a sponsor (see the obligations of an IND sponsor on FDA form 1571) and monitors (see the FDA guidance document for monitoring clinical trials on their website), who are an important part of the team. In some cases, the sponsor may have a contract research organization (CRO) run the trial for it, and both the CRO and sponsor may each have its own monitors who will visit the site, possibly together. Any obligations of the sponsor that are transferred to a CRO should be documented on a transfer of obligation document. A large sponsored trial may have a plethora of additional groups involved, and some of these are shown in Fig. 80.5. These include a steering committee; a Data Safety Monitoring Board; auditors; central reviewers of radiology, pathology, or other data; central laboratories; and possibly other vendors such as an interactive voice response system group to help with randomization. Almost any of these additional groups might also participate in smaller trials.

The primary requirement is an ability (and interest) to pay compulsive attention to detail in adhering to both the protocol and record keeping that are part of Good Clinical Practices (GCP; see the FDA or International Conference on Harmonisation consolidated guidance E6) and FDA standards. An investigator becomes part of a team of professionals, whether there is a single or many investigators and one or many sites involved in the trial. These attributes create an issue for many academic or private
practice physicians who feel that the patient’s interests come first and cannot be compromised, even in the interests of adhering to the protocol used in a clinical trial. Some of the primary motivations of pharmaceutical sponsors in choosing investigators and sites are shown in Table 80.1.

Once a physician has reached a decision to participate in sponsored clinical research, the question becomes how to attract the interest of the industry sponsors who are looking for investigators. Fortunately, this is not too difficult. The essentials, particularly in a developed country, are to have a study coordinator, be able to demonstrate that you have a pool of patients able to be enrolled into a trial, and hopefully have a track record of participating in trials with other investigators (or sponsors), if not conducting trials on one’s own. Enthusiasm and interest are important, but being able to convince industry staff of your ability to pay attention to detail and to follow a protocol is essential. Some of the primary concerns of individual investigators within an academic institution or private practice who are considering participation in clinical research are listed in Table 80.2.

The issues for a university or other institution are different than those mentioned earlier. The institutions may be organized to facilitate the work of their research physicians by having a centralized office with regulatory and other professional staff who can obtain documents needed for the initiation of trials and have the ability to apply for an investigator’s IND (also referred to as a research IND) or IDE. They usually can offer the investigators a menu of services, including the ability to interact with sponsors, foundations, and government agencies to attract studies to the institution. An actual list of services provided by the University of Minnesota is shown in Table 80.3, and readers are referred to their website (www.ahc.umn.edu/research/ind-ide/) for additional documents, information, and templates that are provided. An institution may be able to provide temporary staff to help the investigator with a clinical trial by supplying study coordinators, monitors, and consultants from inside or external to the institution. Consultants could provide the investigator help with designing specialized parts of the protocol (e.g., pharmacoeconomics, patient-reported outcomes), or they may be able to conduct specialized procedures or tests. Other possible services of this office include interacting with the Institutional Review Board (IRB), Data Safety Monitoring Board, FDA, and National Institutes of Health, as well as reviewing protocols and informed consents and, possibly most important, providing important advice. For example, if the office is staffed with knowledgeable professionals, they might be able to give advice on (a) obtaining a patent, (b) developing a publication strategy, (c) learning how to list a protocol on various websites, and (d) understanding grant management and grant issues. Some of the main issues for an institution to consider that is becoming or is actively involved in centralizing the clinical trials procedures within their institution are shown in Table 80.4, and a list of possible services for such a group to offer is provided in Table 80.5. All of the services of this office may be provided without charge to faculty researchers who are IND/IDE sponsor investigators.

The office that provides these services may be separate from or part of the technology transfer office that focuses on intellectual property issues, such as helping faculty obtain patents and licensing out its inventions to commercial or other groups.

Some institutions market their clinical trial services and the abilities of their investigators to pharmaceutical companies. For this to be done effectively, it is necessary to identify areas of excellence at the institution, investigators with an international reputation, and research neophytes who are highly motivated to conduct clinical research and have the necessary skills to perform
trials well. Unique patient populations, facilities, and equipment are also important to bring to the attention of potential sponsors. A brochure that can be widely disseminated as well as placed on the institution’s website is one of many means of publicizing the institution’s capabilities.