Coordinating Clinical Trial Schedules for PhDs

Simulation author – Chiara Rancan, PhD

Simulation vetted by professionals from Genentech and UCSF

Simulation Objective:

Coordinate the schedule of clinical trial events for medical staff and study enrollees

Associated Simulation Library:

Background

The Clinical Research Coordinator (CRC) is a specialized research professional whose goal is to ensure the smooth and accurate progress of clinical studies. A CRC is involved in all stages of a clinical study, from the planning and approval stages through study completion and post-study closure.

A CRC will often work under the direction of the Principal Investigator (PI) of a clinical trial, who is responsible for the overall design, conduct, and management of the trial. A CRC provides support, and coordinates the daily clinical trial activities. One aspect CRCs may find rewarding about this job position is the close contact with patients involved in the trials. A CRC will often witness firsthand how advances in scientific knowledge and drug discovery affect the lives of patients and their families.

One of the important roles of a CRC is to organize, coordinate and schedule participants’ tests and procedures, and to make sure timelines are correctly followed for the entire course of the study. The CRC is responsible for setting and coordinating the schedule between the patients and the doctors and/or nurses performing the medical examinations and the drug administration.

The Process

  • The CRC’s interaction with the medical clinic starts before the official enrollment of the participant.

  • Before a patient is enrolled in a trial, his/her eligibility needs to be assessed, following the procedures highlighted in the clinical trial protocol. For this assessment, a series of medical examinations specified in the study protocol must take place. Only after it has been confirmed that no exclusion criteria are encountered and that all the eligibility criteria have been met, the patient can enter the trial and the administration of the drug(s) can commence.

  • After enrollment, the participant follows a very specific schedule for the drug administration. This schedule is decided by the PI together with the trial sponsor and it is highlighted in the study protocol.

  • During and after drug administration, routine check-ups must be performed to make sure that no adverse event is taking place.

  • Additional medical examinations and analyses may be necessary for the evaluation of end points indicated in the study protocol (ie: tumor shrinkage, safety of the drug).

Resources

The Exercise

Create a schedule for the clinical trial for the clinical staff and the enrollees. As a CRC, you organize and schedule all the interactions between patients, nurses and doctors to fulfill the requirements of the study including analysis and drug administration.

For this exercise, you are part of the team responsible for the initiation of a Phase III randomized study that will compare the efficacy of the combination of two immunotherapy drugs to single therapy in the context of untreated unresectable or metastatic melanoma.

Scientific Background

Nivolumab and Ipilimumab are novel biological drugs called checkpoint inhibitor antibodies. Nivolumab is a human anti-PD-1 antibody, while Ipilimumab specifically recognizes human CTLA-4. Both PD-1 and CTLA-4 are immune-inhibitory receptors that dampen and downregulate the functions of the immune system, particularly of T cells. In the context of cancer, PD-1 and CTLA-4 prevent the proper activation of T cells, hindering T cells from attacking and clearing cancer cells. Nivolumab and Ipilimumab block the interaction of the receptors PD-1 and CTLA-4 with their targets, thus enabling proper T cell activation. Blockade of PD-1 and CTLA-4 allows T cells to fulfill their cytotoxic function against cancer cells.

Task 1 - Coordinate Calendar for Study Staff

Set a schedule or calendar addressed to the nurses that includes the pre-screening assessment, the drug administration and the subsequent follow-up analyses. This must include the list of analyses that the clinic and nurses need to perform. We suggest using an Excel file for this task – see this example. For this exercise, use the abbreviated study protocol provided.

Summary of the abbreviated study protocol:

  • Synopsis (p6-10)

  • Drug administration information (Tables 4.3-1 and 4.3-2)

  • Medical examinations before, during, and after drug administration (section 5.1, p46)

IMPORTANT: This is a double-blind study: make sure the details of the drug administration, like the type of drug, are not included.

Task 2 - Coordinate Calendar for a Patient

Craft a calendar for a new patient, Jane Micro. Prepare a prospect of the timeline of all the examinations and appointments she will need to attend to before, during and after the completion of the drug administration. Divide the appointments according to type: pre-screening, drug-infusion, follow-ups. For this exercise, we suggest using Excel to help you create the first draft, in a similar way to Task 1.

For this task, provide information about the procedure to help the patient prepare for the examination. Examples could include whether there will be a blood draw and the volume or whether there will be a scan for that visit. For this task, you will not need to include information about the length of the visit. The level of detailed information may depend on the organization and the team for which you are working.

IMPORTANT: This is a double-blind study: make sure the details of the drug administration, like the type of drug, are not included.

Deliverables

Task 1

A standard deliverable is an Excel file or electronic calendar. Feel free to organize the information in a way that makes sense to you. There is no correct way for this task. Note that the format for calendars and timelines will depend on the site and its procedures.

Task 2

The timeline in Task 1 will give the CRC a complete picture of the scheduling s/he needs to organise. The timeline in Task 2 will serve as a reminder to the patient of all his/her appointments. A more experienced CRC might not need to draft a table (Task 1) or a timeline (Task 2); they may instead gather the information they need directly from the study protocol.

A new CRC starting out may receive guidance from a colleague or the Clinical Research Manager (CRM) or the PI of the study who is responsible for oversight of the trial and for patient safety. After this introductory period, an experienced CRC will mostly work independently and run the study.

Additional Tasks

  • This is the full study protocol. As you can see, a protocol can be very long and additional modification can be added during the course of the study PDF of the complete protocol.

  • This is the resulting scientific publication of the clinical study the simulation refers to. Interesting read if you want more information on the results of the trial and on the science behind the trial PDF of the publication of the study.

  • Consent participants for a clinical trial (see simulation for Responding to Patient’s Concerns)

  • Collect samples from the patient and deliver them to the research laboratory for analysis

  • Keep track of the status of all the patients and updates colleagues and the clinicians involved in the study on the status of the patients

Skills Used to Perform this Task

  • Organizational skills

  • Ability to communicate effectively with clinical staff and patients

  • Simplifying complex information for a lay audience

Skills Used in the Field

  • Excellent organizational skills

  • Ability to communicate effectively with clinical staff and patients

  • Multitasking

  • Quick problem solving

Learn about competencies for CRCs from The Association of Clinical Research Professionals

To view detailed lists of skills in job descriptions for policy careers, please see workforce data generated by Boston University’s BEST program.