FAQs for the Early Drug Development Service: Phase I Clinical Trials Program

FAQs for the Early Drug Development Service: Phase I Clinical Trials Program


Do the experts at the study clinics only conduct research or do they also see patients who are not participating in trials?

The doctors, nurses, and others working on clinical trials primarily see trial patients, but they may also see some patients who are not in a trial.

Are there clinical trial nurses at the study clinics, and what is their role?

There are clinical trial nurses at each clinic. They support clinical research by:

  • providing professional protocol-related nursing care
  • performing screening and eligibility determination, participant assessments, care planning, implementation, documentation, and evaluation
  • educating staff, families, and participants on clinical trials
  • ensuring patient compliance with protocol requirements
  • assessing and documenting severe adverse events (SAE), assisting with SAE management within protocol requirements, and providing clinical information for and assisting with SAE reporting
  • providing updates at group meetings on the clinical status of patients, including the management of serious adverse event (SAEs), dose limiting toxicities (DLTs), and dose modifications, among other data
  • ensuring that participants are scheduled per protocol requirements, that order entry is accurate, and that participants’ visit documents are accurately completed and collected
  • working with research staff on query resolution
  • assisting with ensuring the availability of source documentation in the EMR

The PI meets regularly with clinical trial nurses or the protocol CRA to:

  • review the trial’s overall progress, including accrual information and barriers to accrual
  • manage all participant data, no matter the treatment location
  • report deviations for all participants
  • review the current participants on the study, including dose modifications, toxicities, SAEs, and protocol-specific response criteria (if applicable)

What is a DTU?

A Developmental Therapeutics Unit (DTU) serves as MSK’s central treatment and data collection site for people in phase I and phase II clinical trials of novel anticancer agents. The DTU provides the necessary infrastructure to test new drugs and combinations with associated translational endpoints in high-intensity studies.

Services provided by the highly trained DTU staff include:

  • on-site investigational clinical laboratory services, such as collecting and processing specimens
  • serial pharmacokinetic and pharmacodynamic blood sampling, as well as EKG and cardiac monitoring
  • preparation and storage of samples per protocol specifications for simple and complex pharmacokinetic and pharmacodynamic analysis
  • mononuclear cell isolation from whole blood by centrifugation using Ficoll-Plaque
  • centralized data collection

What is the CSP?

The Correlative Sciences Program (CSP) acts as MSK’s core facility for Protocol Core Services to support biological specimen management. A core facility is a centralized shared resource that provides access to services, best practices, standard operating procedures, and technology, as well as expert consultation for scientific and clinical investigators.

The CSP offers the following services for clinical trials:

  • preparation of kits for research specimen collection, including source documentation
  • research specimen storage according to protocol specifics
  • research specimen shipment
  • query resolution regarding research specimens handled by CSP

How many review boards are there? Are study and budget reviews concurrent or sequential?

The Research Council reviews study proposals for scientific merit and priority prior to submission to the Institutional Review Board as well as existing studies for progress. The Research Council is made up of two groups that meet fortnightly. Submissions must be received nine days before the meeting date.

The Institutional Review Board/Privacy Board (IRB) is responsible for protecting the rights and welfare of trial participants in accordance with federal and state regulations, as well as with institutional standard operating procedures. The IRB reviews all human subject research under the OneMSK platform and monitors ongoing research. The IRB is made up of two groups that also meet fortnightly on the alternating weeks.

All budgets and contracts must be submitted with the original regulatory packet during a study’s start-up process and must be finalized and executed for a trial to be considered open to accrual by the IRB. Budget and contract reviews occur in parallel with committee reviews.

For more information and to see a flowchart of proposal review steps before study approval, see the Submission Review Process.

How do you manage studies at regional locations?

Our regional outpatient clinic sites provide comprehensive clinical research services with dedicated staff.

For more information about the services at each MSK site, see Locations.

How do you manage studies at outside locations?

The primary investigator has overall responsibility for the trial across all study locations.

What training do you provide?

All research staff across all locations are MSK employees. MSK has a requirement for investigator education that meets applicable training standards.

Site initiation visits (SIV) are coordinated by the protocol study team. All investigators, pharmacy staff, research nurses, research sample management team members, and study teams are invited to SIVs. Staff can attend in person, by phone, or by video conference.

If a regional site is added to a protocol after an SIV has been conducted, a separate SIV is conducted for the new regional site staff.