ICCTR | About Us | Experimental Therapeutics/Interventional Trials (ET/IT)

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The mission of the Experimental Therapeutics and Interventional Trials (ET/IT) Center at Boston Children’s Hospital is to provide exceptional support and service to investigators conducting interventional clinical trials (drugs & devices), including clinical trials involving experimental therapeutics, with the goal of translating basic research findings into novel therapeutic and curative interventions. The ET/IT Center staff support all phases (Phase 0-IV) of interventional trials and can provide expert guidance in the following areas:

  • design, conduct, and analysis of interventional trials and studies involving experimental therapeutics
  • project management for planning and implementation of studies
  • management of multi-institutional clinical trials
  • single patient INDs
  • support for FDA-regulated trials
  • development of data safety monitoring plans and data safety monitoring boards or committees
  • facilitating collaborative partnerships among key institutional resources that support clinical research
  • foster collaborative relationships between clinical trialists and basic/translational researchers
  • study monitoring for investigator-initiated studies and investigator sponsors
  • support for grant applications and publication submissions
  • medical writing
  • scientific review of interventional protocols
  • support for consortium work

Study monitoring

Study monitoring is an important component of study conduct that is designed to ensure compliance with the protocol, Good Clinical Practice, state, federal and local regulations, and institutional policies.  Where the investigator is serving as the sponsor, study monitoring also offers protection to the sponsor-investigator and the institution. In many cases, a developed study monitoring plan is a required element of NIH grant applications, involving proposed clinical research studies. The process of study monitoring begins in the protocol development phase when a monitoring plan is developed and monitoring continues through to study close out.

Monitoring services

The ET/IT Center at Boston Children’s offers monitoring services for investigators in need of independent monitoring. Study monitors are experienced clinical research professionals that have completed competency-based monitoring education. Priority for monitoring is given to faculty acting as the sponsor-investigator of an IND or IDE clinical trial to aid those investigators in the fulfillment of federal regulatory requirements to perform safety monitoring. 

The number of staff that monitor studies is small. Therefore, studies are monitored on a first-come, first-served basis. If Boston Children’s personnel are not available to monitor an investigator’s study, the names of experienced outside individual monitors or contact information for companies that offer monitoring services for interventional trials involving drugs and devices is provided.

The ET/IT Center’s Monitoring Program uses a risk-based monitoring approach. Risk-based monitoring assesses all risks related to a study, which informs the development of a proper plan for risk management, including systematic monitoring and controlling/mitigating risks through the conduct of the study. The intensity and frequency of monitoring varies across studies and among sites depending on the phase of the trial, complexity of the protocol, disease being evaluated, experience of the investigator and study team, number of subjects enrolled, site performance, and sponsor monitoring SOPs. Likewise, the number and location of sites and rate of enrollment are considered when monitoring a study.

Pricing of monitoring services

Pricing of monitoring is dependent on elements such as: phase of the trial, complexity of the trial and risk posed to human subjects, single versus multiple participating sites, and numbers of subjects enrolled. The monitoring services that are offered to Boston Children’s sponsor-investigators are intended to be a service. The pricing has been structured to be as economical as is feasible. The rate for study monitoring is $90.00/hour. The costs include: development of the monitoring plan, time spent conducting the monitoring visits, report preparation, and time to meet with investigators and study teams to review the findings and develop corrective action plans, where needed. Sponsor-investigators are also responsible for the costs associated with travel for monitoring multi-center studies. The monitoring staff will work with sponsor-investigators to create a monitoring budget.

To further discuss study monitoring for your protocol, please contact Maggie Malsch.

ET/IT scientific review

The ET/IT Center offers investigators scientific review of interventional protocols with the goal of strengthening the scientific rigor and study design of interventional studies. The scientific review process is also intended to expedite the IRB review process by anticipating and addressing protocol issues that stand to be raised during the IRB review. The ET/IT Protocol Review Committee is an interdisciplinary team of experienced investigators, biostatisticians, research nurses, regulatory experts and other clinical research professionals with experience in conducting interventional trials. Feedback is provided to the investigator within 14 days of submission of the protocol.

There is no requirement or expectation to address or change the protocol based on the reviewers’ comments. Nor do investigators respond to the committee’s reviews.  The feedback/comments are strictly for the investigator’s consideration. The review is confidential and intended as a service to the Boston Children’s clinical research community. There is no charge associated with the review.

To further discuss scientific review for your protocol, please contact Cindy Williams.

Leadership

Andrew Place, MD

Andrew Place, MD, PhD

Chief Medical Officer, Institutional Centers for Clinical and Translational Research (ICCTR); Co-Director, Experimental Therapeutics & Interventional Trial Center; Clinical Director, Pediatric Hematologic Malignancy Program Assistant Professor of Pediatrics, Harvard Medical School
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CIndy Williams, DNP, RN, PNP, NE-BC

Co-Director, ICCTR Experimental Therapeutics and Interventional Trials Center (ET/IT); Nursing Director, ETU