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Massey Clinical Trial Concept Program

Massey Translational Clinical Trial Concept Program

The Massey Cancer Center provides support for development of translational clinical trial concepts based on laboratory discoveries of MCC Scientific Program investigators, into innovative early phase clinical trials.  The Translational Trial Program solicits concepts twice a year (January & July) with the intent to provide support for both development and conduct of innovative and collaborative Investigator Initiated Translational Trials in order to bring discoveries from Massey research laboratories to our patients. 

Members and associate members of the MCC are encouraged to apply for support by developing and submitting translational concepts for review by the Massey Clinical Trial Concept Review Committee (CTCRC).  Investigators submitting concepts receiving initial, prelimary approval, receive support of the Scientific Writers and Clinical trial Office staff to develop an initial protocol with proposed correlative studies and budget for submission to external sponsors to request investigational product supply and investigate possible funding support for both the clinical trial and the proposed correlative studies.   If an investigator requests Massey resources be utilized to purchase investigational product or support correlative studies, the costs must be included in the proposed study budget.  Once the source and cost of investigational product supply and available external support have been identified, the initial protocol and proposed budget will undergo a second review by the CTCRC to obtain the final approval required for investigators to proceed with submission of the protocol for the reviews and approvals by the PRMC, the IRB and the FDA which are required for activation.   Final approval by the CTCRC also initiates processes for establishing the data base and eCRFs to be utilized for the trial.

Submitted Translational Trial Concepts must include:

  • Scientific background supported by peer-reviewed, published preclinical data from MCC investigators supporting the concept
  • Description of the proposed patient population for this trial, and how this concept would help address unmet needs for that population
  • Evidence the proposed population is available at MCC (contact Cancer Informatics Core) or through collaborations with other centers
  • Synopsis of the proposed study that addresses the following:
    • Primary and secondary aims and endpoints
    • Inclusion and exclusion criteria
    • Any requirement for inclusion of pharmacokinetic studies
    • Statistical plan provided by the Biostatistics Shared Resource with sample size
    • Overview of proposed collections of biospecimens and correlative studies
    • Projected number of clinical sites required for completion of accrual to trial within 2 years
    • Projected time from activation to primary analysis
    • Plans to employ genomic or other biomarker as inclusion or exclusion criteria
    • Any patient-centered outcomes or nontraditional outcomes being evaluated.  (The former may include patient reported symptoms, quality of life, etc. The latter may include biomarkers of stress, immunologic functioning, etc.)

Support for development and conduct of approved Translational Trial Concepts includes:

  • Biostatistics Shared Resource
  • Clinical research team
  • Coverage analysis with OnCore calendar build
  • Data management with development of eCRFs
  • Collection and storage of biospecimens
  • Services of CTO science writers
  • Protocol activation and reporting services
  • IND management
  • Regulatory services
  • Post award financial management
  • Budget and contracts
  • Guidance from CTO scientific leadership upon request

Support that may be provided but requires development of budget and specific approval by the CTCRC include:

  • Purchasing investigational product
  • Developing investigational product with pre-IND application
  • Correlative science studies
  • Costs of research biopsies
  • Pharmacokinetic studies
  • Imaging or other diagnostic studies that cannot be billed to 3rd party payers

Formal solicitations for submissions of translational trial concepts will be released in early January and early July each year.  Deadlines for submission of concepts will be the last business days of March and September for review by the CTCRC in late April and October respectively.  Investigators may submit Translational Trial Concepts at any time, but in general they will be held until the next review cycle.   Investigators may request an early review with supporting justification for the special review.

Upcoming Translational Clinical Trial Concept Reviews:

 

Submission Due Date

CTCRC Meeting Date

September 29, 2017

October 24, 2017

March 30, 2018

April 24, 2018

September 28, 2018

October 23, 2018

 

For questions regarding the Massey Translational Trial Development Program please contact:

Martha Wellons
Director, Clinical trial development and program management
(804) 628-1939
mwellons@vcu.edu

 

Massey Investigator Initiated Clinical Trial Program

While Translational Trial Concepts bringing Massey discoveries into the clinic receive the highest priority for activation, Massey leadership recognizes the importance of supporting Clinical Trial Concepts developed by our clinical investigators for career development and maintaining a robust clinical trial portfolio.   Since these studies are not based on MCC laboratory discoveries, provision of investigational product and some level of funding support by pharmaceutical partners is a requirement for approval of these trials.   Early concepts can be submitted to Director of Clinical Trial Development and Project Management (Wellons) for review by AD of Clinical Research and other Massey leadership for preliminary assessment of scientific merit and feasibility.  While not mandatory investigators are encouraged to consider obtaining this early informal input.

When an investigator is ready to submit a formal Clinical Trial Concept for initial review by the CTCRC, the concept must include:

  • Description of the proposed patient population for this trial, the number of potential patients presenting to MCC annually and how this concept would help address unmet needs for that population
  • Overview of the current standard of care for the proposed patient population, and the rationale for how the proposed trial might improve the efficacy or reduce the toxicities associated with the standard therapy
  • Summary of peer-reviewed preclinical, translational and clinical trial manuscripts or abstracts presented at recent major scientific meetings supporting the rationale for the proposed trial.
  • Synopsis of the proposed study that addresses the following:
    • Primary and secondary aims and endpoints
    • Inclusion and exclusion criteria
    • Requirement for inclusion of pharmacokinetic studies
    • Statistical plan with projected sample size
    • Overview of planned collections of biospecimens and proposed correlative studies
    • Projected number of clinical sites required for completion of accrual to trial within 2 years
    • Projected time from activation to primary analysis
    • Plans to employ genomic or other biomarker as inclusion or exclusion criteria
    • Patient-centered outcomes or nontraditional outcomes being evaluated.  (The former may include patient reported symptoms, quality of life, etc. The latter may include biomarkers of stress, immunologic functioning, etc.)

Clinical Trial Concepts receiving initial, preliminary approval will be developed and reviewed for final approval using the same processes employed for development and final approval of Translational Trial Concepts.   These concepts can be submitted at any time for review at the next scheduled CTCRC meeting if received at least 4 weeks prior to the meeting.

Upcoming Clinical Research Concept Reviews:

 

Submit anytime, but before:

CTCRC Meeting Dates

September 26, 2017

October 24, 2017

December 19, 2017

January 23, 2018

March 27, 2018

April 24, 2018

June 26, 2018

July 24, 2018

September 25, 2018

October 23, 2018

 

For questions regarding the Massey Clinical Trial Development Program please contact:

Martha Wellons
Director, Clinical trial development and program management
(804) 628-1939
mwellons@vcu.edu