CLINICAL TRIALS REORGANIZATION
 PROGRESS TO DATE
 July 2007

 

Dr. Weiss met with representatives from each of the clinical trials teams in February to review the reorganization plans for the Cancer Center Clinical Trials Office.  A follow-up meeting was held in early May to finalize the plan.   Since that time we have made significant progress in restructuring the CTO.

SUMMARY OF REORGANIZATION:

The level of Cancer Center support for the Clinical Trials Office will not change.  The major change is that the CRAs will now be employees of the academic departments.  The Cancer Center will provide financial assistance for CRAs working on cooperative group trials and investigator initiated trials.  The Cancer Center will continue to support significant CTO infrastructure, as detailed below.  

Reassignment of staff:

All of the CRAs who were CC employees have been reassigned to a clinical department.   Many of the clinical investigators were very cooperative in helping to transfer these positions and we thank you for your assistance. 

The CRA positions were transferred, and thus the departments did not have to post new positions and interview candidates and the CTO staff were not required to apply for positions.

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Financial Support for CRAs Working On Cooperative Group Trials:

The Cancer Center will continue to use institutional support (SOM and Medical Center) to help support the CRAs working on cooperative group trials.  Initially, the level of support will be approximately $30,000-$50,000 based upon the projected accruals.  Investigators interested in receiving the support were asked to submit a formal request by May 5th.  The request was to include:

  • Description of staffing, and names of existing CTO staff to be transferred to your department to do the cooperative group work.
  • Your projected number of new patients to be enrolled into therapeutic clinical trials.
  • Your projected revenue from the cooperative group, based upon your anticipated number of patients on therapeutic and other trials and the reimbursement that you will receive from external sponsors.

The Cancer Center Clinical Trials Oversight Committee will review your request and commit funds for Fiscal year 2008 (7/05-6/08).

On a quarterly basis, the CC will review enrollment.  If a department is lagging significantly behind the projected enrollment, the lead UVa cooperative group physicians will be asked to comment on the enrollment.

It is our goal to support cooperative groups, but if enrollment is very low, the Clinical Trials Oversight Committee (CTOC) will carefully consider reassignment of Cancer Center resources.

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Financial Support for Investigator Initiated Trials:

The Cancer Center will use the balance of the Institutional Support, the Commonwealth Foundation for Cancer Research and the one position funded through the CCSG to support UVa investigator initiated clinical trials.  Investigators interested in obtaining support should submit a request to Dr. Weiss.  The due date for requesting support for fiscal year 2008 is May 18, 2007.  We understand that new ideas for clinical trials will develop throughout the year, so we will attempt to hold back some money to support new ideas that develop.  The application for support should include:

  • A description of where you stand with opening the trial.  For example, the protocol is approved by PRC and IRB, or you have a draft, etc. 
  • A copy of the trial budget. Also a description of the existing funding such as an R21 or partial industry support and any pending requests for support.  If the trial has not been approved, please provide a copy of the approved protocol and budget.
  • A budget request for CRA support.  The budget should be based upon a support for each patient accrued.  In general, a CRA can be expected to manage between 15-30 new patients per year based upon the complexity of the trial.  The Cancer Center could fund a CRA based upon a percent effort or based upon work performed, such as patients enrolled, or cycle of treatment completed.  If you request reimbursement of a percent of effort, you should include figures on projected enrollment

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Industry Funded Trials:

It will be the responsibility of the P.I. to fully fund industry trials.  The Cancer Center cannot use any of its resources to fund industry trials.  The Cancer Center and the School of Medicine will help with the development of budgets for new trials.  However, given that the economic responsibility for the trial is in the department, it is important that the academic department is satisfied with the final budget.  An industry trial is defined as a trial that was presented to the UVa investigators to open at UVa.

We understand that in some instances a UVa investigator will develop a trial concept, go to industry for support and actually write the clinical trial.  The Cancer Center will provide partial support for trials that were written by UVa investigators and receive partial support from industry.  You are encouraged to speak to Dr. Weiss if you are planning to ask for support of a trial that received partial funding from industry.  The decision to provide CC resources will be made by Dr. Weiss and the CC CTOC.  The Cancer Center will not support a trial that is not appropriately funded by an industry partner because that will limit our ability to fund other trials.

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On Going Infrastructure Support for Clinical Trials:

The Cancer Center will continue to provide significant support for the CTO infrastructure.  The major difference in how the CTO will function is that in the future the employment of the CRAs will become the responsibility of the academic departments.   

The actual level of Cancer Center financial support for clinical trials will not change.  The Cancer Center will use its resources to support CRAs and clinical trials infrastructure as described below. 

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Assistance with IRB Related Work:

At the request of the clinical investigators, the Cancer Center will employ one person to assist with IRB related work.  The Cancer Center will use approximately $70,000 of the $350,000 in institutional support and fund an IRB position. The current CC IRB coordinator, Debbie Krenitsky, will continue in this role and will now report to Barbara Kurth.  Debbie will support the IRB maintenance for all cooperative group trials and for investigator initiated trials.   To help the investigators writing their own new protocols, Barbara Kurth will help prepare the initial IRB submission for investigator initiated trials.

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Trials Scientist Position:

The Cancer Center will continue to support the position of trials scientist, Barbara Kurth.  Barbara will be available to help investigators with the overall protocol development and writing of new investigator initiated clinical trials.  She will continue to work closely with Gina Petroni, Cancer Center Biostatistician.  We believe this is a critical investment.

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CTO Budget Development:

It is our belief that the academic departments would benefit from help in the preparation of budgets and in putting into place systems for billing external sponsors and tracking the collection of funds.  For the next year, you will have several options:  A) You can do the budget through your home department; B) You could ask the SOM CTO to support the development of new budgets; C) You could request support from Laura Simmons to help with the budgets.  At the end of the next year we will compare notes on which system has worked the best and decide if we need to continue the CC support for budget development support. 

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Training of CRAs:

The School of Medicine office of Clinical trials has staff to assist in the training of new CRAs.

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C3TO Support:

The Cancer Center will continue to provide approximately $70,000 per year to maintain and improve the CTO trials management software.  If your CRAs have requests for upgrades or changes, they should be submitted to Dr. James Harrison.  He is over seeing the management of C3TO.

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Protocol Review and Monitoring Committee:  

The Cancer Center maintains a Protocol Review and Monitoring System as a requirement of the CCSG, which also provides the majority of its funding support.  The main focus of the Committee is scientific merit, with an emphasis on the scientific/clinical rationale, trial design, biostatistical analysis, feasibility and programmatic appropriateness.  The membership of the committee draws from the various disciplines with an interest in cancer research, including surgery, chemotherapy, radiation therapy, quality of life, pharmacy, and biostatistics. 

Review of NCI-sponsored cooperative group protocols is not required by the PRC unless review is requested by the IRB.  All other interventional protocols with therapeutic, chemopreventative or supportive care intent are due at the beginning of the month for review at the monthly meeting.  Letters of response are sent to investigators within a week of the meeting and the minutes of the PRC are shared with the IRB via e-mail.  Non-therapeutic protocols such as questionnaire studies and banking studies undergo expedited review and may be submitted at any time.  Expedited reviews are completed within 14 days, which is comparable to the timeline for agenda review. 

The Cancer Center must maintain a Protocol Review and Monitoring System.  Most of the costs for this program are covered by the CCSG.  The PRC is responsible for the scientific review of all cancer trials.

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Data Safety and Monitoring System:

The Cancer Center must also maintain a Data and Safety Monitoring Committee.  The charge of the committee is twofold: to safeguard both the safety of patients and the integrity of data collected. Data that are reviewed include, but are not limited to, all AEs in aggregate, timeliness and accuracy of data entry, protocol violations, and the number of consents and registrations. Audit reports that are conducted by the Post Approval Monitoring office are reviewed as they are available. These audits are conducted annually or biannually, depending upon the level of risk of the study and are performed at the request of the DSMC.

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