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| Frequently Asked Questions |
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(Q2) What is an NCI-sponsored Clinical Trials Cooperative Group? (Q3) How does CTSU support Clinical Trials Cooperative Groups? (Q4) How do physicians enter patients on a CTSU study? (Q5) Can physicians enroll patients on all clinical trials on CTSU's menu? (Q7) Is there an easy reference tool containing CTSU instructions that our site can use? (Q8) Do the surgeons who will be participating in CTSU studies need to register with the CTSU?
(Q10) Does insurance cover costs of CTSU trials?
(Q11) Where is the CTSU IRB Certification Form located? (Q13) How can I find out if my Investigator(s) are active CTSU members? (Q14) My site does not have a local IRB, can I still utilize the CTSU? (Q15) What is the payment process for CTSU enrollments? (Q16) How do I know if a particular physician is approved to participate in clinical trials? (Q17) How can I become a Cooperative Group Member? (A1) The Armitage Report, a 1997 report from the National Cancer Institute's Clinical Trials Program Review Group, launched the planning for a new clinical trials system, of which the CTSU is a part. The Cancer Trials Support Unit (CTSU) is a pilot project sponsored by NCI's Cancer Therapy Evaluation Program (CTEP) to accomplish the following objectives:
(Q2) What is an NCI-sponsored Clinical Trials Cooperative Group? (A2) An NCI-sponsored Clinical Trials Cooperative Group is a large network of health care professionals, from both academic institutions and community-based cancer treatment centers throughout the United States, Canada, and internationally that develop and conduct large-scale cancer treatment trials (research studies) as well as smaller, developmental trials. Cooperative Groups enroll approximately 20,000 new participants per year into cancer treatment trials. Each is a separate organization with different leadership and research goals. The nine Adult Cooperative Groups sponsored by NCI are as follows:
(Q3) How does CTSU support Clinical Trials Cooperative Groups? (A3) CTSU supports the Cooperative Groups in the following manner: (Q4) How do physicians enter patients on a CTSU study? (A4)
The first step is to obtain regulatory approval for the protocol. The CTSU has implemented the Regulatory Support System (RSS) to verify whether a physician is authorized to enroll patients on CTSU trials.
(Q5) Can physicians enroll patients on all clinical trials on CTSU's menu? (A5)
CTSU member physicians belonging to a Cooperative Group may only enroll patients through CTSU on protocols that are not accessible through their current Cooperative Group affiliations. CTSU member physicians not associated with a Cooperative Group may enroll patients on any clinical trial on the CTSU menu.
(Q6) Can physicians not associated with a Cooperative Group participate in clinical trials through the CTSU? (A6) CTSU has opened its protocol menu of NCI-sponsored Phase III treatment trials to qualified oncologists outside of the Cooperative Group Program. Physicians will need to meet similar standards as those for Cooperative Group members before they can enroll patients. Some of these requirements include verifying investigator credentials and assessing site preparedness. A physician practicing in the United States who is interested in becoming a CTSU credentialed investigator and is not a member of a Cooperative Group should visit the Non-Group Investigators page on the CTSU Public Web site.
(Q7) Is there an easy reference tool containing CTSU instructions that our site can use? (A7) Yes, the CTSU Process Checklist is a one-page reference tool that includes CTSU information on contacts, member and protocol-specific site registration, protocol access, and patient enrollment.
(Q8) Do the surgeons who will be participating in CTSU studies need to register with the CTSU?
(A8) All Cooperative Group members that are participating in CTSU trials must be registered with the CTSU and the Pharmaceutical Management Branch of the NCI.
(Q9)
I am trying to find information on a cancer clinical trial, but I'm not sure whether or not it is on CTSU's menu of trials. Who should I contact for this information?
(A9) Please refer to the CTSU Active Protocols List that is available on both the CTSU Public Web Site and the CTSU Registered Member Web Site. If the protocol is not available on CTSU's menu of studies, use the National Cancer Institute's (NCI) Clinical Trials Search Service -- Physician Data Query (PDQ) to locate the clinical trial of interest. PDQ has a database of over 1,800 active and 10,000 closed cancer clinical trials Search the database and use the PDQ Clinical Trials User's Guide located at Cancer.gov.
(Q12) What if a physician or research nurse does not have an email address to register with the CTSU?
(A12) All associate staff and investigators are strongly encouraged to register with the CTEP-AMS and there are many no cost e-mail services available to establish a unique e-mail account. Investigators that are unable to establish an account may contact the CTSU Help Desk 1-888-823-5923 to request CTSU membership for patient registration purposes, but will not be able to access the CTSU web site.
(Q13) How can I find out if my Investigator(s) are active CTSU members? (A13) Call the CTSU Help Desk at 1-888-823-5923. (Q14) My site does not have a local IRB, can I still utilize the CTSU? (A14) A local IRB on some level is required for CTSU participation. Commercial IRBs exist for a fee and the NCI has implemented a Central Institutional Review Board (CIRB) to reduce the burden of local IRBs. (Q15) What is the payment process for CTSU enrollments? (A15) The CTSU pays approximately $2000 per patient enrollment. Sites choose a Group to credit for each enrollment through the CTSU, this Group is responsible for dispersing funds to the site. If the credited Group has also endorsed the trial, funds will be allocated from the Group. CICRS sites will be paid directly by the CTSU. Additional information concerning payments may be found on the members' website under Resources. (Q16) How do I know if a particular physician is approved to participate in clinical trials? (A16)
All physicians must have submitted the following to the Pharmaceutical Management Branch (PMB): (Q17) How can I become a Cooperative Group Member? (A17) Contact the Group that you are interested in directly, a detailed list may be found in answer #2. |
