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CANCER THERAPY EVALUATION PROGRAM (CTEP), NCI

CANCER THERAPY EVALUATION PROGRAM (CTEP), NCI. Dale Shoemaker, PhD Head, Regulatory Affairs, CTEP, NCI. ACCESS TO INVESTIGATIONAL AGENTS FOR PATIENTS UNABLE TO PARTICIPATE IN CLINICAL TRIALS.

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CANCER THERAPY EVALUATION PROGRAM (CTEP), NCI

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  1. CANCER THERAPY EVALUATION PROGRAM (CTEP), NCI Dale Shoemaker, PhD Head, Regulatory Affairs, CTEP, NCI

  2. ACCESS TO INVESTIGATIONAL AGENTS FOR PATIENTS UNABLE TO PARTICIPATE IN CLINICAL TRIALS Purpose: To make available to individual cancer patients and their physician investigational agents that have notable clinical activity against specific malignancies.

  3. MECHANISMS FOR EARLY ACCESS • Special Exception Protocol • Group C/Treatment IND Protocols • Treatment Referral Center Protocols

  4. ISSUES TO CONSIDER IN A REQUEST FOR EARLY ACCESS • Is the patient ineligible or unable to be treated on a research protocol? • Have standard therapies been exhausted? • Is there objective evidence that the investigational agent is active in treating the malignancy for which the request is made? • Is the investigational agent likely to benefit the patient while posing an acceptable risk?

  5. SPECIAL EXCEPTION PROTOCOLS • Functional equivalent of an emergency Investigational New Drug application (IND) • A request may be made for any of the investigational agents sponsored by CTEP • Generally not granted for agents in phase 1 clinical development

  6. SPECIAL EXCEPTION PROTOCOLS (continued) • Agents must have demonstrated efficacy in disease state for the request (generally agents in phase 2 or phase 3 clinical development • Approval depends on meeting the criteria outlined above and agent availability • Requests reviewed and approved by physician staff in CTEP

  7. GROUP C PROTOCOLS • Process initiated in the mid-1970s • Request made to FDA for an investigational agent which has demonstrated reproducible efficacy in one or more specific types of tumor • The agent is likely to alter the contemporary treatment of a tumor type and can safely be administered by properly trained health care providers without specialized supportive care facilities

  8. GROUP C PROTOCOLS (continued) • FDA approval sought for those investigational agents for which an NDA or BLA will be submitted in the relatively near future • CTEP has sponsored more than 20 Group C protocols with only one active Group C protocol at the present time

  9. TREATMENT REFERRAL CENTER PROTOCOLS • TRC Protocols used for highly promising agents for diseases such as breast, prostate, lung, and ovarian cancer • TRC Protocol is similar to a simple multicenter clinical trial (a large one-arm study with relatively open eligibility and simple objectives) • TRC Protocols used to ensure equitable distribution of investigational agents with limited availability • Safety and efficacy data are typically collected • TRC Protocols initially offered to the NCI-designated clinical and comprehensive Cancer Centers

  10. CTEP TREATMENT REFERRAL CENTER • Managed by the Pharmaceutical Management Branch, CTEP • Provides information to community oncologists and other health care professionals about therapeutic options for cancer patients • First priority is to refer patients to Cooperative Group or Cancer Center trials

  11. CTEP TREATMENT REFERRAL CENTER (continued) • If patient unable to participate in a clinical trial, an early access mechanism might be considered • Treatment Referral Center can be contacted by phone (301-496-5725) or fax (301-402-4870) • More information available on the CTEP home page (http://ctep.cancer.gov)

  12. SUBMISSION OF REQUEST • Group C and TRC protocols have set criteria to determine patient eligibility while Special Exceptions are assessed on each request • To properly evaluate each request, the following information is needed — patient identifier (initials or identification number), age, sex, diagnosis, previous cancer therapy, current clinical status, intended dosage and schedule of intended agent, potential concomitant therapy, and pertinent laboratory data

  13. SUBMISSION OF REQUEST (continued) • Each request is reviewed and assessed on the basis of established guidelines developed by staff oncologists for each investigational agent • Response is provided as quickly as possible — usually the same day of the request

  14. REQUIREMENTS FOR INVESTIGATORS • Protocol — standard protocol form to be completed and signed is provided • FDA Form 1572 • IRB and Informed Consent • Final Patient Report — to be provided for summary of the treatment including efficacy and adverse events • Agent Accountability — records must be maintained by the investigator

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