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Expanded Access Policy
At PCI Biotech, our aim is to provide improved treatment for cancer patients through our innovative photochemical internalization technology platform. To achieve this goal it is necessary to conduct clinical trials to evaluate safety and efficacy of our investigational drugs. The common path for access to investigational drugs is to participate in a clinical trial. In these trials treatment is tightly controlled and data from the trial can contribute towards approval in order to make this treatment available to a broad patient population as soon as possible. However in some rare occasions, where it would not be possible to participate in a clinical trial, and the patient has exhausted all other viable treatment options, and has a serious or life threatening disease, PCI Biotech may grant access to the investigational drug and treatment to single patients on a case by case basis (Single Patient Expanded Access). Currently PCI Biotech has an ongoing phase II clinical trial of the investigational drug Amphinex in patients with non-resectable extrahepatic bile duct cancer.
Following a request for single patient expanded access, a thorough evaluation will be performed by an interdisciplinary team at PCI Biotech where many factors and aspects will be considered, such as:
Risk-benefit analysis of PCI treatment outside of a controlled trial for the specific patient
Potential impact on ongoing clinical trials
Country specific regulations
Availability of investigational drug and necessary ancillaries such as light sources
Inclusion and exclusion criteria of the ongoing clinical trial
The criteria for single patient access that PCI Biotech will evaluate may differ from case to case depending on the particular circumstances, but will generally include the following:
There is sufficient evidence of the safety and effectiveness of the investigational medicine to support its use in the particular circumstance.
The disease is serious or life threatening.
There are no available beneficial alternative treatments or patients have exhausted all other therapies.
A patient is not able to participate in a clinical trial
The efficacy and safety data available at the time are of sufficient strength to determine whether the benefit to patient would likely outweigh the potential risks.
Access is compliant with local rules and laws.
The request must be made by the patient’s treating physician, unsolicited by PCI Biotech or any other individual or organization.
The patient’s treating physician has determined that there are sufficient safety and efficacy data, including dosing information, to support the use of the investigational medicine, that there is no comparable or satisfactory therapy available to treat the patient’s disease and that the probable risk to the patient from the investigational medicine is not greater than the probable risk from the disease itself.
Only treating physicians with a patient that is not able to participate in a clinical trial, and may be eligible for access to the investigational drug through expanded access, is allowed to request access to the treatment, and can inquire about expanded access by sending a request to clinicaltrials@pcibiotech.com. The request must include the following information:
Treating physician full name and CV
Date of request
Country and city of intended treating facility
Rationale for why the patient is unable to participate in a clinical trial
Medical rationale for the request, including a rationale for why other potential treatments are deemed unsatisfactory
Any other data or information that may be important in the evaluation of the specific request
PCI Biotech strives to handle such requests in a timely manner, however we cannot guarantee the response time for these requests. In general we will be able to provide you with a receipt of the request and start evaluation within 5 working days.
PCI Biotech reserves the right to revise and update this policy at any time.
Mener denne har vært diskutert tidligere men ble der noen konklusjon?
Man kan jo nesten tolke det dithen at en på visse villkår utenfor clinical trial systemet kan tilby PCI behandling allerede i dag (expanded use)?
Hvorledes blir eventuelt mulige pasienter oppmerksomme på denne eventuelle muligheten?