The CRA profession may be different according to the pathology on which you are required to work. Some diseases have specificities, especially if you have to work on an oncology study. Indeed, cancer follow up is long and specific and most of the time files are heavy: there are more adverse events and concomitant medications. Furthermore, an oncology study involves a large number of on-site staff: nurses, pharmacists, radiologists, pathologists … Staff to be listed in the list of delegation of tasks and formed to the study. Moreover, these diseases have proper documents: did you know that the Oncological pharmacology society has released recommendations for the management of cytotoxic drugs? You will find them here.
A brief overview of the oncology study specificities.
The treatment response monitoring in oncology
Clinical trials in oncology is often judged in the patient global survival and / or the patient no relapse survival. Patients will be followed for an indefinite period. A clinical trial in oncology can last several years.
The investigating doctor will regularly evaluate the treatments response, data that you will have to monitor as a CRA. To assess the treatment response, the doctor has standardized scales, defined by the study protocol. Here are some example of scale: RECIST (Response Evaluation Criteria In Solid Tumors) for solid tumors, the criteria of IMWG (International Myeloma Working Group) for myeloma or Cheson criteria for lymphoma.
These scales are composed of several parts:
- CR: Complete Response
- PR: Partial Response
- SD: Stable Disease
- PD: Progressive Disease
Every stage corresponds to a certain criteria such as the presence or the size of solid tumor (S), the plasma concentration of a protein…
For this, you will use data called reference (baseline), collected before the treatment administration. For example, for the RECIST criteria, one or more target lesions will be selected. The treatment response will be checked against this reference value.
However, if you notice the disease progression, it will be checked against the NADIR. The NADIR is the best response obtained since the treatment beginning. In the case of a solid tumor, NADIR will be the size of the smallest tumor observed since the beginning of the study.
A tip, set up a table to document the different values measured at the baseline and during the study to evaluate the treatment response. So you will get all the values available for your calculations. Yes, you will weapon yourself with your calculator to check disease progression / response and determine the response rate (in %).
2. Adverse events monitoring in Oncology
As mentioned above, cancer is a serious illness and the treatments being cytotoxic, adverse events are more frequent. To evaluate them, the promoter will usually ask to rank them on a scale previously established: It will be asked to code the event on the CTCAE (Common Terminology Criteria for Adverse Events) established by the US oncology society, the NCI (National Cancer Institute) that you can find here.
For example, a hemoglobin rate at 9 g / dl is a grade II anemia according to CTCAE version 4.0. Be careful to the used version, it is specified in the protocol.
This will allow you to check the gradation of the doctor. But beware; ask the doctor to indicate it in the patient’s medical record because everything has to be documented in the patient’s medical record: the adverse event, the start and end dates, grade, as well as the accountability to the treatment.
3. Treatments accounting at the pharmacy
Chemotherapy may be given in two forms: either as an injectable treatment, or as oral chemotherapy. In both cases, the CRA will check if the treatment is well followed, either by monitoring the chemotherapy preparation sheets, either by counting the tablets that the patient returned.
Since the publication of the oncological pharmacology company recommendations, some measures have been taken. Before, all the treatments were kept as well as their conditioning for the CRA to monitor accounting treatments. However, chemotherapy being cytotoxic treatments, security measures have been taken in some pharmacies. Indeed, according to recommendation n°10 of the Oncological French Pharmacy Company, preparation for cancer treatment is followed by the immediate destruction of all container used for the said preparation. The pharmacy will not keep the treatments used in injectable form until your coming for monitoring. However, the center will provide you with a destruction process at the beginning of the study and a certificate of destruction after every destruction. Secondary packaging if any (external cardboard box containing the product bottle) may however be preserved for accounting. You will then use the treatments accounting paper, the preparation sheet and the external packaging for monitoring.
In case of chemotherapy taken orally, the pharmacy realizes tablets accounting the patient returned. As CRA, you would check if the accounting was correct. Recently, you’re the one to check patient compliance in some pharmacies because according to recommendation n°22 of the French Oncological Pharmacy Company, accounting of cytotoxic treatments is not carried out by the pharmacy staff for internal use. In all cases, make sure that your center keeps the bottles the patients returned.
Finally, certain chemotherapies should be stored under certain temperatures. Make sure to ask regularly to the pharmacist temperature readings to check the products preservation. If treatments should be stored at an ambient temperature and that the site does not have an automatic temperature collection device, the center must use a thermometer indicating the minimum and maximum temperature reached. The center must raise that temperature indicating the minimum and maximum temperature reached; thus, temperature excursions can be identified. Some centers do not provide temperature readings, but provide a certificate of good conservation.
Here are some of the monitoring specificities in oncology. Obviously, there are other rating scales and tools used in the study protocols. Make sure to set up tools to monitor disease progression and time to review the patients medical records.
Have you ever worked on cancer? What do you think of these features? Do you work with Pharmacies which already implemented the recommendations of the SFPO? How does it go daily and what do you think of these new measures
- Recommendations SFPO – Clinical Trials in Cancer May 2015
- Explanations of RECIST criteria
- IMWG response criteria for myeloma
- Cheson response criteria
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