Authors: Jessica Hartmann, Martina Schüßler‐Lenz, Attilio Bondanza, Christian J Buchholz
DOI 10.15252/emmm.201607485 | Published online 01.08.2017
EMBO Molecular Medicine (2017) e201607485
In recent years, an increasing emphasis has been put on cancer treatment in the field of change in the patient’s immune response. One of the promising therapies is called CAR T-cells therapy. The essence of this process is in three steps:
1, T-cells are gathered from the patient’s or donor’s blood
2, T-cells are genetically engineered by an artificially constructed recognition receptor (Chimeric Antigen Receptor, CAR)
3, the genetically modified T-cells (that are able to detect and kill the cancer cells due to their new receptors) are returned to the patient (usually infused intravenously)
Although the first clinical study with CAR T-cells was carried out about 20 years ago, the number of trials has been increasing every year for the past 10 years. Majority of trials was made in the USA and in China. In Europe, such studies are mainly conducted in the UK, Germany and France. There are many reasons why making far fewer CAR T therapeutic clinical trials in Europe compared to the USA. Just a few of them: lack of places where high quality and consistent CAR T-cells can be produced in Europe, different EU states use different application forms and different approval timelines, the rules on clinical trials are not fully synchronized in Europe.
CAR T-cell therapy is particularly effective for malignant B-cell diseases. The best result is achieved when patients are suffered from acute lymphoid leukemia. However, only modest successes were reported when non-Hogdkin lymphoma or chronic lymphocytic leukemia were treated with this therapy.
Of course, CAR T-cell therapy may have many serious side effects, for example: neurotoxicity, CRS (Cytokine-Release Syndrome), TLS (Tumor Lysis Syndrome), acute anaphylaxia, B-cell aplasia.
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The FDA (Food and Drug Administration) has released the well known standard 21 CFR PART 11, which governs how affected systems should handle electronic records and signatures. The scope of this standard extends to all companies within the food, clinical or pharmaceutical industries.
The question is if a web-based training system (also called Learning Management System or LMS for short) is required to be compliant with Part 11 or not. There is no clear answer to this question however; just as it is the case with any type of system (be it web-based or not) it depends on two main factors:
- What the system is/will be used for.
- If the system’s output (electronic or paper) will be used as official records.
If the system is/will be used to train employees and the electronic records of this process will be the proof of completion, compliance with Part 11 is required.
On the other hand, if compliance is not required, it may still be a good idea to verify if the employed system would confirm with Part 11 or not. The standard itself was created for the purpose of information security and the general requirements of confidentiality, integrity and availability (also known as CIA) are represented in it. The same view is employed here as is in many standards regarding information security.
More information and resources on the subject can be found here: