Newsletter June 2018

Before we all go on vacation,
we wanted to send out our Newsletter
to share with you information
and news related to our industry
and Life Sciences Expertise

E-Health and the rise of ambulant Chemotherapy

Oral chemotherapy treatments that enable patients to administer the treatment independently and at home are growing in their adoption rate.
In France, for example, according to a 2013 study by UNICANCER*, by 2020, 50% of chemotherapy treatments will be home-based or ambulant and orally administered.
By comparison, the figure was only 25% in 2013.
The proportion of intravenous treatments given in the patient's home is also projected to increase in the same period, from 3% to 14%.

A medical oncologist and hospital practitioner, who is in charge of the Functional Oncology Care Support Unit at the Georges Pompidou European Hospital, organizes the Transatlantic Oncology Conference, an annual conference that aims to exchange knowledge and experiences between American and European specialists.

In the problems raised by the committee for 2018 there were:

Toxicity related to new treatments
Complications linked to new modes of administration
Innovative toxicity management
Patient follow-up
Digital solutions

This specialist demonstrated that the support of care could lengthen the survival of patients. Different surveys from patients and from oncologists raised the need for a follow-up consultation application. There are many other applications in the field of cancer, on tumour diagnosis to better target treatments. The same applies to the diagnosis of rare diseases. More than 50% of patients are undiagnosed when they have rare diseases because it is too complex.

The American Society of Clinical Oncology is the world's leading professional organization for physicians and oncology professionals caring for people with cancer.

The ASCO held a conference in Chicago last month whose main theme was online patient monitoring and the issue for this year is to permit to patients to send by themselves data called PRO (Patient Reported Outcomes).

"Ma Chimio Sympa", a new E-Health App for cancer patients coming soon...

We collected recommendations and ideas from several interested healthcare professionals and potential partners anywhere in the world in relation to "Chemo at Home" topic to launch the best possible e-health application in the follow-up of cancer patients treated orally.
We interviewed some oncologists from different hospitals, clinics and private practices in Strasbourg, who gave us their opinion and recommendations about the app:

In general, the cancer professionals interviewed raised the need to have a follow-up of patients in digital form to avoid clutter in paper files and to have a better overview of the interventions of other doctors and patients' adverse reactions and compliance
Currently the patient follow-up is not always efficient because only part of the information is reported and the communication between the different health professionals who follow the patient is not always optimal
Such an application seems necessary and in perfect adequacy with the era of time: the digitalization of medicine to facilitate the follow-up of the patients, to save time and specially to lengthen their survival by improving the quality of the follow-up.
The challenge for us will be to launch an application that will satisfy both patients and healthcare professionals at the functional levels, and to provide them all with the best possible training
The application needs to be compliant with any technology owned by the patient (computer, smartphone, tablet, wearable devices, and even smart TV) in order to ensure that the maximum number of patients can be involved in the program without producing extra cost or extra troubles
We also need to provide an application able to speak the mother language of the patient, regardless of his country of residence
It must mainly provide two functionalities: the patient must be able to provide data to the oncologist regarding his health state, and receive recommendations and information related to his treatment and disease, and also links to associations of patients providing support
Any anomaly in the data, missing information, lack of compliance to the treatment will automatically generate alerts that the oncologist can review and prioritize
The patient should also be able to ask any question
The goal is to allow patients to manage better the side effects of their treatment from home, to ensure that the data is controlled by health professionals and that in case of anomaly the appropriate action can be made as soon as possible, and also to improve the quality of life of the patient
It will be possible to associate to the project any health professional treating for other diseases the same patient, so that all doctors involved understand clearly the interactions with the treatments given to the patient
And of course the data privacy regulations in such a project have a very important place - the patient is really the owner of the data, and is the only person who controls who exactly may view his data

Medrio: R39 is now live!

In case you missed the Msquared event in March, the following new features are available in the new release:

Who Drug new B3 Format
Improved options fr Submission Casebook
Standard VeDDRA Report
New reporting platform: more flexible and faster
Bulk upload of large files improved
Source of data in the Audit Trail (EDC, eSource or ePRO)

Data Management

If you are looking for a place to share information about Data Management, maybe you can try this new group on LinkedIn:

Clinical Data Management Club

Oracle: How Artificial Intelligence Will Revolutionize Safety

If you are interested in learning more about how artificial intelligence, natural language processing and machine learning may change Pharmacovigilance for Case Processing and Signal Management, you may want to watch the webcast on-demand recorded by Oracle.

To register, click here

Eudravigilance news

EudraVigilance Human integration with EMA services for account and organisation management

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SCOPE - Risk-Based Monitoring

If you are interested by integrating Quality into Clinical Trials to Ensure Effective Monitoring, you may like this place.

The conference will be held on October, 16-17 in Barcelona

For agenda and more details, click here

CDISC Training in France

Public CDISC courses are planned in Paris during the week of September 10 (some classes are done in French!)

Topics : SDTM Theory and Application, CDASH Implementation, Define-XML, ADaM Primer, and ADaM Theory and Application

For registration or more information regarding the content, click here

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