Patients The Key to Real World Data?. Alan G. Wade. Real World Data Sources. What is real world data?. Reflects the average patient in a real-world setting Demographics Sex Age Social status Education Diagnosis Co-morbidities Co-medications Medical system Social impact
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Alan G. Wade
Reflects the average patient in a real-world setting
Does it work in
Does it work in
Does it contribute to a
more efficient use of
To assess performance of drug in real world setting
Do we achieve this with formal PMS?
6. Patient reports ?
2. Michael Rawlins
Hierarchies of evidence should be replaced by accepting—indeed embracing—a diversity of approaches.
The Lancet Vol 372 December 20/27, 2008
Patient and public involvement
The views of patients, carers and the public matter to NICE. We want to involve them, as well as doctors, nurses, other healthcare professionals and managers in our work.
http://www.nice.org.uk – accessed 22 06 09
The assessment of the benefit-risk balance should be based on the available tests and trials, which are designed to determine the efficacy and safety of the product under normal conditions of use (Directive 2001/83), and which are generally performed under ideal conditions.
It is important to be explicit about the perspectives of different stakeholders that are taken into account in the assessment of the benefit-risk balance,in particular the perspectives of patients and treating physicians.
Considerations about how the treatment is expected to perform under real conditions of use are relevant in the context of pharmacovigilance activities, for example, to take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation
of their benefits and risks (Directive 2001/83).
EPF is the umbrella organisation of pan-European patient organisations active in the field of European public health and health advocacy.
The European Patients’ Forum (EPF) currently represents 57 patient organisations and an estimated 150 million patients across the 27 Member States throughout Europe.
EU drugs agency working with patient groups bankrolled by big pharma
23.04.10 @ 19:17
But equally, we have a right and responsibility to look at the interests of other patients who use the healthcare system. What I am critical of, however, is patient organisations that are acting on behalf of pharma companies. I am not alone in complaining about them.
The Lancet Vol 372 December 20/27, 2008
No single agreed definition
The bottom line: whatever the disagreements over the definition, everybody agrees on one thing: big data is a big deal, and will lead to huge new opportunities in the coming years.
http://timoelliott.com/blog/2013/07/7-definitions-of-big-data-you-should-know-about.html Accessed 27 01 14
Claims Databases (US)
e - Medical Records
Specific hospital databases
Specific disease or procedure databases
To effectively use any registry it is important to understand how it has been developed and its strengths and weaknesses
What the Patient Knows
What the Patient Shares
Ask the patient – but how?
What the physician understands
What the Physician records
Collect data directly from patients
Patient Reported Outcomes
Patient Reported Outcome Based Evaluation
Generally require alternative data collection routes
Nurse manned telephone
...the benefits and attraction to each individual will differ but we believe the main reasons are :
7. REPORT CONCLUSIONS.
The above report has shown the public’s enthusiasm towards a system that would let
consumers report adverse drug reactions through the Internet. The findings of the
survey carried out by us revealed to us this enthusiasm. The report has further shown
that health professionals have a positive opinion towards such a system, which
in favour of the overall mission of Patients Direct. Not only has the report articulated
the publicity campaign that Patients Direct can carry out to raise its awareness, but
also examples of different medicine inserts has been provided with reasoning behind
them that could be used by the company to make itself different from its competition.
Patients Directs corporate identity is important to begin the process of publicity. IT
has been noted that establishing a user friendly website that is easily navigable is
fundamentalto setting the pace for a strong brand and image that will appeal to
Patient’s Direct customers.
EDGE Survey - Market Research, 2008
...tailored to attract patients of interest with a conscious effort to reduce bias and population selection issues
Core recruitment methods include :
Special focus can be given to groups of interest such as children if appropriate and recruitment monitored to ensure sufficient numbers in each cohort.
3 Todd Campus
G20 0 XA
Cover all 4 areas of use
Reported Side Effects
In response to “What did you do
about these side effects?”
Male – 449
Female - 663
The Virtuous Cycle
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A real world study using Patient Reported Outcomes to assess the consequences associated with the forced switching of asthma medication/device in stable adult asthma patients
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