Today there is an increased demand on real world data from:
- Regulatory agencies as FDA and EMA
- Agencies as NICE (UK), IQWiG (Germany) and TLV (Sweden)
There is an increased need for Late Phase activities such as patient registries.
The value of real world data
Regulatory approvals are today often conditional; therefore additional real world data needs to be collected
- to prove long term effectiveness and safety
- to understand factors normally not accounted for in Randomized Clinical Trials (RCT) (eg adherence, varied patient populations, concomitant medications, morbidity)
Real world data provide you with:
- Evidence of real-world patient benefit, improves patient management
- Long term effectiveness (vs. efficacy)
- Earlier identification of potential safety risks
- Assist in market access and penetration; optimize product use and raise awareness both of the products and of the diseases
- Support conversion of marketing authorisations approved under exceptional circumstances
- Label extension
The Late Phase Arena
Compared to earlier phases (I-III) there are specific challenges in the Late Phase in relation to collecting complete non biased data:
- Patients are to be followed during busy daily clinical practices over several years.
- Clinics involved are often research naive in terms of experience from clinical trials procedures.