Albert Labs' Malcolm Barratt-Johnson, the Chief Medical officer joins Proactive London after recent guidance provided by the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) supporting the company’s strategy to use the Real World Evidence approach for regulatory approval.
On December 17, MHRA produced guidance acknowledging and setting out criteria for the use of Real World Data and Evidence in regulatory decision making.
The guidance emphasizes that a study or studies considered under this guidance need to be of the same standard as would be expected from a traditional Randomized Control Trial (RCT). The guidance further states that well-designed and conducted prospective RCTs provide a high level of evidence irrespective of the categorization of the data source.