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R&D activity is currently under mounting pressure from increasing competition and regulation.
Virginie Grosso, Associate General Manager France & Delivery Director – Keyrus Life Science, and Brigitte Marcheterre, General Manager Canada & USA – Keyrus Life Science, outline their vision.
R&D activity, which is essential to providing new medications and medical treatments, is currently under mounting pressure from increa- sing competition and regulation. How can digital be leveraged to combat these challenges? Virginie Grosso, Associate General Manager France & Delivery Director – Keyrus Life Science, and Brigitte Marcheterre, General Manager Canada & USA – Keyrus Life Science, outline their vision. R&D represents an industry pain point: cycles of 10 to 15 years, very little chance of success (the probability of obtaining regulatory approval once a molecule has been identified is 1 in 10,000!), the need for high numbers of pa- tients with a suitable profile, and the increasing complexity of clinical protocol (59% more certifications and 25% more patient visits in 10 years), makes it difficult to recruit pa- tients for trials. Public authorities appear to have decreasing funds avai- lable to invest in healthcare, despite increasing safety requirements and an expectation for ever-more effective medication. Now more than ever, the main challenges in clinical trials are delays, cost and quality.
The immediate advantage of digital technologies in this context is the access they provide to an incredibly rich pool of information. This improves decision-making regar- ding the efficiency and conduct of clinical trials. Typically, the creation of government databases of comprehensive, anonymous, electronic medical records allows trials to be conducted in a faster, more reliable, and – for the patients – more personalised manner. This data also allows us to measure the medication’s effectiveness in a real-world situation, and the patient’s quality of life. The second advantage concerns patient selection. Remem- ber, 80% of clinical trials do not recruit their target number of patients, and 50% of research centres only recruit one patient... By developing online recruitment using specialised platforms, we widen the net, increasing both the quality and quantity of potential candidates. Another use for data and digital in healthcare could be the analysis of patient experiences shared on social media. This indicator can be used, among other things, to enhance trials by offering the patient’s perspective, collect real- world data on the use of medication, and even identify misuse and prevent health crises. This incredible technological potential puts new responsi- bility on CROs to drive innovation among their customers, by combining traditional and digital expertise.
On the other hand, this potential is currently held back by a legal framework that lacks clarity. AI, Big Data, smart devices to be worn or implanted, and Blockchain as a means of gaining trust, each raise important legal and ethical questions. To whom does the data belong, how is it anonymised, how do we obtain patient consent, what is the share of responsibility between the doctor, the biotech that developed the algorithm, the algorithm, and so on? We are still grappling with these fundamental questions.
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