How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?
New ways clinical trials and real-world studies will be conducted…
As the site staff are the key people in creating relationships with the patients, make sure you choose the right ones.
The WIIFM (what’s in it for me) is sometimes lacking. If they live in a health care system where health care is free, they have a lot of hassle by being in a trial but not necessarily extra benefits – in their eyes. The incentive needs to be there.
Secondly, the number/complexity of assessments are often high which is a burden.
Thirdly, there are often requirements of long-term safety, follow-up, effect of drug, hard outcomes, etc., which make the trial very long. To commit to a trial with site visits and treatment for a long time is very challenging.
The best strategy is to create a relationship with the patient, hence the site staff are key people. They are the ones meeting the patient, seeing their needs and fears, having to train and educate, talk and listen to the patients. A good study nurse is what makes the difference!!!
• See above
• Patient-centric activities and training
• Make sure they understand ‘WHY’
• Address and fulfil WIIFM for both patient and site staff
Birgitte Claudius is a MD, Director, Head Clinical Operations at Novo Nordisk. She is a Medical Doctor by training and has after years of clinical work and research been working in the pharma industry – for almost 20 years. This experience covers in-depth competencies from Medical Affairs, Clinical Development and Clinical Operations. The past 13 years she has been working in the headquarter of Novo Nordisk AS with development programmes within Diabetes, Obesity and Cardiovascular diseases taken several drugs from first phase II trial to submission of the NDA/IND. As part of this trial journey dedicated strategy for and execution of recruitment and retention tools/activities have been key to ensure sufficient data volume and quality. Hence much focus and many learning’s have been collected in her department. One recent area of expertise has been to conduct excellent virtual external meetings as a tool to reach sites and interact with our key customers.