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…
There are many things that can effect how patients approach decentralised clinical trials, but regardless of their preferences, they should be properly educated.
Within Janssen we collaborate with patients throughout the whole development journey of a medical compound. It starts with understanding the medical needs for a specific indication and it continuous throughout the protocol writing process. If a clinical protocol does not reflect the patient’s interest, it will be hard to recruit the required number of participants. Otherwise, and this is the challenge in global projects, the patients’ needs and interest might differ across the world. Hence, it is always a balance what to incorporate and what to leave out. DCTs can be of great help to further decrease the patient burden for trial participation.
Many aspects are likely to influence the patients opinion on a DCT. Moreover, we expect a clear stratification of patients, but it is not possible to know if they are likely to join or not to join a DCT. Patients who value the face2face interaction with the medical staff, might see this as a disadvantage of a DCT. Patients, that live far away from the next clinical site, might welcome a DCT as it enables them to participate in a trial at a much lower burden.
All in all, patients must be properly educated about DCTs and potentially required “skills”. Availability and accessibility are key criteria that must be given.
DCTs are nothing new to the industry but the pandemic was probably a booster for DCTs in general. Janssen has increased its efforts significantly to implement more and more DCT-elements in clinical trials. In the near future, DCTs and hybrid trials will play a major role next to conventional trial models.
Also regulators have picked up the DCT topic. The recently published guidance by the Danish Medical Agency on DCTs and the ongoing GCP ICH E6 revision are good evidence, that regulators are working on providing more general guidance on DCTs.
Karl-Ludwig RADEK, Ass. Director Global Clinical Operations at The Janssen Pharmaceutical Companies of Johnson & Johnson is an economist by training and certified financial advisor. After several years working in the public health care sector in Germany, he joined J&J in Germany in 2015. Although he has no direct clinical operations background, one of his key strength is to see things differently. In his current role, he is responsible for establishing and managing relations with site networks across Europe, Middle East and Africa. Besides this he is also the Janssen project lead for the IMI project Trials@Home. In 2020/2021 he was also a member of the European Health Parliament – a group of next generation health care leaders, that is developing health care policies for a better health care provision in Europe.