Ask Alcedis with Bernhard: "Social media and digitalisation will play a central role"

Bernhard Remes, Managing Director of Alcedis, explains how simulations, social media and communication are related to clinical trials.

 

What are the potentials of the near future of clinical trials?

"In the future, patient data will no longer be collected on single days, but around the clock, every day. Data sources, such as wearables, apps or sensors built into clothing, can continuously collect data.

In combination with patient records and the entire history of clinical studies, this creates the possibility of simulating studies. Initial results are therefore available, even though the study has not yet started. On this basis, the study design can be optimised and the patient risk in clinical trials minimised. If recruitment, treatment and the statistical analysis have already been simulated in advance, variable parameters can be adjusted in such a way that risks, side effects or the absence of essential data points are reduced to a minimum.

If the simulation of clinical trials is further optimised, control groups receiving the standard therapy or only a placebo will initially become superfluous. One day, pure simulation could be sufficient for drug approval. Drugs would no longer need to be tested on clinical trial participants for approval, but only virtually on data already collected."

What will clinical trials look like in ten years?

"Social media and advancing digitalisation will play a central role for the healthcare industry and will further put the patient at the centre of clinical trials. Patients will no longer rely on their GPs or a surgery in decentralised clinical trials, but will register on a social media platform to communicate transparently with researchers, medical experts and other patients about their condition.

Through networked devices and virtual communication, many check-ups will be able to be done at home from the comfort of their sofa with self-tests or at the local pharmacy. This logistical advantage alone will lead to improved recruitment, fewer treatment discontinuations and financial savings."

What challenges will the industry and clinical trials face in the future?

"So far, communication has mainly taken place through the doctor. If the patient becomes more central, a dialogue between patients or between pharmaceutical companies and patients may also become more important. This poses challenges for the industry, new questions have to be answered: Who is allowed to interact with the patient? Can the patients enrol themselves in a clinical trial? Who decides which results are passed on to the patient? How are risks explained?

The resulting new constellations require new regulations. But inertia and bureaucracy often stand in the way of progress. For example, it takes seven to ten years for a new drug to be approved - time that is lost mainly due to extensive regulations.

I fear similar hurdles in trial simulation, direct interactions between patients or communication between patients and the pharmaceutical company. Research itself is fast, only politics and regulations unfortunately take a long time. Ensuring that technological and scientific progress is not slowed down by political ideology is probably the biggest challenge."

 

^{Text: Alcedis-Redaktion}