VIDEO: Doctor pushes for big changes in clinical trial implementation

 

For Jean Louis Vincent, being an intensive care doctor is the most beautiful of professions. Taking care of people who are in dire need is an acute medicine requiring fast, energetic intervention, but it makes such a difference for an individual in that particular moment that it is highly rewarding. It is, as Vincent says, “fantastic to take care of people’s health like this.”

As Professor of Intensive Care Medicine at the University of Brussels, an Intensive Care doctor at Department of Intensive Care at the Erasme University Hospital in Brussels and a past President of the European Society of Intensive Care Medicine and the Current President of the World Federation of Societies of Intensive and Critical Care Medicine (WFSICCM), Vincent’s interest is deeply focused on major life-threatening problems.

“This is part of my job. I try to save lives,” he said when asked about what keeps him motivated.

Vincent is enthusiastic about improving lives quicker through developing new therapies. “In particular, I’ve been interested in severe infections. What we call sepsis. These are very severe infections that cause organs to fail. I have been looking for new therapeutic strategies, new medications and new interventions that could hopefully make these patients better quicker,” he said.

Developing new interventions through clinical trials

In developing new strategies for this goal, clinical trials have a massive part to play. This is however, a complex balancing act involving several groups of different people working together.

“Initially, there is a triangle between industry, academia and the regulatory authorities,” he said. “There is a relationship between industry and academia through the advisory boards and steering committees for trials. And there is also a relation between industry and regulatory authorities because at the end of the day, they would like to have a product registered.”

Vincent says there are practicalities that need to be brought into consideration to uphold the quality of the study, among these is the necessity that proper patients are enrolled and data collection is appropriate. “For a quality trial, we want ensure that we are not going for a futile trial. We want to make sure that as we go along, there seems to be a difference between the two groups which hopefully at the end will result in significant differences between the treatment group and the control group,” he explained.

The challenges presented within clinical trials are numerous. They require the harmonizing between the ambitions and size of study in order to achieve successful and worthwhile results. Ambitions have to be in balance with the duration of the trial and the number of patients needed to show an effect.

Moving forward in clinical trial strategy

Despite obstacles, the necessity of clinical trials cannot be denied. But it can be difficult to progress quickly.  “We need clinical trials. We need new drugs. We need more strategies to improve outcomes, but sometimes the rules that we have now are too heavy, too strong, and that makes the process too slow,” Vincent said.

New strategies for the implementation of clinical trials aim to simplify and find balance in challenges presented. “We need to add some oil to the process so that it can move on a bit more rapidly and hopefully smoothly to reach our results earlier. We are all striving for that. We are all trying to make things simpler,” he said.

For patients, clinical trials are essential as they improve not only their own health, but also the health of others requiring the same critical care. Vincent believes every patient should have the opportunity to partake.

“I think that every patient should at least be in one clinical trial. Why not two…or three? Some people sometimes say ‘oh, a patient can only be enrolled in one clinical trial’- that’s not true! As an example; in the field of cancer, virtually every patient is in a trial to try to make improvement in cancer therapies. So when these patients develop an infection, or another complication, can’t we enroll them in another trial? Of course we can and we should! Otherwise the progress will be too slow,” he said.

While enrolling in multiple trials may be a good thing, Vincent clarifies that there should not be any interaction between the two. “You cannot give two new drugs to a patient because if there is a complication you don’t know whether it’s due to drug A or drug B, but if the trials are totally different, yes, it should be acceptable,” he said.

Allowing patients to get involved

Vincent also recognizes that patients remain at the heart of clinical trial studies. He says they should be able to track the significant contribution they have made in helping to save lives. While striving for progress, communication across all groups involved is a necessity and so is solving problems through a multidisciplinary approach. He says utilizing modern technologies can only make this more efficient.

“We need to communicate, to improve interactions between the various stakeholders, and hopefully, in our time of internet and modern computerized systems, it will be easier to have access to this information,” he said.

For patients, Vincent says one exciting development would be enabling them to follow the studies. The patients could look at the results of the study they were included in, so they could actually see the progress made, and hopefully at the end, they can see the success if a new drug is commercialized as a result the study.

Vincent is excited about these new developments and knows all difficulties will be worth the result.

“We must accept this challenge and we must face it. It’s part of the overall game but at the end when we can have a drug which can be available and can improve patients’ outcomes, that’s fantastic. That’s the best reward.”

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