“If they had not had access to a clinical trial, some patients would no longer be here”

– Why Doctor: France, which was still leading European countries for clinical trials in 2021, was only in third place in 2023. What are the causes of this decline?

Dr Arnaud Bayle: It is Spain which is today the European leader, well ahead of us in terms of the attractiveness of clinical trials. There are several reports that show this, including a LEEM report that highlights this. It is a French ambition to be a leader in clinical research, it is recorded in the France Health 2030 plan but we still have a lot of progress to make in this area. There are French biotechs which open clinical trials elsewhere than in France even though they are able to offer innovation to patients in our country from the clinical trials.

“In oncology, less than 5% of patients are included in clinical trials”

The main problem is in fact access to information and having, thanks to a platform, real-time knowledge of open and available clinical trials. In oncology, less than 5% of patients are included in clinical trials and the cancer plan set much more ambitious objectives which we have not yet achieved. The goal is for these trials to become more and more a reality for these patients. Those who are followed in an expert center benefit from it but in many other centers they do not have the same access and our goal is that there is equity of access regardless of the place of care.

– What is the benefit for patients of participating in a clinical trial?

This allows them to access therapeutic innovations well before they are available and reimbursed as part of routine care. We have many examples in oncology with targeted therapies and immunotherapy of patients who benefited from an innovative molecule several years before it was accessible to everyone.

“We can have access to a clinical trial at any time during the care pathway”

For some, if they had not had access to a clinical trial, they would no longer be here. And it’s important to remember that you can access a clinical trial at any point in the care pathway, not just as a last chance, and that’s something that people often ignore because they think that participation to a clinical trial is only possible when they have exhausted all standard treatments when in fact this can be accessible from diagnosis.

– How can a patient be included in a clinical trial, who takes the process, who decides?

It is mainly the doctor who offers his patient to participate in a clinical trial of which he is aware through public registers. The initiative can also come from the patient but current registers make this research very complex because it is often in English and with terms that are not very popular. However, they can search these registers and talk to their doctor or go to an expert center to find out whether or not they are eligible for a trial. We believe that patients can really tackle this issue. But currently, this relies a lot on doctors, moreover, if you are followed in a center where there are clinical trials you have a greater chance of accessing them than if you are followed in a center where there are there is none.

“Doctors do not always have the time to keep up to date with each of their patients”

We have the testimony of a patient who found a trial in her own center. His doctor offered him standard treatment for cancer where there are many innovations with immunotherapy. She told him about a test that she had learned about and she was able to be included in it thanks to her approach. We know that it is very time-consuming to do this type of research for doctors who do not always have the time to keep up to date on each of their patients.

We are all affected one day or another directly or indirectly by cancer and it is important to know that patients’ relatives can also do research, for example for older patients.

– How does the integration of a patient into a clinical trial work?

Concretely, he is seen in consultation in the center in which the trial is open. He is presented with the protocol to verify that he meets the inclusion criteria in the trial and if he gives his consent, he is then taken care of in the center in which the trial is open.

– The DGS and digital health authorities have launched a national clinical trial base project as part of the Health Innovation 2030 plan. How does your initiative fit into this context?

We are in collaboration with them in the sense that they have set up a system which allows their base to communicate with other solutions like ours. The more reliable data we have, the better it is for the platform. This has been good news for us from the start and allows us to make the data on our platform more reliable.

– Facilitating access to clinical trials is a request from patient associations. How do you work with them?

Indeed it is a strong demand. We have worked a lot with patient associations, particularly in breast and skin cancer.

“We are working with patient associations to co-build an easily usable interface”

Each time we open a new type of cancer on our platform, we collaborate with associations in this new therapeutic area to co-construct the interface with them in order to be sure that it is easily usable by patients.

– What diseases are currently covered by your platform?

For the moment we are open to breast cancer, skin cancer and lymphoma in hematology. We will very soon expand to lung cancer and by the end of 2024 we hope to be present in all cancers and all hematological pathologies.

We offer a cancer-based approach and therefore we personalize both the interfaces and the algorithms for each type of cancer with specific fields that allow for the best possible patient-trial match.

– How did you create this platform?

The platform was built by two engineers and myself, who is an oncologist at Gustave Roussy. The initial observation is that I, as a doctor, was faced with the difficulty of finding a clinical trial for my patients both internally and externally in other centers. From this problem was born the idea of ​​Klineo with both a medical solution but also a technological solution to respond to this recruitment problem in clinical trials which has been known for a long time.

– What are the conditions of access to your clinical trial database?

This access is free for patients and doctors and we partner with academic or industrial promoters to update the data.

“20% of clinical trials fail due to lack of recruitment”

There are more and more clinical trials and few patients are included: 20% of trials fail due to lack of recruitment. So we are proposing a solution that addresses a problem that penalizes both patients and clinical trial sponsors. We even manage to have partnerships with hospitals because we clearly see that there is an issue, simplifying the work for doctors and offering a solution for patients.