Opportunity to collaborate with a European patient organization and the patients and physicians communities:

• To expand cohorts and share results and practices
• To encourage the community to work and practice together
• To increase the database and improve the care pathway

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Why DRUP-like clinical trials (DLCTs) are relevant for the European Cancer Patient Community?

DLCTs are relevant because they offer an opportunity to many patients with advanced cancer who have no other treatment solution:

• They reuse drugs for another purpose out of their initial indication.
• They build on the Molecular Tumour Board (MTB) to guide patients care pathways and find new treatments and solutions.

Several similar initiatives operate together in Europe and provide an important framework for medical decision-making and accessible databases of molecular tests. DLCTs therefore aim at wider access to clinical trials and better care and solutions for individual patients and MTBs play a fundamental role in this process. However, their implementation requires addressing several economic, political and technical challenges.

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Case study using the Ishikawa method

Establishing international DLCT cohorts/cross-border access to DLCTs:

An example discussed in the workshop, illustrates the difficulty and rarity of transnational care pathways even between border countries. The demonstration highlighted two important keypoints:

• Bringing patients to clinical trials
• Bringing clinical trials to patients

However, the following challenges and problems were identified :

• Trials are available in few specialized centers
• Limited sharing of information about the trials between centers
• Lack of coordination of health care pathways between centers
• Difficulties for patients to cross borders, get good health insurances, switch language, travel long distances, etc.
• Redundancies between trials is a limitation for pharma companies to open trials in new centers
• Pharma companies select sites, creating competition between centers
• Policy: difficulties with health insurance, autorizations in each country

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Access to Molecular Tumour Boards

Securing drugs to new cohorts in DLCTs is challenging as it depends on the evidence put forward to the pharmaceutical companies. One way of doing this is to share the results of molecular databases with the pharmaceutical industry. Moreover, additional tests are necessary before treatment and equal access to these drugs and to MTBs should be considered.

Several problems were identified, including:

• Variation in recommendations
• No widely accepted set of standards, cut-off point e.g for variant allele frequency
• Limited access to off-label drugs
• Timeline

The workshop worked on the following themes:

• How can we address the limitations of MTBs?
• How can we provide equal access to MTBs?
• How can we empower MTBs?
• How can we disseminate the knowledge of MTB?

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What is next?

The results of the working groups are now being compiled and will lead to another meeting to work on the causes identified through the Ishikawa method. The workshops will continue to include different stakeholders in order to enrich the reflection. These reflections will also be shared within the PCM4EU consortium to contribute to the implementation of precision medicine in Europe.

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EU Prosject Funding

PCM4EU (2023-2025):

• Implementing molecular diagnostics and provide guidelines, documents and educational content
• Sharing protocols and all necessary resources about precision medicine

PRIME-ROSE (2023-2028):

• Helping countries to set up Drup-Like Clinical Trials and precision cancer medicine
  
• Sharing data, results and practices

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