Easy access to oncology clinical samples and corresponding data lung cancer

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Hanneke Janssen

In recent years the treatment of cancer has evolved rapidly, and patients do benefit from new therapies. However effective in many patients, not all patients have the same benefit. That puts the physician in a difficult situation: which patient should one give this innovative (and often expensive) treatment? Luckily, a lot of scientific efforts are put together into finding the right diagnostic tools to successfully screen and treat those patients to maximize the benefit from these innovative treatments.

Case report; Clinical data and sample collection to support the efficacy of a new diagnostic tool in lungcancer.

After years of research and optimalizations the time comes to show proof of concept and efficacy in patient samples. It is not easy for biotech companies with limited expertise in clinical trials to obtain these samples let alone collect these samples and data across borders. So, for that reason a Spanish company contacted iClusion. They already conducted a clinical trial in Spain to validate new technology to predict immunotherapy response but tissue and data collection were running slow. The Netherlands has an excellent infrastructure with regards to conducting clinical trials.Tissue collection and storage is done by professional pathologists and corresponding patient data is stored by the hospitals in digital patient files. For this reason, iClusion's network of hospitals with digital standardized workflows (the Trial Eye platform) was very well suited to assist the Spanish company with their quest for tissue and data. This allowed the collection of more than 60 tissue samples within just a couple of months. A process that would usually take much longer due to cumbersome administrative tasks.

IClusion's efficient study start-up process outline.

We kick-off study start-up with a quick scan through iClusion’s network of partnering hospitals, to check which hospitals are eligible and interested, having the time and the right patient population to conduct a specific trial. This is a seamless and harmonized process by our established relationship between our local manager trial centers and the dedicated iClusion officer at each site.

The online study start-up within the Trial Eye platform allows each hospital to confirm their interest and local approval with just one click.  Each hospital is offered the required documents to have the study locally approved including study budget expediting the clinical start up process. Meanwhile, iClusion will advise in the translation of the protocol, ICF and other required documents if necessary. IClusion also advises on eCRF processes to improve clinical data transfer between hospitals in the Netherlands and the country of residence of any company.

Additional assistance

IClusion does not just stop there. If needed iClusion can help with hurdles often encountered during clinical trials such as sample shipments

Why do diagnostics companies need tissue and data to validate the efficacy of diagnostic tools?

After the validation phase which refers to its ability to measure what it is supposed to measure; In a clinical setting the diagnostic is tested on the ability to distinguish between individuals with and without a particular disease.  

Validating new diagnostic tools can be a challenge. ‘Tissue is the issue’ is often said. Indeed, it is difficult to find, especially tumor tissue derived from patients with accompanied clinical data to support the validation.

Data & Tissue collection for clinical trials, where to start?

Identifying the hospitals willing to participate in the study is the first step. When a hospital responds positively to collaborate and feels the urgency to improve diagnostic capabilities to treat the right patient with the right compound the process starts. With the development of standardized national approval documentation in local language. This is perceived as one of the main hurdles to start up a clinical trial. These documents are crucial to transfer material and data (MDTA). All documentation needs to comply to all local and international regulations.

A smooth communication flow with hospitals and designated clinical research professionals to coordinate the application of approval for non-interventional studies with local medical ethics committees is crucial. The Trial Eye platform is designed to transfer the approval package in a closed environment with automated workflows, which is the backbone for fast startup of any clinical trial.

Support and services for the collection of data & tissue samples for clinical trials.

During the conduct of the trial staying in close contact with study sites and the company to assist with any possible hurdles is an extra benefit.  To name a few;  

  • shipment op samples
  • cross border payments
  • questions on protocol and eCRF

Having a local native speaking go-between is the extra that companies appreciate.

Efficacy validation of diagnostics tools simplified.

With iClusion’s collaborating hospitals using the Trial-eye platform, trials can be set-up fast and efficiently. Possible hurdles are identified quickly, and if needed adjustments can be made and implemented efficiently within all the collaborating hospitals at the same time

Cancer therapies and diagnostics of the future are already tested today. Clinical trials should always be an option for every study site and every patient.

This video explains how to speed up and make your trial accessible for all hospitals, oncologists, and patients.

Less administration and earlier results.

The iClusion clinical oncology trial specialists can help you to speed up the validation of the efficacy of your diagnostic tools.

Press release Philine van den Tol appointed as CEO ad interim at iClusion

Janssen Roepman Oncologie UpToDate sept2018

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