What does it take to conduct a study in ovarian cancer to validate new diagnostics tools?



Hanneke Janssen

Practitioners prefer to prescribe medications with maximum effect and minimal side effects.  A therapy may be effective in many patients, but it’s likely that not all patients have the same benefit.  Using in-vitro techniques as a predictive diagnostic test enables oncologists to prescribe more personalized innovative medicines.

It takes a lot of regulatory work to conduct a validation study for diagnostics.

Suppose you are a promising startup in biotechnology and have developed a beautiful technique for in vitro testing of the sensitivity of tissue to drugs. To put it into clinical practice you have to validate your technique and you need material and data from living patients.

Validation of an in vitro diagnostic technique requires many patients. That means that many clinicians in many hospitals must be approached with the question whether they want to participate in the validation study. If a hospital wants to participate, then you have to sit down with all those involved to explain the study, agreements and budgets to agree upon, arrange the logistics, and not to mention arranging permission for the study with the medical ethics committee. That takes a lot of time. Time a biotech startup would rather spend on optimizing your technology.

Clinical data and sample collection to support the efficacy of a new diagnostic tool in Ovarian cancer.

Technology for fast and accurate tumor testing to support better informed treatment decisions for cancer patients needs clinical validation. To this end Dutch startup Vitroscan started the first validation study for tumor testing in patients with ovarian cancer in 2019. The clinical trial to validate the tumor test with tissue samples was also conducted through the online Trial-Eye platform in multiple Dutch hospitals. Our hospital network provided more access to more clinical data and tissue samples for in vitro testing. With the automatic workflows for study start-up, approval process, up to date protocols and support via Trial-Eye, this trial is ran in 7 hospitals of our network. Of course every next project will profit from a bigger reach as the Trial Eye study site network is expanding rapidly.

IClusion's efficient study start-up process outline for validation of diagnostic tools.

  • Quick scan of the iClusionhospital network 
  • Eligibility report 
  • Automated workflows for quick study start-up with Trial-Eye
  • Real time metrics on study start-up 
  • Advise on protocols, ICF, e-CRF and other required approval documentation.

The whole process 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;

  • Monitor and motivate patient recruitment
  • Logistics & shipment of samples
  • Orchestrate cross border payments
  • Handling questions on protocol and eCRF

Added value

Validating new diagnostic tools can be a challenge. Indeed, it is difficult to find, especially tumor tissue derived from living patients with accompanied clinical data to support the validation. The experts at iClusion can help with hurdles often encountered during clinical trials such as sample shipments. Having the local native speaking iClusion representative is the extra bonus 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.

Watch the video 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.

Janssen Roepman Oncologie UpToDate sept2018

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