Karmen Trzupek from InformedDNA discusses how to address new challenges brought by genetic-based testing in human trials.

Hundreds of genes tested at once generate complex reports with a lot of variants, potentially irrelevant. To reduce confusion, genetic test results need to involve genetic counsellors for clarification.

With more than 2500 different gene therapies, clinical trials are facing patient enrollment challenges.

Pharmaceutical companies try to overcome such issue by gathering clinical data on patient’s genetic profile using telemedicine. However, high levels of competition is impairing the ability to complete rare disease trials.

Engaging patients remotely is more likely to be time and cost-effective when seeking for the right patient with the right genetic mutation to be enrolled in the study.

The inclusion of genetic testing in clinical trial protocols should benefit both patients and sponsors. Testing more genes than the one of interest would help generate more clinical data and consequently moving these trials forward.

3 Key Points:

1. Specific genetic traits are required in patients to qualify for gene therapy trials.
2. Patients enrollment challenges have been addressed with the generation of genomic databases.
3. Telemedicine enables reaching and engaging patients remotely.

Quote: «When a pharmaceutical company or a CRO is starting to target a rare disease, they have to think about how to incorporate genetic testing into their own clinical development program. […]They have to ask questions such as how do I find patients who might have this particular genetic disease? And then, how do we implement a genetic testing program to support those patients in obtaining and understanding genetic testing? »

#ClinicalTrial #ClinicalData #GeneTherapy

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