The Way Forward for Clinical Trials: Decentralized and Hybrid

Over the years, the rising cost and time taken to bring a new drug to the market have led to growing interest in alternatives to the traditional, on-site model of clinical trials. The outbreak of the pandemic accelerated the adoption like never imagined before, setting a new standard on how trials are conducted.

A notable shift to virtualization has seen wider adoption, enabled by an array of emerging tools and technologies, as it allows investigators to meet and conduct trials where the patients are. However, a hybrid approach that combines home-based and on-site activities, brings the best of Patient experience, still meeting complex protocol regimes are gaining traction across various therapeutic areas and Trial Phase journeys.

Despite the several benefits decentralized clinical trials (DCT) promise, the adoption graph fails to reflect the same enthusiasm. As there are several challenges like patient privacy, data security, complex protocol regimes, regulatory barriers, lack of holistic organizational change management plan at the sponsor end and availability of E2E partner ecosystem players are some of the challenges that the sponsors need to overcome in order for them make DCT their backbone method for their Clinical trial processes.

But, as the benefits outweigh the potential risks, we study some of the key considerations that can help pave the way for successful DCT adoption while mitigating the risks.

First of all, the success of DCT largely depends upon an integrated play that is powered by the right tools and technologies as well as a cross-functional team of experts who can guide the Sponsor organizations across a wide range of disciplines. Sponsors would need to approach DCT adoption through a Center of Excellence which helps various Therapeutic owners with the right set of tools, share the latest know-how on Digital endpoints, latest on Country Pharma regulations that have an influence on conducting clinical trials (for e.g. certain countries don’t allow Investigative Drug products to be couriered to patients thereby limiting the extent of DCT), etc

Biopharma companies and research-service providers must carefully evaluate the protocol characteristics of the drug under investigation while determining the suitability of DCT. For example, a clinical trial that requires intravenous, blood sampling, medical imaging, and other complex regimens might necessitate a hybrid approach. Likewise, the trial phase determines whether a traditional method is needed or a decentralized model.


Author Details

Rajan Viswanathan Dalawai

IT Leader, Helping Life sciences clients in their Digital transformation journey.

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