Shionogi

Safwan Kezbor

What are the elements calling for the need to re-imagine clinical trials in the clinical Development space?

The first element to re-imagine clinical trials is the need to accelerate the patient’s access to novel advanced treatment. During Covid-19, we saw accelerated clinical programmes for antiviral treatment and vaccination. Following that era, there is a general expectation among various stakeholders, including patients and pharmaceutical companies, that this timeline should be applicable to other clinical development timelines as well. There are no differences in what happened during the covid treatment availability and development compared to other areas of treatment, according to patients who have severe diseases or diseases with no available treatment.

Second is the need to expedite the go/No-go decision, increase the industry improve overall operational efficiencies, and enhance the participants access to clinical trials. And the last but not least is to take a deep look into the recent technology and innovation and the way we can use it in the clinical trials arena.

Who are the major stakeholders playing driving this vision for the next levels of clinical trials?

I believe Pharma, research sites, patients and regulatory agencies play a vital role in clinical trial. Traditional clinical drug development stakeholders stand to benefit greatly from shortening the timeline and reimagining clinical trials. When it comes to pharma, it's critical to look into ways to improve operational efficiencies, data access, and biomarkers, all of which can enable accelerated decisions to move clinical drug development forward.

What changes do you envision in the future clinical trials?

Clinical trials designs and endpoints; master protocols, adaptive design, seamless design, Umbrella studies, basket studies, platform studies. Flexibility with inclusion/exclusion

Criteria, Broaden eligibility criteria. Decentralizations: Wider access to different population, reduce the burden on research staff. Repurposing the frameworks created during the pandemic. There are high demand for this component at the participants and the research sites level. Diversity and patient-centric and tailored toward patients experience. Including patient insight in the clinical study protocol and the study endpoints. Increasing the collaboration between academia, pharma industry and government research fund. Enhancing the use of real world data and real world evidence. Additional work is needed here to align general framework and strengthen quality. Technology modernization: artificial intelligence in clinical trials, analyzing medical records and social media content and simplifying entry criteria to be more accessible for potential participants. Can be a game changer for life sciences companies in the drug development process. Accelerate the creation of patient-centric designs, Machine learning applied to clinical data could help clearing complex relationships between different data domains. Producing faster trials at lower cost, Increasing reusable data.Data monitoring: using analytics and algorithms to achieve risk-based approach, The way data is collected: better use of the massive data available in EMR and HER.

“I believe Pharma, research sites, patients and regulatory agencies play a vital role in clinical trial”

How are the regulatory agencies playing a role in this future re-imagination of clinical trials?

Embracing early engagement in discussion for novel clinical trial designs and endpoint, including the consideration for Real world data in clinical study design. Recognition of the need to expedite the clinical trial design. New and updated guidelines; e-consent, diversity in clinical trials, remote monitoring and decentralization and ICH guideline E8 (R1), Clinical Trials Regulation (CTR)(harmonisation of clinical trials in the EU)

Are you optimistic about the future era of clinical trials?

We live in exciting period to be part of the upcoming changes. I have no doubt about the massive changes coming.