Decentralized Clinical Trials .. are the answer?
Blair Hirst
Digital Health Expert - Product & Venture Builder | Fractional Executive | Startup Advisor | Board Member
Clinical trials will determine winners and losers of digital health
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Some of the best benefits of digital health for consumers are increased access and lowering cost. But the goal post for getting clinical proven and regulated digital health products into consumers hands is anything but accessible or inexpensive. What does it take to become clinically validated and regulatory approved?
Clinical research.
Running a trial demands collaboration between pharma, clinical research organizations (CROs), hospitals, payers, patients, caregivers, providers and other ancillary services aimed to support patients during their time on trial. Traditional clinical trials are costly, historically inaccessible to non-white males and research is centered mostly around well funded indications (eg. Oncology). During the pandemic, monthly participation in clinical trials dropped by 50%, spurring a huge investment in decentralized clinical trials (DCT).
DCTs are centered on using health technology, such as telemedicine, weareables, eConsent and home health coordination. The benefits of the DCT approach is reduction in overall trial cost and time by easing site management, study burden of patients traveling to sites and centralizing data collection. Reducing patient burden has the potential to improve recruitment, reduce drop-out rates, improve compliance and save sponsors billions of dollars by getting to market faster. Most importantly, DCTs have the power to improve diversity numbers by decentralizing the location of trials sites thus expanding the patient population pool.
But running a decentralized trial doesn't come without challenges. DCTs are heavily reliant on patient reported outcomes, require transparent consent practices that detail access to trial data and must navigate vendors privacy and compliance practices.
Still, big pharma is spending heavily on digital health for the long term. Merck's venture capital arm has invested in four digital health companies, Huma Therapeutics has spent $33 million and Sanofi signed a $30 million dollar agreement.
Only time will tell if more digital health companies position themselves as DCT partners.
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In the News
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MDGroup
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Decentralization of clinical trials has the potential to reduce drop-out rates, increase study effectiveness, and get life-altering drugs to market faster, saving sponsors billions. Decentralized clinical trials offer benefits such as patient recruitment and retention, but also potential risks such as technological failure and patient attitude. Fully decentralized or hybrid clinical trials have the potential to accelerate patient recruitment and increase participant diversity, reducing the recruitment burden on CROs and sponsors. Decentralizing clinical trials can help patients become more knowledgeable, informed and engaged, gather more diverse and applicable data, and improve reliability and accuracy.
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ACRP
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Clinical Leader
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Pharmaceutical Technology
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