Sudip Parikh, SVP & managing director, Americas at DIA Global, sees two trends that will continue to have a profound impact on potentially powerful new treatments and the clinical trials that make them possible. Both will be front and center at DIA’s 2018 Annual Meeting.
Advancements in biosensor technology are becoming increasingly common in the consumer space, with wrists adorned with Fitbits or similar devices, clothing embedded with “intelligent” fibers, and personal safety devices seen in healthcare facilities across the nation. Our culture is increasingly accustomed to tracking health metrics through smartphones and simple recreational wearables. In the pharmaceutical space, we are now seeing where success in the consumer segment can translate to value-adds for clinical trials.
The challenge to recruit and retain numbers of patients for Phase 3 industry-sponsored trials is not new to the industry. In fact, 48 percent of sites miss their enrollment targets and 80 percent of trials are delayed due to recruitment, but there are new opportunities to achieve recruitment goals while also minimizing dropout.
The Deloitte Center for Health Solutions recently interviewed 43 biopharmaceutical industry stakeholders to explore where the industry sees value and opportunities for using digital technologies in the clinical development process; understand reasons behind the relatively slow pace of digital adoption; and uncover strategies to overcome barriers and accelerate the use of digital in clinical trials. This is the first of two articles that shares interview findings and insights published in the new Deloitte Center for Health Solutions report Digital R&D: Transforming the future of clinical development.
Getting drugs to cross the blood-brain barrier can be a challenge for sponsor companies. Kazia Therapeutics is working on a treatment for glioblastoma, the most common and aggressive form of brain cancer. Kazia will use an adaptive approach in a Phase 2 trial using a product which was designed by Genentech to cross the blood-brain barrier.
When it comes to drug development, the pharmaceutical industry has long followed the same model for how we approach clinical trials. However, we are on the precipice of a new opportunity for the entire healthcare system in which emerging technologies can help us develop and deliver medicines to patients in more agile and efficient ways than ever before.
Artificial intelligence (AI), blockchain technology, predictive analytics, cloud computing, and speech and image recognition are the latest buzzwords across industries. Numerous companies are looking to inject these technologies into their operations, and a great deal of funding is pouring into related startups.
Excitement around the potential for blockchain platforms continues to build. This parallels the surge in popularity of blockchain-based cryptocurrencies such as Bitcoin. Meanwhile, “critics argue it’s all hype — a technological hammer looking for a nail — and that the complexities of health information prevent practical use of blockchain technology.”
The START II Study, conducted by Tufts CSDD and technology provider goBalto, attempted to determine how bad the study start-up process had become, and how pharma could address the growing problem. It now takes six to seven months on average to perform study start-up. Despite new technologies making the start-up process easier, we still have 11 percent of sites that are never activated.
Getting new treatments to patients is a long and costly endeavor. Most drugs take upward of eight years and billions of dollars to receive regulatory approval. One of the biggest problems sponsor companies face when trying to launch a Phase 3 trial is finding enough patients to take part in the study.
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