Join Transforming Trials 2030

Transforming Trials 2030

The time to create true and lasting transformation in clinical trials is now. Together, we can harness our experiences and momentum from COVID-19 to shape a future of smarter, faster research.

CTTI’s vision, Transforming Trials 2030, is that clinical trials in 2030 will be:

  1. Patient-centered and easily accessible
  2. Fully integrated into health processes
  3. Designed with a quality approach
  4. Maximally leveraging all available data
  5. Improving population health

And the key to achieving this vision is YOU.

Cross-system collaboration is critical to unlocking the change that we’ve talked about in the research community for so long. Today, we ask you to commit to making Transforming Trials 2030 a reality.

“What are you doing to contribute to Transforming Trials 2030?” 

  • “We're only collecting the things we need, and that's a good thing. Keep it very simple and don’t get too complicated.” - Jules Mitchel, Target Health LLC
  • “Collaborating with stakeholders to use real-world evidence can help identify practical solutions to combat the COVID-19 pandemic.” - Pablo Morales, MD, FDA, CDRH
  •  “We are starting to capture only the most important data for the purpose of the clinical trial and, if possible, capturing it at home or remotely. So, simplifying the trials and making them more patient friendly.” – Theresa Strong, Foundation for Prader-Willi Research
  • “We are really focused on ensuring that remote data are accurate and reproducible.” – Lynne Quittell, Cystic Fibrosis Foundation
  • “Representing the voice of the global clinical research site community, hybrid decentralized trials is something that SCRS has moved into and we will continue to move toward implementing new practices and technologies.” – Jimmy Bechtel, SCRS
  • “With additional agreements in place, we've been able to leverage our electronic medical record in such a way that our monitors can securely access study participants, without coming on-site, and be assured that patients are being followed and that they're not having any safety events.” – Colleen Rouse, Cleveland Clinic Center for Clinical Research
  •  We definitely foresee hybrid as the dominant modality of decentralized trial. It offers excellent flexibility to balance the needs of patient-centricity and the rigor of clinical research." – Ching Tian, Medable
  • “More and more we are seeing remote consenting being built into protocols upfront, so we are working to build up our e-consent capabilities for our researchers.” – Hallie Kassan, Northwell Health
  • “We have increased our engagement with local community partners, and also how we equip our research sites to be thinking through community outreach, to help support a diverse participant recruitment.” – Connie Hamlin, Merck
  • “We launched the HEALEY ALS Platform Trial, a perpetual trial which increases efficiency by using the same clinical trial infrastructure and employs innovative statistical methods that allow fewer participants to be exposed to placebo.” – Marianne Chase, Massachusetts General Hospital
  • “New approaches to remote longitudinal data collection could be harnessed to discover simmering symptoms before they turn serious. Individuals may be more inclined to participate if they feel the clinical team has greater insight into their health at home through a standard set of vitals that are analyzed in real-time. This paradigm shift - from reactive to proactive - radically improves the cost-benefit ratio for participants encouraging greater diversity, engagement, and retention.” – Ingrid Oakley-Girvan, Medable
  • “We are sharing lessons learned from our experience during COVID-19 about how we can make trials high-quality, faster, more collaborative and more patient-centered for all R&D in the future.”  -- Kristin Schneeman, FasterCures, a Center of the Milken Institute
  • “We are gathering patient insights and leveraging molecular and real-world data and to optimize the design of our clinical trials.” – Tracy Vanderslice, GSK
  • “We have integrated remote electronic consenting into our clinical trials and meet with new innovators early to partner in designing trials of the future.” – Petros Okubagzi, MedStar Health Research Institute
  • “We believe re-imagining clinical trials goes by designing smarter, friendlier ways to gather and test biological samples for clinical trials, painlessly, anywhere, when it makes sense.” – Julie Milojevic, Novartis
  • “Achieving a transformation requires investment – in people, infrastructure, process, regulations. Individual investments guided by a shared vision of Trials in 2030 can increase the probability that this transformation will actually be achieved. We work in a complex industry with a complex subject matter – clinical trials are never ‘standardized’ like a manufacturing assembly line. But we can account for this variability to drive new innovations and insights by investing in efforts that simplify collaboration and integration – efforts that can serve to unite our separate interests in a greater cause.” – Edward Seguine, Clinical Ink
  • “Decentralized trials focused on simplified and digital protocol, ObD principle in collection and analysis, and integration of a new data types like genomic and real-world data in our trials.” – Abhishek Dabral
  • “Patient centricity is not a buzz word or a tech term coined by the pharma industry – it is the wish and hope of patients to be heard. As an auditor, I question study designs; collect data; and assure that patients’ safety, privacy, and wellbeing are truly protected, and that clinical studies do not burden patients more than absolutely necessary.” – Kamila Novak, KAN Consulting
  • “We’ve made a commitment to: Enroll patients from diverse populations and regions via decentralized strategies; collect data electronically and integrate systems to reduce duplication; follow a risk-based quality management approach; and share best practices gained through our work with various stakeholders—most notably, patients.”  - Adam Samson, Curebase, Inc.
  • “Far better an approximate answer to the right question, which is often vague, than an exact answer to the wrong question, which can always be made precise” (Tukey 1962) – Greg Ball, Merck Research Laboratories
  • “As a patient-centered organization, we and the patient advocates we empower with information and advocacy sills, work with clinical research teams to bring the patient voice to trial design. We educate the public and patients, enabling them to make informed decisions about treatment options including clinical trials. And, we provide support to patients and advocate for public policies to break down barriers to clinical trial participation, all with the goal of helping ensure clinical trials are patient-centered, accessible and inclusive of all people with breast cancer.” – Kimberly Sabelko, Susan G. Komen
  • “We contribute to making clinical trials patient centered and easily accessible through listening to patients’ needs and bringing this into the development of future trials. We take a patient-centric approach to engaging patients in clinical trials, by identifying their needs and understanding the challenges they face regarding trial participation. We work to ensure active patient reviews of each trial design before it is launched by gathering the patients’ feedback and presenting the results in investigative reports with the aim of improving clinical trials and making participation easy and safe for volunteers.” - Henrik Vincentz, James Lind Care
  • “We collaborate with all stakeholders to ensure innovative and nimble IRB processes for e-consenting and decentralized clinical trials. We remain committed to ensure the protocol requires only essential study activities and the informed consent and related materials are clear, concise, and easily understood by trial participants.” –Priscilla Short, Salus IRB

  • “We foresee the future of how patients interact with both general medical care, and clinical research, to be in a more flexible and personalised way. That means for some cases, we will see more distributed settings for trials, and in the end we will be able to choose how we best wish to receive our care and participate in clinical trials. In addition, we are enthusiastic to be part of the paradigm shift in the way we assess patients – by using digital, objective, and real-world based measurements to generate more meaningful data to both patients and researchers alike.” – Sam Hariry, Novartis Institutes for Biomedical Research

  • In the Duke Clinical and Translational Science Institute we are supporting our investigators and study teams across the enterprise by encouraging patient-centeredness and recognition of the participant perspective in all aspects of clinical trial design and development; we offer support for the creation of stakeholder engagement plans, coordination of stakeholder advisory teams and development of participant-centered engagement and recruitment materials. We work within the School of Medicine and Duke University Health System to identify patient-centered synergies that can be leveraged to promote the research mission of Duke and its importance to improve the care that is delivered and the outcomes that are achieved. Within our community, we work with local organizations, networks and neighborhoods to develop processes that ensure inclusive research processes that are dedicated to giving voice to our community, reducing health disparities and improving health equity. – Jamie Roberts, Duke Clinical and Translational Science Institute