At the forefront of transforming clinical studies is CTTI, which has been instrumental in shaping the future of clinical trials to be more efficient, inclusive and patient-centered.

The evolution of health care is expanding the possibilities for the integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to advance biomedical and clinical research.

The FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for applicable clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered, and when and for which trials summary results information must be submitted.

ClinicalTrials.gov is the go-to source of information about clinical trials, and patients, family members, healthcare professionals, researchers, and the public all use it to discover information about current research as well as the results of completed clinical trials.

In this interview, Michael Torok, Head of Quality Assurance Programs at Roche, delves into the operationalization of RBQM (Risk Based Quality Management) and how AI in clinical trials can enhance RBQM practices. This discussion uncovers the nuanced complexities, challenges, and significant advancements in integrating AI into quality assurance to protect trial participant safety (“safety”) and trial data reliability (“reliability”).

A survey conducted by the Clinical Trials Transformation Initiative (CTTI) indicates a large part of the lack of reported trial results in the U.S. is due to investigators’ and other stakeholders’ limited understanding of the requirements and processes for registering and submitting trial data to the ClinicalTrials.gov database.

The 2024 Clinical Trials Transformation Initiative (CTTI) report, drawing on a broad spectrum of responses from diverse stakeholders in the clinical trial community, sheds light on the significant challenges faced and the pressing need for improved ClinicalTrials.gov reporting guidance and training from the FDA.

At this point, we know that patients are not merely recipients of medical interventions; they should be active participants whose insights and experiences significantly shape the trajectory of research, development, post-market initiatives, and the acceleration of treatments.

The last several years have included many actions and acknowledgments of the need to improve the equitable access to and diverse participation in clinical trials. The National Academies of Sciences, Engineering, and Medicine, the FDA, and the NIH have released several policies and statements that encourage diversity and inclusion in clinical trials. In addition, the Food and Drug Omnibus Reform Act (FDORA) will require the submission of diversity action plans by medical product sponsors to the FDA.

In this interview, Lindsay Kehoe, MS, CGC, from Duke University/Clinical Trial Transformation Initiative, details her session on clinical trials in the community setting. She participated in a session titled “Reimagining Clinical Trials in the Community Setting” at the 2023 Clinical Pathways Congress + Cancer Care Business Exchange.a

The Clinical Trials Transformation Initiative (CTTI) has been ambitiously working towards its Transforming Trials 2030 Vision, a progressive guidepost for how clinical trials should be conducted in the future.

Digital trials have the capacity to improve access for underrepresented communities to participate in research, identify novel digital endpoints to expand our understanding of health outcomes, and elevate the level of engagement and overall experience for study participants. However, navigating and implementing these capabilities can be a challenge for research professionals. In light of this, professional organizations have developed digital trial tools and resources for the research community. In this blog, we take a snapshot of some of the tools developed by Clinical Trials Transformation Initiative (CTTI), Digital Medicine Society (DiMe), and Decentralized Trials & Research Alliance (DTRA).

Whether subjects can use their own personal devices, how to manage mid-study technology updates, and the extent to which data gathered will be shared with patients in real-time are all issues that sponsors, investigators and regulators need to consider.

I wasn’t actively searching to participate in a clinical trial; I just stumbled upon it when researching a new primary care physician. You know how it goes: you click on a website, then before you know it, something catches your attention and with a few more clicks you find yourself down a rabbit hole wondering, “What was it I was looking for?”

Although most clinical trial data quality benefits from centralized statistical monitoring, critical data, processes, and associated risks identified via risk assessment following the Clinical Trials Transformation Initiative (CTTI) framework should drive the overall monitoring approach.

Embedding elements of trials — such as randomization, informed consent, administration of a study drug, and/or data acquisition — into clinical practice is necessary to narrow the gap between clinical research and practice.

Decentralised clinical trials (DCTs) were pushed forward substantially by COVID-19 lockdowns. Over the past year, as societies have reopened, processes for traditional in-person clinical trial activities have gradually been re-established. It is therefore cautiously that we question whether DCTs in 2023 will experience continued growth or return to pre-pandemic constraints.

The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM) programs by creating more objective risk assessments, which could potentially reduce quality defects as well as drug shortages.

Despite good intentions, decades-old guidelines on the conduct of clinical trials have become “overinterpreted” to the point of making such research extremely cumbersome and costly: major cardiology societies have come together to advocate for change.

Women subjects have traditionally been excluded from medical research. Despite the efforts of activists and lawmakers to improve gender equity in this area, women subjects are still largely underrepresented in medical literature, according to a study published by JAMA Network Open.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.

The strive to deliver the very best outcomes sits at the heart of clinical research. Arguably the mechanism for delivering that “perfect” outcome rests squarely on the shoulder of a single key principle – quality. Quality in all areas from study design to data collection to successful publication and many more.

The goal of patient centricity and including patients’ voices is now a top priority across our entire ecosystem. This includes regulators, academia, and pharma.

If technology companies want to make a positive impact on healthcare, they need to explore ways to make clinical trials more accessible and efficient. Faster, more inclusive clinical trials lead to more effective, affordable medical treatments.

Relative to clinical studies conducted at traditional bricks-and-mortar sites, decentralized clinical trials (DCTs) can deliver a higher “expected net present value” (eNPV) that equates to a roughly $10 million return on a $2 million investment for phase 2 trials and $39 million return on a $3 million investment for phase 3 studies, according to Ken Getz, professor and executive director of the Tufts Center for the Study of Drug Development (CSDD). Getz was co-presenting an Innovation Theater session at the recent DIA 2022 Global Annual Meeting on the financial return on investment (ROI) of DCTs with Pamela Tenaerts, Ph.D., chief scientific officer at Medable.

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use.

New digital and hybrid approaches to clinical trials are quickly gaining ground. Are they moving too fast?

Trishna Bharadia has multiple sclerosis and works as a patient engagement consultant and is often asked to take part in clinical trials. Mostly, though, she turns them down. She has to: A resident of rural England, Bharadia lives hours away from most clinical trial sites. Even if one were closer, the trials typically require time off work, which is hard for her to get.

REMAKING TRIALS: Cash is pouring in to support efforts to modernize clinical trials, which have long been plagued by inefficiency, lack of diversity and the inability to leverage data, among other issues.

Benjamin Stecher was only 29 when his aunt, a doctor, noticed his hands were shaking. He was referred to a movement specialist who gave him a life-changing diagnosis: Parkinson’s.

Last November UCB, Parkinson’s UK, and the Parkinson’s Foundation in the U.S., announced that they had joined forces to establish a Patient Engagement Council for Parkinson’s Research (PECPR), building upon existing work they had been doing together for many years.

In an exclusive analysis using GlobalData and ClinicalTrials.gov data, Clinical Trials Arena reveals which therapeutic areas are recuperating and which are struggling to recover past levels of trial activity.

If research involves human subjects at multiple sites, a single IRB review process is required under both National Institutes of Health policy and Common Rule guidelines. Previously, each institution used its own IRB to review study protocols, an inefficient and inconsistent process.

The time to create true and lasting change in clinical trials is now and the Clinical Trials Transformation Initiative (CTTI), a group of individuals and organizations that want to improve the quality and efficiency of clinical trials, is working to shape a future of smarter, faster, more inclusive clinical research.

Technological advances are speeding the development of digital measures and endpoints throughout drug development and across therapeutic areas and patient populations. While regulators encourage stakeholders to pursue patient-centric approaches, few actionable guidances or standards exist.

Transparency is, perhaps, the most important element in collaborations to develop treatments for rare and ultra-rare diseases, according to speakers at Biotech Week Boston’s panel on stakeholder collaborations.

One positive change to come out of the global pandemic is the rapid adoption of decentralized clinical trials (DCTs).

Novel digital endpoints offer enormous promise to transform medical product development and the reach of new therapies to all patients, including individuals typically underrepresented in clinical research.

Clinical trials have always faced challenges when it comes to recruiting and retaining the right participants, with travel time and stress associated with on-site clinic visits often cited as major obstacles.

In March 2019, the agency said it was working with the Clinical Trial Transformation Initiative (CTTI) and other stakeholders to evaluate decentralized clinical trials. CTTI published its final recommendations (PDF) on conducting decentralized trials in September 2018, concluding that this rethinking of the traditional centralized method could lead to faster participant recruitment, increased diversity in enrolled patients, better retention and higher levels of comfort for participants, among other findings.

2021 is poised to be a year of epochal change and transformation in the clinical trial ecosystem. Consider the numerous significant events that have occurred in less than six months. In January, the Clinical Trials Transformation Initiative (CTTI) unveiled its Transforming Trials 2030 vision stating that clinical trials should be patient-centered, easily accessible, designed with a quality approach, and fully integrated into routine healthcare delivery processes.

The quality- and efficiency-focused Clinical Trials Transformation Initiative (CTTI), has said that decentralized trials (DCTs) can follow a range of approaches, from fully decentralized trials to partially decentralized or hybrid trials, in which some aspects of a trial are conducted remotely while others are performed in person. CTTI notes that DCTs are trials consisting of any combination of certain core features, including no physical trial sites used in the trial, all visits performed via telemedicine or mobile/local HCPs, and/or data captured remotely through use of mobile technologies.

On behalf of the Clinical Trials Transformation Initiative (CTTI), Duke University’s Lindsay Kehoe and colleagues conducted a survey of potential research participants to get a better understanding of patient preferences and interests in using digital health technologies. They warned about seeing digital technology as a panacea. “If the use of digital health technology is determined to be appropriate for a trial, technology selection should be based on the requirements of the study and the needs of the intended user population,” the authors wrote in a paper published in Contemporary Clinical Trials Communications. “Furthermore, it is important to carefully weight the impact of any technology-related protocol elements on site staff and clinical workflow against potential benefits, and recognize that digital health technology cannot ‘fix’ a trial that is fundamentally flawed.”

At a webinar in January 2021 hosted by the Clinical Trials Transformation Initiative (CTTI), Woodcock, now FDA acting commissioner, lamented the waste and duplication created by a “plethora of small, single-center trials,” most without control arms and sufficient size and structure to yield results.

During a webinar hosted by the Clinical Trials Transformation Initiative this month, Janet Woodcock, Robert Califf and other key opinion leaders joined lead investigators on COVID master protocol studies to outline the challenges of running the multisite studies and map out solutions.

In the oncology space, the COVID-19 pandemic has also led to adaptations in clinical trial protocols that affect how patients customarily participate in studies. In response, the US Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) published respective guidance documents detailing the best practices for clinical trial protocol changes to address the risks that patients may encounter when participating in a clinical trial during the COVID-19 pandemic.

The Clinical Trials Transformation Initiative (CTTI) sponsors a Public Summit: The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies. CTTI, a prominent and influential public-private partnership co-founded by the U.S. Food and Drug Administration (FDA) and Duke works to identify and promote practices that will increase the quality and efficiency of clinical trials.

Guidelines such as the Clinical Trials Transformation Initiative support such collaboration through recommendations for the use of mobile technology like wearable devices. One of its first recommendations is for R&D departments to start with a clinical trial endpoint and work backward to ensure that investigators select the right device. Consumer and medical device makers, researchers, technology data platform companies, and regulators must coordinate efforts in order to realize the full potential of this technology.

Partnerships and collaborations are very important to Araojo, and she notes stakeholder engagement activities are an important part of them. The Office of Minority Health and Health Equity is working with the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and FDA.

To better understand the future of clinical trial innovation—and what’s changed during the pandemic—we spoke with Leanne Madre from the Clinical Trials Transformation Initiative (CTTI), a public-private partnership (established in 2007 by FDA and Duke University) to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials.

In the clinical trials community, nearly every aspect of research is experiencing unprecedented disruptions due to COVID-19, especially to those trials that were mid-stream when the pandemic hit. The Clinical Trials Transformation Initiative (CTTI), a leading public-private partnership, recently held a webinar to help the clinical trials ecosystem adapt to one of the most common challenges – the swift switch to remote and virtual visits, which has left many sites in uncharted territory.

An 80,000-patient trial that used an FDA network of data from national health plans found that mailed education information did not increase the use of oral anticoagulants (OACS) among patients with atrial fibrillation (AF) who were not being treated. Pamela Tenaerts, executive director at the Clinical Trials Transformation Initiative, says “the study is a successful proof of concept of embedding a randomized clinical trial into a claims system while confirming in a large-scale experiment that the use of educational interventional approaches in medicine might be limited.”

In a COVID-19 article penned by then-CTTI Executive Director Pamela Tenaerts, she states: The clinical trial enterprise has been due for a reckoning for a long time. The good news is that a fundamental re-thinking of how clinical trials are done – one that could bring lasting positive changes – has started to happen.

“People want to help [patients], and they want to be quick. They are forgetting a little bit of the lessons we’ve learned in history,” says Pamela Tenaerts, executive director of the Clinical Trials Transformation Initiative, founded by the FDA and Duke University.

“This is a massive effort, and although we may not run out of patients unfortunately, we may run out of research personnel and time availability to do this in this way, having separate development programs,” she said during a Clinical Trials Transformation Initi-ative (CTTI) webinar last week.

Despite that collaboration, there are still challenges in conducting the gold-standard randomized, controlled clinical trials (RCTs) that demonstrate a drug’s safety and effectiveness in response to a pandemic. For one thing, the trials need to be streamlined and make sense for health care workers who are already overloaded with patient care, said Pamela Tenaerts, executive director at the Clinical Trials Transformation Initiative at Duke University.

Spencer Health Solutions has invited Dr. Pamela Tenaerts to join us on the “People Always, Patients Sometimes” podcast to learn more about an important initiative to improve clinical trials. Dr. Tenaerts is the Executive Director of the Clinical Trial Transformation Initiative known as CTTI.

In September 2018, CTTI unveiled evidence-based and practical recommendations to speed the use of DCTs and potentially improve the efficiency and affordability of clinical trials broadly. These recommendations address barriers that could be hindering the widespread use of DCTs. Use of these recommendations could offer sponsors, CROs, and others many advantages, including improved recruitment and retention, greater participant diversity, and a more comfortable and convenient research experience for participants.

Greater patient-centricity is facilitated by digital monitoring technology, according to Pamela Tenaerts, executive director of the CTTI (Clinical Trials Transformation Initiative). “When endpoints are gathered from participants in clinical trials, assessments typically take place in healthcare settings rather than in the context of patients’ daily lives. In addition to being limited in terms of their objectivity, these measures also may capture only brief ‘snapshots’ of the participant’s functionality and/or disease burden at a given point in time.”

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership cofounded by FDA and Duke University, brought together numerous stakeholders in four working groups to explore different aspects of virtual studies; each produced a comprehensive set of recommendations.

Raman, speaking at a Clinical Trials Transformation Initiative (CTTI) webinar, suggests asking three questions when considering using commonly available data like electronic health records and insurance claims in a clinical trial design: Are the eligibility criteria of interest identifiable in the data? Are the data relevant and of enough quality? Is the data analysis cost-effective?

The Clinical Trials Transformation Initiative (CTTI) has unveiled new recommendations for the use of real-world data (RWD) sources to improve the quality and efficiency of clinical trials.

Coinciding with the tenth anniversary of the PCWP, the FDA and the Clinical Trials Transformation Initiative (CTTI) announced their collaboration and launched a new work group called the Patient Engagement Collaborative (PEC), based on the PCWP model (see Related links). The PEC is patient-led group of patient organisations and individual representatives who discuss how to achieve more meaningful patient engagement in medical product development and related regulatory discussions at the FDA.

She points to the US’ Clinical Trials Transformation Initiative (CTTI), which is aiming to develop a more patient-centered and efficient clinical trial system, as a good example of an initiative that has involved a lot of collaboration. “They’ve involved stakeholders from a lot of large pharma organisations, who are participating on a volunteer basis. That’s a great way to get around corporate firewalls, which often impede collaboration, and put new infrastructure in place.

The Clinical Trials Transformation Initiative, co-founded by Duke University and the FDA, for one, issued a list of recommendations earlier this year to help tech companies and clinicians improve the quality and efficiency of clinical trials involving smartphones and mobile tech.

“The agency has worked closely with stakeholders, including the Clinical Trial Transformation Initiative, to identify innovative trial designs, evaluate the role of decentralized clinical trials and mobile technologies, and help validate novel endpoints that can enable trials to generate reliable evidence needed to assess product safety and efficacy more efficiently,” then-FDA Commissioner Scott Gottlieb said in March. Rodriguez-Chavez said FDA’s current Acting Commissioner, Dr. Ned Sharpless, shares Gottlieb’s pro-innovation philosophy as it impacts clinical trial design.

Pfizer suggested working with the Clinical Trials Transformation Initiative (CTTI) to collect data “to determine whether the factors noted as potentially important are important to quality outcomes.”

The FDA-industry, mutually-funded National Evaluation System for health Technology (NEST) is a similar initiative. And the Clinical Trials Transformation Initiative, a public/private partnership co-founded by Duke University and FDA, also has made progress in developing recommendations and resources to facilitate the adoption of mobile technologies in research.

Another DCRI-affiliated project, the Clinical Trials Transformation Initiative (CTTI), is working on a collaborative project with the FDA, industry, patients, and other stakeholders to advance the use of RWD—which is also used and analyzed to create RWE—in planning for regulatory submission trials. As part of this work, CTTI is developing recommendations and supporting resources for using data from electronic health records (EHR) and insurance claims to evaluate trial eligibility criteria and recruit potential research participants.

More organizations are starting to implement guidelines around digital health strategy and implementation including The Clinical Trials Transformation Initiative, Xcertia, and The American Medical Association.

The agency has worked closely with stakeholders, including the Clinical Trial Transformation Initiative, to identify innovative trial designs, evaluate the role of decentralized clinical trials and mobile technologies, and help validate novel endpoints that can enable trials to generate reliable evidence needed to assess product safety and efficacy more efficiently.

It is critical to understand the patient and site perspective to “maximize opportunities and minimize challenges” associated with the use of mobile technology in clinical trials, says CTTI executive director.

Regulators are working with industry and academia in advisory partnerships such as the Clinical Trial Transformation Initiative (CTTI), which has been actively issuing recommendations in areas such as mobile technologies and use of RWE.

In partnership with the Clinical Trials Transformation Initiative, which seeks to increase the quality and efficiency of clinical trials, we [FDA] recently convened the Patient Engagement Collaborative, comprised of patient organizations and individual representatives, to discuss topics focusing on enhancing patient engagement in medical product development and regulatory discussions at the FDA.

Investigators from the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between the US Food and Drug Administration and Duke University, conducted formative interviews with a range of stakeholders to explore the feasibility and acceptability of enrolling patients at risk for pneumonia into treatment studies for pneumonia before they develop pneumonia.

We [CTTI] entered 2018 with a solid foundation in place for building better, more efficient clinical trials. Throughout the year, progress – particularly in the areas of mobile technologies, real-world evidence, and patient engagement – resulted in new, tangible building blocks for constructing the future of clinical trials.

The Clinical Trials Transformation Initiative (CTTI) recently released recommendations and resources proposing a new approach to investigator qualification – and approach that CTTI Executive Director Pamela Tenaerts said “goes beyond repetitive, identical training, and includes individual experience and protocol-specific preparation.”

This is where industry partners can help. The FDA is working in collaboration with the Clinical Trials Transformation Initiative (CTTI) and the Medical Device Innovation Consortium (MDIC) to facilitate innovative trial designs and patient-centered endpoints. Although these approaches can be more rigorous, they can also make the clinical development process more efficient, enable investigators to learn more about a product’s efficacy and safety, and help regulators and sponsors detect efficacy and safety signals earlier in the development process.

The FDA is working across its medical product centers, in collaboration with the Clinical Trials Transformation Initiative (CTTI) and the Medical Device Innovation Consortium (MDIC), to facilitate innovative trial designs and patient-centered endpoints for drugs and medical devices that can make clinical trials more efficient. These approaches can also be more rigorous. Developing more efficient strategies for generating critical evidence relating to the safety and efficacy of drugs and devices in specific populations (for instance, through seamless trial designs, and the use of master protocols and basket trials) can help make the clinical development process more efficient.

CTTI’s latest recommendations will help researchers deploy mobile technologies in clinical trials and “pave the way for improving how we develop medicines,” says Pfizer exec.

It can be hard to resist generating massive piles of data simply because the innovative technology is capable. Often, those conducting trials might understandably be “trying to get as much as possible out of the [technology] investment,” Skodacek told attendees of CTTI’s Mobile Technologies Event July 16 at FDA’s White Oak campus.

The advocates will work to enhance the US FDA’s understanding of how to best engage across patient communities, according to CTTI.

Leaders of the biomedical research community support these and other changes promoted by the Clinical Trials Transformative Initiative (CTTI), including expanded use of registries, adoption of a “single IRB of record” for multicenter trials, a more effective informed consent process, and rational use of study monitors and data monitoring committees. The group also works to improve investigator training, encourage pediatric studies for antibacterial medicines, and promote effective patient engagement in clinical trial design and implementation.

Last week CTTI and industry professionals gathered to celebrate the initiative’s 10-year anniversary. To learn more about some of the key projects completed and challenges faced over the last decade – and what to expect from the next 10 years – we caught up with CTTI Executive Director Pamela Tenaerts.

Leaders of the biomedical research community recently celebrated progress over the last decade in devising strategies to improve the quality and efficiency of clinical trials. The 10th anniversary of the Clinical Trials Transformative Initiative (CTTI) last week provided an opportunity for FDA officials to join with study sponsors and research experts to examine the policy achievements and plans for future efforts of this multi-faceted initiative.

At a symposium marking the Clinical Trials Transformation Initiative’s 10th anniversary, industry and regulatory discussed the progress made by its Quality by Design initiative and the additional work needed to encourage the research industry to be more focused on trial quality and efficiency.

Nearly half of all so-called “one and done” principal investigators who retreat from clinical research after conducting a single study want back in if they can find resources and advice to help on their second attempt, according to findings from a new Clinical Trials Transformation Initiative (CTTI) survey and recommendations project.

It can be seriously disruptive when the site investigator for your trial leaves or decides to step down, but new recommendations from the Clinical Trials Transformation Initiative (CTTI) aim to mitigate that risk.

CTTI has released new recommendations that can be implemented by sponsors, CROs, and others, in order to decrease the number of ‘one and done’ clinical trial site investigators.

CTTI’s new evidence-based recommendations provide a standard way to plan for and make decisions about pregnancy testing in clinical trials, and also improve communications and transparency with trial participants,” Calvert explained.

“Clinical drug development is generally an inefficient process. The cost of conducting clinical trials drives R&D spending, and much of the elaborate superstructure involved needs to be reassessed and could be pared down without harming participants. The EMA actively promotes better design and more efficient trial conduct and supports the efforts of the Clinical Trials Transformation Initiative, created by the Food and Drug Administration and Duke University, and other efforts to streamline trials.”

“Some of the first formal efforts to outline the science of patient input borrow, from software development, the use of frameworks to provide a logical structure for organizing information, identifying sources of the information, and suggesting ways it might be used and viewed by distinct parties… The Clinical Trials Transformation Initiative (CTTI) created perhaps the most recognizable tool, and its work has become a guidepost.”

CTTI is featured as a driver of action-oriented solutions in this Wall Street Journal article that explores the critical need for improved patient recruitment rates. “We want to create trials that everyone involved can champion, and that doctors can feel good about engaging their patients in,” says Jamie Roberts, senior clinical project manager for the CTTI Recruitment Project.

CTTI contributed to MediaplanetUSA’s Clinical Trials spotlight, where associations and industry experts came together to change the public perception and showcase why clinical trials are so important in helping those in need. The piece was distributed within the centerfold of USA Today.

“In recent years there has been an increasing focus on patient engagement, centering on new opportunities for FDA to incorporate the patient perspective into its regulatory decision making. These discussions have resulted in Congress and FDA establishing new policies and programs… However, the public dialogue has largely left out the opportunities for meaningful engagement between patients and research sponsors (academia and the medical product developers). That changed in 2014, when Clinical Trials Transformation Initiative (CTTI) initiated the Patient Groups & Clinical Trials (PGCT) Project. “

On CTTI’s Quality by Design work: “Those principles were tested and refined through a series of workshops,” says Glessner. “I can’t speak highly enough about the power of those workshops. They actually involved putting materials into individual’s hands and testing them. Then after a period of time CTTI wanted to know whether the workshops were effective, and to determine that approximately 20 individuals were interviewed. These were deep, detailed interviews asking participants what they were able to take away from the workshops, what they were able to apply in their own businesses, and what problems continued to be a struggle for them.”

“We’ve been working [for] the past many years on trying to reform the clinical trial system in both the United States and worldwide because clinical trials are very resource wasteful in a sense… We’re also working with the… Clinical Trials Transformation Initiative, to bite off different pieces of the current trial conduct and design and re-design those, and I think we’ve made significant progress there.”