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Applied Clinical Trials March 2023

Ukraine invasion tests the resiliency and quick action of CROs and sponsors

Mobilizing and Maintaining Clinical Trials in Midst of War

ACT's biennial Salary Survey takes a look at the future of industry following increased adaptation of decentralized technology 

Salary Survey: The Age of COVID

This panel at DIA Europe 2023 on Thursday was focused solely on addressing the issue of carbon emissions (CO2) “Creating an Impact for Patients and our Planet – Advancing Drug Development Towards a More Sustainable, Carbon-neutral and Circular Model.”

Setting the stage for the audience, Marc Philipp, partner and managing director at Kearney, explained the emissions issues related to pharma, as well as water pollution, which lead to extensive effects on the environment and quality of life. To measure effects on emissions, there are three levels or scopes. Scope 1 is direct, Scope 2 is indirect (owned and by the company) and Scope 3 indirect (not owned by the company). Accordingly, 90% of pharma emissions are from Scope 3, comprising 66% pharma suppliers, 12% of pharma itself, and 13% from customers.

At this point, two-thirds of large pharma have certified their CO2 ambitions, with Philipp noting that AstraZeneca is leading the pack.

ESG includes sustainability, where all ESG principles are being largely adopted, if not required, by large publicly-traded corporations globally. Sustainability related to pharma centers squarely in R&D where the needle on Scope 3 can be moved¾specifically the area of clinical trials. Questions around clinical trials emission drivers include, clinical facilities and partnerships (ex., which sites and CROs and why?); sponsor and participant travel, drug product logistics (ex., where to manufacture clinical trial supply, how to store and transport).

James Gallagher, lead Janssen Clinical Innovation, noted that Janssen is involved in the Digital Health in the Circular Economy (DHCE), a collaboration with NGOs, academia, etc. Based on the explosion of digital healthcare, the trade-off is eWaste. “Unlike traditional electronics, these contain unique contaminants that are not involved with traditional recycling,” said Gallagher.

Slawa Troubniakov, leader of strategic programs at the R&D department of Merck Healthcare, agreed that there is a negative impact to innovation and technology. But companies have to start somewhere. “It’s best to look at the whole value chain and identify the most relative/impactful,” he said. Then that should be measured and quantified to determine a baseline that allows decisions to be made from that baseline.

Neil Mackillop of AstraZeneca said the company looked at three of its Phase III trials and estimated between 1K to 4K tons of carbon emissions to year. “In our trials, the three big hot spots were travel, waste and samples.” Waste comes in the form of over-ordering of supplies “just in case.” But the largest was samples. Says Mackillop, “We are flying samples to central labs in dry ice, to shipping to other central labs, and then the samples sit around for 10 to 20 years. Why?”

Juergan Wieland, Global Drug Development Environmental Sustainability at Novartis Pharma AG, concurred that global clinical supply and the carbon footprint of medication shipments is a problem they are targeting. Novartis is asking questions such as, what does it mean to make three shipments a week to a site vs. using machine learning in IRT shipments to determine a more efficient quarterly shipment. “We also consider re-usable shipper boxes,” said Juergan. “We have to consider what is reasonable and what is waste.”

The basic challenge is where to start and how to measure it and do it scientifically. Roberto Rigobello, senior director, Sustainability, International Operations at Novo Nordisk, says the Sustainability Markets Initiative (SMI) taskforce has a goal to develop a methodology or tool to collect emissions data, and member companies will report their data for Phase II and III trials and in 2030, that data will be used to set targets. The goal, says Roberto, is to create a baseline and then track year over year. “You can’t improve if you don’t have the data.”

Fiona Adshead, chair of the Sustainable Healthcare Coalition noted the coalition was formed by the UK government to bring all of players in the systems together. As she said, “not one player in the system can solve this. We have to learn together to co-create in a pre-competitive approach. It’s a safe space for us to put processes in place to learn.”

And sustainability can be used positively, said Gallagher, for example in the common case of a single investigative site that is under-producing, maybe only enrolling one patient. “We can use sustainability to show that it doesn’t make sense to keep the site open and ship only to that site. Sustainability brings a new perspective. It’s a powerful lens,” he said.

DIA Europe 2023, March 22-24, Basel, Switzerland. “Creating an Impact for Patients and our Planet – Advancing Drug Development Towards a More Sustainable, Carbon-neutral and Circular Model.”

Articles

 DIA Europe 2023: De-Carbonizing Your Clinical Trials

Jill Wechsler is ACT's Washington Correspondent

The escalating attack on too-high prices for prescription medicines has heightened debate over the government’s authority to revoke licenses for medical products that are developed with support of public funds. The Department of Health and Human Services (HHS) and Department of Commerce (DOC) recently announced a broad review of the “march-in” authority provided in the Bayh-Dole Act of 1980 in the wake of its controversial decision to let stand licensing rights to a widely used cancer drug.

The review will be conducted by a new Interagency Working Group for Bayh-Dole, which is charged with updating the framework for altering march-in provisions spelled out in that legislation. A main issue is whether a high price for a product provides sufficient reason to revoke a manufacturer’s license. HHS will hold a workshop later this year to discuss when it might be appropriate to implement march-in rights, with input from patient groups, industry, academic, nonprofit organizations, and legal and policy experts. And the discussion will be informed by a recent publication from National Institute of Standards and Technology (NIST) that proposes changes to streamline and clarify licensing procedures for federally funded inventions.

This issue hit the headlines recently when the National Institutes of Health (NIH) rejected a petition to initiate march-in proceedings for the prostate cancer drug Xtandi (enzalutamide), marketed by Pfizer and Astellas Pharmaceuticals.

 Public interest groups had filed a petition in 2021 that called on NIH to take ownership of the patents on the drug due to its much higher cost in the US than in Canada and other countries, which limited patient access to the therapy.

At the same time, Congressional leaders highlighted the substantial NIH funding of Moderna’s COVID-19 vaccine in challenging the company’s plan to raise the price of the preventive when federal subsidies end in May. In testimony before the Senate Health, Education, Labor, and Pensions (HELP) Committee Wednesday, Moderna CEO Stephane Bancel emphasized the years of research and billions invested by his company to devise methods for quickly testing and producing such a vaccine].

 Committee Chair Bernie Sanders (I-Vt) highlighted the $1.2 billion invested by the federal government in the project in blasting the company’s plan to boost the price from $26 to $130 per shot with the end of the COVID health emergency.

The Bayh-Dole Act of 1980 provides a pathway to facilitate commercialization of inventions, including biomedical products, that are developed with support from federal agencies such as NIH. The program permits the government to “march in” to rescind licensing rights if it determines that the benefits of such inventions are not available to the public on reasonable terms. Over the years, various organizations have petitioned NIH and other agencies to initiate march-in proceedings when a product’s high cost might be considered a barrier to access. But federal officials have rejected such pleas, as with several petitions related to Xtandi.

In rejecting the latest filing on Xtandi, NIH stated that the aim of Bayh-Dole is to promote commercialization and public availability of government-funded inventions, and not necessarily to ensure a low price for a covered medical product. NIH noted that Xtandi is widely available to patients, and that instituting march-in rights was unlikely to lower the price. Sen. Sanders and patient advocates clearly disagreed with the NIH decision, pointing out that Xtandi can be purchased in Canada for one-fifth the US price. But manufacturers and industry experts counter that without private sector investment and know-how, most government-funded research would never move from the laboratory to the marketplace—at any price.

Washington Correspondent and can be reached at

https://www.hhs.gov/about/news/2023/03/21/hhs-doc-announce-plan-review-march-in-authority.html

https://www.keionline.org/wp-content/uploads/NIH-rejection-Xtandi-marchin-12march2023.pdf

https://www.help.senate.gov/imo/media/doc/Stéphane%20Bancel%20Written%20Testimony.pdf

https://www.help.senate.gov/chair/newsroom/press/prepared-remarks-help-committee-hearing-on-moderna-covid-19-vaccine-pricing-ceo-to-testify

Amid continued tussling over drug costs, a new working group will review the government’s authority to revoke licenses for medical products.




Feds to Review March-In Authority on Drug Patents

Employing innovative tools to create patient-centric protocol designs is essential for improving patient experiences and trial efficiency. This article highlights the use of novel tools that Eli Lilly presented at SCOPE 2023 (by Hugh Dai, associate director, clinical trial design capabilities, and Jade Dennis, senior director, clinical trial design capabilities at Lilly) to prioritize patient perspectives in clinical trial design, with examples demonstrating their potential value in optimizing patient burden, engagement, and satisfaction.

Innovative tools for assessing patient burden

One of the key challenges in designing clinical trials is minimizing patient burden. To address this issue, Lilly has developed analytical protocol design tools that quantitatively measure the impact of study design on patients, enabling protocol designers to make data-driven decisions and optimize trial protocols.

Lilly built an interactive visual schedule that allows protocol designers to see the patient's journey throughout the study, with data points representing the changes in patient burden at each visit. Protocol designers can review the contributing factors and adjust to reduce patient burden by clicking on these data points.

This tool promotes user interactivity and facilitates comparing the proposed trial design to historical benchmarks. As a result, designers can quickly identify areas where improvements can be made and implement changes to enhance the patient experience, reduce patient burden and improve trial efficiency.

Lilly's quantitative patient burden methodology 

Backed by benchmarking and data-driven insights

Lilly backed its analytical protocol design tools by benchmarking empirical data to enhance patient-centric trial design and facilitate data-driven insights. For example, researchers can compare their trial design to past studies with similar indications and phases by extracting and standardizing data from public and internal study documents.

This process enables protocol designers to identify patient burden trends and explore their design choices' potential impact on operational study metrics, such as recruitment and discontinuation rates. Consequently, researchers can make more informed decisions that benefit patients and improve study outcomes through this data.

Lilly's protocol design tools on DCTs and their impact on patient burden
Decentralized clinical trials have the potential to significantly reduce patient burden by allowing patients to participate from home or their workplace. Innovative tools that assess the impact of DCTs on patient burden can help researchers understand how this approach can improve patient experience and retention.

Using these tools, protocol designers can evaluate the potential benefits of decentralization beyond travel reduction, such as its effect on different patient groups and the overall patient experience. This information can then refine trial protocols and further reduce patient burden.
Important considerations

In my opinion, while using innovative tools in clinical trial design offers numerous benefits, it's crucial to think hard about such approaches before jumping in head first. On the one hand, these tools can significantly improve patient experience and trial efficiency by minimizing patient burden, promoting user interactivity, and enabling data-driven decisions. They have the potential to revolutionize the way clinical trials are designed and executed, ultimately leading to better patient outcomes and streamlined processes. However, on the other hand, it is essential to recognize that the widespread adoption of these tools may present challenges, such as potential biases in benchmarking and the need for continuous refinement to ensure their accuracy and effectiveness.

Lilly touched upon the qualitative aspects (i.e., patient involvement in trial design), as they usually gather patient insights and collect qualitative data during protocol design; however, it is vital not to rely solely on quantitative methods to design protocols. First, FDA recommends incorporating the patient perspective in trial design, and second, patient needs are constantly shifting, and empirical and standardized data may not be a good predictor of changing qualitative study features requested by patients. I believe combining quantitative methods and validating the results against qualitative patient perspectives serve the best interests of patients, researchers, and regulators.

Embracing innovative tools to design patient-centric clinical trials is vital for improving patient experiences and optimizing trial efficiency. By employing cutting-edge technologies that focus on patient perspectives and burdens, researchers can create tailored trial designs that better serve the needs of their participants. These tools enhance patient satisfaction and improve clinical trials' success.

, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and regular contributor to Applied Clinical Trials.

Presentation at SCOPE 2023 highlights tools such as interactive schedules and benchmarked data which can increase patient centricity.






Innovative Tools for Patient-Centric Clinical Trial Design: Examples and Applications from Eli Lilly

Clinical research has experienced a dramatic increase in data volume, velocity, and variety, especially with the emergence of COVID-19. Companies like Merck incorporate AI and machine learning (ML) into their data validation processes to effectively manage this data explosion. At SCOPE 2023, Merck (Christopher Lamplugh, associate VP and head of global data management & standards, and Rakesh Maniar, executive director & head of eClinical technologies, global data management & standards) discussed AI usage in clinical data. This article provides an overview of their presentation, including the challenges faced, the methodology adopted, and the outcomes achieved by implementing AI in clinical data validation while ensuring technology does not impede clinical trials.

Clinical trials generate massive amounts of data that must be accurately validated, analyzed, and reported. Traditional manual data validation processes are time-consuming and error-prone, leading to delays and increased costs. Merck recognized the need for a more efficient and accurate approach and leveraged AI and ML technologies to improve its data validation processes. However, merging new technologies with existing practices requires a deep understanding of the potential challenges and a well-defined strategy.

Merck began by defining the user requirements and identifying the specific challenges it aimed to address with the AI model. These challenges included reducing the time spent on manual data validation, improving prediction accuracy, and ensuring that actionable insights were generated from the data.
Merck used historical data sets to train the AI model. This involved annotating and labeling the data to create a "ground truth" from which the model could learn. An analogy, for example, was described as if the model were trained on images showing cats wearing masks, it would learn to recognize a cat even when its face was partially obscured.

Through iterative training and validation cycles, Merck improved the AI model's prediction accuracy up to 89% after 14 cycles. Data managers were crucial in refining the model by providing feedback on its predictions and suggesting additional features to enhance its performance. In one instance, including a sequence number feature significantly improved the model's ability to identify discrepancies in data records based on a series of comments.

Merck's AI-assisted data validation approach offered several benefits:

1.	Increased efficiency and accuracy: By automating the data validation process, Merck reduced the time spent on manual tasks, enabling data managers to focus on more strategic activities.

2.	Improved prediction accuracy: Through continuous training and feedback, the AI model's accuracy improved over time, resulting in more reliable and actionable insights.

3.	Enhanced knowledge retention: The AI model's ability to learn from historical data and institutional knowledge allowed Merck to mitigate the impact of employee attrition and maintain a high level of expertise.

4.	Streamlined user experience: By incorporating user experience considerations into the AI model, Merck ensured that technology would not hinder clinical trial processes.

However, Merck also recognized that AI and ML technologies could not replace all rule-based checks and that combining both approaches would be necessary for optimal results.

While AI and ML technologies have undoubtedly revolutionized clinical data validation processes by increasing efficiency and accuracy, it is important to consider the limitations and potential risks of relying solely on these technologies. It is important to note that the dependence on AI could lead to overconfidence in its predictions, potentially overlooking human intuition and expertise, which could result in missed discrepancies or incorrect assumptions. Additionally, AI models require substantial historical data for accurate training, which might only sometimes be readily available, particularly in fast-evolving domains like clinical research. On a positive note, combining AI and human expertise can create a more robust and reliable system for data validation, as Merck did by developing a process to build and optimize AI models with human input methodically.

As demonstrated in this article, Merck incorporated AI into clinical data validation processes to significantly improve efficiency, accuracy, and resource allocation. By understanding the challenges, adopting a well-defined methodology, and focusing on user experience, companies can successfully integrate AI-assisted data validation into their clinical research processes while maintaining the quality and integrity of their clinical trials.

Merck presentation at SCOPE 2023 highlights company’s AI-assisted data validation approach.




Enhancing Clinical Data Validation with AI: A Comprehensive Approach to Accuracy and Efficiency

Underrepresented minority groups are more likely to experience exclusionary behaviors in the workplace than their majority counterparts. To examine the impact that exclusionary behaviors in the form of microaggressions can have on work outcomes, Tufts Center for the Study of Drug Development (Tufts CSDD) surveyed professionals working in the drug development industry, asking them about common forms of exclusionary interactions they encounter and what effects these dynamics have on team outcomes. Results confirmed that regularly experiencing microaggressions is negatively tied to psychological safety and reduces performance outcomes. Implications from this study are further discussed and recommendations are provided for leaders and managers to help build inclusion on their teams.

This study received funding from the following organizations: Abbvie, Amgen, BMS, Chugai, Genentech-Roche, Labcorp, Novartis, and Parexel.

An increasing body of research is confirming that underrepresented minorities are far more likely to encounter exclusionary forms of interactions than their majority counterparts in the workplace. Numerous studies have shown that women and racial minorities report experiencing microaggressions defined as subtle behaviors and comments that most often unintentionally demean or putdown individuals based on some aspect of their gender and/or racial identity and that this experience can be particularly salient in Science, Technology, Engineering, and Math (STEM) domains where women and racial minorities remain underrepresented especially at the leadership level.1,2
These forms of exclusionary dynamics often manifest as microaggressions defined as verbal and nonverbal slights that intentionally or unintentionally convey hostile, derogatory, or negative messages to certain individuals or groups based on some aspect of their social identity.

 Although most microaggressions manifest as subtle, brief encounters, their impact is anything but small. Repeatedly experiencing interactions that cause the target to, for instance, question their competence or scientific expertise has been linked to negative affect, cognitive overload, and even negative behavioral changes, such as withdrawal and eventual turnover, all of which can hinder effective team performance. Importantly, these effects are compounded over time.

Much of the research on workplace microaggressions and their impact has remained qualitative, relying heavily on interviews and focus groups.1,4,5 Though qualitative studies provide in-depth nuance into the lived experiences of professionals who must navigate these interactions, generalizability of the study results is limited given the relatively smaller sample size compared to survey studies that can be scaled and distributed to a larger sample, thereby increasing the application of the study findings.

To address this gap, Tufts CSDD conducted a survey study among drug development professionals to quantitatively measure the frequency of workplace microaggressions and tie them to relevant psychological work outcomes and behaviors. We built on a previous study in which we interviewed a range of professionals working in drug development to understand their experience navigating microaggressions manifesting as exclusive behaviors.

Using the themes uncovered from this qualitative study, we developed a survey that measured how often people experienced dynamics of exclusion (i.e., “I am interrupted by others while I speak”) and tied those to work outcomes, including psychological safety and performance.

Evidence that microaggressions can hinder effective team performance

The survey was administered among drug development professionals with the support of a working group comprised of representatives from sponsor and contract research organizations (CRO) who provided input on the content of the survey and helped socialize and distribute it across their organizations. The final sample totaled 543 responses. More than 70% of the responses were from women; about 60% of the respondents were White, followed by 25% Asian, 6% Latino/a/e, 6% Black, and 4% other, which included those with multi-racial and ethnic backgrounds as well as those of Middle Eastern/North African and Indigenous descent. Respondents were mainly from sponsor and CROs, representing primarily clinical research and clinical operations.

More than a quarter of the sample shared that they experienced microaggressions on an ongoing, daily basis. Among different racial groups, Black respondents were more likely than any other group to frequently experience microaggressions compared to non-Black respondents. Among those who experienced microaggressions frequently, individuals who worked remotely shared that they experienced significantly less microaggressions than everybody else, including those who worked on-site and those who had a hybrid work arrangement, suggesting that remote work arrangements can help provide a buffer against experiencing exclusionary behaviors.

There were distinct patterns of microaggressions experienced among different racial groups. For example, Black professionals were more likely to have their technical or scientific competence questioned by others and receive comments about their physical appearance compared to their White colleagues. In a field that prioritizes and highlights scientific and technical accomplishments, it can be damaging to work with colleagues who do not authorize or acknowledge the expertise one brings to the table due to pre-existing stereotypes people have about Black professionals.6 Moreover, this finding highlights ways in which Black professionals may burnout as they try to overcome these biases and behaviors by over-performing to counter the stereotype, a concept that has been documented in the psychology literature among women working in male-dominated areas.

The latter finding focusing on physical appearance also highlights a unique challenge experienced among Black female professionals who have shared in previous interviews the exclusion they felt by comments from colleagues focusing on their hair. Specifically, Black women shared that they felt alienated by White colleagues who only talked to them when they changed their hairstyles. Thus, this finding may help highlight opportunities to shape DEI training that not only sheds light on the thought and behavioral process among Black professionals in response to this type of microaggression, but also encourage more inclusive, and less exclusionary behaviors by majority counterparts.

There were also similarities in experience shared across different racial minority groups. For example, both Black and Asian professionals were more likely to be interrupted during a meeting than their White counterparts, whereas both Asian and Latino/a/e participants were more likely to have their leadership status questioned than their White colleagues.

Finally, we found a significant negative relationship between microaggressions and psychological safety and performance. Psychological safety is the belief that you won’t be punished or humiliated for speaking up, asking questions, or making a mistake.

 Our results provide evidence that working in an environment where you are constantly made to feel lesser than your peers can hinder people from speaking up and voicing their thoughts freely, which can also reduce effective team performance. In fact, our data confirmed that those who experienced microaggressions on a frequent basis were more likely to report lowered ability to effectively collaborate with the offending party.

Cross-functional collaboration has become increasingly necessary for producing high-quality science and this is no exception in drug development, which has grown more complex and nuanced, requiring talent and skills from a diverse array of backgrounds, including biological science, engineering, project management, and data science, to name a few.

 For effective cross-functional work to occur, certain conditions need to be met, including a team climate that allows for the free exchange of information, ideas, and feedback among members without fear of backlash or repercussion.

What we have demonstrated is that microaggressions—behaviors and comments that most often unintentionally exclude and demean minority members—can hinder teams from creating a psychologically safe environment where all members can thrive and reduce effective team performance. Based on the study results, we recommend managers and leaders to pay closer attention to the dynamics within their teams and/or functional areas, focusing on, for example, who is interrupted during meetings; who does most of the talking; and who is authorized and legitimized as the leader.

By addressing microaggressions and explaining why such behaviors are not conducive for effective team performance, leaders and managers can set the tone of what behaviors are condoned and what behaviors are not, helping to create a psychologically safe environment. Through these efforts that can be compounded throughout different areas and levels within organizations, leaders can help their employees show up in the way that is most meaningful to them. However, these efforts are only as good as the tools that organizations use to ensure that such efforts stick. An effective way to ensure the sustainability of DEI efforts is to regularly measure the frequencies of these dynamics using surveys, such as the one developed by Tufts CSDD for this study and use the results to inform and guide employee development practices. Tufts CSDD extends an open invitation to organizations who wish to use our instrument to assess their team’s diversity climate and build this assessment capability into their organization’s business strategy.


1.	Kim JY, Meister A. Microaggressions, interrupted: The experience and effects of gender microaggressions for women in STEM. Journal of Business Ethics. Published online 2022. doi:10.1007/s10551-022-05203-0

2.	Eaton AA, Saunders JF, Jacobson RK, West K. How gender and race stereotypes impact the advancement of scholars in STEM: Professors’ biased evaluations of physics and biology post-doctoral candidates. Sex Roles. 2020;82(3-4):127-141. doi:10.1007/s11199-019-01052-w

3.	Sue DW, Capodilupo CM, Torino GC, et al. Racial microaggressions in everyday life: Implications for clinical practice. American Psychologist. 2007;62(4):271. doi:10.1037/0003-066X.62.4.271

4.	Holder AMB, Jackson MA, Ponterotto JG. Racial microaggression experiences and coping strategies of black women in corporate leadership. Qualitative Psychology. 2015;2(2):164-180. doi:10.1037/qup0000024

5.	Kim JY, Botto E. The Impact of Gender Microaggressions on Team Performance in Drug Development. Applied Clinical Trials. Published online May 19, 2022. Accessed February 2, 2023. 

https://www.appliedclinicaltrialsonline.com/view/the-impact-of-gender-microaggressions-on-team-performance-in-drug-development

6.	Miles ML, Brockman AJ, Naphan-Kingery DE. Invalidated identities: The disconfirming effects of racial microaggressions on Black doctoral students in STEM. Journal of Research in Science Teaching. 2020;57(10):1608-1631. doi:10.1002/tea.21646

7.	Block CJ, Cruz M, Bairley M, Harel-Marian T, Roberson L. Inside the prism of an invisible threat: Shining a light on the hidden work of contending with systemic stereotype threat in STEM fields. Journal of Vocational Behavior. 2019;113(August):33-50. doi:10.1016/j.jvb.2018.09.007

8.	Edmondson AC. Psychological safety, trust, and learning in organizations: A group-level lens. Trust and Distrust in Organizations: Dilemmas and Approaches. 2004;(12):239-272.

9.	Reardon S. Scientific collaborations are precarious territory for women. Nature. 2022;605:179-181. doi:10.1038/d41586-022-01204-1

Tufts CSDD study finds that acts of microaggression negatively impact psychological safety and performance.





Examining the Impact of Exclusionary Behaviors on Team Dynamics

Medidata has launched Rave EDC Certified Study Builder certification, a new offering in its global education program for study build and study management professionals. The Rave EDC Certified Study Builder Program offers a guided learning path to certification for new and existing Rave study builders, and includes core skills and applied skills assessments.

Study builders can expect a guided learning path, including:

an instructor-led prep course to facilitate successful certification

an abbreviated path enabling Classic Rave Certified Study Builders to upgrade their certification without the need to retake core Rave EDC training

Study Builders then complete an expanded core skills exam and applied skills assessment using a mock study build. Successful completion ends with a digital badge recognizing proficiency in Rave EDC study design and build, clinical view data settings, clinical view data review, and the use of Rave Reporter.

Global Medidata Certification Model Helps Rave EDC Study Builders Create New Value for Their Companies. 

Rave EDC Certified Study Builder Program offers a guided learning path to certification for new and existing Rave study builders, and includes core skills and applied skills assessments.

Medidata Launches Global Education Program for Study Build and Study Management Professionals

The very well-attended “Digital Transformation in EU Regulatory Space” opened with speakers from the following entities offering their view of what is required to bring digital transformation to the regulatory environment at the EU. Session chair Rodrigo Palacios is an associate director in Regulatory Policy at Roche. Palacios introduced co-chair Zaïde Frias, head of the digital business transformation task force for EMA offered the current state of the EMA IT landscape describing it as “spaghetti.”

As such, her charge in the task force is significant, and she offered updates for the project, mostly around the training and upskilling for EMA purposes, as well as the current outline to implement transformational considerations.

Jan Geissler, founder and managing director of Patvocates, brought the patient view to the session, including the benefits of a digital transformation for access to trials, but all the challenges of technology, such as a sense of loneliness. But the large part centered on sharing and ownership around patient data, which he described as chickens sitting on their eggs. Chickens being academia and industry who are not willing to let go of their data or eggs.

The industry perspective came from Nick Sykes, senior director, Global Regulatory Sciences for Pfizer, where he offered a leveled a constructive criticism toward the 

 (EMRN) strategy 2025. Sykes believes it falls short on goals and deliverables; setting KPIs, as well as its ability to ensure the strategy announced in 2020 is actually staying up-to-date and adapting to the pace of technology. He also wondered if it was more of a regulatory strategy, rather than a stakeholder strategy.

However, Sykes noted that digitization in the pharma world could be used to help reform a static document strategy to a data focused one, which would be helpful for all parties. He also suggested that digital transformation be broken down to what should be a global collaboration, what should fall under national reformations, and the same for regional. For example, nation and regional interchangeability could help manage discord between EU priorities and national network members.

Lars Bo Nielsen, director general of the Danish Medicines Agency, praised the EMA’s EMRN for the ability to do so much in such a little time. He believes that the speed of digitization is primarily the nature of the reduction in computing and storage costs. Internal trends that are could be transformed by digital are the exponential growth in driving RWD for RWE; enhanced data analysis in assessment in pharmacovigilance and approval during assessment of marketing authorization, and the ability to have common IT systems and harmonization under EMA.

However, Nielsen also noted that the trends of citizen centric data generation and data sharing, along with social media could confound regulators in currently unforeseen ways. For example, he shared that in Denmark, an insurance company was considering an app to allow patients to rate the medicines. Nielsen noted the pressures on both drug makers and regulatory agencies would negatively impact of patients in their country.

Elena Bonfiglioli, lead for health and life sciences, Microsoft, Belgium brought the need for data, specifically AI, to be both responsible AI and generative AI. She said that data needs to be treated with dignity in order to fulfill its promise in health discovery and delivery.

She noted the three things to remember in digital transformation, which it should be

Be able to scale, using standards and skills

Trust based, as a privacy-enhanced data collaboration.

From the non-profit side, Frank Nogueira, CEO of Accumulus Synergy, outlined his organization’s platform and collaborations that could enhance the data relationship and regulatory abilities for both sponsors and regulators.

DIA Europe 2023, March 22-24, Basel, Switzerland. “Digital Transformation in EU Regulatory Space.”

DIA Europe 2023: Digital Transformation in the EU Regulatory Space

Representatives from regulatory authorities of the countries of Malaysia, Australia and South Korea came together in the “International Drug-Device Combinations Session” at DIA Europe 2023 early Thursday. As each described their pathways to approval for combination drug-device products, it became clear that regulation in this area makes sense for each country, but perhaps murky to manage from a global perspective.

In all three countries, the decisions of approval for a drug or a device in a combination situation is determined by the principal mode of action (PMOA). According to Dr. Tony Gill, principal medical adviser in the Therapeutic Goods Administration (TGA) in Australia, and head of the advanced biological and therapies section in the prescription medicines authorization branch of the TGA, the situation of what constitutes a device or a drug in a combination is a complicated scenario of approvals, post-market reporting and involvements of various regulatory sectors, but is predicated on PMOA.

Mariammah Krishnasamy, principal assistant director, head of medical device registration section in the medical device authority for the Ministry of Health, Malaysia, explained here there are two different regulators for the drugs and devices. Again, determining who regulates the combination product is based on the PMOA. In 2018, the two entities came together to propose their guidelines. For both pre-market and post-market needs, the decisions are made between the two agencies on decisions or issues.

In South Korea, Ye-Eun Lee, assistant director, division of novel products approval Ministry of Food and Drug Safety (MFDS) noted that combination products are not classified separately, and when a drug-device product application is submitted to MFDS, the decision is made by the director of novel products, again based on PMOA.

Most countries categorize drug-device combination products as being a single-entity packaged as a drug and device, for example, a pre-filled vaccine syringe and co-packaged combination products.

Session Chair Kathy Wang, regulatory affairs director, devices and digital therapeutics, AstraZeneca (Sweden) followed with audience questions and closed with the following key takeaways: Opportunities for collaboration between countries appear ripe for exploration; that differences exist in philosophies of specific country’s regulators exist on how they approach scientific advice; and the potential to for countries work together to achieve a regulatory framework for combination products.

DIA Europe 2023, March 22-24, Basel, Switzerland. “International Drug-Device Combinations Session.”

Panel finds potential drug rule difficult to manage. 

DIA Europe 2023: Combination Drug-Device Regulation in Malaysia, Australia and South Korea

YonaLink has announced its EHR-to-EDC data integration platform has been implemented by Hadassah Medical Organization (HMO) in Jerusalem. Hadassah is leveraging YonaLink’s SaaS solution to stream and map up-to-date, real-time patient data directly from EHR to EDCsystems, enabling greater speed, quality, and efficiency in clinical trial data collection.

The partnership with YonaLink is part of Hadassah’s larger focus on driving innovation in medical research and making Hadassah and Israel hubs for global clinical trials across therapeutic areas. Using YonaLink’s technology will enable Hadassah to partner with clinical trial sponsors and research stakeholders around the world and expand access to the medical center’s R&D capabilities.

YonaLink’s platform provides the capabilities to stream up-to-date data from any clinical site’s EHR system, in any part of the world, and populate it within YonaLink’s EDC. With built-in eConsent and ePRO/eCOA and streaming EHR-to-EDC capabilities, YonaLink’s EDC provides a solution for today’s clinical trial needs, bringing EDC and eSource functionality together in a single tool.

Hadassah Selects YonaLink’s EHR-to-EDC Clinical Trial Platform to Securely and Seamlessly Integrate Clinical Care and Research Data. 

Medical center in Israel is leveraging YonaLink’s SaaS solution to stream and map up-to-date, real-time patient data directly from EHR to EDC systems.

Hadassah Selects YonaLink’s EHR-to-EDC Clinical Trial Platform to Integrate Clinical Care and Research Data

Emmes has announced the acquisition of Essex Management. Essex offers bioinformatics and health information technology consulting services to government, private sector, and academic organizations. This is the sixth acquisition Emmes has made in just over two years.

Like Emmes, Essex shares a successful track record with the National Cancer Institute (NCI). Emmes has provided a range of statistical and data analysis support to NCI since 1978, and Essex has supported NCI since the company's founding in 2009. Two of Essex's NCI contracts support the Clinical Trials Reporting Program, a database of all cancer clinical trials, and the Clinical Reporting and Research Informatics Initiative. Essex will add more than 100 employees to Emmes' 1,400.

Essex offers bioinformatics and health information technology consulting services to government, private sector, and academic organizations.

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