MedidataNEXT Conference 2020: Our Take
Adaptive Clinical Systems was pleased to have been invited as a partner to the 2020 MedidataNEXT Conference. By going virtual, the conference was open to even more people with 2,500 attendees representing more than 40 countries. This is outstanding!
The keynote by Glenn de Vries and Tarek Sherif mentioned the particularly challenging, but also exciting time we find ourselves in. This was an excellent industry conference. The theme of the conference, “Patient First,” is in harmony with Adaptive’s own webinar, “Patient is the Source.” The other recurring themes included a focus on data, and virtual trials moving to digital trials. Exciting times for our industry, and one in which Adaptive Clinical has a unique advantage. More to come…
Accelerating Innovation in Life Sciences from Concept to Commercialization
The second keynote, “Accelerating Innovation in Life Sciences from Concept to Commercialization”, included leadership from Dassault Systems and Medidata. This included the following speakers: Bernard Charles, CEO, Dassault Systems; Claire Biot, VP Life Sciences, Dassault; Pascal Daloz, COO, Dassaul; Tarek Sharif, Co-CEO, Medidata; and Glenn de Vries Co-CEO Medidata.
Bernard Charles updated attendees on the progress that Dassault Systems and Medidata have made over the last year in strengthening their services for customers. This session noted that by combining data and data science, meaningful change can be driven in new ways. The two companies are stronger together because of their complementary strengths. The patient is now at the center of all they do. By better harnessing data, the companies are better able to help their partners more rapidly launch ever-more complex trials.
COVID-19 and the Impact on Clinical Trial Conduct
Scott Gottlieb, M.D., and former chairman of the FDA, spoke on the topic of the lasting impact of COVID-19 on clinical trials. The session, “A Patient-Centric Discussion of the Lasting Impact of COVID-19 on Clinical Trial Conduct” also included Alison Cave, ICSF Challenge Director, Innovate UK. This wonderful session highlighted the real-time data considerations quickly impacting patient care. There will be challenges of standardizing and harmonizing global data standards. The FDA is moving towards a fully cloud submission model in which they will pull down the sponsor’s data, and then transform and standardize in their format. The EU/EMA has five pillars for moving forward: data accessibility, data governance, regulatory process, training of regulatory colleagues, and how to provide support. This will allow each country’s regulatory body to work with data against their own standards.
Other highlights of the session included these industry changes due to COVID-19:
► Know the data: It doesn’t have to be perfect. Know how data fits within the regulatory process
► Early detection: There was a lack of testing resources early on for COVID-19, which made the pandemic more difficult to track and manage
► Ethics Challenges: Early screening can raise ethical questions: Who gets it? How to treat, if no symptoms?
► Cultural Change in Clinical Trials: COVID is driving cultural change supporting remote versus centralized trials. This trend will accelerate.
Virtual Trials go Digital! D-Trials!
Medidata Detect Presentation – It’s all about the Data! We enjoyed the presentation about Medidata Detect. Over the last decade, there has been an 88% increase in the overall volume of patient data collected within clinical trials.* With this increase in data volume and types, comes the challenges of siloing of data sources, manual data review processes, and non-integrated technology. All further emphasizing the risk of missing critical data errors, anomalies, and trends, and the need for automated data review and for better access to real-time data visibility across stakeholders. Participants learned more about the:
► Value of centralized and automated data quality review
► Importance of enhanced centralized monitoring with data-driven site issue identification
► Strategies to ingest massive data sets such as lab data and sensor data
► How Medidata Detect uses advanced analytics to identify both known and unknown key risk indicators, anomalies, and trends across any data set
The automated flow of issue management information with a closed-loop process for issue identification and action. Medidata Detect operates with MEDS (Medidata Enterprise Data Store) using the CDS Workbench which is the data ingest mapper into a SDTM-like format based on domain.
How to make 360 Patient view
During this session, an in-depth discussion of patient data in decentralized trials was reviewed.
The importance of a complete view of the patient was stressed as sponsors move to
decentralized and digital trials. By using a combined view of data from the EDC and ePRO to
identify patient risk in real-time, clinical trial managers must be able to have outliers show
almost immediately compared with all other data. For example, an outlier could indicate a need
for patient retraining. A patient routine may be:
❶ Check biosensor is seated properly in the am
❷ Make sure urine strips are within reach in bathroom
❸ Scale is powered up and paired with the app
❹ ePRO app is active and ready for data entry
Trial managers should ask themselves, “As we increasingly rely on the patient, do we need patients who are savvier and more comfortable with managing tech? Or is it that we don’t need more sophisticated patients, but we need simpler devices?”
Leaders have expressed concern that eCOA analytics is at the mercy of patient training. Tools are available, such as the Adaptive eClinical BUS, that can provide instant bidirectional feedback to the third-party tool if data entered by patient is an outlier and unexplained. A warning or alert can be issued to the eCOA app, “Are you sure you entered the correct data?”
Clinical trials are entering a new era with devices generating data by the millisecond. This is unprecedented for clinical trials. Data aggregation, harmonization and filtering is going to be key. Data review in real-time will accelerate study. It’s going to be critical that Clinical Trial managers and data scientists have efficient and interoperable data that they can quickly review.
The Patient First Cultural Change
In this panel discussion, State of Patient-Centricity Advancing from patient-first intentions to true co-creation, the panelists discussed the cultural shift that is enabling better collaboration with patients. The panelists were:
Emily Wasik, Senior Editor and Analyst, The Economist, Intelligence Unit
Alicia Staley, Sr. Director Patient Engagement, Medidata
Jessica Scott, Head of Patient Engagement, Takeda
Emily Kramer-Golinkoff, Co-founder, Emily’s Entourage
The highlights of this session included:
► There is a need for culture change that enables collaboration.
► Historically, clinical trials have been science-driven without input from the patient. Little awareness of, or planning for the patient burden in a trial.
► COVID-19 has increased patient advocacy, empathy, and centricity
► Takeda is delivering a model for the industry with KPI’s implemented to track and drive improvement
► Companies that do patient-centricity well will have a competitive advantage
► How technology can help ease the patient burdent
About Adaptive Clinical
With data entering unprecedented levels, and clinical trial managers looking for data anomalies more quickly, Adaptive Clinical Systems has the solutions needed to get to the right data quickly. To quickly incorporate new tools in virtual or digital trials, the Adaptive eClinical Bus® solution helps improve clinical trial operations through interoperability. The Adaptive eClinical Bus® gives our clients the freedom to choose the best eClinical tools of any third-party or proprietary systems while enjoying the benefits of a fully integrated system. The Adaptive Rules Engine makes it easier to monitor disparate data from multiple eSources including EMR, EHR, remote monitoring, RWE and more. We enjoyed being a part of this global discussion. Thank you to the leaders at Medidata for another outstanding event. To learn more about our solutions, download our brochure.
Source: *Tufts Center for the Study of Drug Development (CSDD)