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Q&A Follow-Up to Inaugural CRO Roundtable

Susan Jalbert
Director, Alliances & Channels

On August 11, 2020, Oracle Health Sciences hosted the Inaugural CRO Roundtable event on How COVID-19 Changed CRO Innovation Strategies. Our distinguished panel of guests included Tracy Mayer, Vice President and Global Head, Clinical Data Management and Connected Devices, IQVIA; Rob King, Chief Operating Officer, FHI Clinical; Raghu Chintala, Vice President, Information Technology, ICON; Bola Oyegunwa, Vice President and Head of Virtual Trials, Covance. The panelists discussed how the impact the pandemic has had on their innovation strategies and adoption of new technology. Due to an overwhelming response we wanted to reply to the outstanding questions.

Q. Is anyone addressing a shift to open source analytics tools like R?

ROB KING, Chief Operating Officer, FHI Clinical

FHI Clinical is not utilizing R for statistical computing and visualization. We use SAS and expect to do so for the foreseeable future as a service provider due to the overwhelming prominence of it in our industry. However, there are clearly advantages that should be considered in using other analytic tools such as R, Python or BI. We do use BI for our internal reporting and visualization.

TRACY MAYER, Vice President and Global Head, Clinical Data Management and Connected Devices, IQVIA

Yes, this is a common question we get from customers. IQVIA has experts in source analytics tools to respond to the rapidly growing demand for it.

RAGHU CHINTALA, Vice President, Information Technology, ICON

ICON is in the process of using R within the organization.

 

Q. Is home health care considered a data collection tool?

ROB KING, Chief Operating Officer, FHI Clinical

Home health care is considered an extension of the investigator or primary physician’s oversight of patient care in clinical trials. Home health care is a great way to conduct certain assessments or procedures in the convenience of the patient’s home. In that regard, home health care workers may collect data around those assessments or procedures that are pertinent to the case report form.

RAGHU CHINTALA, Vice President, Information Technology, ICON

For some specific studies home health care can be used for collecting data. Especially if wearables are used for some specific indications.

 

Q. With these new technologies adoption, how can we reduce the timelines for database go-live and database lock?

TRACY MAYER, Vice President and Global Head, Clinical Data Management and Connected Devices, IQVIA

A comprehensive data strategy is the most effective way to accelerate data driven processes like database go-live and database lock. The strategy should include end-to-end data standards and include effective governance to ensure compliance to those standards, as well as standardized operational processes to accelerate database builds. It also would accommodate the growing number of new technologies as data sources in studies and aggregate them in a centralized repository. The centralized data repository would facilitate downstream processes like real time data cleaning and self-service data availability which can help accelerate database lock and analysis/reporting activities.

 

Q. What impact has the need for rapid deployment had on trials staffing, (i.e. number of resources engaged, shifting of resources, etc.)?

ROB KING, Chief Operating Officer, FHI Clinical

At FHI Clinical, we have had to increase our staffing in certain areas in order to complete study tasks in a dramatically shortened timeframe. This includes increased staffing in feasibility, study start-up, contracts and budgeting as well as database design. We have divided processes into well-defined smaller tasks in order to allow more staff to divide the work and complete each individual task quicker.

TRACY MAYER, Vice President and Global Head, Clinical Data Management and Connected Devices, IQVIA

Rapid deployment highlighted the need for staffing agility and increased dependence on organizations like CROs to provide qualified resources on a broader scale that could quickly be mobilized.

RAGHU CHINTALA, Vice President, Information Technology, ICON

Assuming that this question is referring to rapid staffing on COVID-19 trials, we are using a combination of hiring external resources, training junior members of the staff, and redirecting specific resources to enable rapid deployment of resources and expediting the timelines for those studies.

 

Q. In absence of face-to-face interaction of investigator with patients, how are adverse events or serious adverse events are managed?

ROB KING, Chief Operating Officer, FHI Clinical

We are leveraging telemedicine but yet there are limitations to it. Many of the clinical trials that FHI Clinical has conducted recently have been in hospitalized COVID-19 populations where this has not been an issue. For other ongoing trials we have revised study protocols to allow for solicited or unsolicited patient self-reporting either through scheduled or unscheduled telemedicine. For those patients with adverse events that require medical intervention, patients are directed to locally appropriate medical services and follow-up is conducted by the investigational staff for obtaining and capturing pertinent study data.

 

Q. What is the trend of compliance to the libraries?

TRACY MAYER, Vice President and Global Head, Clinical Data Management and Connected Devices, IQVIA

Lack of compliance is still a big issue/trend and one of the biggest inhibitors to efficiency in the database build process. For COVID studies, many companies were forced to comply with standards at a rate of 80% or more in order to achieve database builds in 3 weeks or less. After achieving COVID timelines that were 50-75% better than standard build timelines, the trend is towards exploring how similar practices with respect to higher standards compliance rates could impact builds in other therapeutic areas.

 

Q. The Real Time Data Cleaning is the future in the data cleaning, but all the stakeholders (i.e.: TPVs) need to be aligned to this new process and accept a much more frequent data transfer, am I correct?

TRACY MAYER, Vice President and Global Head, Clinical Data Management and Connected Devices, IQVIA

Yes, it is important to get alignment from TPVs to support RTDC. It is possible now to build capabilities in a system that automate ingestion of TPV data on a daily basis (or more frequent, if required) and aggregate it within a centralized repository with all other data sources. The aggregated dataset is available in near transactional time to support RTDC and automatic data availability requirements. The automation of the process makes it easier to get TPV alignment because there is very little they have to do to support more frequent transfer after the initial setup.

Missed the CRO Roundtable? Watch the recording

Don't miss our upcoming webcast with Pharmaceutical Executive on September 29 with Incyte, IQVIA, CSL Behring and Parexel on COVID-19's Impact on the Digital Transformation of Clinical Trials

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