The COVID-19 pandemic has scientific trial professionals coping with a complete new world, with journey restrictions, fearful sufferers and different elements inflicting issues. Under, Jackie Kent (JK)—government vp and head of product at Medidata, a Dassault Systèmes firm—tells Outsourcing-Pharma (OSP) concerning the unprecedented challenges created by the pandemic, and potential options for the issues.
OSP: Might you please discuss among the methods the COVID-19 pandemic has shaken up the scientific trial trade?
JK: In the beginning of the pandemic, we had been month-to-month year-over-year adjustments in new sufferers coming into trials to know and grasp the magnitude of COVID-19, throughout geographies and therapeutic areas. We began to see a leveling off and in some circumstances a reversal of the affect in China and Italy, as examples; nevertheless, that leveling off could also be reversing in some international locations, significantly the US primarily based on the surge within the variety of new COVID-19 infections, hospitalizations, and deaths.
Not too long ago, we modified the methodology to take a look at month to month adjustments in new sufferers coming into trials for a similar areas and therapeutic classes. Globally, as of the tip of June, we had been seeing a ~30% drop in new topics coming into trials, utilizing October 2019 because the pre-COVID-19 baseline. This compares to a ~70% drop globally in April 2020.
As talked about above, there’s massive variability within the extent and timing of restoration inside geographic areas, as COVID-19 circumstances proceed to alter in geographic areas, and insurance policies are tailored over time.
From a therapeutic areas perspective, peak affect on new sufferers coming into trials occurred in April. Cardiovascular and oncology trials have recovered globally, with new sufferers being added to check websites at a fee related previous to the pandemic. Cardiovascular trials skilled an almost 90% drop in April versus October ranges for brand new topics coming into trials. Oncology trials have been impacted the least, however in the course of the peak nonetheless noticed a drop of >40% in new sufferers coming into trials versus October. Lagging behind are CNS, Dermatology and ID/Anti-Infectives trials, even with the latest uptick in COVID-19 trials.
Moreover, the affect of the pandemic on websites was properly documented by a Medidata survey of over 1,000 scientific website personnel in late April 2020. The responses clearly indicated that the majority websites felt the unfavorable affect of the pandemic on present and future trials, particularly round delays in affected person enrollment and recruitment.
That mentioned, websites have proven flexibility and ingenuity in adopting new approaches and applied sciences – over half of websites reported switching website affected person visits to digital ones and/or are utilizing telemedicine to work together with sufferers.
OSP: What are among the methods websites and sponsors can work to alleviate a few of these challenges and obstacles?
In our white paper, COVID-19 and Clinical Trials: The Medidata Perspective, we define 4 predominant classes of challenges dealing with scientific trials and among the options that each reduce disruptions to present research and advance new trials:
- Understanding the Evolving Scenario
- Examine/sponsor degree metrics and dashboards to know affect on enrollment, affected person visits, information assortment, question response charges, and extra metrics to assist diagnose danger areas
- Trade-wide dashboards and evaluation to know tendencies globally and areas of better or lesser disruption
- Reconsidering Trial Design to Allow Information Seize
- Shift to extra virtualization – scale back affected person visits; reduce website burden
- Shift website combine to lower-impacted international locations / areas
- Take into account artificial controls to scale back affected person enrollment wants
- Sustaining High quality and Provide
- Centralize information oversight and monitoring actions, bringing identification of affected person anomalies earlier within the course of and away from onsite identification
- Intently monitor affected person quantity and drug provide to reduce provide disruptions
- Accelerating Examine Begin-Up
- Sponsors targeted on creating vaccines towards, and coverings for COVID, should safely and successfully speed up research start-up instances by quicker investigator budgeting, so cures and coverings can get to market quicker
OSP: Might you please go into element about how expertise may help scientific trials streamline their imaging workflow?
JK: Using medical imaging in scientific trials is rising quickly. Roughly 50 p.c of all scientific trials use medical imaging as an endpoint or for eligibility standards. And in therapeutic areas like oncology, almost all trials depend on medical imaging; for example the amount of knowledge generated by these research, Medidata processes greater than 500 million pictures yearly.
Know-how permits us to simplify picture and information acquisition, scale back handbook processes, streamline, automate, and optimize imaging workflow, decide affected person eligibility, monitor illness development or response, and expedite go/no go scientific choices. All this helps to reduce the chance and complexity of medical picture administration in scientific trials and guarantee correct and well timed completion of research targets.
OSP: How can firms like Medidata work with scientific analysis groups to provide you with efficient options?
JK: Medidata delivers scientific operational efficiencies round important processes, making certain real-time visibility and management of ongoing research actions and paperwork throughout all stakeholders.
The corporate has been in a position to supply purchasers the options they should assist deal with challenges from the COVID-19 pandemic. Medidata usually shares analyses on the impact of the pandemic on affected person research enrollment and the response from regulatory our bodies to share with purchasers.
Moreover, the corporate created a COVID-19 process drive to collect info from clients on urgent challenges they confronted resembling restricted means for operations at websites, provide chain disruption, challenges for sufferers to get to websites and information integrity. A few of these elements are captured in our white paper, COVID-19 and Medical Trials: The Medidata Perspective.
Medidata additionally created a discussion board to share info and get suggestions with sponsors on potential options for the numerous challenges created by the pandemic by an everyday Workplace Hours collection. Matters embrace:
- Clever Trials (research design, research feasibility, superior efficiency analytics)
- Medidata Rave RTSM (randomization and trial provide administration)
- Medidata Rave eConsent (distant consent)
- Medidata Rave eCOA (scientific end result evaluation)
- Medidata Detect (centralized statistical monitoring)
This collaborative collection of digital conferences with our clients not solely supplied super insights into their COVID-19-related challenges but in addition how our present options may very well be modified or tailored to shortly assist them pivot to a extra virtualized scientific research mannequin. These options wouldn’t solely overcome apparent challenges with affected person recruitment and trial participation but in addition help sponsors to mitigate their danger round potential information high quality points by numerous types of centralized monitoring.
OSP: Might you please clarify Distant Supply Evaluate—what it’s, the way it works, and why it’s particularly helpful and essential within the face of the pandemic?
JK: Medidata Distant Supply Evaluate (RSR) is a streamlined and quick-to-implement answer that helps fill the hole when research have important timelines and no safe choice to gather, de-identify, handle, evaluation and confirm important research paperwork. It has already been deployed at over 15,000 scientific websites in the course of the COVID-19 pandemic. The excellent news is that this answer is so helpful, secure and cost-effective that it’ll proceed for use and adopted by sponsors after the pandemic has waned,
- Acquires paperwork, through safe browser-based uploads, routes and manages doc workflows to assist supply doc evaluation and verification remotely
- Is a 21 CFR Half 11 compliant system that features the power to de-identify and redact Personally Identifiable Info (PII) and Protected Well being Info (PHI)
- Mitigates danger as a consequence of website monitoring and affected person go to disruption for some research with no safe choice to handle important paperwork
When contemplating a distant monitoring answer, one of the crucial widespread issues expressed from websites is the time and sources required to scan and redact supply paperwork. RSR helps websites by straight connecting to EMR methods so redactions could be made straight within the utility, considerably lowering effort and time.
When there are obstacles to adequately monitor lively research, sponsors shouldn’t be required to make use of much less safe, outdated expertise resembling fax, electronic mail, video, and file sharing software program to handle important paperwork. Regulatory steering in a variety of areas world wide helps sponsors to search out methods to remotely carry out important doc administration and supply information evaluation through a safe cloud-based viewing portal.