Right here, Mark Clements, MD PhD, paediatric endocrinologist, medical investigator, and chief medical officer at Glooko Inc. takes half in a Q&A concerning his views on distant medical trials and information administration instruments
Medical trials have used linked digital merchandise to gather patient-generated well being information for the previous 20 years with a compound annual development charge within the utilization of such merchandise of greater than 34%. (1) Whereas that development elevated quickly already over the previous 5 years, the development got here into even higher focus in 2020 with the onset of the global COVID-19 pandemic.
With the arrival of the virus, many medical analysis trials – as excessive as 80% – got here to a sudden halt as a result of trial centres needed to stop internet hosting trial contributors for on-site information assortment as a result of security causes. (2) In response, a huge quantity of medical trials had been revived by means of linked digital merchandise for distant information assortment, the use of real-world information and real- world proof, and the capabilities of contemporary medical analysis platforms. With out such platforms many – if not most – of the impacted trials would proceed to be at a standstill.
Mark Clements, MD PhD, paediatric endocrinologist, medical investigator, and chief medical officer at Glooko Inc. is an professional. His focus contains linked digital merchandise, real-world proof, and medical analysis platforms in help of CROs and life science firms. The next is Q&A overlaying Dr. Clements’ views on distant medical trials and information administration instruments:
How has the arrival of the pandemic impacted the acceptance of telehealth visits and distant affected person monitoring and, by extension, the decentralised/digital medical trial mannequin?
There was a large enhance in telehealth visits with the arrival of the pandemic, however even simply earlier than the pandemic, there was proof that the pondering of physicians was evolving concerning the utility of patient-collected information. (3) For instance, within the U.S., Stanford Medication’s 2020 Well being Tendencies Report (launched Jan 2020) reveals 80% of docs consider self-reported information from sufferers’ well being apps is clinically useful, and 83% mentioned there’s medical worth in information obtained from wearable gadgets.
Further causes for physicians’ altering attitudes are as a result of following: (3)
- Wearables have confirmed to be correct, dependable and helpful, e.g. A Fitbit used for measuring blood oxygenation.
- Excessive profile analysis demonstrating promise and utility of wearables, e.g. Apple Coronary heart Research.
- Latest expertise developments whereby information administration techniques can reliably movement patient-reported information straight into an digital information administration, enabling docs to view all related affected person information by way of a singular portal like diasend® by Glooko.
In response to the pandemic, there’s ever-rising demand for distant information assortment from medical researchers for randomised managed trials (RCTs), together with decentralised/digital medical trials. (3) In March of 2020 within the U.S., the FDA issued pointers, recognising the boundaries to conducting in-person RCTs safely throughout the pandemic. Researchers had been inspired to think about options for affected person assessments and information assortment in RCTs, together with distant information assortment and remote patient monitoring by way of acceptable applied sciences and cellphone or video visits. (4)
With Glooko’s medical analysis platform and its capabilities for distant information assortment and administration, we now have mitigated danger throughout the pandemic and have created broad openness to the decentralised trial mannequin, thereby introducing a serious shift in how trials are run.
In your opinion, what are the capabilities of Glooko’s medical analysis platform which have enabled in-person RCTs to both convert extra visits to distant visits or to transition to a wholly decentralised/virtual trial model?
The platform is really ‘analysis grade’ and capabilities embrace:
- Protocol design.
- Website choice and affected person recruitment.
- Information assortment.
- Affected person monitoring and examine administration.
- Information export.
- Potential to help product lifecycle throughout all phases of clinical research.
- (Phases 1, 2, 3 &4)
- GDPR and HIPAA compliant in a position to securely gather and defend delicate private and well being info and importantly, certification as FDA 21 CFR, Half 11 compliant, recognising the system meets the factors underneath which digital information are thought of reliable to be used instances akin to medical analysis.
What are you seeing with regard to regulatory authorities, researchers, and healthcare professionals recognising the worth and significance of real-world proof (RWE) for CRTs?
Through the pandemic, researchers have been utilizing RWE in medical trials, for instance, to offset the burden and problem of recruiting trial contributors by facilitating the creation of artificial management arms and standard-of-care arms. (5) Pandemic or not, the usage of RWE advantages embrace:
- Serving to researchers perceive many facets of diabetes care, together with the advantages of earlier behavioural and therapeutic interventions, which can’t be understood from standard RCTs. (6)
- Making it potential to conduct longitudinal analysis in methods which can be sooner and more cost effective than what is feasible with standard RCTs. (6)
- Utilizing the RWD to copy, lengthen and make sure the proof generated by RCTs. (7)
- Extending the outcomes of RCTs to affected person populations which can be often not nicely represented in RCTs. (7)
- Offering outcomes and views which can be more true to how sufferers truly use medical gadgets than is feasible with information generated within the extremely managed setting of a CRT. That is significantly necessary for classes the place there’s common and vital affected person interface with the expertise, e.g. diabetes (e.g. CGM, insulin pumps, and so forth.) the place therapy and monitoring could also be occurring each 5 minutes.
In abstract, medical analysis platforms are in a position to present wealthy units of RWD which can be invaluable for researching a variety of interventions, variables, and particular affected person populations.
And Glooko is the one diabetes-specific medical analysis platform enabling distant information assortment and providing the world’s largest repository of real-world diabetes affected person information, with greater than 20 billion information factors.
- Caroline Marra, et al. “Quantifying the usage of linked digital merchandise in medical analysis,” npj Digital Medication (2020) 3:50.
- IQVIA Q2 earnings name, 2020.
- “HCPs lastly embrace the patient-reported-data revolution,” Medical Advertising and Media, 10/15/2020
- “FDA Steering on Conduct of Medical Trials of Medical Merchandise throughout COVID-19 Public Well being Emergency,” March 2020(Up to date 9/21/2020)
- “Easy methods to Leverage Actual-World Information as COVID-19 Transforms Medical Trials,” Sarah A. Alwardt, Focused Oncology, 10/27/2020, 9(14):75
- “Bettering diabetes remedies and outcomes with insights from actual world information,” Elizabeth Adamson, Naomi Boxall and Matthew Reaney, IQVIA Weblog, 6/7/2020
- “Utilizing RWE analysis to increase medical trials in diabetes: An instance with implications for the long run,” John D. Seeger, et al, Diabetes, Weight problems & Metabolism, April 2020, 22(Suppl. 3): 35-44
*Please be aware: This can be a industrial profile