COVID-19’s negative impact on clinical trials–can remote patient monitoring and telehealth companies help?

We’ve previously noted the interest of large drug clinical trials companies in remote patient monitoring–example the acquisition of the much-passed-along Care Innovations by PRA Health Sciences [TTA 8 Apr]. Logically, these clinical trials have been hampered by the COVID-19 pandemic, affecting recruitment, data sharing, preservation of data, and how trials can be conducted.

TMF Futures: Keeping Data Alive has just been published by Arkivum, a University of Southampton (UK) spin-out which specializes in the digital preservation of valuable data for the life sciences industry and global scientific institutions through the Arkivum Trust. This initial survey was conducted in July 2020 by Arkivum, Phlexglobal, the Ethical Medicines Industry Group (EMIG), and Survey Goo. The 206 senior representatives surveyed all have responsibility for/knowledge of clinical trials, with senior and director-level positions in general and senior management; regulatory; quality assurance; clinical; operations.

TMF refers to the trial master file that is required by FDA and EMA. Paper TMFs have largely converted to electronic form (eTMF). Life science organizations have also largely transferred data to eClinical applications. Despite that, the survey found that 45% of clinical research organizations (CROs) struggle to manage, locate and report data, while 50% are unable to convert documents from multiple software applications in order to make them usable. 

Topline findings of the survey:

  • 74% of respondents say that COVID-19 will continue to compromise their ability to deliver on clinical trial objectives for the next six to 12 months;
  • 70% say that COVID-19 has triggered a change in the way clinical trials will be conducted;
  • Interoperability between eClinical applications used in trials remains a major challenge – for example, 39% of all respondents and 50% of contract research organizations are unable to convert documents from multiple eClinical applications;
  • Current archiving of clinical trial data is not always fit for purpose – for example, 65% of compliance, legal, and regulatory professionals describe their ability to access data as ‘extremely inadequate’ or ‘very inadequate’.

Of interest to our Readers is page 11 of the survey, which found that 56% of respondents believe that there will be increased remote patient monitoring in post-COVID clinical trials, and that 22% believe that new technology will be developed to shorten clinical trial duration and reduce cost. In addition, recruitment has to come from more diverse areas and to mitigate the difficulty of finding people to be in clinical trials.

For telehealth developers, providers, and software developers who have the systems, data, and access to patients/users, clinical trials and CROs may be a strong future market. We may also have profitable insights into interoperability and data sharing.

To obtain a free copy of the survey, fill out the short form here. Arkivum press release. Hat tip to Penny Lukats of SENSO Communications (UK).

The Future of Clinical Trials in the Post-Pandemic Era: HITLAB Seminar Series 6 May

Wednesday 6 May, 11am to 12 noon Eastern Daylight Time

How can virtual trials improve patient enrollment, retention, and engagement in a clinical trial? How much of the future CRO model will be defined by digital solutions? These are two questions key for many digital health companies as they expand and/or pivot their business model. Answering these questions will be the task of the panel discussing “Clinical Trials in the Post-Pandemic Era”, a free virtual midday seminar hosted by HITLAB in New York.

Panelists are: Joris van Dam, Head of Digital Therapeutics at Novartis, Natalia Kotchie, Vice President R&DS Applied Data Science Center at IQVIA, Bill Taranto, President & General Partner at Merck Global Health Innovation Fund, and Jeff Ventimiglia, Senior Vice President, Medidata Solutions (sponsor). The panel will be moderated by Professor Stan Kachnowski, Director of the Digital Health Strategy program at Columbia Business School.

Seats are limited to 1,000. Registration is necessary through Eventbrite here. Registrants will receive a follow-on email with instructions on how to access the webinar.

PharmaTech Innovations/Health 2.0 NYC Wed 19 July –speakers confirmed, reserve now!

Wednesday, 19 July, 6-8:30 pm at Cohn Resnick LLP, 1301 6th Avenue, NYC

Health 2.0 NYC‘s July event examines innovation in the pharmaceutical business. It’s changing radically, from companies like PillPack which disrupt traditional pharmacies to apps that monitor clinical trials or prescribed as adjuvant therapies. Presenters on Wednesday night include:

  • Dan Conely – Managing Director, NJ Angels, active investor in drug discovery automation
  • Grace Cordovano, PhD – Enlightening Results – CEO and private cancer patient advocate. She founded Enlightening Results, LLC in 2010 to foster private, personalized patient advocacy services.
  • Jodie Gillon – Achillion Pharmaceuticals, Senior Director, Patient Advocacy and Professional Affairs

Early stage companies presenting: ClearRx. Other speakers/presenters to come. 

For $25, you get engaging speakers, beverages, food, and plenty of networking time amongst the like-minded and leaders in health tech! More information and registration on the Health 2.0 NYC Meetup page. (Disclaimer: Editor Donna is an event host and TTA is a long-time sponsor and supporter of Health 2.0 NYC) 

Google X develops health tracker–for research and clinical trials only

And it’s not for sale. The life sciences group within Google X is testing on small groups a wrist-worn device which can sense with high accuracy pulse, heart rhythm, skin temperature and environmental information like light exposure and noise levels. Bloomberg News, which appears to have broken the story, quotes Andy Conrad, head of the life sciences team at Google: “Our intended use is for this to become a medical device that’s prescribed to patients or used for clinical trials.” Obviously it will be more accurate both in hardware and in back end algorithms than what’s currently marketed via Android Wear for smartwatches. Perhaps this is meant for the ‘superusers’ of healthcare services at the top 5 percent using 50 percent of spend, the new ‘It Girls’ of healthcare, TTA 28 May)? However, he’s also projecting out 20-30 years, so health systems and researchers, do not hold your breath waiting for this to become reality. (This is also a counter to Apple’s ResearchKit.) Also Yahoo Finance and The Verge, which has a gigantic photo of a smartwatch but no caption attribution. The Verge also mentions their research in MS. Gizmodo also adds that Mr Conrad is directing the Google X Baseline project, which is doing human testing and crunching data to develop a baseline of normal human health.

More about Google X in this video interview on Tested with Astro Teller (for real), ‘captain of moonshots’ for the company, on ‘thinking big and failing quickly’. (24 minutes)

Medivizor patient info site goes public with additional information

Medivizor, which was one of the better discoveries of our CE Week (NYC) coverage and the H20NYC/Healthcare Pioneers evening back in July [TTA 3 July], has moved out of what was a largely private beta to what they interestingly term a ‘public beta’. The site provides individualized content, understandable by the layman, for subscribers on a larger group of diseases which were on track for this fall: lung, colorectal, breast, and prostate cancer, as well as melanoma, diabetes, coronary artery disease, hypertension and stroke. The goal is to improve doctor-patient communications by better patient education. Another important feature is a “personalized system for matching individuals with specific clinical trials available worldwide.” Company release, Xconomy article.

A related New York Times article is an appreciation of how physicians are overwhelmed by information and that “doctors also need a skilled docent to help walk them through all that curated data.”  Healing the Overwhelmed Physician