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

September 30, 2020 | by

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).

Pharma company ‘breaks the Internet’ with Kim K, gets FDA testy

August 14, 2015 | by

But it may break them…well, give them a fracture. Or a good hard marketing lesson. Specialty pharma Duchesnay thought it had hit the jackpot with negotiating a promotional spokeswoman endorsement from pregnant celebrity Kim Kardashian of its morning sickness drug Diclegis. The Kardashian Marketing Machine cranked up. Kim (and mom Kris Jenner) took to Instagram, Facebook and Twitter in late July with (scripted) singing of Diclegis’ praises to their tens of millions of followers. The Instagram posts linked to an ‘important safety page’ a/k/a The Disclaimers. That wasn’t near enough for the Federal Drug Administration (FDA) which governs the acceptable marketing of all drugs in the US. On August 7th a tartly worded letter arrived at Duchesnay’s Pennsylvania HQ cited multiple violations of marketing regulations, notably risk information, and told Duchesnay to cease these communications immediately or withdraw the drug, which would be highly unlikely as it is successful. They also were require to provide “corrective messages” to the “violative materials”.

Our takeaway:

* Duchesnay reaped a bounty of free media (see below), on top of the (undoubtedly expensive) Kardashian endorsement. Yes, they did pay the cost of a FDA nastygram and a legal response, and the warning will live on in their file. However, a lot of target-age women now know Diclegis and others know about the relatively obscure Duchesnay.

* This was a calculated marketing risk that tested the boundaries of social media and celebrity endorsement. (more…)

Bayer AG enters the healthcare accelerator game (DE)

September 9, 2014 | by

Bayer HealthCare AG’s Grants4Apps program announced its support of five startups that, in their words, will support improved outcomes or pharmaceutical processes. Unlike companies like GE or Pfizer, Bayer is outright granting a substantial amount of cash to each–€ 50,000–and offering space plus 3 1/2 months of mentoring in their Berlin HQ in return for the usual small equity stake. Of 70 applications, five were granted to European companies which will have their Demo Day on 1 December:

  • Cortrium:  their C3 device is a state-of-the-art wearable tech sensor for clinical-quality hospital wireless monitoring of health data including electrocardiogram (ECG), body surface temperature, respiratory rate, and body posture/physical activity. Blood oxygen and blood pressure to come in 2015. (Denmark, spun off from Nokia R&D)
  • PharmAssistant: self-management tool for chronic disease patients, consisting of a smart pill container and a remote cloud-based monitoring service (Portugal) (more…)