Technology and Clinical Research in COVID times.

June 23, 2020

The emergence of COVID-19, in addition to a colossal health and humanitarian crisis, has brought shock to most sectors of our economy. I think that it is not worth dedicating many (more) lines to cover how COVID-19 is going to change forever sectors such as hospitality, tourism or mobility, and yet I want to stop at one that affects all of us more or lesser measure.

Clinical Research is one of the main activities these days. We have never read so assiduously about studies and clinical trials in general media (with more or less scientific rigor), reason for which one may tend to think that the main sectors surrounding these studies and trials (pharmaceuticals, CROs) have probably been economically benefited by the circumstances. Without wishing to enter who is or is not benefiting from this crisis, those of us who work in this sector on a daily basis know that there are many practical difficulties that COVID 19 has imposed on the field of clinical research.

To begin with, those who promote studies and clinical trials are finding important limitations when it comes to accessing hospitals. Whether for obvious security reasons, for saturation of the centers or for the promoters’ own policies, today it is more complex than ever for a promoter to have a physical presence in a center, either to promote a certain study or trial, to perform monitoring tasks or to collect clinical data in a Data Collection Notebook. Additionally, researchers’ time in clinical centers is today extremely limited. Even with the virus in decline and the ERs less saturated, healthcare personnel still do not have the time they had before to collaborate in clinical research activities (and this time was already limited!). Therefore, it is nearly impossible to involve them in activities such as manual data collection or manual patient selection. And, finally, access to patients. Except for urgent need, how realistic is it to expect a patient to get exposed to the risk of contagion from a hospital by attending a daily review, in the framework of the clinical trial in which they are participating? How realistic is it to make him come to sign an informed consent in person?

All facts considered, and derived from these and many other complications, data from GlobalData and PWC indicate that up to 50% of the studies and trials in progress could be affected 1 and 75% of the promoters assure that they will have delays 2. In this situation, faced with the possibility of a new outbreak of COVID-19 and without any signs that previously mentioned restrictions will completely disappear, one of the most repeated mantras emerges these days: the crisis of COVID-19 is going to encourage technological adoption. And it does, for several reasons. If we go over the circumstances described above, tools such as telemedicine, electronic consent or applications for the collection of results reported by the patient will surely come to mind, but I would like to highlight another field: data. What if there was no need to physically send staff to clinical centers for monitoring? What if no one had to manually enter clinical data into a Data Collection Notebook? What if there was no need to take up physicians’ time, to recruit patients for clinical trials?

The solution to these questions lies in the right use of clinical data by hospitals, for which, first, they must have data. For the purposes of what interests us in this post, data has been “buried” in clinical records of hospitals. And we say “buried” because most of the clinical data is hidden in text formats that do not allow their exploitation. It is therefore about transforming text into data, and this can be done by using a variant of Artificial Intelligence known as Natural Language Processing (NLP). Through NLP, a hospital can transform, in a very short space of time, all the clinical digitized information into exploitable data, which will then be used to participate in studies and clinical trials without the need for anyone to manually go over patient’s records, or without the need to steal precious time from healthcare personnel. All this can be done in a fraction of the time and, and looking into infinitely larger populations of patients.

One last requirement with which I close this post: data belongs to the patient. The patient has only authorized the hospital to use it for certain purposes (which, according to GDPR, includes research) and therefore only the hospital can decide how and for what this data is used. To do this, hospitals must be able to control this data, which implies that data must always be stored in the clinical center or its infrastructure. No room for half measures.

[1]: Erin McCallister (20 de marzo de 2020). COVID-19: Clinical trial delays likely. Disponible en: https://www.pwc.com/us/en/industries/health-industries/library/clinial-trials-delayed-3-20-20.html

[2]: Globaldata (14 de abril de 2020). Coronavirus (COVID-19) Executive Briefing. Disponible en: https://globaldata.com/covid-19/