COVID-19: Forcing a focus on sustainable trials

By Jill Bederoff 

As new clinical studies have hit a brick wall named COVID-19, an acute need for innovative solutions has become apparent – both for the present and for the future.

The impact of COVID-19 on clinical trials has been immediate, due to such challenges as travel bans, hospital or clinic visitation restrictions or social distancing.

“The companies have acted based on the situation in different countries, but clinical trials have been affected in all countries”,

says Karolina Antonov, Head of Strategy at the Swedish Association of the Pharmaceutical Industry (Läkemedelsindustriföreningen, LIF).

“In Sweden, clinical testing has been reduced, but have not come to a complete halt”, she adds.

Pfizer, one of the world’s largest pharmaceutical companies, decided to put new studies on hold in late March, with the exception of those concerning fatal diseases, says Christoph Varenhorst, Country Medical Director for Pfizer Sweden. Sweden takes part in about one fourth of Pfizer’s global trial programmes.

“Now, we’re looking at restarting the trials”, he says. “We’re having a dialogue with the trial clinics, and the situation is looking a little different in different parts of the country”.  

There is a long tradition and a rigorous set of rules and regulations behind the current methods of conducting clinical studies. The industry has been considering changing the process for a long time, but few have dared to translate their thoughts into deeds.

Crises being the mother of invention is a worn cliché, but one cannot get around the fact that the pharmaceutical industry, as have most other industries, has had to rack its brains to a considerable degree since the virus pandemic broke out.

“It’s a pandemic that highlights the need for new solutions”, says Karolina Antonov.

Verifying source data is one of those things that the companies have been focusing on the most during the crisis.

“Usually, this is being done by the monitors going to the healthcare and comparing data from medical records with those registered in the study database. We’re seeing a need here now to be able to do that remotely. We need to work with new solutions together with the agencys”, she says.

To Jenny Söderberg at the Swedish Medical Products Agency (Läkemedelsverket), the need for innovation was obvious. Using money from the Swedish innovation agency Vinnova and a burning desire to make a change, she is leading a unique project on virtual clinical testing.

“As far as I know, there is no other medical products agency in the world that has taken this kind of initiative”, she says.

“In Denmark, there is a similar project, but it is run by Trial Nation Denmark, a private-public partnership where the Danish government agency isn’t included. We’re seeing a great advantage with the agency handling both permits and monitoring also initiating this type of projects”, Jenny Söderberg says.

The focus for the project is to investigate the conditions for carrying out trials that are being conducted in a decentralised and remote way, with some virtual elements. According to the project’s definition, this means that the gathering of data and documentation of treatments and follow-ups will mainly take place at the patient’s own home or near wherever the patient is located.

“Either the person conducting the trial, or a research nurse, will visit the patients in their homes, or examination and documentation will be conducted by phone or by video call. We’re also seeing that the patients themselves are able to document information that’s relevant to the trial, for instance through digital diaries. Virtual elements in this case means the use of technology conducting patient measuring, and that these data are being sent directly to those conducting the studies. Investigating how the distribution of trial medicines could be carried out directly to the patients is yet another issue that’s included in the project”, Jenny Söderberg says.

Following an analysis of the activities included in a trial, all the way from screening to follow-up, Jenny Söderberg and her colleagues in the project have been able to conclude that this type of trials has every ability to be carried out.

In theory, that is. 

“But there is much fear from the actors”, she says. “That’s probably because of the exposure to risk. Clinical trials of medicines mean an enormous investment. You want to be sure that the results gathered are valid, that the conduct has been correct”.

The start of the project, in March, was well-timed, to say the least, considering the fact that the corona crisis had forced the actors to change their attitude. At the same time, this also constitutes a challenge to the project and among the actors concerned, since all focus is now on managing to complete trials that have already begun during these days when all focus is on COVID-19 and the rest is at a standstill, she says.

Part of the project will include a number of pilot trials. These trials will offer applications where fees are being waived and free advice by the Medical Products Agency, saving the applicants costs of about SEK 100,000, according to Jenny Söderberg.

“It’s possible to submit preliminary applications now, and this autumn, we’ll need protocols ready for application”, she says.

“We’d love to see a mix between trials initiated by academies and by companies”, Jenny Söderberg says, adding that she hopes that Vinnova will approve an extension of the project through 2021 so as to enable summing up and presenting the experience gained from the pilot trials.

One actor that has boldly gone where no company has gone before within virtual trials is the Swedish CRO company Clinical Trial Consultance, CTC. 

“We’re working both with studies at clinics as well as with virtual ones, but two years ago, we conducted a study by video link only”,

says the CEO Anders Millerhovf.

“We sent the product home [to the participants], and received their consent by Bank ID. It was very successful”, he says.

CTC has also been using a few other technologies facilitating decentralised studies. One example is “dried blood spots”.

“That means that you take a drop of blood from a person’s finger, absorbing it with something looking like a Q-tip. This enables sampling of the patients on themselves at home and then sending the sample in an envelope”, Anders Millerhovf says.

In addition, he highlights other aids, such as various types of wearables, but for them to be able to be used, they need to be formally approved by the relevant body, which few are at this time

Just as with other industries under pressure to reform and become more digital, Anders MIllerhovf believes that the future here will also consist of a mix between presence at clinics and virtual solutions.

“There are parts that cannot be carried out in a virtual manner, and the personal encounters should not be underestimated”, he says.