The New Era Of Informed Consent

Technology promises to transform the knottiest area of the industry



Ensuring that patients receive the best information and give truly informed consent has been a perennial challenge for trial sponsors, but innovations in this area are transforming the process.

Pharma companies are increasingly harnessing technology in order to deliver a better clinical trial experience for both patient and sponsor, and a critical area in which eTools can provide meaningful benefits is that of informed consent. Yet these new approaches to how patients learn about trials and ultimately give their consent face myriad ethical and practical challenges.

Janssen is one of the companies at the forefront of this, and Cassandra Smith, Associate Director, Clinical Insights & Experience, tells eyeforpharma that a small but important component of a much broader undertaking to become more patient-centric was the introduction of electronic consent (eConsent). This was a “challenging but necessary” move, says Smith.

“Informed consent is something that pains many clinical research Sponsors,” she admits. “Most companies have issues balancing patient-centric language and lay language and all the legal-ese and scientific and technical concepts. Janssen wanted to do our part to figure out how we could simplify things from our end.”

The organisation is working to improve informed consent overall, by examining the templates, the design and the language, she explains. Research into which elements of consent patients found most tedious or stressful delivered unprecedented insight into how patients read consent forms, as well as the emotions, positive or negative, associated with the content. Patients articulated their feelings about the language used and the format of consent forms – lengthy, wordy sections were a no-no, for example. Janssen then engaged in a process to co-create a new informed consent document with patients – this was hugely successful, says Smith.

The next step was to introduce eConsent. The concept has been around for a couple of years, but many companies remain fearful due to the paucity of regulation in this area. Yet Janssen decided to tackle these problems – meaning long-term gain for some short-term pain.

“There are significant challenges, but we can overcome them, and we have overcome them,” she states happily. “When regulations and legislation continue to mature around electronic signatures and some other issues that our industry faces, I think it will be an easier road, but we still have to press forward.”

Globally, the company has had to focus on how eConsent can be compliantly and effectively deployed in the absence of regulations. Smith notes there are only two countries that have any formal guidance pertaining to eConsent; in the US, the FDA issued a guideline for the use of electronic signatures at the end of 2016.

“That has been wonderful, as that’s what we have been using as our guide as we work to implement eConsent across all our countries. Canada is now also looking at some sort of implementation guideline for eConsent, and the UK has been on top of it with the HRA/MHRA’s joint statement on eConsent that was issued in September 2018. The reality is most of industry is running global trials, and that’s the differentiation Janssen has made, we are not just keeping eConsent to our studies in the US, we are expanding eConsent in a global nature by speaking to ethics committees and regulators.”

Ultimately, Janssen wants to deliver eConsent as part of the informed consent process, making it de rigeur for their trials. Smith says that following completion of their pilots last summer, the organization is now exploring full implementation across all their clinical studies.

And what does the future hold for informed consent? Virtualization of trials is the hot topic, says Smith.

“One topic that continuously comes up, is BYOD or bring your own device in eConsent, meaning the ability to remotely consent patients with a device they already own such as a smartphone or tablet,” she notes.

“That is something that we can do from a technology perspective, absolutely, the challenge really becomes how can you ensure that patients are adequately consented and that investigators remain having oversight of the informed consent process – how can they do that if patients are permitted to give consent remotely? It is about becoming more comfortable with eConsent and ultimately expanding out into virtual trials.”

Janssen are currently seeking to employ eConsent in one of its virtual trials, but, crucially, it is non-interventional, adds Smith.

Further down the line, integration of the eConsent system with some of the other clinical trial systems would lead to a truly patent-centric clinical trial process, she says.

“Say with randomization, if eConsent and the IWR/IVR system could talk, the investigators save a step and they don’t have to do double data entry. Also a little further out is having the ability of eConsent to track lab systems, which is another huge burden for industry, such as linking informed consent to a lab sample. That means if a patient withdraws their consent, or when the time period for retaining samples is over, there is a way that we can effectively send word down the chain to ensure samples are destroyed appropriately.”

Christian Hebenstreit, General Manager and Senior Vice President EMEA at Medidata, agrees with Smith that the conversation around eConsent is becoming harder to ignore for clinical trial organizers. Medidata’s virtualization of clinical trials has been streamlining the consent process for some time now, and last year they received a Scrip Award, with their solution Rave Engage being named one of the breakthrough technologies of 2018.

“We have been working on this topic for quite some time – it’s becoming more and more current when we are talking to clients, patient groups and regulators. Technological innovations can help improve quality of life of patients and also de-risk clinical trials and accelerate the process,” Hebenstreit tells eyeforpharma.

“From a patient perspective, when you enroll in a clinical trial you need to inform yourself thoroughly in terms of what will happen to you, the treatments, any specific reactions your body may have to the treatment. Consent forms that are 50 or 60 or even 80 pages long are not helpful for a patient who is nervous embarking on a clinical trial, nor is it suitable for vulnerable patients, such as younger patients or those with reading or sight difficulties,” he says.

Hebenstreit says Medidata’s thinking is that there has to be an easier way to let patients know what will happen to them during as trial, while also obtaining their consent. “For people affected by a serious illness or disease, that is a very intense and difficult period in their lives,” he says, explaining that the most appropriate solution will depend on the particular trial.

Medidata are already working on the BYOD model. Hebenstreit explains that their goal is to make use of technologies that are already there, such as iPads, iPhone or Android devices – something the patient already has and is comfortable to use. “For example, we are making videos that clearly describe what will happen during the clinical trial, and what the schedule will be.”

And while he acknowledges the regulatory hurdles in this still evolving area, he believes regulators are finding it increasingly difficult to ignore the benefits of eConsent for both patient and sponsor and the potential impact on both the feasibility and success of trials. “They are becoming more interested in listening to us, and what can be done to enhance the quality of engagement of patients before and during clinical trials. As trials become more complex and unwieldy, spanning different locations and different countries, this can enhance and accelerate clinical research overall.”

Another organisation doing exciting things in this growing space is IQVIA. Eric Delente heads up eConsent at IQVIA, and he outlined to eyeforpharma how the organization has been working on this area for over 15 years, only to see it explode in the past three years. Their Informed Consent Form (ICF) Author, a SaaS eConsent tool for use in clinical trials, provides an online portal that allows sponsors, sites, and contract research organizations to produce their own ICFs for delivery via eConsent or traditional paper.

According to Delente, widespread implementation of eConsent is imminent.

“In general, it’s becoming more ubiquitous, and less of an innovation and more the standard way to do studies. Virtual trials are also increasing in number. In our experience we are starting to see a lot more companies that are seeing the benefits of it,” he says, noting that while there continues to be concerns about global regulatory adoption, this isn’t as much of an issue within the US.

Another concern that trial sponsors may have is that eConsent is more expensive, adds Delente. “This is especially so if you continue the standard paper process and simply add on the eConsent process, a lot of the work in that arrangement is duplicated as paper documentation is sent to the eConsent vendor and digitized. That’s cause for more back and forth and additional reviews,” he explains.

IQVIA has addressed this by directing the same efforts at eConsent that the current paper documentation process demands, he says. “Instead of doing it that way and tacking on eConsent afterwards, if that was directed at our tool, a document management system, they see the benefits of improved workflow and very controlled checklists. It’s not that different to using Microsoft Word. Pharma are very keen on this – they sometimes push back when it comes to the cost, but removing duplication can ultimately help streamline costs.”

And the demand is there. IQVIA has found itself working with 15 of the top 20 pharmaceutical companies, says Delente. “Consent-related findings for every company are in the top five problems with findings and audit issues in clinical trials. Consent is the first transaction of any given study – if you don’t have consent, then you don’t have the patients, and you don’t have the data and you can’t make the drug.”


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