Evaluation and Management of Pulmonary Hypertension in Noncardiac Surgery: A Scientific Statement From the American Heart Association

5 Cybersecurity Guidelines For Remote Monitoring In Clinical Trials

Remote monitoring has many advantages in clinical trials. It can streamline the record-keeping process, minimise data entry errors, and enable simultaneous tests across multiple areas and demographics. However, remote monitoring technologies also introduce cybersecurity concerns.

Internet of Things (IoT) devices, cloud platforms, and other digital technologies used in remote monitoring are all potential targets for cybercriminals. Given the sensitive nature of this data, pharma organisations must address those risks. These 5 cybersecurity guidelines will help:

1. Emphasise security awareness for all involved

The first step in remote monitoring cybersecurity is to ensure all parties understand the risks and relevant best practices. That includes any employees with access to clinical trial data and the trial participants themselves.

Up to 95% of cybersecurity issues stem from human error. The key to preventing security-jeopardising mistakes is to explain proper usage to system users. These best practices include using strong passwords, multi-factor authentication (MFA), learning to spot phishing attempts, and never giving away sensitive information over email.

Staff will be more likely to follow best practices when they know why they're essential. It's also important to stress the potential damage cyberattacks can cause. When patients understand these risks, they make informed decisions about their participation, reducing liability.

2. Collect only what's necessary

Pharmaceutical companies should also rethink their data collection practices. More specifically, they should only collect information relevant to the study's goals and regulatory standards. Businesses should not gather any unnecessary data under that umbrella to minimise the amount of information a breach could expose.

This step may seem counterintuitive, as more data produces more reliable results. However, not all information is useful. Some studies may not need patient names, location data, or other personally identifiable information (PII). Gathering and storing such details increases risks without increasing benefits, so it's best not to include them in the first place.

Organisations can also use anonymisation techniques to remove unnecessary PII. Data masking is an ideal option, as it renders materials useless to cybercriminals without changing their values and relationships, which are more important for the study. Pseudonymisation and generalisation provide similar benefits.

3. Test monitoring systems before use

Remote monitoring involves a lot of specialised equipment. So, it's important to source this hardware from trusted providers. IoT devices should have strong built-in protections, and cloud vendors should have proof of their security, such as industry-recognised certifications. Even after getting trusted systems, brands must test them before using them in clinical trials.

Misdelivery is the most common cause of data breaches in healthcare and pharma companies must ensure all trial details go to the right place. Testing will ensure the system works from a technical standpoint and get employees used to operating it, preventing these errors.

Similarly, pharma businesses must continually check their remote monitoring systems to ensure they're working properly. Any instance where data appears to be missing or errors have arisen warrants further investigation.

4. Restrict data access

Another crucial step in protecting clinical trial materials is to restrict internal access to it. Fewer people being able to see or edit sensitive information translates to fewer potential entry points for cybercriminals.

Even trusted, seasoned workers shouldn't have access to clinical trial data if they don't need it for their role. Over half of all organisations have experienced an insider threat in the past year, and many have suffered several. That doesn't mean all companies have malicious employees — rather, most of these breaches stem from mistakes and social engineering. In either case, restricting access privileges makes these incidents less likely.

Pharma organisations must also realise restrictions only work well when they coincide with strong authentication measures. Simple username and password combinations are easy to break through, so MFA is vital.

5. Create an incident response plan

Finally, all clinical trials using remote monitoring systems need a back-up plan. Cybercrime is too common and the consequences are too severe to assume a system will never fail. An incident response plan will minimise the impact.

AI-powered continuous monitoring is an important part of these plans. Automated detection tools can spot and contain breaches faster than human teams, enabling more effective responses. As a result, companies using them save an average of $1.76 million in data breach costs.

Pharmaceutical businesses should also keep back-ups of all essential data. Back-up sets require the same amount of protection as primary databases, like encryption and restricted access controls. Beyond that, a response plan should include communication protocols and steps to get the monitoring system back online.

Remote monitoring brings new cybersecurity concerns

Remote monitoring could bring new drugs to market in record time. However, brands must consider its risks to capitalise on it safely.

IoT endpoints and similar remote monitoring systems increase a pharmaceutical organisation's attack surface. Recognising and responding to this risk will allow businesses to use these technologies without unnecessary liability.

FDA Sets Out Its Stall On Digital Tools For Remote Clinical Trials

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic.

The new guidance sets out the regulator's current thinking on how trial sponsors to incorporate DHTs in the design of studies of drugs or medical devices.

COVID-19 has already prompted a big increase in the use of decentralised or remote studies as it became increasingly hard for patients to participate in trials at investigator site, a shift that has relied heavily on the use of DHTs like remote monitoring systems, electronic data collection and consent forms, and web portals for studies.

One recent survey found that around 28% of biopharma companies and contract research organisations (CROs) were running remote trials before the pandemic, but that had risen to almost 90% by the middle of this year.

Aside from helping to maintain social distancing, DHTs can also improve the data collected in a trial, for example by allowing 24-hour monitoring wherever participants may be, rather than simply at a clinic.

The guidance gives advice on the design and selection of technologies that are suitable for use in trials, how they can be verified and validated as fit-for-purpose by the sponsor, and the sort of information that needs to be included in an application to start a clinical trial or seek marketing approval.

It also covers the evaluation of clinical endpoints from data collected using DHTs, including novel endpoints, as well as statistical analyses, consideration of clinical and privacy-related risks and securing informed consent, and best practices for securing and retaining patient data.

"Advances in sensor technology, general-purpose computing platforms, and methods for data transmission and storage have revolutionised the ability to remotely obtain and analyse clinically relevant information from individuals," says the FDA in the document.

"Remote data acquisition may also address challenges associated with centralized trials, such as the burden of traveling to the trial site for participants, especially for participants with physical or cognitive limitations, time constraints, or for those who may be geographically dispersed," it goes on.

The draft is open for comment until 22 March.

Real-world Evidence Trials Set To Increase For 2024

According to the FDA, real-world evidence (RWE) is clinical evidence regarding the usage, potential benefits, or risks of a medical product derived from an analysis of real-world data. RWE trials are crucial for further understanding newly approved medicinal products in the real-world setting. These trials provide clinical evidence of the long-term safety and efficacy of these drugs from real-world data where patients are treated using these drugs.

RWE trials mainly involve observational data outside the traditional involvement of randomised controlled trials. Using real-world data is an integral part of RWE trials as it allows researchers to monitor and assess patient outcomes and treatment methods. It also allows for the effects of a medicinal product to be investigated over a long period. Information for RWE trials may be sourced from clinical trial registries, patient-generated data, electronic health records, wearable technology, and mobile devices, among others.

According to GlobalData's Clinical Trials Database, 2021 has the highest annual amount of real-world evidence trials trials. For 2024, the current number of RWE trials stands at 331 trials and is set to surpass 336 trials as the year is still ongoing.According to an analysis of the different trial statuses of RWE trials, 53.9% of trials were completed, 22.1% of trials were ongoing and recruiting, 8.1% of trials were planned, 7.0% of trials were ongoing but not recruiting, and 8.2% of trials were suspended/terminated/withdrawn (S/T/W). When looking at geographies, China had 29.9% of the global total number of RWE trials. This was followed by Italy with 10.1%, Germany with 9.8%, the US with 9.2%, and Japan with 8.3%.

RWE studies are becoming increasingly popular, mainly due to the efficiency and accuracy of real-world data. RWE studies have been shown to aid in clinical planning, participant recruitment, trial design, and post-marketing surveillance. By using real-world data from virtual trials, synthetic control arms can be developed for rare therapy areas/indications. Healthcare costs can also be reduced by using patient personalisation, early diagnosis, and remote patient monitoring within trials.

Regulatory authorities such as the FDA and EMA are actively promoting the use of RWE trials. In December 2018, the FDA released a framework for the RWE programme, using real-world data and RWE to help approval decision-making for drugs and biologics. Additionally, the EMA recently launched framework contracts with academic and research institutions to conduct EMA-funded efficacy or safety research. Since the beginning of the Covid-19 pandemic, real-world data has been used in EU trials to test and monitor potential treatments.

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"Real-world evidence trials set to increase for 2024" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.

 

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