Most industries are engaged in ongoing debates about technology’s ability to improve processes and outcomes. For those working in clinical trials, the discussion holds even greater weight. After all, when trials are made more efficient and cost-effective, patients can reap the benefits.
However, the clinical trials industry faces the added concerns of tight regulations and balancing the adoption of any new technology with patients’ best interest.
This post explores some of the challenges that arise when implementing new technology in clinical trials and how to overcome them to ensure the desired outcomes.
Fears over data security and compliance, the inability to integrate systems, and an unpleasant user experience are some of the main reasons the clinical trial industry has been slow to adopt new technology. But these fears are often unwarranted, explains Kunal Sampat, senior manager of clinical research at Abbott Vascular, especially when steps are taken to safeguard against any challenges.
The best approach is to test your tech on a few sites to see that it works, Sampat suggests. The proof-of-concept stage will reveal opportunities and challenges.
Despite the benefits technology promises to deliver, the clinical trials industry has been slow to adopt digital innovations. Some of the technologies already being touted could take as many as ten years to become common practice in clinical trials, says Dan Stempel, CEO of medical marketing service firm, MD Connect. He refers to a 2018 Deloitte report that categorizes the uptake of technology into three timeframes.
The ready-for-adoption category concerns technology ready for use now or within the next three years. These are technologies that deal with processes such as protocol design and patient inclusion and exclusion, e-consent and patient-reported outcomes, medication adherence solutions and monitoring trial trial sites.
Next is the three-to-five year timeframe, which concerns tools that mine electronic health records (EHRs) and measure endpoints in virtual trials. The final category is for advanced technologies set for realization in the next five to ten years, which includes completely virtual trials, natural language processing for medical writing and digital biomarkers as primary endpoints.
Of course, the use of AI, blockchain and digital assistants are also included within the next few years.
Early adopters of technology will reap the rewards of improved patient engagement, more accurate insights and faster products development. And even a fast follower may find the organizations they are in are already too slow to earn a competitive edge, explain Dawn Anderson, Jonathan Fox and Natasha Elsner at Deloitte Insights.
The challenge to successful adoption of digital technologies is especially acute when adopting digital at scale. Barriers here include sophisticated data infrastructure and analytics, regulations and compliance, and cultural barriers. Plus inadequate data flow from old and non-integrated systems are holding researchers back, especially when designing in-silico trials and synthetic trial arms.
There is also a significant shift in focus to include data from EHRs, claims and genomic databases, so infrastructure needs to support this trend of sharing and collating data from multiple sources. Attached to this vigorous pursuit of data is the concern over its security and that it is not interoperable. Patients’ privacy requirements differ between states and countries, as do requirements for consent. And there is a lack of data standards to govern these differences.
A way around this is to ensure that biopharma companies demand that vendors adhere to their own data management standards, Anderson et al write. They add that biopharma companies should develop better data infrastructure and data governance, ensure patient consent of data is usable for secondary analysis, and set up public-private partnerships or industry consortia to define data-sharing agreements.
Digital assistants, mobile devices and e-tools are all part of the shift towards more remote-based clinical research. However, taking studies and treatments to patients’ homes requires that certain adoption challenges are met. The starting point is adopting a new mindset, say Marcin Stefanowicz, Ph.D., CEE regional study manager at biotech juggernaut Roche.
This means that the study is no longer just about the project outcome, but requires devoted focus to patients’ needs. Accordingly, engagement with patients and advocacy groups is essential for effective implementation of mobile technology. Built into this patient focus is understanding that technology alone — mobile or otherwise — does not change lifestyles but rather equips researchers and healthcare providers to work with patients to change their lifestyles and their health.
The uptake in electronic consent processes is significant. As many as 66 percent of the top 50 pharma companies are using or planning soon to adopt this method, notes Sandra Sather, regulatory and quality consultant for trial consent at CRF Health.
The promise of the technology, as when used to update most existing processes, is to improve efficiency. According to a survey from CRF Health, Sather says 61 percent of respondents believe electronic consent will ease the process of giving consent and boost the number of patients in a trial.
However, when adopting this technology, it’s essential that researchers understand consent requires more than a signature. Patients must be made to understand exactly what they are consenting to. Failure to get this right, as well as to ensure an integrated consent system, will likely result in compliance issues, lower enrollment rates and increased expenses.
Ironically, given the belief in technology’s ability to makes processes more efficient, Sather highlights concerns of added burden placed on study sites when adopting this new type of technology. There is also expectation that staff will need training to equip them to deal with the new technology. Another concern is whether adopting electronic consent technology would be compatible with existing processes required to obtain a patient's informed consent.
And yet another challenge to overcome surrounds how electronic consent will impact handling of documentation. Much will become automated, but manual documentation processing will remain important. Developing a plan of action to manage documents will overcome this challenge, Sather says.
Sponsors and CROs may well be enthusiastic to reap the rewards of adopting new technology but sometimes the reality of the study population will inhibit their ambitions.
Consider mobile health technology, as mentioned earlier. This requires reliable wireless internet that is not necessarily available to the level needed, explains Abbe Steel, founder and CEO of HealthiVibe. Similarly, mHealth technologies will not be effective when used with patients unfamiliar with mobile devices, such as the elderly or severely cognitively impaired.
Of note too is that mobile technologies may not be best-suited to the study protocol, Steel warns. For instance, some studies may rely more on investigator assessments rather than patient-reported data. Another potential issue is that some specimens cannot be collected by a mobile device.
When mobile health technologies are used, trial staff must make sure that patients understand how and when to report any adverse effects. This is vital as incorrect procedure can lead to trials running foul of regulators.
And when conducting multinational trials, trial staff must be aware that device selection — and how they meet a country’s specific regulatory requirements — will vary from site to site. This includes questions of data privacy and security and multi-linguistic offerings.
By now most modern clinical trials will rely on an effective CTMS, but this technology is always changing and being updated. It’s best to ensure that when adopting a CTMS or updating it, key considerations are taken into account, says Ryan Monte, senior product marketing manager at Forte.
A CTMS should provide efficiencies across multiple parts of a trial, incorporating EDC, payments, compliance and business intelligence. It should also integrate various data sources to deliver a single source of truth to share across workflows. Issues can arise if a CTMS is not interoperable with some vendors’ products, so ensure integration wherever possible.
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