The game of technology in clinical trials

The significant evolution of technology in the last two decades has remarkably affected various industries and sectors including drug development and the healthcare industry. Earlier, conventional ways of clinical trials posed challenges that impeded the structured conduct of research affecting the creation of a knowledge base in support of patient products. Contemporary operational inefficiencies pertaining to the recognition, recruitment data acquisition, and follow-up of participants escalated costs, increased participant burden, and stretched the already-long timelines, all of which further contributed to reduced participation in clinical trials. 

Impact of technology on trial design

Even though technology has yet to make a major impact in clinical trials, recent revolutions in several technological fields have come up as a game-changer by conferring huge benefits for clinical trial design and efficiency in several ways. Technological innovations have offered to improve productivity and efficiency via the use of increased patient engagement, novel outcomes, decreased patient burden, and improved management of the clinical trials. The technology has enabled any clinical trial awareness among the patients. The Internet has been instrumental in providing patients with access to medical and scientific information, enabling them to have heard about clinical trials. It is the fastest medium for the outreach of communications and is efficient enough in raising awareness regarding developments in a clinical trial in sought-after study locations in emerging markets. 

Contract Research Organisations (CROs) play an important role in all phases of clinical trials. To add more efficiencies in a data-driven world, CROs are adopting digital technology. This is expected to improve collaborations across the clinical trial chain, enhance products, services, and processes and improve the conduct of clinical trials.

Impact on patient recruitment

One key aspect to consider when planning a trial is the recruitment and retention of participants. Even though the adoption of technology in the clinical trial has been slow, the COVID-19 pandemic has changed the game of recruitment. To discover life-saving drugs and vaccines for the coronavirus, about 5,000 clinical trials were launched in 2020. And the enrolment in these clinical trials was recorded to be 80% higher than the average. But in the case of clinical trials being conducted for other diseases, similar statistics are difficult to find. For example, in the case of cancer, less than 10 percent of patients who are eligible register for clinical trials. More rigorous research is needed regarding the efficiency of the tools for recruitment. In fact, researchers are increasingly using social media in clinical trials to improve outreach, education, and delivery of interventions. Mobile technology such as the use of smartphone applications, telehealth, etc. provides an opportunity to increase the efficiency and reach of clinical trial recruitment processes, including remote consenting. 

Impact on capturing patient data 

Capturing patient data is an essential part of the clinical trial process. Mobile devices, wearable medical technology, and smartphone-based apps have significant potential for improving patient data capturing. Patient data is central to clinical trials as it gives information regarding research directions and final clinical outcomes. Wearable devices help to automate data monitoring, and the use of central data hubs collects a wealth of data that would otherwise be complex to capture. Researchers can virtually access relevant information across multiple locations and can also keep a statistical eye on data.

New consumer focus solutions are being developed like:

1. Social networking platform that is disease-specific 
2. Open-source frameworks so new apps can be created while researchers can use the materials to study.

Blockchain technology

Blockchain technology uses a peer-to-peer, decentralized, computer network that enables databases to store encrypted timestamped records and documents. This technology is still being explored in the health sciences for resolving the issue of common threats to the security of clinical trials and patient data, and the integrity of this data. This technology can further help in preventing data manipulation. 

Impact on management of patients

During the start of the intervention in a trial, starting from enrollment to the administration of a drug or therapy, the patient’s response to the drug needs to be recorded. Often it resorts to pen and paper, and it results in inefficiency. It also increases patient drop-outs when the patient often needs to go to the clinical research site for regular check-ups. Migrating to an electronic system for this process can greatly affect the management process. It will not only prove to have better accuracy of the study with real-time patient updates, but the medication adherence policy can also be followed without fail. 

Also, artificial intelligence (AI) is being used for remote patient monitoring in clinical trials. An added layer can be used in machine learning for interpreting patient data and integrating them with home monitoring devices. Additionally, the wearable devices backed with AI offer the recruiter and the remote physicians and researchers the opportunity to monitor the physiological changes in the patient in real-time. This eventually reduces the difficulty of on-site check-ups and is also cost-effective.  

Consideration of ethical, privacy, regulatory, and data standards in the use of technology

The protection of participants’ data privacy and confidentiality has been an ongoing topic of concern. Therefore, it is essential to ensure that proper informed consent procedures are being followed with electronic materials and privacy/confidentiality of participants is being protected when using digital technology in clinical research. Various Institutional Review Boards (IRBs) have developed procedures and best practices with specific guidance on this subject. Several other organizations across the globe have also developed guidelines on the use of social media, mobile devices, and other technology tools in clinical trials. The Food and Drug Administration (FDA) has developed guidance for IRBs, sponsors, and researchers on the use of electronic informed consent (2016) and using EHRs/electronic signatures (2017). When using apps in randomized controlled trials (RCTs), investigators should carefully ensure participant understanding during the consent process and review the privacy and data sharing policies of the app.

Challenges of using digital technologies in clinical trials

Even though technology-enabled clinical trials offer a significantly promising future in the field of research, there are certain challenges in the implementation of these technological innovations such as:

1. Conserving confidentiality/ privacy of participant data assessed by digital methods, including accidentally sharing data with unknown third parties
2. Making certain that regulatory guidance considers the latest technological advances
3. Ascertaining the access to adequate resources, infrastructure, and staff expertise
4. Keeping participants occupied and increasing retention, 
5. Keeping in mid patient preferences, as potential trial participants may consider using their data as a violation of their privacy
6. Ensuring data quality/accuracy given that there are still concerns with data quality, completeness, and accuracy (as technological tools are usually developed for use in other areas and need to be adapted for research use)
7. Controlling the convolutions surrounding big research data (ensuring technological tools capture adequate data and selecting specific outcome data from the digital sources).

What the future holds?

Advancement in clinical trials has exponentially increased in recent years due to the use of novel and breakthrough technologies. The landscape of clinical trials is undergoing swift change as trials are getting compacted and are now including more remote elements, especially after the COVID-19 pandemic. Further, pharma companies have increased spending on AI technologies and big data analytics, which are driving down costs and transforming the R&D process. The future of clinical research now lies in adopting new technologies which are central to research development.

The article has been written by Dr. Kavita VIG - Medical Scientific Liaison at Healthminds Consulting Pvt. Ltd.