Clinical trials refer to testing the effectiveness of experimental drugs. They are experiments conducted on humans that are designed to assess the safety and efficacy of a particular health intervention, such as a drug, medical device, surgical procedure, diagnostic test or a type of public health program.
Clinical trials are typically categorised into 4 main phases (with an initiation of a pre-clinical phase), with each phase progressing only if the previous phase has been deemed a success:
|Phase||Summary of clinical trial phases|
|Pre-clinical||Research/Drug target identification|
|Phase I||Testing of drug on healthy volunteers for dose-ranging|
|Phase II||Testing of drug on patients to assess efficacy and safety|
|Phase III||Testing of drug on patients to assess efficacy, effectiveness and safety|
|Phase IV||Post-marketing surveillance – watching drug use in public|
It is illegal to sell medicines without permission from a licensing authority. Permission will not usually be granted unless a clinical trial has demonstrated the medicine’s success in treating the condition for which it will be marketed¹.
Clinical trials, in addition to generating valuable scientific evidence, also provide patients with an important way of accessing products that have not yet reached the market, offering hope to those for whom existing treatments have failed. The necessity for a clinical trial to be performed before a medicine can gain regulatory approval means that clinical trials are also big business.
As mentioned in a our write-up, technology is not necessarily new in healthcare, or in this context-clinical trials. The last major technical evolution in clinical trial execution was moving from paper-based processes to electronic data capture (EDC). Since the third wave of IT hit healthcare, we are now seeing full digitisation of this industry i.e. digital health, including usage mobile health, cloud server technology, wearables as well as advanced analytics that enable new operating models.
As most of us are aware, most of clinical trial data comes from the patient and it is these data that creates value in a clinical study. Hence, the patient in a clinical study trial is significant. As healthcare becomes more patient-centric, it makes sense to place the patient right at the centre of a clinical trial study.
The emergence and popularity of patient-centric applications provide a great opportunity for pharmaceutical manufacturers to engage patients and create a customised, direct relationship with them. And the clinical trial space provides an excellent channel to leverage these technologies. The integration of mobile technology in new clinical trial design holds promise for aligning site and patient needs with faster study execution and reduced costs. Mobile technologies are already being used in clinical trial recruitment and retention, with the capacity to be used even more.
In addition, there is an increasing trend in using mHealth technologies to integrate with existing electronic patient record outcomes (ePRO) systems, electronic medical records (EMR) or electronic health records (EHR), case report forms (CRF) and clinical trial management systems (CTMS) , with the objective of to create a seamless connection from one to another so everyone on the trial i.e. clinicians and patients a like, can be on the same page about how they are progressing with the study. In addition, cloud server technology has become even more advance with the added ability to store data safe and securely.
Also, the rapid grow of low-cost health wearables for the consumer market is a promising avenue for the clinical trial industry in identifying potential patients and gathering huge volumes of data spanning years of an individual’s life. This is possible due to the ease of data collection from these devices.
mHealth in clinical trials have the potential to:
- Capture data accurately – with apps, wearables and medical devices connecting seamlessly. Note that many wearables contain sensors that are just as sensitive and accurate as those found in clinical settings.
- Remote tracking and monitoring – earlier reporting of adverse events might translate to safer patient outcomes throughout the study
- Real-time analysis – enable to improve efficiencies in processes and improve workflow
- Influence behaviour and health on patient (e.g. through gamification) – assist in patient retention
It is becoming more apparent that traditional clinical trial is becoming financially unfeasible. The cost of clinical trials is discouraging both sponsors and healthcare enterprises from conducting traditional clinical trials.
Despite the advance in technology, organisations have conducted clinical trials utilising a variety of disconnected methods, including paper, spreadsheets, homegrown databases, data warehouses, electronic data capture systems (EDC) and clinical trial management systems. Data from many different repositories are stored in a proliferation of disparate data silos that cannot be cross-queried so decisions are made with limited collaboration.
Users often receive disconnected reports that do not provide a comprehensive, holistic view of trial performance, trends and issues. These complex components can also be extremely expensive and difficult to integrate, often resulting in long implementation times with a high degree of risk.
Now, mHealth has the potential to reduce cost of clinical trials. BiotaConnect has been developed to address all these issues and provide a holistic system for a clinical trial to run efficiently. The cost reduction projected for each phase of a trial in multiple disease state areas with the use of mobile technologies has been estimated in a recent report by the Department of Health and Human Services ².
|Phases||Cost savings||Clinical study therapy area|
|Phase I||Highest savings are $0.4 million||Immunomodulation and respiratory system|
|Phase II||$0.5 million and $2.4 million||Cardiovascular and hematology respectively|
|Phase III||$6.1 million||Pain and anesthesia|
|Phase IV||$0.7 million and $6.7 million||Genitourinary system and respiratory system respectively|
Source: Eastern Research Group Inc.²
Trial stakeholders need a more robust solution with more cohesive data exchange and the ability to analyse data across different source systems. They need real-time multi-data access and analysis of data, event-driven collaboration and full auditability that can be quickly deployed. As a clinical trial operation grows, investing in a robust data capture solution with sound reporting tools and workflow capabilities becomes increasingly critical. The accent of clinical trial management process is highly critical for any organisation performing clinical trials. There is a need to improve all aspects of clinical trial operations and the digital health technology can do just that.
1. MHRA, Medicines and medical devices regulation: what you need to know, 2008, p 5; Council Directive 2001/83/EC
2. "Examination of Clinical Trial Cost and Barriers for Drug Development." Product Development for Better Clinical Trials. Eastern Research Group, Inc., 25 July 2014. Web.