The clinical trial industry is always looking for innovative ways to improve trial outcomes and lower costs. To do this they need to consistently re-evaluate their methods of patient recruitment, monitor and compare data collection methods, and allow for flexibility in trial design to ensure patient centricity. Here’s a look at some of the trends that are revolutionizing clinical trials today:
1. Patient Centricity
Patient centricity has been a major trend within the clinical trial industry over the last few years. Today, patients are very comfortable navigating the internet and they are drawing on the increasing influence of advocacy groups to get more involved in all aspects of their clinical trials. They’re also forming more support groups to discuss their disease and available treatments. These support groups often continue past the trial and this information shared can benefit pharma, allowing them to adjust patient protocols to better suit real-world conditions and improve patient quality-of-life.
The best way to retain patients is to make the entire data collection process is simple, efficient, and secure. Using uniform devices, managing all the alarms and notifications, and providing knowledgeable tech support are all ways to encourage patients to stay on track with their data collection.
2. Tapping into Technology
Pharma and biotechs are using mobile devices like phones, tablets, and phablets to increase patient recruitment ahead of trials and then keep patients on track during clinical trials. Mobile apps can notify patients about appointments, tell them when to take their medications, track dosage, and provide step by step instructions.
Life science companies should maintain control over these devices to ensure data security and compliance. Patients using their own devices, for example, can turn off alarms and notifications that they find interruptive. If they lose their phone or delete relevant data stored, life science companies must have contingency plans in place. The surest way to prevent delays or complications and ensure on-time trial completion is to have full Mobile Device Management (MDM) of all devices used in trials.
3. Wearable Data Tracking
The world of wearable fitness trackers opens a new level of data collection for clinicians and pharmas since the device can be with patients at all times. In an increasingly “always-on” environment, the worldwide adoption of wearable devices is expected to jump from 325 million in 2016 to about 830 million in 2020. For the clinical trial landscape however, organizers should supply their participants with these devices, otherwise they risk isolating their samples and excluding relevant data from individuals unable to participate.
Additionally, the collection, use, and exchange of clinical trial data raises significant concerns about the storage, security, and privacy of that data, particularly when in the final stages awaiting FDA approval. This is the primary concern with the BYOD approach regarding wearables. Organizations handling sensitive personal health and clinical data should safeguard patient data and ensure global clinical trial compliance with privacy laws of relevant markets.
4. Increasing Compliance
While patients may be more comfortable with their own devices, there are many concerns about how secure the data may be and what happens if a patient loses their device.
We can’t know for sure which new technologies will be integrated into global clinical trials—especially those in early development or yet to be invented— but these advances are expected to make clinical trials more efficient and possibly shorten drug development timelines. The question sponsors and CROs should be asking is how to facilitate patient compliance when introducing new technologies. More importantly, the players in this industry need to be prepared to overcome regulatory pitfalls quickly and adopt innovations before their competitors do.