Innovations in clinical trial data capture

In the first of our new series on clinical data collection and management, Michelle Petersen explores innovative data capture strategies to improve patient retention and recruitment. 

When asked about the future innovations of data capture in clinical trials, the majority of experts will say concentrating on the qualitative as opposed to the quantitative is key here. There are lots of technologies moving forward with a view to data collection in clinical trials and it’s moving quickly; since my last featured post for this community (Aug 17), my conceptual non-contact lab tag monitoring system has become a reality with Cornell University developing a non-invasive method for gathering blood pressure, heart rate, and breath rate using a cheap system of radio-frequency signals and microchip tags. With so many studies concentrating on big data and their respective Electronic Medical Records (EMR), the quantity of data in large-scale trials has left the quality of patient data in its flotsam and jetsam, along with full transparency for patients, better quality of life (Qol) measurement systems for patients and patient retention.

Pharma is already investing in several big data, or quantitative-based, technologies such as eSource - which involves electronic informed consent and direct data entry into tablet computers - and remote patient monitoring involving wearable or home-based medical devices transmitting patient data securely to enable real-time data capture and analytics. However, with an astounding 85% of all clinical trials failing to retain enough subjects to successfully complete a study, patient retention and Electronic Captured Patient Reported Outcomes (ePROs), or qualitative-based technologies, should be the main focus for innovation here.

Should there really be a main site handing out masses of paper-based reading materials to patients, when electronic data collection tools have been available for more than two decades? When was the last time you printed off a whitepaper or held an actual magazine in your hands? Converting to remote paperless trials should be a given for every clinical trial organisation in terms of cost, convenience for the patient, as well as affording patients the ability for information intake using the electronic methods they’re familiar with.

Improving patient retention and recruitment

This leads onto retention of patients, keeping them interested using the techniques and technologies they’re used to. Should a clinical trial be fun for a patient? Well, yes it should. Fun doesn’t have to be construed as not taking their role in the trial seriously, and conversely taking the clinical trial seriously shouldn’t mean that the patient feels like they’re not being rewarded or benefiting from taking part; a clinical trial shouldn’t be viewed as a chore.

Instead of handing or sending patients extensive reading material, why not put together a low cost virtual clinical trial programme? This could be another option for patients to ‘play’ or run through using their computer by way of explanation as to what to expect and what their role will be in the coming weeks or months. This engages patients via an interactive experience giving them the data they need without the burden of extensive reading materials, providing more of a natural flow of information at a subconscious level. Even the most basic marketing survey systems now incorporate these virtual games or programs to discern what large data sets of the general public are thinking or choosing in specific industries.

Instead of offering patients an upfront enrollment fee, why not stagger payments by way of daily or weekly surveys? These could be made up of a mixture of gated questions and freestyle comment forms for Health-related quality of life (HRQoL) measurements, or any unforeseen treatment effects to streamline into gated questions as the clinical trial moves forward. Explain at the beginning of the recruitment process that the trial will involve weekly cash or voucher-based rewards throughout the whole process with a certain amount of points having to be fulfilled each week by way of surveys. This can also be a great recruitment tool; having a set time of completion for these surveys may also make the trial seem less daunting.

Today’s electronic survey systems also have automatic data quality and consistency checks which will immediately end the survey and refuse to award points; another incentive for patients to fulfill their trials. These survey systems also lead to standardization, with psychology facilities already using these survey sites to recruit participants and to host experiments.

Another incentive could involve full transparency of the patient’s status and health outcomes, with apps that notify them of their progress, and the luxury of having medical professionals at hand on the phone or via email to explain their status and aspects of their treatment to them. Home-based visits should also be a must in cases where patients are infirm, with a recent study on rare disease patients reporting that over 54% of participants indicated that home-based research visits would increase the likelihood of clinical trial participation. Hopefully, in this way companies can run a more patient-focused trial whilst gaining the personalized patient outcomes crucial for their trial.

In short, there is no point in having big data when the data is low quality, and as patient-centricity is proven to be vital for both retention and data quality, perhaps clinical trial innovation strategies should be geared towards this end.

ABOUT THE AUTHOR: Michelle Petersen is the founder of Healthinnovations and the Health Innovator community. She has worked in the health and science industry for over 21 years which includes time within the NHS and Oxford University. An avid campaigner in the fight against child sex abuse and trafficking, Michelle is a passionate humanist striving for a better quality of life for all humans by helping to provide traction for new technologies and techniques within the health sector. You can follow her on Twitter at @shelleypetersen.