Direct Data Capture: the optimal data solution in DCTs

In clinical research the transition towards decentralized clinical trials (DCTs) is in full swing, with remote patient monitoring, digital enrollment and electronic data capture being just a short sample of the technologies incorporated into such clinical trials. However, the platforms used to collect trial data are in need of revision¹.

In DCTs, data is collected from a wide range of sources such as medical devices, wearables or from the patient's smartphone for electronic patient reported outcomes (ePROs). As a result, the amount of data generated in clinical trials has increased tremendously. This vast pool of data, together with advanced analytics, enables researchers to improve therapies and develop more accurate medicines. Meanwhile, site teams and sponsors can observe and analyze these data in real time and detect adverse events or non-adherence by patients in due time to intervene².

To exemplify, in EDC, the data is stored electronically, yet it frequently relies on paper-based documents that need to be transcribed into the system. As a result, these electronic case report forms (eCRFs) need to be controlled with source data verification (SDV). Therefore, in the long run, standard EDC is error prone and does not work for high-volume data input. To improve data collection, direct data capture (DDC) has been implemented effectively in DCTs³

In DDC the data is captured directly from an electronic source and transferred automatically into an eCRF during the clinical visit thus negating the need for SDV. As a result, erroneous data entry is reduced to 0, and time savings of up to 37% can be achieved⁴. In addition, DDC is developed with the patient in mind to make it easier for them to fill in eDiaries and ePRO questionnaires. This in turn has been shown to improve adherence to medication and even reduce the length of hospital stay⁵. 

Since DDC databases are updated in real time, data becomes interoperable and shareable between different organizations. This greatly simplifies the data workflow and allows quick decision making⁶. In addition, DDC paves the way for fully remote patient monitoring, which benefits patients as they are spared from burdensome visits to the clinic⁷. All together, these aspects greatly reduce the costs of clinical trials, for instance by cutting in the on-site costs which account for around 30% of total clinical trial costs⁸. 

Successful data collection depends on the participation of patients. Therefore, patient engagement is crucial for success. At PatchAi, we integrate intelligent engaging solutions with a smart data collection platform. Want to know how? Click here.

References

1. Van Norman et al: https://www.jacc.org/doi/full/10.1016/j.jacbts.2021.01.011

2. https://www.pharmoutsourcing.com/Featured-Articles/576417-Data-Capture-in-the-Age-of-Decentralized-Trials-Why-Electronic-Is-Not-Enough/

3. Harper et al: https://link.springer.com/article/10.1007/s43441-020-00213-4

4. Nordo et al: https://www.sciencedirect.com/science/article/pii/S138650561730103X

5. Jones et al: https://search.informit.org/doi/abs/10.3316/INFORMIT.081533177649769

6. Shanbehzadeh et al: http://ijmi.ir/index.php/IJMI/article/view/236

7. Perl et al: https://www.sciencedirect.com/science/article/pii/S0167527313018330?casa_token=aQtx4H17xewAAAAA:i99szemvjeuuRWT7iHvMGCl7NRlJ8oB2CRxb4ojT3UPFMxU_DEliUmAslpNxnFVsJLnSEHBr

8.Office et al: “Examination of Clinical Trial Costs and Barriers for Drug Development. 4.6.3 Data and Site Monitoring.” Office of the Assistant Secretary for Planning and Evaluation, July 25, 2014.