Data collection sits at the foundation of clinical trials, historically gathered from meticulous in-person visits to clinical trial sites. To improve efficiency, clinical trial research has significantly transitioned in recent years. The expansion of technological data collection methods, from wearable sensors to smartphone applications, has facilitated many aspects of clinical trial research, allowing patients to share information from virtually any remote location. However, this shift to digital methods presents a new challenge: How do we navigate the technological hurdles that may arise?
Growth of Decentralization and Reliance on Technology
As decentralized clinical trial models grow in popularity, technology is playing an increasingly vital role in data collection. In fact, one recent study found that 80% of biopharmaceutical companies expect the decentralized clinical trial model to be used more frequently than the traditional model over the next few years. Congruently, statistics also show that nearly 80% of clinical trials use some form of electronic data capture system to facilitate various aspects of research.
These statistics further validate the need for strong and robust technology that adequately prepares sites and patients for unexpected technical disruptions.
However, as our reliance on technology increases, how are participants and clinical trial stakeholders supposed to react when technology fails? In the case of lost or broken devices, sites and patients lose the ability to enter data per protocol. This inability to enter data can cause missing data and, if not rectified in a timely manner, could impact the validity and outcomes of the research, leading to incomplete datasets and invalid conclusions.
Mitigating missing data as a result of broken or lost devices is an essential part of every electronic Clinical Outcome Assessment (eCOA) strategy. If a patient is relying on a provisioned device to enter their data, it is imperative that the eCOA provider is equipped to deliver a new provisioned device in a timely manner, regardless of patient location. If a bring-your-own-data strategy is being deployed, patients have the advantage of re-installing the eCOA application on another personal device, negating the need for a replacement provisioned device, reducing the time that the patient is without a collection method.
Loss of Connectivity
While rare, sites and patients may experience loss of connectivity due to poor cellular infrastructure. Therefore, it’s beneficial to work with an eCOA vendor that offers offline capabilities. With offline mode, participants and sites can continue to enter data, as well as receive any device reminder notifications that drive protocol compliance and adherence to study schedules.
When All Else Fails, Use Temporary Online Diaries
In cases where devices malfunction or replacement devices can’t be addressed in a timely manner, temporary online diaries serve as an interim solution ensuring seamless data capture even in the face of technological failures. A temporary web-enabled interface that mirrors the primary mode of electronic data capture allows participants to continue entering their data in the manner specified in the protocol.
Benefits of a Temporary Online Diary
Providing alternate options, such as a temporary online diary, increases flexibility and availability of data collection in clinical trial settings. It also prevents additional financial burdens by negating the need to extend timelines to compensate for missing data. Extended clinical trial timelines can often increase budgets. Experience shows that increasing clinical trial timelines due to delays can cause millions of dollars in additional costs for sponsors. A temporary online diary is critical to timely continuity of clinical trials.
Continuing to capture data electronically, even when a device malfunctions, is another benefit that eliminates the need to transcribe handwritten data into a digital database, saving hours of manual labor. It also means that the data is uploaded sooner.
Moving Forward with Temporary Online Diaries
The digital transformation of clinical trials offers a wealth of benefits, from increased accessibility to improved efficiency. However, a complete reliance on technology introduces the potential for unforeseen technological mistakes and malfunctions.
To address this concern, temporary online diaries serve as a critical safeguard against such disruptions. These diaries ensure that clinical trials can progress uninterrupted, maintaining data quality and preventing costly delays.