Collecting patient data challenging in evolving trial landscape

Outsourcing-Pharma recently checked in with two specialists from Phastar:

• LaRee Tracy, director of biostatistics
• Jenny Bradford, director of data science

Together, the experts weighed in on how decentralized trials, remote patient monitoring, wearables, and other technologies are impacting the work of clinical trial professionals, including patient-reported outcomes.

OSP: Could you please share how the challenges in obtaining/disseminating patient-level data in decentralized/remote trials differ from in-person studies—and how they might be the same?​

Collection is the main factor that changes with decentralized trials in comparison to in-person studies. There is the potential to receive information at a higher frequency and thus, more data.

Of course, interactions are also greatly changed with patients and clinicians who are no longer face to face. In remote trials, this can affect the sharing of information with some patients being either more or less forthcoming -- depending on how comfortable they are with the virtual interactions and/or different methods of data collection.

Remote trials may use methods such as traditional phone calls or video calls or a remote monitoring tool/dashboard to collect information. In the latter case especially, clinicians must assure the patient that their 'voice' is heard.

Dissemination is another factor to consider. When using remote monitoring tools, clinicians may need to manage the amount of information and details that are returned to the patient, particularly if the patient has access to dashboards of data.

For example, if returning lab measures to a patient that include details of the normal ranges -- what is normal for the patient may not be within the normal range for the general population. Therefore, from a medical perspective, there are no concerns but relaying this to the patient requires careful management.

OSP: Specifically, how can trial professionals ensure data collected from wearables is up to snuff—is it difficult to ensure they’re charged and working, that patients are properly wearing them, that data collected is flowing to the proper place, etc?​

When using wearables, there are several factors for the clinical trial lead to consider. This involves:

• what and why data is being collected
• which type of device will be used
• how much data is used and what information is shared with the patient
• who owns the data
• frequency of data sharing and data flow

Initially, clinicians should think about what data they need and why this particular information is being collected. Decisions should also be made at this stage regarding the format of the raw data and how it will be analyzed.

Along with determining the frequency of data collection, this will drive the device election, e.g. BYOD (bring your own device), consumer devices, or medical-grade device options.

Depending on which type of device is being used, there are challenges in terms of access to the data, data format, frequency of data extraction, the validity of the data, etc. Different types of devices lead to different ownership of the data, such as in BYOD.

Once a device is selected, understand the flow of data (from device to trial team). Measures should be put in place to ensure the flow is efficient and successful as well as deciding who is responsible for different parts of the data flow. For example, the device manufacturer or patient or clinical trial sponsor.

Clinicians need to decide if the data from wearables will be used during the trial, and if so, how? Is the trial receiving all of the data available or only certain aspects? What are the expectations for the patient in terms of wear time?  How will non-wear time be detected, monitored, and/or managed during the trial?

There are also considerations such as whether the clinician should discuss the data from the device with the patient, and if so, how and what elements are included. Is the patient expecting the discussion and may feel disengaged if that doesn't happen? What if device information doesn't match the information from the patient?  

OSP: Please provide your perspective on how the use of ePRO has evolved in recent years. How was the use of patient-reported outcomes viewed and incorporated in the years leading up to the pandemic, and how did the impact of COVID-19 shift things?​

In recent years there has been an increased focus on patient engagement with some regulatory authorities embracing the need for more patient-centric drug development and wider access to assure accurate data collection as trials become more decentralized. ePRO has therefore taken a higher priority in assuring accurate patient experiences are collected.

COVID-19 has expedited the use of these technologies, as trials adapt to accommodate social distancing and to keep patients safe while still collecting the necessary information. ePRO and other approaches can transform trials, making them more pragmatic and patient-centric, helping trial managers make reliable data-driven decisions, and to mitigate risks.

OSP: How can trial teams ensure their patient-level data collected remotely is accurate, complete, in line with any regulatory considerations, etc?​

Sponsors should attempt to standardize the remote data collection across participating sites, trial participants and study visits to reduce variability in the data. For example, use of one approach, e.g., video monitoring, would be implemented across all sites and standardized per visit without allowance of other methods, e.g., telephone, etc. so as to maintain consistency.

Along these lines, prior to implementation of remote data collection, trial sponsors need to assess the feasibility of the remote data collection method and if trial sites and participants are equipped and able to comply with the data collection methods. Site training may also be required to ensure systematic data collection and the need to maintain patient confidentiality.

To provide the same information that would have otherwise been collected during a face-to-face study assessment, documentation of the video assessment (including the date and time) should be included in the study source documents.

There is also the possibility of increased missing data when switching to remote monitoring, e.g., incomplete data collection on a remote patient-reported data. To preempt this, sponsors should consider use of technologies to remind patients/participants to report their information.

OSP: Can you offer any advice on how research professionals can balance the need for accuracy, efficiency, thoroughness and other positive aspects in their trials, with the need to reduce patient burden?​

The biggest factor to consider is how to reduce the frequency and quantity of data collection. The more parsimonious the trial, the less burden on the patients and the clinical site.

For example, sponsors may consider spreading out the assessments and reducing the number of assessments performed at each visit. Implement verbal or electronic reminders for patient reporting to reduce the amount of missed assessments/reporting. Provide remote training to clinical sites on how to efficiently capture study data remotely.

OSP: Is there anything else you’d like to talk about regarding patient-centricity and data collection considerations in remote/decentralized studies?​

Prior to the pandemic, telemedicine was largely restricted to clinical care outside of clinical trials and was focused in a few therapeutic areas, e.g., mental health care. Now, telemedicine has become a common tool in some clinical trials out of the necessary need to reduce patient risk by avoiding face-to-face study visits. Questions remain as to how these technologies will continue to be used once the pandemic ends, given existing regulatory standards.