How to write a winning grant for digital research studies

Focus on the who, the why, and the how; who are we targeting, why are we targeting them, and how do we plan to help them? By integrating the target audience in the planning, you will ensure maximum impact.

Make sure you’re asking about symptoms, disease progression, alleviating and aggravating factors, and treatments that are relevant to that lived experience.

Is your app or interface design friendly enough? Are you asking too many survey questions? Are you asking the right questions? How can we make this a more impactful, effective study?

Allow them to target different aspects of good health and wellbeing: CVS Extracare card, caregiver hours, massages/spas, food meal prep companies.

Running digital research studies is still a relatively new concept for most funding bodies and internal review boards. When using a technology, you want to be very clear about how it augments your ability to collect study data.

i. Test end-to-end functionality

Test your participant-facing digital experience by recruiting test participants to your study or running focus groups to collect feedback. Often, collecting participant feedback during testing can highlight issues in technology such as long screen loading times, unfriendly UI/UX or unclear instructions.

ii. Ease of data collection

Digital studies allow for an increased audience size due to greater reach, less clinician or participant time commitment, ease of participation without the hassle or cost of traveling for in-person visits.

i. How do we monitor adverse events?

Adverse events or symptom exacerbations can be a part of disease progression during a study. As such, many reviewers will want to know how the physical "distance" between the PI and the participant will impact their interactions- particularly when it comes to liability and reporting of adverse events. It’s your responsibility as a researcher to show that the technology you’re using can collect data appropriately, but also takes into account risk of adverse events. Using digital methods can both increase and decrease risk based on therapeutic areas.

ii. Allows for better record keeping

Physicians are at the mercy of patient’s ability to record home blood pressures and glycemic indexes to titrate medications, timing and severity of symptoms to understand progression. By allowing this data to be saved into a server in real time, patients can pull up data or send data to physicians to allow for more accurate representations and treatments of their disease progression.

i. Disclose financial conflicts of interest

The NIH is a great resource for this. See the NIH’s “elements of an FCOI report” for more information: https://grants.nih.gov/grants/policy/coi/index.htm

ii. Data storage details

How is data going to be managed or stored? Who will have access to it?

iii. Who owns the data?

Do participants own their data? Can they request copies or downloads of their data? Can they request that their data be deleted? 

iv. Is the technology you're using compliant?

Note any certifications such as HIPAA, SOC2 or ISO27001 for your tools.

v. Where is my data going?

Ensure that it is clear whether de-identified data is being sent or used outside of the application or if it is being shared with third parties. If so, will the data generated in the study be used to develop academic publications, presentations or reports, or used to inform other efforts, such as additional studies or marketing campaigns? Be very clear about how the study data will shared with parties outside of your immediate research group.

Funding and regulatory bodies are increasingly interested in how digital and virtual studies can increase diversity among study participants. Digitizing research allows you to include participants in different time zones, across language barriers, in rural/urban settings, and across socioeconomic cohorts through universally accessible smartphone technology.

Document how your specific digital study aims to include a diverse cohort of participants across geographies and experiences. Digital studies can also give you the ability to incorporate rich data streams not often utilized in brick-and-mortar research settings, such as wearables and other connected device data, social determinants of health data, and even rich data collected via photos, video and audio recordings. Leverage the opportunities that digital real-world data collection afford you in your grant application.

Digital studies allow for more accessible research– are you including this in your design? Are you allowing for videos as an alternative to surveys for populations for whom reading may be a barrier? Do you have language accommodations? Does your study have accessibility considerations for the vision or hearing impaired? Does your study consider overall disease burden when planning for study-related tasks and data contribution, especially for conditions that may be associated with functional impairment? Personalizing study design to include these features in the study can occur through pre-screening questionnaires.

It has been well documented that participants are more likely to engage with researchers who look like them, sound like them, and come from similar cultural backgrounds. Promote the diversity and experience of your research team by including their biographies, CVs or NIH biosketches in your application. Showing how the diverse backgrounds of your research team will help you to understand and engage with participants is the key.

The most successful grant applications have a realistic approach to recruitment timelines. Studies need to be long enough to have measurable data, but not so long that participants burn out. Be realistic.

Partner with established organizations that work with the target patient population in order to aid recruitment, build communities with shared diagnoses, and encourage adherence. Today, organizations like ACIRAH, Acclinate, or even your local community patient networks specifically focus on enrolling and educating underrepresented minorities in clinical trials - leverage their networks or simply ask them for expert advice.

With data privacy and participant burden being ever increasing concerns in healthcare and research, do not over-collect. Your proposal should clearly define what every data stream will be used for (graphics and images of your data flows may help here). Have clear objectives, rationales, and end points for your study.

Ensure that your study has appropriate and compliant compensation with a clear timeline, for both researchers and participants.

Will it be rolling participation or strict timelines for cohorts? How will you monitor success in this study? What are the milestones at which you offer incentives, elicit feedback from participants or share insights from their data contributions?