Clinical trial sponsors must consider pandemic burnout - MedCity News

Never before have clinical researchers had more choices in study design. As technology advances, companies send more notifications, collect larger amounts of data, and add more apps, wearables, and ePROs to surveys. But researchers should be mindful of the fact that many potential participants are dealing with burnout and uncertainty after more than two years of living in a pandemic.

During the pandemic approx four out of ten adults in the US reported symptoms of an anxiety or depressive disorder, a significant increase from one in ten adults who reported these symptoms from January to June 2019. And for patients suffering from new health problems or struggling with existing conditions, the pandemic has caused delayed diagnoses, postponed surgeries and more uncertainty.

In general, many potential participants are tired and stressed. Some may even worry about adding another commitment by joining a clinical trial. Therefore, research studies should prioritize simplicity, authenticity, and practicality to gain patient trust for better enrollment and retention.

Human-centric recruiting and enrollment

Informed consent should not be read as a doctorate. thesis. It should be simple, most likely in the form of eConsent using a phone, tablet or computer. This remote approach lowers barriers to enrollment by reducing travel costs, eliminating potential exposure to Covid-19 risks, and allowing participants greater flexibility with their schedule. Increases understanding and retention of information as complex procedures or investigational treatments can be shown visually and explained aloud. It allows study participants to choose their preferred learning method and features can be included to support vulnerable populations (eg visually impaired, pediatrics).

eConsent also simplifies recruitment efforts by reaching and engaging with patients on the platforms they use. Social media platforms such as TikTok, Snapchat, and Instagram have user-friendly advertising interfaces that position recruitment materials in front of a larger portion of eligible participants. Clinical investigators can streamline their search efforts to speed up efforts to identify the right participants.

A decentralized approach to recruitment may reach underserved minority populations that are underrepresented in clinical research. This supports the recruitment of remote study staff who are representative of the patient population or who have experience in cultural competence in communicating scientific concepts to populations who have experienced deprivation of autonomy. Using video chat, staff can guide participants through the informed consent process. eConsent offers greater engagement with the consent process and can offer participants empowerment, ownership, and autonomy—often a significant step in overcoming reluctance to join a study.

Technology consolidation for improved patient data

Another key to streamlined, patient-centered trials is automation. In particular, APIs can overcome the need for patients to juggle multiple applications. Researchers should explore intuitive software that offers an excellent user interface and useful features. This has previously been a challenge as the regulatory environment and development have created a very commercialized environment with research tools that are more similar than different. But now innovative companies are offering new solutions – and researchers must choose the optimal research platform that offers the best patient experience while maintaining quality clinical research.

Another way to use technology to improve the participant experience is direct-to-patient devices. Sending participants to a Bluetooth-connected medical device delivered with a phone pre-installed with an appropriate telehealth product for easy visits is one idea. This approach also helps to streamline the study site, as sending participants pre-configured devices (rather than BYOD models) reduces the need for help desk staff. Ideally, participants should use the provided device or phone for various tasks within the study, such as reporting results and communicating with researchers.

Using rear wheel drive power

Real-world data will play an even bigger role in clinical trials in the near future – to the benefit of all involved. If a researcher can show that a single measurement (eg, heart rate) can infer the same as a more complex measurement (eg, electrocardiogram), this paves the way for further simplification of study design. For example, if a study involves a chronic condition that the participant needs to see a doctor to manage, such as blood pressure, then real-world data from the doctor’s office can be used for the study, rather than taking the same measurement twice times. In other cases, participants may use a wearable device to collect and transmit data to the study site in real time. This kind of efficiency can increase both enrollment rates and retention rates in studies and allows more data to be consistently collected.

Let’s push for simple, authentic and practical studies – and give participants a break! Let’s meet people where they are and put their needs first. By doing this, we will recruit more participants and hopefully keep them engaged and retained throughout the study. Let’s work together to develop new cures for a better tomorrow.

Photo: undefined undefined, Getty Images

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