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Clinical trials

5 ways to make patients stakeholders in clinical trials today

Posted by on 29 April 2021
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By Megan Liles, MS, VP, Operational Strategy, Precision for Medicine

Patient-centricity has been a term used in the industry for years and yet there is still not a clear implementation strategy for Sponsors and CROs on how to make it a reality in their clinical trials. Have we as an industry made progress? Yes, but there is much more to be done. With the recent creation of the Decentralized Trials & Research Alliance (DTRA), there is now a group trying to take on this charge directly and to keep pushing the industry forward as we come into a post-COVID era.

With increasingly niche patient populations being targeted for clinical trial recruitment, sponsors are looking to maximize data points to make it to the next critical step in their development program. Unfortunately, patient-centricity and relieving patient burden is not always assessed. Simply put, we need to do more, and we need to do better in putting patients first.

Are patients treated as stakeholders?

Arriving to the point of diagnosis is often challenging enough - as a key stakeholder in clinical trials, we have made it difficult for patients to participate and may forget that they are dedicating their time and often doing so altruistically in the hopes of helping others.

Feedback from patients note difficulties in even locating clinical trials within a specific disease area. Inconsistent or missing information from government sponsored online registries, such as, is often problematic. Patient burden is not fully assessed in terms of visit frequency or visit procedures and then the ICF is often too complex, lengthy, or filled with medical jargon to be absorbed and retained by the patient in a single setting.

Patients are stakeholders and we need to make it easier for them to find suitable clinical trials, become educated on what we are asking of them, and make it less burdensome to participate.

Patient-centric approaches

Realizing that several companies may not be in a position to readily adopt DCT strategies into their clinical trials – either because of trial design, planned patient population or the associated cost - here are a few things that can be done now.

1. Keep online trial registries current: Online trial registries are effective in that patients do often find them and the most frequent downfalls – out-of-date or missing information– are easy to avoid. Explaining the study purpose and goals of the study as well as the drug being tested in simple language is an important first step. But then also including the start and stop dates and providing adequate information about the locations of participating sites will aid patients in determining whether there is an appropriate study and location nearby.

2. Sharing allowable data – supports engagement & retention: Patients want to be well-informed on the status of the study so tailoring published study data or abstracts into lay person language so that patients currently participating have up to date information can go a long way in maintaining patient engagement.

3. Asking for patient feedback: We have all heard the importance of obtaining patient feedback upfront on study design; however, there is also value in asking for their feedback during the study. This can shed light on the overall patient experience while participating and where there may be opportunities to improve upon it as well as provide the Sponsor with insights for future studies in development.

4. Improving ICF and providing educational materials: Patient-directed resources regarding clinical trials abound on the internet which are easily accessed through simple internet searches. Where we can improve though is providing better transparency on anticipated costs to the patient from their participation (e.g., co-pays, parking, transportation, etc.) and then also assessing the readability of the ICF to make sure it is written at an appropriate reading level.

5. Assessing patient burden: As studies are designed, an assessment of patient and caregiver burden should be completed with consideration of the required procedures, how invasive these procedures are and then visit frequency. Coordinator feedback is key as well as they can assess the logistics of scheduling study procedures within a designated study visit window.

Moving toward patient-centricity

These suggestions are a start towards a more patient-centric approach, but there is still room for improvement.

With the formation of DTRA, we are trying to improve decentralized clinical trial strategies and work with regulatory authorities as this area continues to evolve. How we can make patients the key stakeholders in the process and how we truly take that to a new place is still being examined. In the meantime, it is easy to get caught up in the documentation requirements and erring on the side of caution instead of thinking how we can better serve patients today and tomorrow.

Going forward, we can make the best inroads by working through the logistics of patient participation and working to incorporate clinical trials into patient care, so they are accessible to everyone. While we are making progress, we need to continue to work to shift the paradigm so patient-centric strategies moves away from being the exception and becomes part of our new normal.

Megan Liles presented a session at Decentralized Clinical Trials Digital Week on 'Putting the Patient First - Decentralization Strategies in Clinical Studies'. Watch the full session here.

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