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Important Considerations in Working with Caregivers in Clinical Trials

Important Considerations in Working with Caregivers in Clinical Trials
17 September 2019

Clinical trials involving qualitative, psycho-modulated endpoints based on caregiver-reported data present challenges for most sponsors. But it does not have to be that way.

Communicating with caregivers may seem like just another constituency, and expense, to consider in clinical trial development. However, effective communication with caregivers can enhance the quality of data. And with caregivers having a vested interest in clinical trial success and playing an important role in ensuring patient participation and compliance, involving caregivers can actually reduce costs, through better and more consistent follow-up, greater access to data, increased enrollment, reduced requirements on patients, and so on. 

An important formula to consider is this:
 

How can you gain caregiver buy-in to support your clinical trials? Following are 12 tips from Synteract’s VP of Rare and Orphan Diseases, Lisa Dilworth, from her recent webinar on this topic:

  • Communication
    • To help gain successful participation, incorporate caregivers’ perspectives throughout the full drug development lifecycle, starting at the very outset of the trial. This will help to gain valuable insights on protocol planning as well as cooperation. Caregivers may be helpful in identifying novel endpoints and providing valuable feedback on quality of life issues that sponsors and others might not consider.
    • Speak, not only in patient-centered, but also caregiver-centered, language. For example, when discussing the protocol, ask the caregiver whether she/he is able and/or willing to perform certain duties. Support him/her in figuring out the most effective and realistic ways to comply with protocol requirements.
    • Communicate in familiar terms. Explain medical jargon used throughout the clinical trial. The caregiver needs to understand what the researcher is saying so as to effectively communicate this information to the patient.
  • Education
    • Guide the caregiver on being an effective observer--explicitly describe subtle changes to look out for, how to identify them, and how to respond to them.
    • Help caregivers to gather both quantitative and qualitative information via innovative technology solutions which ease the burden of trial participation
    • Prepare the caregiver and patient for emotional aspects of clinical trials, including feelings that may arise in starting and ending treatment at the conclusion of a clinical trial. Communicating with them before key stages can be helpful.
    • Additionally, newsletters to patient and caregiver populations can keep these audiences aware of how the trial going, when another one is planned, additional sites opening up and where, impacts or adverse events being seen, and more.
    • Coach caregivers on what to expect in the different stages of the trial. Encourage them to find opportunities, private places to report on sensitive information, especially if the patient is argumentative, difficult to deal with, or depressed, and what to do in these instances.
  • Respect their time
    • Consider participating in advocacy groups and performing focus groups to get caregivers’ perspectives. Listen to their stories and understand their pain points to be able to better address them throughout the trial.
    • Where possible, reduce the caregiver’s burden of participation. Recognize that caregivers may be sacrificing just as much as the patient to participate in the trials. Consider alternatives to accommodate them, such as:
      • Consider occasionally working outside of 9-5 at an ideal site.
      • Use wearables to assess how active patients have been as opposed to making the caregiver record all data.
      • Employ electronic diaries to gain timeliness and eliminate bad data, such as recall bias from a family member filling in information in the parking lot that they may have forgotten to record in the week prior to the trial visit.
      • Consider artificial intelligence (AI) for drug compliance support, to record dosages taken.
      • Leverage mobile nursing to bring clinic visits to the home.
      • Consider a travel concierge to help caregivers handle logistics.
      • Consider providing monetary support to caregivers for missing work. This is something often done for the patient, but rarely done for caregivers. Consider that they may also be missing work to drive the patient to appointments or to care for them afterwards.
    • Other Considerations
      • Realize that dealing with an illness and participating in a clinical trial may be stressful for all parties. Find a balance between the caregiver’s and patient’s perspectives, while respecting both.
      • Where possible, keep the same caregiver contact throughout, such as mom or dad, to help ensure that information is rated consistently, responses are in the same sequence, and so on.
      • Ensure you are compliant with all legal requirements. A good CRO partner can help to ensure you are gaining proper consent and valid data.

Though considering the caregiver may seem like an extra step in an already full clinical trial, it is a necessary and important part of them. Working with caregivers is encouraged by IRBs, and enforced by the FDA. The incremental cost additions to support this important group far outweigh the expense of a failed trial.

Want to know how to better tap into the important role caregivers can play in your clinical trial? Watch our recent webinar on this topic or contact us for more.

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