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How sites and sponsors can support patients in clinical trials

In this series - The Pain Clinic - Kate O’Brien, formerly a senior research nurse and now a site consultant, examines the most common problems facing clinical trials today and what the potential solutions to them are (read the previous posts here). This week she looks at how sites and Sponsors can support patients during trials.

Sites and Sponsors need to start supporting patients as soon as they have expressed an interest in joining a trial. The relationship that develops between the patient and site staff directly impacts on the experience the patient has of clinical research, the probability that they will complete the trial and their likelihood of participating in future studies.

This support begins with the Informed Consent. The problems with the Patient Information Leaflet were discussed in the previous article so I will now focus on other areas. This may be the first time the patient meets the research team and they are not sure what to expect. The site needs to ensure that they have a calm, informal approach encouraging the patient to relax and feel comfortable. Taking time to fully explain all aspects of the trial, checking that the patient understands what is involved and what will be required of them, encouraging them to ask questions and voice concerns means that at the end of the process the patient will be 100% happy with their decision.

I found that the best outcomes were when this was a team effort with the nurse explaining the general aspects of taking part in a trial, the visits, the lab tests and investigations and other methods of collecting data. The investigator would focus on the rationale for the trial, the IMP and possible side effects, as well as other treatments available. I also liked to introduce them to the administrator who was their point of contact for technological support. The emphasis was placed on the patient being part of the research team, this is not the usual doctor – patient roles. This meant that they were not afraid to ask questions or contact us if they had any issues, however minor, preventing potential problems escalating into Protocol violations. As clinical trials are our focus it is easy to forget what an alien experience this is for most people.

 

9 ways to support patients during trials

During the trial there are several simple ways to provide support helping to maintain patient engagement and aid retention.

  1. Having a direct line, with an answerphone, so that callers do not have to go through the rather frustrating systems normally in place when calling a medical Practice so that patients are not deterred from calling.
  2. Using a text messaging service to remind patients of their appointment date and time, if they need to fast, or the need to return unused IMP and diaries ensures better compliance. Texts can also be used as a prompt to complete any procedures required between visits.
  3. Providing personalised feedback on their progress. This can take the form of graphs and tables to highlight achievements such as weight loss, improved HbA1C, better control of BP or cholesterol.
  4. For trials involving devices that patients may be unfamiliar with, identify a member of the team to act as their IT support. Make sure that this person will use technophobe friendly language. I found it so frustrating when I was unable to understand what so called helpdesks were talking about!
  5. Use a holistic approach. Adverse events need to be identified, evaluated and recorded as do changes to concomitant medications so treating other conditions at a study visit means that all data is collected efficiently. I had the misfortune to work with a GP who refused to do anything other than what was required for that visit insisting the patient returned for a routine appointment for other problems. Not only did this mean chasing records later to identify changes, it was also extremely inconvenient for the patient.
  6. Identify patients that may be likely to withdraw during the trial. Warning signs may include missed appointments, difficulty booking appointments or contacting the patient, non-compliance with IMP dosing, frequent illnesses, difficult external circumstances, problems at home or with travel and no visible improvement. Early discussion and offers of help may resolve issues and enable the patient to continue in the trial. It is important that the patient identifies a solution that will work for them rather than having a decision made for them that they may be reluctant to accept.
  7. A patient may have a specific problem that causes them concern. For example, many people have a needle phobia, and most trials require numerous blood tests. Explain why this is necessary and recognise their worries. Lie the patient down for the procedure, make sure you have an experienced phlebotomist and have someone talk to them whilst it is done to distract them.
  8. At each visit reinforce how important their contribution is and show that they are appreciated.
  9. Remember to say thank you.

 

How Sponsors can help

I think it is important that Sponsors recognise sites that engage with patients outside the remit of trial participation to push forward the development of Best Practice for research.

  • Provide scope for pre-consent activities in the site budget.
  • Consider scheduling a pre-consent visit
  • Allocate resources to support retention
  • Obtain patient feedback when selecting retention items on what is most useful.
  • Provide a personalised schedule of projected visit dates at the start of the trial so that patients know when their appointments will be and enable them to plan for this.
  • Provide IMP dosing instructions either clearly on the packaging or on a small laminated card.
  • Have a dedicated patient helpline provided by the vendor for technology issues and ask for feedback to ensure it is user-friendly.
  • Enable sites to perform visits in the evening or at weekends, often couriers have restrictions around collecting packages to go to central labs that prevent this.
  • Reimburse patients for their time as well as travel. Patients are expected to be altruistic when it comes to clinical trials. Looking at the chain of those involved – they are the ones who can least afford this.
  • Develop an app for patients to install. This could provide updated information, record details and track progress as well as remind patients about appointments and visit requirements.

 

RELATED ARTICLES
    - INDUSTRY REPORT: Patient-centricity in Clinical Trials
    - How patient-centricity can be achieved in clinical trials - INDUSTRY VOICES

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