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The Pain Clinic - Solving the five most common problems in clinical trials

At Partnerships in Clinical Trials in Barcelona (Nov 2018), Kate O’Brien, formally a senior research nurse and now a site consultant, led a problem solving forum for all aspects of running clinical trials. Here she examines the most common problems and the potential solutions to them. Download this piece as a PDF here.

The concept behind this initiative was to identify some of the issues that face different areas of the industry when developing, setting up and conducting clinical trials. With the wealth of experience available at Partnerships in Clinical Trials it was then the task to develop possible solutions to these. Discussions prior to the event with patients, site staff, CRAs and pharmaceutical companies highlighted a number of areas to address. These were then categorized under five headings.

1) Patient Engagement

- Lack of research awareness
- The Patient Information Leaflet
- Unaware of available trials
- Can’t take time off work/school
- No local site
- Travel issues

2) Feasibilities

- Not enough details provided to enable sites to search accurately
- Lack of transparency from sites regarding workload
- No feedback if not selected

3) Site Performance

- Under recruitment
- Excessive screen failures
- Data entry out of timelines
- Slow response to data queries

4) Technology

- Inadequate training for site staff and patients
- Devices under performing
- Poor support from helpdesks

5) Patient Payments

- Patients not keen on cash payments
- Difficulties holding petty cash at site
- Trials not standardized, some pay, some don’t

 

Solutions

 

The forum saw excellent participation from many delegates at the symposium. Attendees were encouraged to discuss problems and post ideas for solutions.

1) Patient Engagement

LACK OF RESEARCH AWARENESS

- Develop a research registry for patients interested in participating in clinical trials. (MEDICOLLECT, NIHR)
- Collect positive comments from trial participants and display these to promote trial participation
- Look at a community outreach
- Generic information from the government

PATIENT INFORMATION LEAFLET

- Involve patient groups in design (NIHR)
- Use a professional company (LIFE HEALTHCARE)
- Consider health literacy, ensure that the document is formatted to enable the majority of the population to read and understand.
- eICF – have an interactive online document. Facility for investigator to check what patient has viewed and for patient to raise questions

UNAWARE OF AVAILABLE TRIALS

- Consent to contact registries
- Better/wider advertising
- APP and website

DIFFICULTY TAKING TIME OFF WORK/SCHOOL

- Virtual and hybrid trials. Utilise mobile technologies for remote data collection.
- Home visits
- Assistance with travel arrangements

NO LOCAL SITE

- Concierge service to arrange travel to sites (GREENPHIRE)

TRAVEL ISSUES

- Pay travel expenses
- Concierge service for those patients who can’t afford to wait for reimbursement (GREENPHIRE)

 

2) Feasibilities

NOT ENOUGH DETAIL PROVIDED FOR ACCURATE SEARCH

- Use data led solutions (DISCOVER)
- Sponsor to provide more information at feasibility
- Data provided to be search friendly
- Sponsor could have search built to export to sites

SITES OVER OPTIMISTIC TO SECURE WORK

- Assess previous recruitment history, numbers recruited and timeliness
- Sites to provide evidence to support claims

SITE LACK OF TRANSPARENCY OVER WORKLOAD

- Check site website for ongoing work
- National registry for the industry of site information. To contain details of site facility, history of trials run, numbers recruited, ongoing trials.

NO FEEDBACK IF SITE NOT SELECTED

- Sponsors to contact sites and provide individual feedback on reasons for non-selection.
- Sites to be proactive in contacting Sponsors and asking for feedback

 

3) Site Performance

UNDER RECRUITMENT

- Access site’s previous performance data, check numbers recruited, targets met
- Investigator engagement, is the PI available to meet with CRA, are the investigators engaged and interested during meetings?
- Improve the feasibility process to ensure Sponsors are selecting quality, transparent sites
- Details of five sites who consistently perform at the highest levels were available at the forum and are attached to this report

EXCESSIVE SCREEN FAILURES

- Cap screen failure rate
- Lower screening fee and higher randomization fee
- Pre-screening assessment visit (WOODLEY)
- Better Protocols to limit screen failure risk

DATA ENTRY OUT OF TIMELINES

- Sites to utilize two linked screens for simultaneous data entry
- Withold site payment
- CRA to monitor and follow up issues with PI

SLOW TO RESPOND TO DATA QUERIES

- Daily reminders
- Withold site payment
- Sponsor to clear resolved queries from system to ensure open queries are easily found
- CRA to support site in answering queries
- There are several tools available to help sites with the daily management of trials. Examples of this include the laboratory supplies caddy developed by ACM Global laboratories that makes it easier for sites to select the correct visit kit and to monitor supplies. World Courier unpack IMP shipments at site, helping to avoid temperature deviations. Companies including Oracle Health Science and Medidata and developing single platforms for data entry and trial management.

 

4) Technology

INADEQUATE TRAINING FOR SITE STAFF AND PATIENTS

- Assess site’s previous experience with systems
- What provision does site have in place to support patients using mobile devices
- Select vendors that provide comprehensive training
- Listen to site and patient feedback on training
- Vendor to provide ongoing support

DEVICES UNDER PERFORMING

- Sponsor to assess positive previous performance when selecting vendor
- Sponsor to provide clear details on back up plans in case of device failure
- Sponsor to listen to site’s feedback on device performance

HELPDESKS

- Sites to report bad experiences
- Sponsors/ Vendors to follow up on these reports
- As above regarding communication issues with language barriers

 

5) Patient Payments

PATIENTS NOT KEEN ON CASH

- Discussions with patients show that the majority do not like to receive cash. They have concerns over safety if carrying sums of money and feel that other payment systems are more compatible with modern life.
- Utilise alternative payment system (GREENPHIRE CLINCARD)

DIFFICULTIES OVER HOLDING PETTY CASH ON SITE

- If cash is the only option – Sponsor to provide float or Pre-pay site

TRIALS ARE NOT STANDARDISED SOME PAY SOME DON’T

- Sponsors to recognise that the patient’s commitment and reimburse for their time, this would also assist with recruitment and retention
- Sites to negotiate patient payment as part of contract discussions

 

Conclusion

 

The input from sites, CRAs, CROs and vendors showed that there is an appetite to identify and resolve the issues that hamper the efficient delivery of clinical trials.

Disappointingly there was a lack of input from the pharmaceutical companies directly and without a willingness on their part to engage, change and improvement becomes difficult. The Pain Clinic achieved its goal in highlighting problems and pinpointing solutions.

Some of the areas of difficulty related to site performance. Available at the forum were profiles of five UK Primary Care sites who consistently perform at the highest level. The author does not work for any of these sites and received no financial incentive to include them.

With thanks to Sammy Ainsworth, Eamonn O’Brien and Vivienne Van De Walle for their contribution.

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