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Patients Weigh in on Clinical Trial Materials



By Maxine Bookbinder 

December 6, 2013 | In the first survey of its kind, a collective of large pharmaceutical firms, under the auspices of the International Society for Pharmaceutical Engineering (ISPE), conducted an international study investigating patient feedback on their clinical trial materials.

The purpose of The ISPE Patient Initiative: Survey on Patient Experiences with Clinical Trial Materials, conducted by ISPE’s Investigational Products Community of Practice with support from 11 underwriting companies, was to collect patient responses regarding how their clinical trial materials impacted satisfaction, compliance, and completion. Investigators also gathered patient recommendations for future trials.

“We wanted to understand what patients think. This is an opportunity to better meet the needs of the patients,” said Dr. Christine Milligan, Global Director of Strategic Development Solutions at Catalent Pharma Solutions and Team Leader of the project.  “We want to know patients are informed about their clinical materials. What is the patient’s feedback? How does this feedback improve our performance?  The primary challenge for the investigational product professional is to get the right product to the right patient at the right time, every time. We now want to challenge ourselves to ensure the right product is in the right format to meet the needs of the patient.”

Approximately 100,000 surveys were sent to former and current trial patients in North America, South America, Africa, Asia, and Europe; 1,425, 97% from the U.S., were evaluated. (The remaining surveys were either not returned or did not meet study criteria.) The study focused solely on packaging and materials and how the industry can increase patient compliance by being more flexible, cost-effective, and more user-friendly while still adhering to strict regulations.

Milligan said participating agencies no longer want to produce clinical materials “from the perspectives of only the pharmaceutical industry; going forward, we want to ask the patients and the investigative sites. Our industry has reached the tipping point at which information will flow both ways.”

The project goals were simple but important: 1) to understand what patients experience while dealing with medicinal instructions and packaging; 2) to determine how suitable these materials are; 3) to produce improvement ideas for future packaging; 4) to increase collaboration between industry and regulatory bodies under the scope of ISPE; and 5) to construct and publish 21st century global guidelines.

Christine Milligan
Dr. Christine Milligan, of Catalent Pharma Solutions and the ISPE

Some of the results were encouraging to the task team. For example, 90% of participants said that packaging and instructions were either “very easy” or “somewhat easy” to use. A majority (82%) reported taking all medicine as directed; 60% said the packaging and/or instructional design and layout of the medicine kit helped them take their medicine on schedule. In fact, 52% reported that no packaging changes were needed. Participants stated they wanted the medicine to work, they wanted to follow instructions, and they wanted their trials to succeed.

More study is needed. All patients rely on getting detailed information, but those who don’t understand what to do or how to use their medicine want additional reinforcement.

Project investigators are honing in on weak areas. For example, 78% of patients replied that it would be “very helpful” or “somewhat helpful” if prescriptions and refills could be delivered to their homes, rather than patients travelling, sometimes long distances, to pick up resupply medications in person.  A majority also said they wanted increased communication with clinical staff. However, this could be done electronically; patients prefer to select the method of communication, whether through email, text messages, smartphone app, a website, telephone, regular mail, or in person. The key is having the option to choose.

“Patients want reassurance they are taking their medication correctly,” says Milligan.  “They want to be valued and they want to comply.” According to the study results, many patients said they wanted to feel they can ask questions, to know their questions will be answered, to repeat instructions back to staff for clarity, and to check in with staff when necessary. At focus groups, patients discussed feeling that protocol was more important than their physical symptoms.  When staff increases involvement with patients in the clinical process, patients feel more important, resulting in higher compliance.

One critical issue involves improving the process of returning unused medicine. Some patients claimed they didn’t know they had to return it; others chose to keep it. It is imperative that clinical staff clearly explain at the beginning of trials, before any medical kits are dispensed, that unused medicine must be returned and why.

“We need to eliminate the ‘one size fits all’ approach,” says Milligan. “Of course, scientific inquiry must maintain consistency. There are other ways to accommodate patients without jeopardizing integrity. This includes labels, reminders, and staff communication.”

Patients also want more pictograms to help explain instructions. Still in development, these will need to be understood by patients worldwide.

Improving the appearance of packaging instructions is a small change with a potentially big impact. Instead of having all text in the same font, size, and color, important text can be in larger, bold print, which draws attention and is easier to read.

The project, which took almost a year to complete, is entering a new phase. Team members met again in December 2013 to “dig deeper into the data, talk to regulators, and present findings,” says Milligan. The team will present its findings internationally, including China, Japan, and Europe. “We will take suggestions from specific regions. We want to know, ‘What do you see as really unexpected? What do you see as really expected?’ ” ISPE will eventually publish a best practices guide based on expert recommendations and patient input.

The ISPE Patient Survey Project Team includes members from ISPE, Almac, Novo Nordisk, Pfizer, Catalent Pharma Solutions, Takeda, and CISCRP.

 
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