Why Paper Diaries Should be Banned in Clinical Trials


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Why Paper Diaries Should be Banned in Clinical Trials

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Why Paper Diaries Should be Banned in Clinical Trials

  1. 1. Article Reprinted from www.pharmexeceurope.com March 2009 Why Paper Diaries Should Be Banned in Clinical Trials By Dr Valdo Arnera E very now and then, a shift in technology revolutionizes an entire industry. Consider the advent of email and automatic banking machines. batches, invent data, forward-fill, and mark multiple responses in the same question. All these situations present serious data analysis problems. Once the mainstream adopts these processes, it is We are all familiar with “parking lot syndrome,” difficult to imagine how we managed without them. in which patients retrospectively complete days or Today a similar transformation is taking place in the weeks of diaries just prior to a site visit. Patients also pharmaceutical world, as more companies worldwide forward fill paper diaries. A study published in the replace paper diaries with electronic patient diaries in British Medical Journal showed that 45 percent of clinical research. Electronic patient reported outcome (ePRO) solutions capture self-reported data directly from patients at home or at investigator sites around the world. Most often patients use PDA devices which transmit these data to a central server. An ePRO system provides sponsors with higher quality data than paper, accurate timestamps and real-time access to vital compliance, enrollment and safety information. If market adoption continues at its current pace, in ten years paper diaries no longer will exist for studies using PRO as primary or secondary endpoint data. I propose that we accelerate the pace and call for paper diaries to be banned. If your study depends on what patients tell you, you have no choice but to use electronic diaries. It very well could be the difference between making your study a huge success or a failure. It is impossible to get high quality data from paper Paper diaries offer no controls over timeliness or quality. Subjects make entries that are incomplete (skipped items), illegible (poor handwriting), captioncredit_ and illogical (inappropriate responses). Further, patients respond days later, complete diaries in
  2. 2. subjects in a pain study invented data to be able to ask patients how they as compared to paper. This enables by forward filling at least once. feel at a precise moment and get an smaller, more conclusive studies. With paper, the burden is placed immediate, accurate answer. Biostatisticians could adjust on patients to remember diary and lower estimates on how many response times. Paper diaries can be Electronic diaries empower patients are needed to prove efficacy confusing for patients to understand subjects to be more in Phase II studies, based on the and accurately answer. In many compliant expected variance of paper data at studies, the questionnaires branch An elderly female fibromyalgia hand. This can create a significant into different paths depending on the patient in the UK once reported that savings in money and time. In Phase patient’s responses. The burden is on her electronic diary alert sounded III studies, such high quality data the patient to understand which set during a wedding reception. She provide more reliable scientific of questions to answer based on their simply laughed, excused herself, and conclusions. Instant access to up- reactions or symptoms. took five minutes to complete and to-the-minute ePRO data allows Electronic diaries allow sites to send her diary. It did not occur to adaptive trial designs which are obtain accurate, real time information her that this activity was a burden. almost impossible with paper. on patients’ reactions during a trial. It is highly unlikely that she would They are the best way to collect both have carried a paper diary with her Electronic diaries are the objective and subjective assessments to the wedding. History tells us that future, today of patient experiences. she would have completed her diary Paper might do well enough in retrospectively, or not at all. rare exceptions, such as when Paper is slow Patients using electronic diaries time sensitivity is not an issue If a patient is not performing well in enjoy a much higher degree of and a question relates to patient a study by failing to complete diaries privacy. They can respond more experiences over a week. But when regularly — or more importantly, freely than on a piece of paper that it matters if a subject completes because of worsening symptoms will be read by others. In a study on the diary on Monday instead of next — it can take weeks or months for female sexual dysfunction using a Thursday, it is certain that paper data sites to notice. Site personnel have to cross-over design, patients reported ultimately will fail. spend time reviewing paper diaries 80 percent more sexual episodes Despite continued increasing and making manual, error-prone on the electronic diary than they adoption in the ePRO industry, calculations and measurements where reported on paper. some companies still are reluctant needed. These activities detract Electronic diary patients say that to change. Managers may worry from time that could be spent caring they are encouraged to comply that if there is a problem with for patients — one of the reasons because they feel that someone is electronic diaries it will hurt their site investigators become study paying attention to their symptoms careers, because no one was ever coordinators in the first place. whenever they transmit their data. reprimanded for using paper — yet. Electronic patient diaries allow They are aware also that their study The real danger lies in spending responses only during the appropriate coordinators are supposed to review millions on trials that failed because times specified by the protocol. They their data, which compels them to of outdated, inaccurate paper diaries. use controls to ensure complete, complete reports as expected. If the primary efficacy endpoint legible and logical reports; encourage Patients in a year-long lower is coming from the patient it makes compliance through alarms; reduce back pain trial showed 90 percent no sense to use paper diaries. Trials respondent burden; and provide compliance because they could hold are all about data. It is the only thing real-time site management of patient the electronic diaries in any position they produce. performance. In short, electronic they pleased. One man said he would For efficacy and faster, smaller, diaries solve the problems of not have been able to fill in detailed less expensive trials it is time to put paper diaries. responses with paper because he away the paper and pick up what was too uncomfortable to write. has proven to be extremely effective Electronic diaries promote a These patients completed electronic technology: the electronic diary. fast, honest response diaries six times a day, seven days In a Merck Research Laboratories a week because they could use the Dr Valdo Arnera insomnia study comparing paper and device even when lying down. And Dr Valdo Arnera has more than 18 years electronic diaries, one patient reported they felt encouraged because they of experience in the pharmaceutical that he enjoyed using the paper diary were actively involved in managing industry. He is skilled in both science because he only had to play catch-up their pain and health. and management, and speaks frequently about 60 percent of the time. This kind on these topics. Dr Arnera has been of statement that should convince all Electronic diaries enable an active co-chair of the DIA’s Special of us involved in data quality that paper more reliable, smaller, faster, Interest Area Communities (SIAC) diaries are nightmares. safer trials eClinical and Standards committee. Studies prove that electronic diaries One of the major advantages of motivate subjects to complete their ePRO solutions is that they have diaries. It is much more efficacious been shown to reduce data variance