Imagine you work for a pharmaceutical company, and that the future of the company depends on its development of new drugs. Your job is in the clinical research department. That is, you are responsible for running studies to prove that these new drugs are safe and that they do, indeed work.
You’ve just been assigned to a project that involves a new drug for the treatment of migraines. You have a lot to do. First you have to determine what you want to claim this drug does. For example, you might know that while all of the current migraine drugs on the market claim to relieve migraine pain, none of them can state how quickly the migraine sufferer can expect their pain to go away after taking the drug. And that could be a big deal. I mean, if I suffered from migraines I would want my doctor to prescribe the drug that makes my pain go away as fast as possible. So, there’s your goal – you want to prove how fast your new drug works at relieving migraine pain.
Now you have to find those migraine sufferers and identify who would be willing to be part of a clinical study and take this new drug to determine if it works. You find doctors who typically treat migraines, give them a list of your study’s requirements and ask them to identify those migraine patients into your study. There’s not much that the patient has to do – they just have to take the drug whenever a migraine occurs and, oh yeah, they also have to keep a diary of every time they have a migraine and how long it lasts. Sounds simple enough, right?
But it never works that easily. In most clinical studies, patients are given paper diaries, and asked to complete the questions in that diary every time they have a migraine. Even though those instructions don’t seem very difficult, most patients will not follow them. Instead of completing their patient diary questions as soon as a migraine occurs, they likely wait until much later – hours, days, or even weeks later – to record that migraine. And, let’s say the migraine happened on Monday- the patient took the drug and at some point started feeling better. If the patient doesn’t pick up that diary until, say, Wednesday, can you really rely on what they write down? I mean, it’s now 10:00 am and I can’t remember what I had for breakfast this morning, let alone a migraine that happened 2 days ago, and was it 2 hours or 3 hours later that I started feeling better? This is why a lot of pharmaceutical companies are no longer using paper diaries to answer these critical questions.
So, here’s where an electronic diary – or patient eDiary comes in. An eDiary is merely an electronic version of the paper diary, but with a lot more benefits. In this clinical study, you would likely want the patients to use an eDiary instead of a paper diary. Why? Because they are very easy for the patient to use, will let you know if the patient is falling behind and not entering their data on time, and save you a lot of time and hassle at the end of the study. Here’s how they might work in this study:
