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How Important Is Collecting Soft Data In A Clinical Trial?

In any clinical trial, there are tons of data points to collect and report. CROs and pharmaceutical companies alike, are working hard to capture all the necessary hard data they need to prove the drug cycling through a trial is effective. The thing to consider is that their trial participants are human. Humans have lots of qualitative feelings and opinions about things that may not be on the data collection sheet of a CRO. Should collecting soft data in a clinical trial be just as important as the hard facts?

Ask any scientist what the differences are between qualitative and quantitative data, and you are going to get some funny looks. Traditionally, qualitative data didn’t matter all that much in science. Scientists are looking for hard facts you can’t argue. Feelings don’t qualify as data points to a scientist.

Ask any clinical trial participant if how they felt about the experience or to describe how they felt about the drug they were trying, and you might get a lot more information out of them than you imagined you would. People like to talk about their feelings when it matters. You can learn a lot from those conversations, even in a clinical setting.

Collecting Soft Data In A Clinical Trial Reveals More Than Opinions

At first glance, sitting around with each clinical trial participant to ask them how they feel would feel tedious and even unnecessary. All most CROs and pharmaceutical companies are really after is whether or not the drug on trial made an impact on the patient’s illness, and to what effect. However, there is something that happens when people feel comfortable enough to share their feelings with someone — the accurate information they are holding in starts to spill out. Instead of barely answering rote questions, they start to give more details that are being asked. They start to not only talk about how they feel but why they feel that way. That, my friends, is where the research gold lies, just waiting to be unearthed.

There are two kinds of collecting soft data in a clinical trial to consider if you are going to do it. The first one center’s around patient centricity and patient experience. There is getting clinical trial participants to participate, and then there is keeping them engaged long enough to complete the trial. Which one is harder is up to the individual CRA to answer, but both of them are a challenge. The soft data points or qualitative questions you might ask of a clinical trial recruit could be something like:

  • Why did you decide to try a clinical trial?
  • What are you hoping to get out of the experience?
  • What do you think it will be?
  • What would you expect us to do for you?
  • What will you do if this is not successful?
  • How do you feel about your doctor’s opinion of you participating?

These are all great questions that if collected over time, will start to map out a more patient-centric way to conduct a clinical trial based on aggregate information taken from soft data in a clinical trial. Patterns will emerge that will give CROs a better picture of how a patient views patient-centricity instead of the CROs making their best guess about what it is supposed to look like.

There Are Great Soft Data Questions On Trial Exit To Ask

There is always an exit survey when anyone completes a program, a trial, etc. Companies who perform any trial, never mind clinical trial, want to know what they could have done better to make the experience more appealing for the next round of participants. This is no different with clinical trials.

Allowing patients a little more latitude with responding to exit questioning will yield better information than just “1 out of 5” type questions. If you care about the experience, get the patient to open up about what their experience was like. There is much to mine out of the paragraphs they will write in the long run. Any good sales training program tells sales trainees to ask open-ended questions for better results. CROs should take this approach, as well.

How Do You Go About Collecting Soft Data In A Clinical Trial?

CROs can go about gathering soft data points the old fashioned way, with email forms or paper, but the better solution is to use technology to do it. There are a few reasons this is a good idea for everyone involved. First of all, having a solution that is being used over time with a clinical trial participant is going to yield better results than just an online data collection tool to use at the end.

Patient communication platforms are the new frontier with healthcare in keeping patient-centricity at a maximum. Healthcare systems are seeing the value of continuous patient involvement for outcome success in treatment. Communicating with a patient is not a one-time thing. CROs would be wise to follow suit with patient communication in a clinical trial setting, as well. A communication and data collection platform allows the patient to communicate on their terms. It also provides for a permanent record and open-ended communication even long after the clinical trial is completed. This gives a much broader view of patient outcomes over time with a clinical trial. How valuable would those soft data points be?

eCare Vault is the first solution of its kind, designed to be the patient communication and management platform that CROs have been looking for. This HIPAA compliant, cloud-based solution can be used from any smart device, making use by CRAs and clinical trial participants as easy as using any other app they regularly use. If you’d like to find out more about collecting soft data in a clinical trial with eCare Vault would do for your next clinical trial, contact us today for a free consultation.

Thank you for sharing!