Clinical Trials – Slow Enrollment

If slow enrollment is the problem, here is the solution.

You need qualified patients. This is how I propose finding them.

Patients are seen by doctors.

Doctors keep detailed medical records. They have created huge silos of their patient data. This data is highly coveted, and seldom shared. However, doctors are free to share “de-identified” patient data.

“De-identified” patient data … that’s the key. Even NISTR says that’s ok. They say so right here.

So, here’s the plan. We ask clinicians for de-identified patient records. We have a tool to easily perform this task for them.

Then, we scan the data for patients that meet your eligibility requirements, and we produce a list. We contact the clinician with our list, she re-identifies the patients using her “Re-Identify Key Report”, and decides if your trial is a good fit.

You now have genuinely eligible patients and a primary care doctor on board. This is how it should be done. This is so much better than trying to use “social media”, TV commercials, print ads, or surveys.

Let me demonstrate how this works.

The clinician is probably using medical software that is Meaningful Use Stage 2 certified. If so, she can easily prepare a CDA for every patient. CDA stands for Clinical Document Architecture. It’s the format clinicians use to share healthcare information. If the clinician is not using MU2 software, don’t worry, we can handle that too.

So now there’s a folder full of CDA’s. But you can’t touch it. You provide the doctor with our software tool called “Practice Today CDA Transformer”. Super easy to use. Just point and click. That’s all.

CDA Transformer

Notice that the doctor can decide what type of data to include.

Presto. Now you have a folder full of de-identified patient records.

Now, we are going to import these records into your Practice Today Clinical Trials Software and prepare your eligibility query.

Here’s a sample eligibility statement from a real Clinical Trial. These are the requirements:

Inclusion Criteria:

–  Type 2 diabetes
–  age > 18 years old who are at high risk based on any one of the following criteria:
–  HbA1C > 8.5
–  LDL > 130
–  BP > 140/90 within the last 6 months

Exclusion Criteria:

–  patients who are pregnant upon entry in the study (however if a patient becomes pregnant during the study, she can continue with the study)
–  unable to communicate in either English or Spanish
–  in nursing homes (and therefore unable to attend outpatient visits)

We select our query, and click GO.

Presto, a list of eligible patients.

“What if zero patients are found?” you ask. Good question. We can re-tweak our query. In this example, maybe the clinician does not keep track of whether the patient is in a nursing home. If so, removing it from our query will increase your output.

We can also eyeball the data by opening the data tabs to see what’s there. Perhaps the clinician uses another title for her lab results. Again, we can re-tweak our query, and run again.

The ability to adjust, and re-adjust your query is a powerful tool for finding eligible patient.

So, now we have a truly eligible patient list. We take our list back to the clinician, and she can match up and consent the patients.

You can take it from there.

We can cure your slow enrollment TODAY.

Let’s get started. Click here. Make sure you read the PS.