The Vaccine Trial Obstacle Course

Vaccination is a difficult choice for some, and a necessity for others. Why is it so hard to develop effective vaccinations?

 

Six Challenges to Recruiting Among the Senior Citizen Population

Recruiting patients for any clinical trial involves some bumps in the road. But recruiting among the senior citizen population for a vaccine-related clinical trial can be a veritable obstacle course. Here are six of the challenging elements you will have to overcome.

See the original article by Craig Curtis here:

The Vaccine Trial Obstacle Course

1. The Medical Record Mud Run
Obtaining medical records can be incredibly frustrating. You want to move fast, but you are bogged down by unresponsive physician offices. It can take multiple faxes (Really? Faxes in this day and age?), phone calls, and emails to get the records you need. And if all else fails, you may have to turn the mud run into a relay – and ask the patient to show up in person at their doctor’s office and get the records personally.

2. The Medical History Crawl
Senior citizens often have significant medical history data to compare to inclusion/exclusion criteria. It is not unusual to have one or two dozen disorders listed in their medical history dating back sixty years or more. And even if you have all the records, it can be easy to overlook certain conditions.

For example, assume that autoimmune disorders are exclusionary for your trial. You do your due diligence by asking the patient if they have any autoimmune disorders, to which they answer in the negative. But as you read carefully through thirty pages of medical records, you find an obscure reference to Vitiligo – a disease that some medical professionals consider to be an autoimmune disorder and others do not. For your clinical trial, this condition means exclusion … but you would never have realized that the patient should be excluded without doing an intensive medical history crawl.

3. The Medication Maze
All medications taken by the patient must be viewed with extreme caution, since trial data can be invalidated if certain concomitant medications are taken. The protocol should clearly define classes of allowed and excluded medications, but the site staff have to be vigilant to track every medication down and assess it, lest a patient fail to realize that a certain medication belongs to an excluded class.

The Medication Maze is made even more complicated because senior citizens may have new medications prescribed or current medication dosages changed during the course of a clinical trial. They may not be aware that such a modification in their medication can invalidate them for the clinical trial, so site personnel need to ask frequently about any medication changes.

4. The Scheduling Shuffle
Scheduling requires serious agility! After randomizing a patient, you might be told that they are a snowbird, and only live in this location half the year. Or, they might be retired and take extended vacations of six weeks or more. Or, alternatively, they might say that they cannot make the vital post-randomization visit because they booked a cruise – over a year ago! To beat this challenge, printing a calendar of every required site visit is helpful. You can give it to the patient and ask them to review it at home to ascertain if there are any conflicts.

5. The Data Collection Hurdle
Data collection with senior citizens can present multiple hurdles. For example, they prefer documenting results on paper, rather than using an electronic alternative. They also tend to take measurements in inches, not centimeters, even if centimeters are stressed as necessary for the protocol. This might lead to a false recording of a 6 inch – instead of a 6 cm – injection site reaction.

6. The Resistance Wall
Finally, there is the obstacle of sheer resistance to vaccine trials. It can sit there like a massive wall, daring you to get to the other side. Resistance usually stems from a lack of understanding about what is involved in a clinical trial, or why vaccines are important for the senior citizen population. There are many ways to get beyond this wall, but they all involve one common element: education. With greater understanding, you don’t have to climb over the wall – it will fall down all by itself.

It’s quite an obstacle course – but you can get through it successfully and win the prize… a vaccine clinical trial filled to optimum capacity with qualified senior citizens!