I recently got a visit from a new patient at my orthopedic practice. He walked in with severe osteoarthritis of the right knee. It so happens that I am currently doing a clinical study in lower extremity osteoarthritis and have already enrolled twelve patients in over one year. I ask the patient if he would be interested in participating in the study, I also ask him to sign a 10-page consent form, which he does not read. He seems somewhat uncomfortable with the situation. On top of it all I give him a questionnaire and ask him to answer the 50 questions every three, six and twelve months. Oh, and every year after that. After a long day at the clinic, my research assistant starts to enter –one by one– the variables that have been gathered from the completed forms into a spreadsheet. Only when –in my opinion- sufficient information is gathered, I transform all this data into number codes and give it to a statistician to enter it into a specific program that will determine whether the data is statistically relevant. Most likely the statistician will com back telling me that in order for the tests to be significant, I need to enroll more patients. Yet, all I want is to finish the study. It’s all too time consuming…
Does the above sound familiar? Most physicians that conduct clinical research probably work through a similar process. If their practices or institutions cannot afford several research assistants, the process will most likely be a slow and tedious one. Physicians are eager to contribute to advancing medical knowledge, but things are not getting easier with all the institutional review boards (IRB) requirements, patient follow-up and manual data entry.
Medical research –and especially clinical research– is falling behind when it comes to taking advantage of current technologies to improve and optimize all the processes involved. Here are some ideas:
- Consent forms – When a patient is detected for enrollment in a study, the physician should ask the patient to carefully read a consent form from a tablet while he or she is in the waiting room. The form should be enhanced and have help buttons that explain each of the clauses. The patient electronically signs the consent form and will be safely stored for IRBs purposes.
- Patient surveys – There are vast amounts of online resources that manage surveys or questionnaires. Physicians should make use of them and send questionnaires directly to patients via email. Questionnaires could also be loaded on the tablets for patients to complete while in the waiting room. All variables are then automatically stored in a database. This process saves the physician or his research assistant the tedious work of data entry.
- Statistics – A decent programmer should be hired to relate simple statistical formulas with the information that is being stored in the database, leading to the automatic creation of graphs that will immediately tell the physician when he or she has reached a statistically significant research sample.
The above-mentioned points are just some of the ideas that could have great impact on the way physician practices engage patients in clinical research with very little resources and time. The technology is there; we just need to use it.
Next up: Future Possibilities for Clinical Research.
The ball is at your side of the court: Which current technologies do you use for medical research or know about?
Keep pushing forward.