Clinical trials have become increasingly complex over the past several years, and unfortunately, this has resulted in the typical scenario described below. We are fortunate that there are so many promising agents available for patients, and we want to encourage their participation in clinical trials, which will advance the field and provide exciting new therapeutic options. However, as physicians, we need to be cognizant of the tremendous impact that participation in a clinical trial has on the quality of life of our patients.
Consider the following scenario:
MD: Hello, Ms. Smith. Thanks for coming in today. As we discussed at our last visit, the computed tomography (CT) scan showed that the chemotherapy has stopped working, and we need to come up with a plan for your next course of therapy. There are other chemotherapy options, or we could consider a clinical trial with a new drug.
Ms. Smith: I can’t say I’m too enthusiastic about getting more chemotherapy. Tell me more about the clinical trial.
MD: We have seen excellent results with this drug in other cancers, and we think it has a good chance of working in your cancer also. You are in good shape, so I think you would make an excellent candidate for the study.
Ms. Smith: That sounds encouraging. Can I start that treatment today?
MD: No. First you need to have some testing done to make sure you are eligible to participate. You will need to come back later this week to get some blood work and three electrocardiograms (ECGs).
Ms. Smith: Can I get the blood work done today while I am here?
MD: No. It needs to be collected in the morning after fasting.
Ms. Smith: Ugh, okay. It’s just that I live an hour away. Can I start after that?
MD: Well, you also need a biopsy of the tumor in your lung.
Ms. Smith: Don’t we already know this is cancer?
MD: Yes, but this biopsy is being done for research purposes.
Ms. Smith: When will I get the results of this biopsy?
MD: You won’t. The samples are sent to the pharmaceutical company for analysis.
Ms. Smith: How is the biopsy done?
MD: You will have a consultation with the doctor from interventional radiology, who will explain the procedure. Then you will return a few days later to have the biopsy. You will be sedated for the procedure, so you will need to have someone come with you to take you home.
Ms. Smith: Okay. I guess my husband will need to take another day off of work.
MD: You also need a CT scan with contrast of the chest, abdomen, and pelvis.
Ms. Smith: But I just had a CT scan 2 weeks ago.
MD: I know, but by the time all of this testing is completed, the CT scan will be outdated.
Ms. Smith: Okay. So I will need to come back in for the blood work and ECGs, then the biopsy, and then the new CT scan. How soon can I start? I’m worried the cancer in my body is growing!
MD: This will all take about 2 weeks. The day you start, you will need to get to the office first thing in the morning. You will get more blood work. Then you will receive the treatment, which takes about 30 minutes.
Ms. Smith: That doesn’t sound too bad. I should be home by noon then.
MD: Well, not really. You will remain in the office for 8 hours after the treatment, so we can draw multiple blood samples to measure the drug levels in your body. You will then go home that night, but you need to come back the next day for additional blood work.
Ms. Smith: Wow. And then when is my next treatment?
MD: Three weeks later. But you need to come back each week for a checkup and more blood work.
Ms. Smith: Can I do any of the blood work near my home?
MD: No. It all needs to be done here.
Ms. Smith: Doctor, is this all worth it?
Increasing Complexity
This anecdotal description of the requirements for participation in a clinical trial does not even touch on the behind-the-scenes work involved with this patient’s accrual into the study. Her blood work must be properly collected in special kits and shipped to the outside lab. ECGs must be performed and transmitted from machines provided by the outsourced company, which reviews them. CT scans must be digitized and sent to the vendor, who is independently reading them. Pathology specimens must be prepared and shipped to yet another site for the correlative studies. And all of the testing must be conducted and reported in strictly defined windows of time; otherwise, paperwork regarding violations to the protocol must be filed.
As oncologists and cancer care specialists we obviously want to maintain safety in drug development, but we need to do a better job asking whether each added test improves on that. Each box that is checked on the table of clinical trial assessments has real implications for the patient who has to go through that test and adds another layer of complexity for the investigator and the research staff. Perhaps it is time to open the dialogue with pharmaceutical companies and the U.S. Food and Drug Administration and push back on the intense testing and monitoring that have insidiously become the standard in clinical research.
When our patient asks, “Doctor, is this all worth it?”, we should be able to say “Yes, but we recognize the process is burdensome and we are working to minimize the inconveniences and maximize the potential for beneficial outcomes. Clinical trials are our best means to advancing research and improving patient care. I believe you are a good candidate for this trial.” ■
Disclosure: Dr. Krug reported no potential conflicts of interest.
Dr. Krug is Associate Attending Physician and Deputy Chief of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center, New York.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO.
