How do I enroll people for clinical trials?
Dr EJ sent me a question about clinical trials. “I partnered with a pharma company to bring this amazing treatment for Hepatitis C to the country. It’s a proven treatment in big trials in the West. I’m having trouble enrolling people for these studies. How do I convince them participating in these trials could possibly cure them or achieve SVR status?”
I picked this question because I did write a paper on this recently and agree the newer drugs for Hepatitis C are a big improvement over what we currently have. (DAA’s or direct act antivirals, for anyone who wants to know.) The only issue is cost. These drugs are very expensive.
That being said, trials and in particular pharma companies have developed a bad reputation. And they’re not doing anything about it. I’m not here to argue about it, let’s discuss how you can get participants. At the very outset, let me underline that the hardest part of clinical trials is getting participants. I’ve been part of many research projects and I believe second to drafting the plan, this first step is the hardest.
But here’s how I go about it:
Evaluate the patient’s needs
Sit down with the person and go through their records, their labs, their adverse events and improvement or lack of it. Talk about where the drugs have failed or succeeded. Mention the development of new drugs and how it could help them.
Explain the Clinical Trial
What is the trial? How much time will it take? Will everyone participating get the drug? Explain the mechanism of action, how the drug works and how it aims to work. Is it a blind trial, what is the dose, the frequency of the drug, will they have to travel and will they have to pay. Pre-empt all their questions and answer them.
Explain the Risks
Don’t make it all look rosy. Other than preliminary findings, there will be a laundry list of side effects in clinical trials. Mention them and repeat the risks. The goal is to get participants who will go all the way. Often, clinical trials fail because patients drop out midway, the slightest doubt scares them off. You don’t want that. The success of any clinical trial is to have your sample in tact to the very end, irrespective of the outcome.
Talk to them Often
Many participants will have questions. They will ask repeatedly about the drug or the study. Remember this is a kind of litmus test. The participants want to see if you’re going to just commit them and leave or if you will stick around even while the trial takes place. So they will come to you with doubts, they will call you about minor issues. Reassure them as often as is needed. Don’t push them away.
Often participants are worried about confidentiality. You have adolescents, women, certain communities who are not decision makers at home and so they may want to be part of a trial secretly. Talk to them about HIPPAA and confidentiality. I’ve participated in some studies and I hate that doctors sometimes reveal these details in the elevator or in the car park and then everyone knows you’re in a trial. In fact, I suggest you head over to NIH and participate in a trial yourself to understand the mentality of participants.
Talk about Your Association
Be upfront with patients about what you’re getting from this trial. Your association with the pharma company may be the reason why some may not agree. They will automatically assume you’re getting kickbacks from them . So tell them how this helps you. Why do you think this trial is good. One example of this discussion is in the movie, “Miracle from Heaven.” Here the pediatrician explains to Anna’s mother in under three minutes, but it’s a good honest explanation of talking to patients about clinical trial participation.
Don’t Make it Sound Like an Emergency
There’s no reason to rush things. That in itself will hurt you. People don’t like being rushed into making decisions. Tell them the deadline and leave things there. You can remind them and if they don’t sign up, don’t bring it up ever again. There’s no need to guilt people into it.
Make Research an Aim of your Practice
I think one of the problems today is that our practices are like bars. Come and get what you and then leave. Instead, the practice needs to have a mission, a purpose and education should be one of the aims. In your waiting room, you’re sitting on a gold mine of opportunities to educate your patients. Instead of playing the news or reality TV, why don’t you run educational material about diseases, clinical trials, new developments and science. Use the wall space to highlight new trials that people can participate in. Mention it in your newsletters and make research a part of your practice. When patients know that this isn’t just a curative place but a place where you’re interested in learning and furthering medicine, they’ll be open to participating in studies and may even tell others about it because it won’t be the first time they’re hearing about it.
Don’t Force Anyone
This goes without saying but don’t force anyone. People will come around, a clinical trial is a big deal. Yes, some drugs are winners but let’s face it, not all are and we want to follow the dictum, “Do No Harm.”
How do you enroll participants in clinical trial. Any tips? Share them with us.
If you’re a doctor who would like to send in a question, you can DM me on twitter @PamelaQFerns or even message me on LinkedIn or simply use the contact form or email me.