By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
Thirty years ago, patient recruitment was a challenge for pharma companies. Today the patient participation rate in trials still hovers around five percent and is not expected to improve anytime soon. Patient recruitment remains a challenge that pharma must work to overcome.
I recently spoke to a clinical operations director about patient centricity and social media, and the impact they are having on patient recruitment. Because of a recent job change, this individual has asked to not be identified in the article. However, I do believe these insights are valuable and shed light on how the industry is changing its perspective on patient recruitment.
Ed Miseta: How much of the success of patient centricity efforts simply depends on hard work and productivity?
Director: It’s definitely a lot of hard work. When discussing what it takes to properly recruit patients, I like to equate it to losing weight. If you want to lose weight, you can’t address one habit. You must address many. You must eat less, you must eat healthy, you must focus on when you’re eating, you need to drink more water, there are things you need to stop drinking, and you must exercise. You also must recognize that what works for one person will not always work for someone else.
That is true of almost everything in life, and it is also true for patient recruitment. If you have a study going on at 60 sites, you might have to go to all 60 sites, find out what recruitment strategy works for each, and create a personalized plan.
I had to do that once. We did not have a recruitment team. This were three individuals, including myself, who went out and spoke to all 60 sites. I had to live out of a suitcase for about two and a half months, but we did it because it was too important a task to delegate to a CRO. We wanted to have that face-to-face interaction to understand what works at each site.
Miseta: How much of a role does patient centricity play in trial recruitment?
Director: It plays a huge role. The patient recruitment efforts I just mentioned came after we had discussions with patients. In that instance, we spoke to patients and investigators at the beginning of the trial, before we had finalized the protocol. We asked them to look at the protocol and tell us what they thought of it. We ended up producing a wonderful protocol. Unfortunately, the FDA did not approve it. We had to go back and recreate it, but we were at least able to tell the patients and investigators why we were not able to incorporate some of their suggestions.
Miseta: Is there a key takeaway from that?
Director: What I continue to learn is that you must always ask yourself, “What more can I do?” Always be communicating with your patients, your sites, and your vendors. Patient recruitment isn’t a one-time thing; it’s an ongoing process. You can’t have one patient recruitment plan. It should always be evolving.
Miseta: It seems no matter how hard you plan, some things come up that will always be unforeseen.
Director: I hear people say that you need to do proper upfront planning. I agree, but you will never catch everything. I was involved in a trial where we found out during the study that one of the required medications would not be covered by insurers. Even with all the planning we did, and all the people we reached out to, that was something that we didn’t anticipate. When you are thinking about what needs to be done for the trial, throw everything into the discussion, including the kitchen sink. You will find there is no perfect situation for any study.
Miseta: Do you recommend working with patient advocacy groups?
Director: Absolutely. We partnered with one of these groups for a rare disease trial. We worked with one of these groups to have patients review our protocol. We went to the advocacy group and they provided us with a list of patients who were willing to perform the review. It’s a mistake to ignore any group that can have a very positive impact on your trial.
Miseta: Pharma used to find a site and then identify patients. Today we are finding patients and then connecting them with a site. Is this a growing trend?
Director: We did both in one rare disease trial. We identified sites but were also able to find patients. Keep in mind that just because a patient has the disease doesn’t mean they will qualify for your trial. A patient might look like a perfect fit, only to be ruled out because of their lab work. I would be wary of opening a site for one patient if you don’t know whether they will make it to randomization.
Miseta: Are you using social media for recruitment?
Director: We will perform social listening by embedding ourselves in groups that discuss a specific disease. Social listening will allow us to geographically identify where patients are located. Then we can search for clinical sites in that area.
Keep in mind that this does not always lead to a patient. It just leads you to a group of people who have that disease. You will also find patients who are interested in the trial but will drop out when they find out what the study encompasses.
For example, I once had a patient go all the way through screening. Visits one and two were 28 days apart. There were another 28 days between visits two and three, which is when randomization occurs. At that point, the patient decided to drop out. They really didn’t provide a reason, and this was after we determined they qualified for the study. That can be very frustrating, and it’s one of the reasons why patient recruitment is so difficult.
Miseta: Sometimes you find sites that are a great fit for your study or where the staff seems to be more interested in it. When you find those sites, is it worth it to make a bigger investment in them?
Director: When I worked at one Big Pharma company we didn’t have CROs. Our site monitors and project managers were employees. For that reason, we made the necessary investment in sites. If a site had an issue, we invested in it and developed it. Later when I joined another Big Pharma company, everything was outsourced but that model was still somewhat supported. However, when I went from there to a small company, I was on a team made up of three people. We do not have the capability to go into a site and be a supporting resource for them.
That being said, I also don’t want to select 100 sites and find out only 60 of them are going to enroll patients. A factor that complicates the problem is that a site that’s great today might not be a site that’s great tomorrow. If a great study coordinator or investigator quits or retires, things can change quickly. It’s getting more difficult to select the 20 best sites because you never really know where the elite sites currently are. This is a changing world. I don’t think you’re ever going to have data to tell you which sites are best. Sites are always evolving.
Miseta: Why is it still so difficult to get physicians to refer patients to trials?
Director: That’s a good question. I’m not sure we know the answer. I have actually had oncology physicians tell me they will not refer patients to trials. I was told they do not believe in clinical trials and we will not refer patients to one of them. That was amazing to me. I know if I’m a patient with cancer, I would be concerned about my life and my well-being.
I do think technology will help solve the problem. We can now get a patient’s vitals from their watch. Patients can Skype or teleconference with their doctors and not have to leave their home to visit a clinic. All of that will help, but the main problem is physicians are afraid of losing their patient. This is a financial decision, and we must find a way to overcome that.
Let me add one more thought. I have found that if a site is referring patients to a research center that only does research, they will be more apt to make the recommendation. But when a gastroenterologist is asked to refer their patient to a trial conducted by another gastroenterologist, they won’t want to do it. That is when they will fear losing their patient if that patient starts to develop a preference for the other physician.