Why do we need to dwell at the 80% of clinical trials being delayed due to recruitment problems, you might think? Why is this number so important?
I tell you why, because in this number lies one of the keys to improve drug development, ensuring that lifesaving medical treatment can be developed faster and probably cheaper, benefiting patients as well as the industry.
But more importantly, the 80% are also hurting the backbone of the pharmaceutical industry, trust. When you are dealing with testing of new medical treatments, you need to have trust between the patients and the industry. And delayed or even cancelled clinical trials are slowly but steadily erupting that trust.
In order to fix the 80% of clinical trial delays and increase the trust among patients towards pharmaceutical companies we need to shift the perspective on the role of the patient in the drug development process from being passive to being an active contributor. Here is where patient engagement will be the solution.
WHAT’S THE PROCESS AND ROLE OF PATIENTS IN TODAYS´ CLINICAL TRIALS?
At what step in drug development process would you guess patients are normally involved?
In the design phase of the clinical trial, so they can provide their input on how many site visits they would be able to make a month? Or weigh in on the decision making on whether or not the clinical trial participants can take their regular medicine while being a part of the clinical trial?
Surprisingly enough, it’s still the norm to design a clinical trial without involving the patient voice. A 2023 Tufts Center for the Study of Drug Development (Tufts CSDD) survey (1) among several hundred sponsor companies found that only 27% are routinely soliciting patient input into protocol design decisions.
This is the reality despite that data are starting to show early patient engagement can save a clinical trial from being delayed, adding extra costs and risk of being cancelled all together.
In fact, the standard approach would be to involve patients when the clinical trial is looking for participants to test the medical treatment. At this point it is too late to change any of the problems that you highly likely will face with the design and protocol of the clinical trial. Therefore you often risk an amendment which is costly in time and financially. Again, research shows that you can save up to a mind-blowing $62 million through the avoidance of just one protocol amendment (2).
Both historically, but also still today, the role of the patient in clinical research has been very passive. But the tide is slowly shifting as new regulation, research of the benefits on patient engagement and strong advocacy are paving the way for more patient engagement and slowly transforming the role of the patient.
Within the industry, we are realising the benefits of patients being active contributors and thereby adding value to the drug development process.
AWARENESS, EDUCATION, ENGAGEMENT, PARTICIPATION
But the problem is more than a one-solution-fix-it-all, because even though we could fix the issue related to lack of patient engagement in clinical research, we also need to work more actively with the patients’ awareness about clinical trials.
The vast majority of patients don’t know about the existence of clinical trials. A study showed 85% of patients were either unaware or unsure that participation in a clinical trial was an option at the time of diagnosis (3). 75% of these patients said they would have been willing to enroll had they known it was possible.
So the problem with activating possible clinical trial participants among patients relates mainly to awareness and not motivation.
It would be lovely if we could solve the problem by solely creating a lot of awareness campaigns about clinical trials, but we also need to invest resources in education.
A lot of patients have trouble understanding what clinical trials are and what it entails to participate in a clinical trial. This is underscored by the need from patients for more information when interacting with clinical trials. A study showed that 77% of the surveyed patients want the industry to make it easier to learn about clinical trials (4).
This problem probably relates to the fact that we are operating in a complex and highly regulated industry where it’s important to use the correct terminology which involves using many abbreviations and difficult words. I must also admit that it took me a while to get into the vocabulary of clinical trials, so I definitely understand patients, who are dealing with a disease at the same time, would have trouble understanding the industry lingo.
My point is that we need to invest in information and education about clinical trials and drug development processes targeted towards patients after they have been made aware about the existence of clinical trials.
This means that we should focus on developing patient facing material that is providing them with information about clinical trials in an easy-to-understand form. Often the material you find for recruiting participants for a clinical trial is using too complex terms and language which indirectly screens out a lot of patients.
And the best way to develop patient friendly material is to involve patients in the process, which brings me to the third step of the process: Engagement of patients. Once we have succeeded with generating awareness and providing information that educates the patient about clinical trials, we can engage them.
This would make sense to do in as many processes as possible. The most used excuse not to do it is a lack of time. But clinical trials that are showing higher levels of early patient engagement tend to be less delayed and costly.
So rather invest time in early patient engagement than paying the price for a lack of it later on.
Now we have finally reached the step where we can start to ask the patients whether they would like to participate in the clinical trial. By taking this four-step approach we should experience a larger pool of possible participants due to the fact that more patients are aware of the possibility of participating in the clinical trial and know what it entails to participate in a clinical trial.
There’s also a higher likeability that the patients will enroll in the clinical trial if the patients have been engaged in the process of designing of the clinical trial, providing input on factors that would affect the motivation of participants. The same goes for higher retention rates.
CONSISTENT AND CONTINUOUS ENGAGEMENT
Using this procedure is my preferred method of recruiting patients for clinical trials as I also carry it out in my professional work. In my experience, the best way of recruiting patients for clinical trials is through patient communities where you can engage with the members on a consistent and continuous basis.
Via this procedure you can produce awareness campaigns about the possibility of participating in clinical trials, develop news and articles about what it means to participate in a clinical trial and engage with the patient community and listen to their opinions and input about certain topics and trends in clinical research which then can be presented to the pharmaceutical companies.
I am also experiencing that more and more pharmaceutical companies work more methodological and dedicated with patient engagement in the drug development process.
FUTURE OF PATIENT ENGAGEMENT ROI
In order to unleash the true power of patient engagement in drug development, we still have work to do.
The Russell Reynolds Associates (RRA) released an interesting article covering the subject around the (r)evolution of patient engagement in biopharma (5). And from this article I would like to highlight the following;
“Patient engagement is a relatively new function in the complex organizational mosaic of pharmaceutical companies. After rapidly evolving in an erratic way through the impulses of internal and external forces, its profile and purpose is now stabilizing both from a structural and talent point of view, entering a more mature phase.”
I believe this is one of the most important reasons in order to understand why we are at a phase where we are experiencing a lot of talk and discussion around how to work with patient engagement in drug development. Some stakeholders criticise the current state of patient engagement by saying not nearly enough work is being done, while others say we are doing more patient engagement activities than ever. Both statements can be equally true.
From what I have learned talking with multiple people working with patient engagement in the pharmaceutical companies is that 2 elements will be crucial to unleash the true power of patient engagement in drug development.
- Work with patient engagement holistically in your organisation
Patient engagement is something that should be done holistically within the organisation, so you don’t risk being slowed down by a silo structure. Try to influence as many divisions and departments within the organisation as possible and implement your processes so they can experience the upsides of
patient engagement. - Start collecting ROI data on patient engagement
All of us working with patient engagement need to face that pharmaceutical companies are businesses and therefore also need to be presented with a business rationale. The good news is that studies are starting to show positive ROI data from trials where patient engagement has been an integral part of the strategy from the beginning. So it should be just another reason to do patient engagement.
I believe that in order to truly succeed with patient engagement in drug development the next challenges will be to develop standard processes for patient engagement, ensuring these processes are integrated into as many divisions and departments within the organisation as possible and then collecting ROI data on the patient engagement.
Then we will experience that the power of patient engagement can fix the 80% problem.
REFERENCES AND NOTES
- Getz. Kenn, “Calling Out ‘Check-the-Box’ Patient Engagement”, Applied Clinical Trials, March 8, 2024
- Parexel, “Incorporating the Patient Voice for Inclusive Medical Communications”, Applied Clinical Trials, September 21, 2024
- Harris Interactive Survey, National Institutes of Health, 2001
- Wahlstrom-Edwards, Lindsey, “The Patient Perspective on Clinical Trials”, Applied Clinical Trials, March 1, 2019
- Russel Reynolds Associates, “BioPharma leaders: Are you prepared for the next patient engagement (r)evolution?” ,Russel Reynolds Associates, March 27, 2024
