We have all probably heard someone mention that a patient-centric approach in clinical trials is time consuming. We can surely find enough reasons to back this up. We can also find enough reasons explaining why we need to postpone adapting policies to accommodate a more patient-centric approach.
In my previous article, ‘Patient-Centric Trials of the Future,’ I mentioned that if the patient’s perspective, expectations, fears and doubts are not being addressed, then clinical trials can never fully become successful. If we want patients to be committed to clinical trials, then we need to commit to engaging and empowering patients before, during and after clinical trials.
The Barriers Facing the Industry
In the report, ‘The 8 biggest challenges facing clinical trial professionals’ published in 2016, the major challenges confronting clinical trial professionals were:
- Complexity of trials (21 percent of respondents)
- Regulations (15 percent)
- Spiraling costs (15 percent)
- Patient access (12 percent)
The people involved in running the trials felt pressure to design studies ‘that give the right answers, in the most simple and unobtrusive way for patients, which are acceptable to regulators and payers.’ Many felt constrained by the complexity of the guidelines they follow. Some mentioned the increasing complexity and tight timelines were putting more pressure on the ‘need for resources to implement and control every step.’ Patient recruitment and retention is seen as a major challenge for those running trials, with a high percentage not meeting targets and drop-out rates increasing. The drop-out rate was blamed on the ‘increased burden for patients through study participation without adequate “return of investment” in the form of personal benefits.’
It is my belief that a patient-centric approach will have a positive impact on the challenges clinical trial professionals face. I guess the question we should be asking is not ‘if patient-centric trials are time consuming,’ but ‘how patient-centric studies can help us deal with the challenges faced in clinical trials?
Complexity of Trials
The complexity of clinical trials creates a challenging situation for patients, and professionals. Trials can often be a burden for patients, who already find themselves in a stressful situation.
A patient-centric approach can be used as a tool to help better understand the burden that patients encounter throughout the course of a study. Clinical trial professionals will be able to develop and implement patient-centric policies that will help make the process as convenient and pleasant as possible. In turn, clinical trial professionals will most likely benefit by having lower dropout rates.
In 2019, the Clinical Trial Regulation EU No. 536/2014 will replace the existing EU Clinical Trial Directive (EC) No. 2001/20/EC. The goal of the new regulation is to create an environment with the highest standards of safety for participants, and increased transparency of trial information. Patient-centric trials and patient-centric policies can be used to measure and evaluate safety standards and transparency.
Clinical trial professionals can implement patient-centric policies to supply relevant information on the impact safety standards and transparency can have on the well-being of participants during the trial.
There are a number of cost variables to account for during clinical trials. The top three cost drivers of clinical trial expenditures were clinical procedure costs (15 percent-22 percent of total), administrative staff costs (11 percent-29 percent of total), and site monitoring costs (9 percent-14 percent of total).
Although patient recruitment and retention may affect the clinical trial budget, patient-centric trials can supply information that could benefit enrolment and retention rates.
Patient access is a challenge not only for clinical trial professionals. Patients also face challenges to participating in clinical research. Patients are often unaware of the possibilities of taking part in studies. A patient-centric approach can help to alleviate not only the challenge faced by professionals, but also by patients as well. In this case a patient-centric approach may involve collaborating with patient organizations and patient advocacy groups. Investing in a collaboration with these new stakeholders may lead to better patient access. Furthermore, building on these relationships may lead to a positive increase of patient awareness and advocacy. Patient organizations and patient advocacy groups can help to bridge the communication gap between professional and patient, which in turn will lead to a better patient access.
A patient-centric approach is not too time consuming, but requires an investment in time. This approach will help to overcome a number of challenges trials are facing. A patient-centric approach will help in creating policies that will benefit the patient and the professional. Collaborating with patient organizations and patient advocacy groups will help professionals create better tools to engage with patients, and help to understand the burden patients encounter during the study. The sum of a patient-centric trial = Better engagement, better patient access, better recruitment, and higher engagement.
1) Patient-Centric Trials of the Future, Clinical Trials Yearbook 2018
2) Key Cost Drivers of Pharmaceutical Clinical Trials in the United States