The following article is written by George Clinical’s CMO, Maria Ali.


When outcomes are all that drive us we miss out on many important opportunities.  

There has been a clear paradigm shift over the last few decades with regard to patients’ role in their medical care and treatment options. The old system whereby a patient simply followed the doctor’s orders without question is gone. Ready access to health-related information and pharmaceutical advertising efforts have significantly changed the dynamic between patients and their doctors. While there are some obvious perils associated with “informed” patients, such as questionable or incomplete information they may have received, the benefits to having a more vocal, involved patient/caregiver population are clear. But where do clinical trials stand in this new era?


Patients are ultimately the most important of our team members.

Improving their experience should be a priority in our sense of purpose.


Clinical trials are, for the most part, still conducted in a manner that is heavily focused on obtaining data to support outcomes. Unfortunately, this method can be less beneficial to the patients who often make great sacrifices to participate. Trial designs often add unnecessary burdens on patients who are already facing significant challenges. The very act of getting to a lab to give a blood sample can take both a physical and mental toll. When the patient experience is not pleasant at any given step, dropout rates increase, and the entire trial is jeopardized.

Without the patients/participants we have no trial, but an increased focus on including them as team members or partners in the process is a relatively recent phenomenon. Improving and enhancing their trial experience and the returns on their very personal investment should be a priority in our sense of purpose. As teams who implement clinical trials, we should thoughtfully consider innovations that we can incorporate into these trials to ensure that our participants and their caregivers feel more like partners in the mission of advancing treatments and less like “subjects” who simply provide us with data.


George Clinical believes that every step in all research and every clinical trial should result in something useful and beneficial for patients.


At George Clinical, in collaboration with our clinical and scientific partners at The George Institute for Global Health, we are making a concerted effort to build into every clinical trial the goal of improving the quality of life and the access to the best treatments for all people regardless of their demographic or economic background. We believe that every step in all research should result in something useful and beneficial for patients, regardless of whether the “outcomes” prove to be a success or a failure. We continue to seek ways to evolve the clinical trial process in ways that address this issue and move toward more of a partnership relationship between all parties.


Outcomes are not enough

In the same way that a patient’s care and progress benefit from an open dialogue with their physicians, the “success” of clinical trials, regardless of outcomes, could be greatly enhanced by a greater degree of “patient centricity” in the trial process. When outcomes are all that drives us, we miss out on many opportunities to better understand how illness and disease affect patients and, consequently, the real-world ways in which the treatments under investigation are affecting them. These are lessons that can be applied to clinical practice regardless of a trial’s outcome. If one of our goals in running a trial is that participants are fully engaged in the trial process and actually learning along with us as we progress, the end result will greatly enhance the value that every trial can have for the healthcare community.

We as research teams need to be thinking about how we can make that happen. How can we build more value into the clinical trial process for patients and their caregivers? It is time to get more innovative and more compassionate in our approach. A fundamental change in the design of trials that is more patient-centric/participant inclusive will ultimately lead to fewer trials ending up delayed or over budget or without “outcomes.”


From trial design to follow up — Innovations for patients

This approach needs to be in place even before we initiate a clinical trial in the creation of timelines and budgets, which should include line items dedicated to improving the patient experience and inclusion. Resources should be made available on the front end for things such as adding quality orientation for patients and caregivers, possible increased tele-communications, alternatives to traveling long distances to give blood, greater opportunities to discuss with the patient incremental improvements in their symptoms/quality of life, more consistent and frequent feedback at every interval in the process and post-trial contact to monitor the patients’ condition and update them on any new information that could help them live a better life. There is currently much discussion about allowing patients to be at the table during the design process. Although not happening on a regular basis, there is certainly a loud voice of advocacy for this.


George Clinical is unique in that our model incorporates scientific leadership into our operations, and our scientific leaders are also clinicians.


One of the most important ways George Clinical improves the patient experience in clinical trials is built into our model of having scientific leaders who are also clinicians involved in the entire trial process. These researchers/clinicians are not only experts on the research behind the scientific purpose of specific trials, but also have the day-to-day experience of caring for the very types of patients who will be participating. This unique scientific leadership model not only creates more empathy for participants, but has also proven to increase recruitment and retention rates.

As a steering committee member for the Clinical Trials Transformation Initiative, I participate in a working group focused on the development of novel endpoints that are more meaningful to patients and are not just numbers. If we can improve the experience of our participants and incorporate ways to give them useful information during a trial it could be transformational. This is likely to be a gradual process, but as trials transform to include greater dialogue with participants, patients and caregivers, we’re going to begin to get a real-world picture of how a drug really affects a patient’s life. Regulators will value that information above other parameters. Drugs will get registered earlier and move more quickly into clinical practice. Ultimately this re-setting of goals for both research and clinical trials will bring a greater integrity into the system that builds value for every person in every trial. Trials will have a greater impact on the healthcare community and the benefits of clinical research will be far more broad-ranging.

True transformation will come when it becomes accepted practice that patients and their caregivers should play a central role in not only care decisions, but also in the research that informs those decisions. When everyone from trial designers to those who review and analyze the data recognizes the value of this new approach, both the efficiency and effectiveness of trials will be improved. Costs will be reduced and lessons learned will be more quickly translated into clinical practice. Along the way to full transformation, we as CROs need to continue to innovate and evolve in order to serve our customers, the greater healthcare community and the many patient populations across the globe who suffer from the effects of illness and disease.


Possible Ways Clinical Trials Can Become More Patient-Centric/Participant Inclusive



Trial Start-Up

During Trial

Trial Closeout and Post Trial


Line Item for Patient Centricity

Patient-Centric Training for Participant Demographic/Culture

Concierge Services/

Other Value Adds for Patients

Communication Pathways / Feedback / Updates to Patients



Involve Patient Advocates

Info in Lay Language

Clinician Involvement

Allow for Adjustments After Patient Input

Create Open Dialogue

Regular Patient Evaluations & Review of Concerns / Issues

Advice for Quality of Life Improvements

Multiple Feedback Pathways / Online Support Communities / Patient Input for Future Trials


Set Clear Expectations

Communicate “Added Value” to Patients of New Patient-Centric Features

Early Patient Input on Trial Expectations

Be Open to Some Trial Revisions

Frequent & Consistent Patient Feedback

Information To Improve Patient’s Quality of Life

Digital Options/Personal Contact/Options for Inter-Patient Communication