There is an ever-present desire in the clinical trial industry to practice ‘patient-centricity’. This practice is featured predominantly during the protocol design phase, in which patients and caregivers provide their input to improve study design.
Furthermore, the participant experience is expected to carry more importance when determining the value of a cancer drug in the near future. According to the ASCO Cancer Research Committee, improved survival and quality of life (QoL) are essential components to producing clinically meaningful results for patients and medical oncologists1.
At the Site Initiation Visit (SIV), CRAs have the opportunity to lead a discussion with the entire clinical site study team to reflect on the participants’ experience while conducting study assessments. Questions from the CRA such as: ‘What will a typical screening visit look like at your facility?’ ‘How will the participant get from point A to point B for all their assessments? Is there a way we can bring the ECG machine to the patient in order to prevent a long walk? In what order can procedures be conducted to minimize back-and-forth for the participant?’ can prompt the group to troubleshoot ahead of time and allows the site study team to visualize the first patient’s visits. A better prepared clinical site team will gain confidence and make a more flawless deployment, which ultimately leads to a smoother participant experience.
Once a clinical site is open for participant accrual, enrollment numbers and screen failures should be carefully followed. Additionally, it is valuable to understand why participants decline to participate in the study when this information is voluntarily disclosed. In response to a CRAs gentle questioning identification of unnecessary obstacles for participants in the study design can be shared for the benefit of the overall study.
In the event of a recurrent complaint against the study design, identified by an effective CRA the clinical trial team may consider making trial-wide adjustments to improve overall study recruitment.
Treatment and Follow-up Phase:
Even though patients are the most important stakeholder in drug development, without a patient-centric platform to support their work it can be easy for CRAs to focus solely on data and documentation, with little regard for the participants’ experience.
If this ‘patient-centricity’ is truly of importance your CRAs should regularly inquire about how the participant(s) are doing on the trial and if they’ve commented on aspects of the study drug or trial design (for example: method of IP administration; managing adverse events; study-specific assessments; etc.). While this is an informal way of collecting information, it may very well be the only systematic method to reveal aspects of the patients’ experience that are not captured elsewhere.
This type of inquiry conducted by an effective CRA who is on top of all aspects of the trial at the clinical site level can prove to be an invaluable asset to the Sponsor’s clinical trial team.
Foremost Clinical Trial Participants are People:
To effectively conduct a patient-centric trial, it is imperative that the CRA conducts clinical operations with a patient-centric mindset. Scimega’s Reverse Feasibility™ Program is a patient-centric platform that allows Investigators to seek clinical trials their patients would be most interested in. Once a site is selected and the study has begun, QoL questionnaires are often the main source of information about a participant’s experience.
However, these questionnaires do not capture the full picture. To bridge the gap, Scimega CRAs and CTLs maintain a patient-centric mindset throughout trial implementation. This specialized niche company’s CRAs are always aware that there is a human being behind every data point. Moreover, site personnel appreciate a CRA who has empathy for the study participants’ struggle with their disease.
As the site personnel’s primary point of contact with the Sponsor, CRAs are positioned to best represent the values of the clinical trial team to sites and study participants. When site personnel are advocating on behalf of a patient’s questions or concerns, the CRA is an ally who conveys these concerns to the CTL for further discussion with the clinical trial team.
The Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies. Scimega SIV to Site activation is 8 calendar days across all programs in 2019. With Scimega Site activation to FPI 5.5 weeks across all programs.
With inspection ready processes and key metrics performance that clearly reflects the caliber of combined skill and service the Scimega team of oncology experts consistently delivers, this CRO works hard at working smarter every year for over two decades.
Contributed by: Catherine Simard-Morissette, B.Sc, Clinical Research Associate
Sources: Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol.