Patient Centricity: Where Can Pharma Go From Here?

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

The pharma industry is no stranger to the terms “patient-centric” and “patient centricity,” however there is still a lot of work ahead before pharma can begin turning these buzzwords into a reality. As enrollment and retention become more arduous tasks than ever before, pharma has its work cut out for it to ensure that patients remain the heart of the industry.

Patient Centricity: What’s At Stake For Pharma?

I reached out to Clare Grace, VP of site and patient access for INC Research, to learn more about what the industry stands to gain from making the patient the focus of the trial, as well as what needs to be done to make patient centricity a regular practice in the clinical space. As Grace says, there is no better time than the present to refine the industry’s focus on the patient, especially since the industry as a whole is staring down the barrel of an unsustainable drug development model.

“Investigator sites capable of conducting studies to the required level of quality are a finite resource, and the general population still remains, at large, unaware of the clinical trial environment,” says Grace. “Until awareness and access to patients is improved and the huge administrative burden on investigational sites is reduced, the industry will not be able to achieve a sustainable model. Placing the needs of the patient at the center of clinical development will increase patient participation and the efficiency of investigator sites.”

The alternative, Grace points out, is that fewer patients will be willing to participate in clinical trials — a situation that will translate into longer development times, higher development costs, and a dramatic reduction in the amount of new medicines.  

However, like most important tasks, taking patient centric trials from concept to reality is easier said than done. There are currently several roadblocks to a quicker, more efficient clinical trial. One of these roadblocks, Grace says, is the lack of supporting technology that can streamline data capture during a trial. Grace hones in on the industry’s need for technology that will free up patients’ and investigators’ schedules and make the patient-physician relationship more thorough and productive.

“New electronic health technologies are emerging that will capture many vital signs and transmit those to the study team in real time, thus saving the patient and investigator team time during clinic visits,” Grace says. In particular, Grace touches upon the emergence of Fitbit activity trackers and iPhone apps that can be used to measure physical activities, heart rate, and other vitals.

However, while these apps and devices hold great promise for use in clinical trials, there is still a ways to go before they are reliable enough to use in the clinical space. “Currently, the accuracy and reproducibility of the data from these technologies is insufficient for use in clinical trials,” Grace says. These inaccuracies largely stem from the fact these technologies are targeting the end user, who most likely will be less concerned about the data’s accuracy. “Most people don’t care if their pedometer is 10 steps out or if the calorie count is off by 50 or so calories. However, this is obviously not the case for clinical trials,” Grace says. “While experimentation with new technologies is necessary, it will be important for both device manufacturers and the industry to find solutions to test and validate these new data capture modalities rapidly to ensure their swift inclusion in future clinical trials.”

But the answer might not necessarily rely solely on the use of new technology; the answer could also lie in the way the industry uses and shares the data gleaned over the course of a trial. As open innovation becomes a hotter concept in the industry and pharma companies become more transparent allies in their efforts to bring patients new medicines, Grace says a shake-up in the way companies use patient data could benefit both the industry and trial participants.

“Novel trial designs like collaborative trials are being developed that enable a more efficient use of patient data. These efforts allow pharmaceutical companies to share the same trial design and results while requiring fewer patients. This ensures that the valuable patient data set that is created during the trial is most effectively used to support the development of more than one drug,” says Grace.

Avoiding A Sponsor-Centric View Of Patient Engagement

One of the best ways the industry can move closer to patient centricity is by successfully managing relationships — not just the relationship between the industry and the patient, but the relationship between sponsors and investigative sites as well. Grace emphasizes the importance of clinical research sites in the whole clinical trial process. It goes without saying that, without clinical research sites, patients would be cut off from the therapies and the care they need. However, these sites are faced with just as many burdens as sponsors in the realms of drug development, including high operational costs and complex regulations. Given the narrow margins for success, along with the financial and regulatory issues, many sites — especially the less experienced ones — are alienated from participating. According to Grace, the solution lies in pharma’s support of organizations like the Society for Clinical Research Sites (SCRS).

“Organizations such as the SCRS support sites in terms of sustainability and mentorship. These organizations also advocate for this important partner. The pharmaceutical industry needs to work with the clinical research site base in a much more strategic and cohesive manner,” Grace says. “Much of the current interaction is tactical and piecemeal. It is important to build strong relationships with the site community so sites can better understand their long-term pipelines and best position themselves for the future.”

One way to help bolster the site community, Grace says, is by assisting SCRS and sites develop guidance that sites can use to navigate the difficult financial and regulatory environment. In particular, she points to an SCRS white paper that sites, with the help of pharma, developed on the standards clinical research sites should have and how these standards can be achieved. The white paper, titled “Responsible Site Management: Best Site Practices,” includes sponsor and CRO insights on the best SOPs and training requirements, financial best practices, and the importance of a quality management and CAPA process.

Patient advocacy groups, such as PatientsLikeMe, are another key resource for sponsors looking to keep the patient, indication, and site in mind during development. With the help of these groups, sponsors can be better able to pinpoint the most meaningful endpoints, as well as ensure the trial will provide the necessary data without demanding too much from patients’ and sites’ schedules. Grace says, “Often ‘softer’ endpoints are more relevant to a patient living with a disease — particularly a rare disease — than some of the more robust overall survival or symptom reduction primary endpoints. Working with patient advocacy groups when approaching regulators with clinical development plans can be very effective in ensuring the development process is not overly burdensome.” 

What Can Pharma Gain From Patient Centricity?

Pharma can expect that shifting its clinical trial perspective from sponsor-centric to patient centric will bring with it several business benefits: a more efficient trial and the cost savings associated with that boosted efficiency. However, Grace says striving to adjust engagement practices also can boost risk management throughout a trial.

“By incorporating patient review into protocol design, risks and opportunities are identified earlier. While this may result in a slightly longer start-up process, it also results in a more effectively planned trial with a more effective risk management plan that will impact overall development times and create a faster time to market for important new medicines,” Grace offers.  “All parties are more invested in a successful and efficient trial process, which not only leads to time and cost savings, but also creates a true partnership between the pharmaceutical industry, clinical research sites, and most importantly, patients.”