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Sollers Blog

Improving Patient Experience In Clinical Trials!

Posted by Doctor Dan on Feb 21, 2017 11:44:33 AM

The focus on clinical trials has always tended to be more towards the pharmaceutical or procedural or organizational aspects such as sponsor responsibilities, regulatory approval process, drug safety and efficacy, drug development, marketing and sales tactics. Apart from these, patient safety is also ensured stringently, especially after standardization of regulatory guidelines around the world. But the direct engagement of patients with the actual trial has not been dealt with as much as the other aspects of clinical trials/studies. This is due to the fact that in clinical research, research tends to be more focused on being carried out on patients rather than with patients. This approach has made the change to a patient-centered approach slow in clinical research. The traditionally "introvert" nature of the clinical research field in accepting new technologies or ideas is also a major limiting factor in making the change to improve patient participation and thereby experience in clinical trials.

Clinical Research with Patients 3-1.jpg

One of the founders of PRC Clinical promotes the vision that patient engagement is the next big thing in clinical research. It is not a new idea though since patient advocacy groups have existed in the US since the 1980s and have helped in engaging federal authorities, research sponsors, physicians and academia with patients. In the current era, clinical research plagued by high costs and uncertainties related to clinical trial outcomes and drug efficacy or safety, engaging on a comprehensive level with patients participating in the studies or trials will benefit companies and sponsors in achieving the best cost-benefit ratios and also in improving the outcomes of the trials. Active engagement will also lead to better patient enrollment and retention and provide credibility to research outcomes which in turn has a higher chance of attracting patients to participate. Some examples of patient engagement or advocacy groups include "PatientsLikeMe" and "ePatients". These are online platforms where patients having the same or similar conditions can discuss the various treatments that they have undergone and share insights or inputs to other patients about clinical trials with potential.

Another aspect of improving patient experience is the relationship between regulatory agencies and patient advocacy groups. For instance, PatientsLikeMe has signed an agreement with the Food and Drugs Administration (FDA) to collaborate and determine the effects of patient-reported clinical data on drug safety. When patient-generated data is accepted and validated by regulators it can provide a whole new aspect in surveillance of drug safety and efficacy over time, even after market approval for a drug is given. Another organization that has been created and promoted by the government to help bring together industry, patient advocacy groups, and other stakeholders in prioritizing research focus is the Patient-Centered Outcomes Research Institute (PCORI). Its major goal is to enable and ensure patients are actively engaged with the internal working of an organization that is conducting the trial.

Access and use of mobile technologies, like smartphones, cloud-based technologies and wearable devices also can enable patients to engage directly with physicians, investigators, and sponsors by understanding what is happening in the trial and what processes are they undergoing. This will lead to trust development on the patient's side towards the clinical research process.

Topics: Clinical Research