Essential Components of Patient-Centric Clinical Trials

Changing Clinical Trial Landscape

In my previous post I discussed how Patient engagement in health-care is the latest trend which is acting as a key driving force to transform the clinical trials.

Till now, the traditional system of medical discovery considered patients as a group of people undergoing trials. A particular therapeutic delivery was essentially considered to be same for all patients. Patients were not considered as unique individuals with different preferences, needs and desires. Moreover, clinical trials largely have been designed by considering scientific observation, sponsor's requirements and most importantly, to get the approval of regulatory bodies. To summarize, the patient was considered only as a subject.

In recent times, patient-centeredness has become an acknowledged hallmark

This paradigm is slowly changing these days as today's patients tend to know more about the disease, treatment, side effects and alternate treatment options available. With ever-increasing internet access, more and more patients tend to get information from internet. The level of patient engagement is increasing with changing technological landscape, and the healthcare industry is acknowledging this change by transforming the way clinical trials were performed earlier.

 Patient-Centricity: Rebuilding Trust With Greater Transparency

In recent times, patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Bio-pharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results.

The following section explains how patient-centric approaches are helping to transform traditional clinical trial setup.

Patient Recruitment

Involving the patient in trial process can help pharmaceutical companies to identify the positives of new trial design. Decentralizing mobile trial sites by leveraging mobile technology backed by internet of things (IOT) by offering site-less or decentralized clinical trials, which are more patient friendly. Thus digital technologies can be leveraged to streamline finding and retaining participants for the entire length of the study, thus removing delays.

Patient Compliance

Using Artificial intelligence backed digital technologies, mobile devices can be used as a tool for monitoring and compliance. There are apps which require the patient to take the pill in front of mobile camera, and once the pill is taken, the mobile app registers that the drug was taken. Thus digital technologies can help clinicians to tackle the issues of non-compliance and red-flags can be raised at right time.

Real World Evidence (RWE)

Patients often have different characteristics and they might have different treatment protocols that might differ from controlled RCT conditions. Present day clinical trials used to adapt a 'generalized' approach for all the patients. To evaluate real world product effectiveness, more information is needed regarding intervention efficacy in different age groups, gender and ethnicity. Other factors like co-morbid conditions also play a major role in treatment outcomes. Thus RWE can provide important health information which have been ignored by traditional clinical trials setup. The data obtained from RWE can provide key insights and can bring down medical costs while improving both, safety and effectiveness.

Social Media

With ever-increasing penetration of internet, and increasing affordability of internet-enabled mobile devices, the potential of social media in clinical trials has been already recognized. Patients not only use social media to discuss trial issues, they also hint about problems as barriers. Patients participating in educational forums and online clinical trial communities create useful online information repositories. Such patient-engagement resources can be utilized to learn and improve overall clinical trial outcomes. 

• Check out my blog explaining how social media is important for Pharma:

Turning Conversations to Insights: How Social Listening Can Help Pharma Companies

• Here's my blog on TCS website mentioning how social media can help pharma to build a positive brand perception.

Big Data Analytics

Unlike other industries, healthcare industry is a highly regulated industry. Almost every process is documented, be it manufacturing, hospital records, reimbursement or clinical trials; and the data is largely stored in electronic format these days.

Speaking of clinical trials, the vast volume of data collected across the clinical trials process from various sources like EHRs, personal health records (PHRs), clinical trial data, hospital records, bio-markers, insurance claim data, real world data and social media provide an excellent opportunity to extract and explore already available information, which can ultimately lead to improved drug development. The full potential of these data sets can be utilized to improve the design of clinical trials. Further, the data sets can aid in patient recruitment, study site selection and identification, trial monitoring insights, hence it can further improve the overall clinical decision making processes.

Closing Thoughts

To conclude, it is evident that patient-engagement is transforming the form and function of clinical trials. More and more companies are coming forward to partner with patients to develop new drugs and devices to meet patient's expectations in real-world conditions. While currently there is no consensus regarding the ideal approach for patient engagement, it is sure that regulatory agencies will work with pharmaceutical companies to develop a patient-centric ecosystem.

.........................................................................

Disclaimer: Opinions expressed in this article are solely authors' own and do not in any manner express, reflect, supported, endorsed or represent the view of the organization to which he is affiliated.