Technology Based Protocol Development in Pharmaceutical Industry

With the evolution of the pharmaceutical industry, the advent of digital tools, processes, and platforms has also been prominent. This has dramatically transformed the face of clinical trials and is making way for new opportunities to improve the trial processes further. However, in this changing scenario, the professionals need to develop new systems and procedures to evaluate new technologies and analyze if these can streamline the trail experiences.

On a global scale, the expenditure of Pharma companies on R&D is more than USD 140 billion. Over the past decade, the clinical trial costs have increased greatly and there is more than 150 percent increase in the average cost per patient. And, the highest cost in a clinical trial can be attributed to patient recruitment cost, which has more than 30% of share. A major contributing factor in this is a late-phase clinical trial where patient engagement and retention is an issue that must be handled carefully for the success of the trial. Often clinical trials fail to complete within the proposed time-line owing to ineffective recruitment method which, in turn, adds to the expenses. To tackle such issues, the pharmaceutical industry has turned to new innovations and digitalization for better managing clinical trials.

Technology-based protocol development

Technology can bring a lot of improvement in protocol development. Clinical teams can use collaborative platforms and tools to streamline the process of acquiring input from a vast range of external and internal stakeholders, regardless of the structural differences in organizations. Post-initiation of the protocol, the investigators can accomplish their task efficiently by strategic use of technology. Infographics can make investigations and be understanding the protocols easy for the investigators as well as their staff. Virtual simulations and interactive displays can be helpful in highlighting the crucial aspects of the study. Using such tools, the investigators can not only find better subjects but can also respond to issues effectively to pave the way for completion and higher retention rates.

Social platforms for identification and analysis

The patient recruitment process can be enhanced by using the power of social networks. Technology can help in geo-targeting around important study centers. Also, digital infographics and videos can be shared over social platforms for encouraging enrolment. Big data analysis is excellent in risk-based monitoring where data streams, supplemented by digital tools like artificial intelligence algorithms, real-time chat, live video chat etc, are assembled and analyzed. This helps the sponsors to identify and analyze issues quickly. Other forms of technology like voice activation through devices such as Amazon Echo and Apple Siri, in combination with distributed sensors, also hold immense potential to provide a strong framework for patient support, in-home compliance and real-time contact with national sponsor representatives and local study site.

Making trial experiences better

Digital tools can be very helpful in improving the subject on-boarding process. These tools help the subject to understand informed consent and set realistic expectations for the trial experience. Apart from the enrolment process, the technology can also bring innovation in patient compliance and behavior modification. It’s often difficult to generate motivation in clinical trials, but it can be achieved by aligning the technology with the existing predispositions and motivation of the patient, thereby improving retention.

Development in technology can have a huge and positive impact on the process of clinical trials, with improvement in every aspect. However, the teams must assess the technology trends with respect to patient care as well as behavior change. Application of technology to clinical trials in a systematic and strategic manner can lead to successful trials for investigators, sponsors,

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