The FDA’s regulatory requirements mandate the conduct of pre-clinical studies and clinical trials to establish product safety and efficacy of drugs, before they are launched in the market. Data from clinical trials represents the most pragmatic method of detecting possible new Adverse Drug Events (ADEs). They can be conveniently assessed by officers at the FDA and may be used to mark the drugs’ safety positioning / profile. These ADEs are listed, and the information about them is readily available on FDA’s website.

Once the drug is marketed, a healthcare practitioner, who suspects the prevalence of Adverse Drug Reactions (ADRs) or possible ADEs to a medicament, is obliged to share that data with the broader medical fraternity e.g., by submitting an article, report, data or letter to a medical journal or notifying the manufacturer of the suspect drug. In the case of a Serious Adverse Event (SAE), the same should be conveyed to the FDA as per the procedures. These spontaneous reports are a source of valuable evidence about drugs and medical   devices; predominantly about their rare, infrequent or delayed effects, and their safety in vulnerable subject populations. While pre-marketing and post-marketing trials deliver information about almost all safety issues with respect to population health, the only inherent drawback with the process is its diminished capacity to identify rare or unexpected effects of the investigational product.

Individual ADR reports to the FDA (by the medical practitioners or from the concern person), can make a substantial variance in the safety profile of a drug after it has been approved for use by a varied population group. However, experts have warned that even with the conduct of clinical studies with large sample sizes in a diverse population, there is a possibility that some of the safety issues may remain unidentified. One of the possible reasons for this is the extremely low occurrence of infrequent ADEs/ ADRs of prime public health concerns. Once the medicament is approved for marketing and is utilized by millions of individuals across geographies, the rare manifestation of these issues can transform into a substantial number of cases.

With worldwide digitalization, pharmaceutical industry is looking upon another channel to collect the information about possible ADEs of approved products, i.e. from the social media websites. This is now the need of the hour, as it is inevitable to avoid  the said data. Social media tools, which were not present till a few years ago, have become part of an individual’s life. Trends suggest that most adults in the US (>90%) have searched online for health information; this percentage has increased to more than 75% as compared to the previous year.

Thus, there is an immense possibility, yet to be explored in a ‘big way’ by the industry, to utilize the data on these social media sites for information on possible ADEs. This will help in further investigating and reinforcing the safety profile of the medicament. It is expected that if the data about possible ADEs exists in social media, then it shall be helpful for proactively mining, maintaining, building, and protecting information, which may be further leveraged to report to the FDA.

HCL’s in-house pilot analysis of data on social media – has been a testimony to the fact that this data can help to highlight and point-out the safety issues.  Also, it cannot be avoided or left unheard!

HCL has the required solution for effectively exploring this information. The solution is expected to have the positive impact in driving industry trends by extracting information about the possible ADRs/ ADEs from social media with precise accuracy.

A prospective industry view suggests that the role of CDM personnel is in a state of flux. This role is not only about accomplishing routine activities like designing case report forms (paper CRF/eCRF), annotating CRFs, designing databases, entering, validating and coding data, locking databases, and creating CDISC/analysis datasets, but also about stepping forward to meet all the expectations of the pharma fraternity. Here’s a quick list of some of these expectations:
■Augment the process of subject recruitment and retention in clinical trials
■Establish a vision for subject care, by maintaining subject profile and population health outcomes based on classifications such as – geography, gender, race, and more
■Extrapolate trial information for future use, with respect to medicine safety and efficacy, subject profile/disease information/drug price
■Evolve as a main subsidiary for risk based monitoring, centralized monitoring, and study site support
■Coalesce clinical trial data with Big Data, to help forecast trial success or to establish brand positioning, etc.
■Optimize the cost of clinical research with predictive analysis techniques
■Effectively manage links, alliances, associations and CRO data, based on historic performance and user friendly classifications, in order to help retrieve information by other teams of clinical research
■Enhance study digitalization for an overall boost in the processes

In most of the organizations, CDM managers have already established the procedural activities. They are, however, still struggling to find the right, most adaptable solution, which is made up of the right IT infrastructure that can support regulatory mandates.

The available software packages cannot sustain all activities at one time and are not adaptable enough to address constantly evolving regulatory requirements. Hence, these are not the preferred choice. But if chosen, the cost of licensing, validating, implementing and supporting them are high. When implemented, it takes considerable time to complete the training, and production time also increases because of complicated programming.

Stakeholders believe that primarily two work models can be adopted, to achieve desirable results:
■Work model 1: Develop a new, customized, low-cost software with all the capabilities built into it
■Work model 2: Integrate all individual (existing in-house) software into one common functional platform

The good news is that HCL can deliver tailored and regulatory-compliant support for both models. HCL can handle every contingency, help enhance data quality and enable timely regulatory submissions, cost-effectively. HCL helps organizations achieve their study/project/program objectives through the use of adaptable technology and the seamless integration of all their processes. And by taking on some of the tasks of the data managers, we free them up to focus on more crucial and strategic missions.