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Clinical Trial, current trends and new opportunities.

Today the clinical research industry is undergoing a major renovation. Companies are continuously looking to adopt and implement effective and innovative ways to accelerate drug launches in the market. Companies today are more open and do not view patients as mere “subjects” who generate data, – but as informed collaborators whose participation is “core” to the overall success of trials leading to the emergence of the concept of “patient-centric trials.”



In an era of increased complexity and escalating costs of clinical research, a focus on personalized medicine and patient empowerment, drug development is undergoing a metamorphosis. Typically, when a clinical trial is conducted, clinicians and patients collaborate with the sponsor for determining the safety and effectiveness of a molecule under experimental treatment. Trials are usually designed keeping in mind the feasibility and ease with which the sponsor can conduct the study.


This can lead to a large number of costly and complex trials being conducted, without addressing the patient's convenience or needs. As per an IMS Health Study forecast, global spending on medicines is targeted to increase 30% to $1.3 trillion by 2018. The cost has grown, but patient's needs are not being met. Thus, patient-centric drug development is now becoming the model that the industry is following. Today, patients are aware, technology-driven, and informed-driving the change in mindset and way clinical trials are being approached and conducted.

A number of factors can influence a patient's decision to participate in a clinical trial including financial, social, philanthropic or altruistic. Prior to enrolling in trials, patients today invest time in learning about the disease of interest, the drug mechanism for cure, locations where trials are being conducted and results from similar trials to name a few, through the internet. This has enhanced the quality of discussions occurring between the physician and patient. Benefits of engaging these “digital patients” have been realized. Contract research organizations (CROs) are offering a ready repository of patients who have enrolled in different trials to pharmaceutical companies keen on conducting trials-driving cost and effort saving. For example, quintiles have more than three million patients under their “Digital Patient Unit” program which also helps to use real world patients for the faster testing of inclusion/exclusion criteria and allows sponsors to prescreen the subjects and refer them, if needed, to clinical trial sites.


Pharmacies are using technology to run contests and competitions to gather ideas and feedback on trial designs, informed consent forms (ICFs) and protocols. Open discussions on draft protocols specially focused on endpoints and visited structure are encouraged, and updates are made based on the responses received. Some of the areas where patients are being actively engaged are listed below.

The draft guidelines on the informed consent released by the Food and Drug Administration (FDA) in July 2014 could be used as a ready reference for building effective ICFs. While building ICFs, an approach, which is behavioral but science-based helps uncover patient insights. The usage of simple language easily deciphered by the participating subject will establish expectations regarding foreseen and unforeseen risks. ICFs that are short and precise will hold the attention. Clearly defining study objectives, end points and providing a detailed summary would retain the interest of the patient. It could also help in understanding the enrollment risks and also highlight factors that could be adjusted in the protocol for minimizing those risks.


Having the ICF reviewed by a layman could also be considered as it would shed light on content that is too scientific in nature. Understanding the section of the protocol that led to distress while review (e.g., surgical procedure related requirement) could help one making amendments, if needed, in earlier stages of protocol development. Seeking clarification from patients on their understanding of the protocol could provide insights on building ICFs that would be better accepted by a larger patient population.

While designing the study protocols, time should be invested in understanding the lifestyle of the patient population. Real world patients providing their inputs to building study protocols and study designs, which are more real and closer to life experiences, cost-effective and patient-centric is needed. Designing patient friendly visit schedules that are more flexible is important. In the case, patients are dependent on caregivers, considering the schedule of a caregiver would be beneficial. For better retention, care should be taken to provide facilities and an environment conducive to patients, especially during prolonged on-site visits, or visits that require patients to be in a fasted state. By being sensitive to a patient's comfort and needs, a better retention rate could be achieved.


Companies should provide appropriate trainings to the study staff and groom them to handle sensitive situations, especially when invasive procedures are followed.

The traditional communication mechanisms where Biopharma companies were at the center and messages were directed toward physicians, who in turn shared the messages with patients, have changed. There is a need to adopt newer tools and technologies that drive two-way communication. Promoting and accelerating direct to consumer advertising where companies still control the delivery of the messages, but the loop in media for a greater effect. Companies are actively using social listening techniques to review what patients are discussing online regarding disease state and issues to drive better patient participation and relationships. Researchers are skeptical regarding the type and extent of clinical information that is being shared and discussed by patients via online chats, such as protocol details, their experience of participating in trials, adverse event reactions etc. That can introduce bias for future trials.

Understanding the importance social media and its role in the dissemination of information, FDA has released draft guidance for industry on social media usage in June 2014. It provides recommendations for presenting benefit and risk information for FDA regulated prescription drugs or devices using social media such as Twitter, Yahoo, and Google. Medicine's New Zealand also released its updated code of practice in June 2014 where it has included its guidance on social media usage by the pharmaceuticals. This was done to separate social media from other type of advertising and clearly outline pathway for pharma companies keen to use social media channels – an indication of increasing global acceptance of social media usage.

To improve clinical outcomes, increase patient satisfaction and incur profit revenue, engaging patients in their own healthcare is critical. The US government is encouraging the use of Electronic Health Records (EHRs) via HealthIT.gov and promoting incentives to doctors who use EHRs meaningfully to reduce medical errors and improve the quality of care. CROs and independent service providers are designing educative websites that can be accessed via mobiles or the internet for educating patients on diseases.

A few examples of available websites and tools below

  • Agency for Health Research and Quality maintained by US Department of Health and Human Services

  • ClinicalResearch.com

  • WELVU – Mobile First, an iPad- and iPhone-based educative tool providing medical illustration, quality scores, and health outcomes to engage patients

  • Krames patient education from StayWell

  • ExitCare OnScreen™ video solutions for patient education

The retention of patients in a trial is the key to the success of the overall project. Acurian, a service provider for recruitment and retention services uses platforms such as Facebook and Myspace for patient referrals and retention strategies. The easier it is to be compliant to study schedule, the better is the retention till the end.

Thus, we see that as the focus on healthcare and its access to patient's increases, it calls for the clinical research industry to adapt. It needs to consider technology advancement such as technology driving patient education, application of crowdsourcing to drive patient's contributions towards innovation, activities like ICF and protocol build based on patient's inputs, the usage of social media for data transparency as an integral part of the patient-centric move. The future seems to be bright where pharma and patients have the potential to work symbiotically that could result in better research results, improved health care and profits.


The retention of patients in a trial is the key to the success of the overall project. Acurian, a service provider for recruitment and retention services uses platforms such as Facebook and Myspace for patient referrals and retention strategies. The easier it is to be compliant to study schedule, the better is the retention till the end.

Thus, we see that as the focus on healthcare and its access to patient's increases, it calls for the clinical research industry to adapt. It needs to consider technology advancement such as technology driving patient education, application of crowdsourcing to drive patient's contributions towards innovation, activities like ICF and protocol build based on patient's inputs, the usage of social media for data transparency as an integral part of the patient-centric move. The future seems to be bright where pharma and patients have the potential to work symbiotically that could result in better research results, improved health care and profits.


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