As of May 17 2017, Clinical Trials website had 245,042 public and private Clinical Trial studies registered worldwide. Ironically, only 26,317 studies have managed to submit feasible results on the website. Clinical Trial is the key to optimal care but whenever any private or public organization thinks of conducting a clinical trial, they have to deal with two major challenges which have had an ostrich effect in the clinical trials failure. Huge losses are incurred due to following Patient Enrollment challenges that are posed by “Patient Recruitment” and “Site Selection”.

Challenges in Patient Recruitment:

From 2008-2011, there was a 70% rise in the per-patient clinical trial cost and 46% was due to delayed or no Patient Recruitment. Also, 45% of studies carried out are delayed due to patient recruitment.

Patient Recruitment Timelines:

80% of Clinical trials fail to meet their patient recruitment timelines

50% of sites enroll no patients or only one patient

Only 18% of the Trials proceed to Phase three due to lack of Patient Recruitment

Reasons for the challenges faced:

Increasingly complex trial protocols

Manual Process of Steaming Patients

Competition for patients in certain therapeutic areas

Expanded global landscape

Increased regulatory requirements

Challenges in Site Selection:

Site Selection is one of the integral and pioneering task of any clinical trial. Selection of a low or a non-performing site have to bear a start-up cost of approximately $50k which is fully burdened by the sponsor if they end up recruiting no or only one patient in the longer run.

Non-performing Sites

From 2006-10, total of $1,917,550,000 was wasted on non-performing sites

$20,000 to $30,000 is spent on activating a site

Investigators

5% decrease in the number of Active investigators (annually)

10% reduction in number of new investigators (annually)

Reasons for the Challenges Faced:

Manual Process of Site Selection

Competition of the high performing sites in the common diseases area

Inaccurate assessment of the correct qualifications and credentials of the site

Solution to the challenges- Digitization:

Healthcare IT has abetted Medical Industry to reach the pinnacle of Optimal Care. The digital health products and solutions have enabled increased Physician Engagement and has also increased the patient convenience for personalized care. Following IT solutions possesses equal capabilities for overcoming this giant elephant of Clinical Trials:

Automated Patient Identification and Site Selection

Patient screening takes months if not years to find the exact match for the study. Daily screenings and manual processing is an exhaustive task for the researchers and one which is prone to human errors. Manual patient recruitment may lead to overlooking the deserving candidates and can also lead to fatal consequences like loss of lives of patients due to dark data.

With automated Patient Identification, researchers can recruit the Exact Match for the clinical trial in least possible time. There are solutions out there which collect, process and analyze data in real-time. The systems can be integrated with local EMR systems of Hospitals and Life Science Organization, and hence breaking the silos using the EMPI systems covering the inclusion and exclusion criteria of the complex and personalized research protocols.

Automated site selection is also made possible covering vital information that help researchers identify and exclude the under-performing sites. It also aids in taking critical decisions such as setting up the study budget leading to decreased administrative cost of the sites.

Big Data and Analytics:

Data is the most important part of any clinical study. Data leads to important and reliable information that abets in patient recruitment as well as in patient retention. More the data, better the analytics. You can follow these steps to effectively integrate Big Data in order to achieve efficacy in clinical trials:

Identifying and analyzing data points leading to critical patient data which can make a big difference



Integrating structured and unstructured data from various platforms like social media, HIE, Clinical Trials Government platform and IoT products (Wearables and Mobile apps)



To avoid the inefficiencies due to dark data

Leveraging Social Media

80% of adult internet users access social media networking platforms for health-related information and only 14% of Clinical Trial candidates end up getting information about trials from their physicians. Thus, it is essential to leverage social media platforms for increased awareness about the studies. Some platforms that can be targeted are:

Health-Focused Social Communities





Social Media Platforms





Health Forums





Clinical Trials Government sites





Healthcare focused Mobile Apps

Currently, Patient Enrollment is severely affecting the success of Clinical Trials. The failure has led to humongous cost and even after spending on clinical trials, it is failing to operate effectively. Digitizing Patient Enrollment procedures will not only save cost, but it will also help in providing optimal care to the rightly deserved which is the ultimate goal of any Clinical Trial.

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