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International Clinical Trials

Casting a Wide Net

Benjamin Jackson of Quartesian reviews patient recruitment and the difficulty in finding willing participants

There has been much written about the current state of patient recruitment across every major publication, website and blog that focuses on clinical trials and drug development. All elaborate on how recruiting the right patient population is critical to the success and timely completion of a clinical trial and invariably, also focus on the lagging enrolment rates. Much has been said about the declining participation in clinical trials due to the high level of patient care in the developed world, as well as the declining participation of investigators in clinical research. In the US, clinical trial participation has dropped to two per cent from four per cent of the total population. The growth rate of investigator participation in the US was 10 per cent in the 1990s; now it is two per cent. One-third of clinical investigators drop out of drug research every two years.

Delays in completing clinical trials are costly. Companies lose patent exclusivity since there is a finite period of time from, in the case of the US FDA, the filing of an investigational new drug (IND) to the patent expiration. With the clock ticking, companies potentially lose millions of dollars for each day that approval is delayed. Pharmaceutical companies are also reportedly spending 60 per cent of their R&D capital on clinical trials. More delays in completing clinical trials lead to higher costs and further bleeding of R&D capital.

According to the Tufts Center for Drug Development, 90 per cent of all clinical trials are delayed by an average of six weeks, and only about seven per cent of all sites deliver what they proposed in the feasibility assessment. Companies are also under pressure to provide more robust and detailed data, thereby requiring more patients to be recruited and ensuring that a sufficient number of patients pass more stringent inclusion and exclusion criteria. Table 1 shows the average number of patients enrolled in a typical Phase III registration trial for a mainstream therapeutic candidate today as compared to 10 years ago.

Table 1: Enrolment numbers for a mainstream therapeutic candidate
  10 years ago
Today
Number of patients in a typical
Phase III registration trial
 2,000
 5,000 to 10,000

The quest for naïve patient populations and willing participants in clinical trials have led many sponsors of clinical studies to look overseas for conducting part or all of a clinical trial. For the first time, more clinical trials are being conducted outside of the US than within. The aforementioned ‘willing participants’ are the key to striking a vein of promising patient candidates. While naïve patients are certainly attractive to have, they don’t necessarily help enrolment rates – willing participants do.

By concentrating less on traditional patient recruiting techniques, such as investigator databases, community outreach and print, radio and TV advertising, and shifting to internet marketing and social media, new populations of willing participants can be found. The rest of this discussion is centred on finding theses willing participants. The first part focuses on global clinical trials and the search for patients, the second on internet marketing techniques. 

GLOBAL CLINICAL TRIALS

Low enrolment is the major factor that causes delays in completing clinical trials – especially in the developed world (primarily US, EU, Canada and Japan), where patients receive the best medical treatment. As a result there is no strong desire to participate in a clinical trial unless one feels it is the only means of getting the best treatment for a particular illness. Completing a clinical study on time can save millions of dollars in patent-protected sales revenue, and since the clinical research markets of countries in the developed world are saturated, pharmaceutical and biotech companies will benefit enormously if they conduct clinical trials in locations such as central and eastern Europe (CEE) and India.

In CEE, the hierarchical structures of the health delivery system (large regional hospitals that treat ailments within therapeutic areas for a given geographic region) direct large patient populations to a single centre. Patients themselves are willing participants since this may be the best medical treatment that they will receive. On the negative side, some countries within CEE have long approval processes – for example, some regulatory authorities meet infrequently, thus delaying critical study start-up dates. This is a particularly acute problem for Phase I bioavailability/bioequivalence (BA/BE) studies for generic drugs as the brief patent exclusivity for the first generic drug is lost. This is not as much of a problem for later phase studies where the delay in the study start-up is often more than compensated for with aggressive enrolment rates during the conduct of the study. 

India, with its large naïve patient population and growing pharmaceutical industry, is a promising area for conducting clinical studies. India is moving forward in all areas, from strictly generics and outsourcing back-office operations to drug discovery, late preclinical development and conducting late-stage clinical trials. Since English is widely spoken, there are few language barriers for multinational companies conducting clinical trials in India. Physicians, research coordinators, CRAs and data managers are being trained in Good Clinical Practices (GCP). The sheer size of the population, the growing knowledge base in pharmaceutical research and development, a good flow of capital, as well as the country’s global connectivity have lowered the resistance to conducting clinical trials in India. Here is a population willing to participate in clinical studies that can be mined for the volumes of data required for regulatory approvals.

PATIENT RECRUITING & THE INTERNET

The internet is a revolution that has had a significant impact on our daily lives. In the narrow area of media advertising, the fundamental shift is from ‘casting a wide net’ to bring in qualified leads, to drawing qualified leads to you in a more focused manner by increasing the visibility of links to a website, landing pages in search engine results page (SERP) through paid placement and search engine optimisation (SEO). With regards to patient recruitment, internet advertising, paid placement and SEO are means to find the ‘willing participants’. Visible placement of links to website landing pages on SERP draws people who are actively looking for information about a condition they have. Whereas historical databases have a large volume of patient data, perhaps gleaned from laboratory data, previous clinical studies and insurance claims, a well placed web page will capture a more dynamic patient population, including patients actively seeking answers and treatment for their illness, or indeed family members and friends seeking answers and treatment on their behalf.

Another factor to consider is: ‘what are patients looking for?’ Many people do not know what a clinical trial is; and they are looking for treatment for their illness rather than participating in a clinical trial. Once they are brought to the website landing page through the visible link on the SERP, they must not be lost. The website should have content that educates the patient about participating in a clinical trial such that, if the patient is willing to participate, they will either call a phone number that is provided or leave their contact information online. Needless to say, there must be compliance with patient privacy regulations, ethics committees and institutional review boards. Table 2 gives a side-by-side analysis between traditional recruiting methods and internet-based recruitment.

Table 2: Traditional recruiting compared to internet-based recruiting
Traditional recruiting
 Internet-based recruiting
  • The sponsor initiates the search for study participants
  • Cast a 'wide net'
  • Expensive advertising budgets
  • Potential study participants initiate the search for their treatment
  • Focus on qualified leads
  • Lower advertising cost

CONCLUSION

Finding the willing participants is crucial to the success of clinical trials. One approach is to conduct trials in parts of the world where patients are more likely to participate, since they may not be receiving adequate treatment for their illness. Given the growing number of qualified clinical research professionals and adequate facilities, and the elimination of traditional barriers through global connectivity, conducting trials in developing regions of the world is becoming more feasible.

Recruiting patients for clinical trials through internet marketing techniques is a solution for the developed world, where it is becoming difficult to recruit patients to meet the demand of the more robust data requirements of regulatory authorities. The solution here is the internet, which captures patients in that narrow window of opportunity when they are actively seeking answers and treatment for their illness, and for whom participating in a clinical trial may be an option they would consider.


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Benjamin Jackson is a 25-year veteran of the pharmaceutical industry. He has held management positions at a number of major pharmaceutical companies. He is responsible for defining and developing Quartesian’s competitive strengths and providing strategic direction for the company. He has an MSc in Computer Science from Villanova University, US, and a BBA in Statistics from Temple University, US.
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