Monday, December 22, 2014

Need patients for trials? Don't hire a promoter to find them

Since patient recruitment is the rate-limiting factor in completing clinical trials, it's not surprising that many pharmaceutical companies hire 'niche' vendors to help locate willing subjects.

Need patients for trials? Don't hire a promoter to find them

Since patient recruitment is the rate-limiting factor in completing clinical trials, it's not surprising that many pharmaceutical companies hire ‘niche’ vendors to help locate willing subjects. These include marketing firms, database suppliers, ad agencies and other vendors claiming to specialize in patient recruitment. The fact is, however, that in the vast majority of cases, the money that sponsors spend for this purpose is an unnecessary waste and, in some cases, the antics of these promotional recruiters can embarrass the pharma or even expose it to civil liability and regulatory sanction.

An instance of precisely such embarrassment landed on GlaxoSmithKline's doorstep last week when it was revealed that the company hired a marketing firm, TouchPoint Digital, that placed blog posts and other online messages soliciting UK college students "by emphasizing that payments [for enrolling in clinical trials] may alleviate their financial problems." 

At least one of several TouchPoint posts on various sites "included a link to a Glaxo website for clinical trials." They made the point that participating in trials can provide much-needed income and suggested that enrolling in four trials a year "can pay more than $13,000" plus travel expenses.

The proprietor of one of the UK websites, Graduate Fog, a job locating service for college and graduate students, soon removed TouchPoint's recruitment posts after reasonably concluding that they sought to exploit her readership. Many visitors to the site, she claimed, are "vulnerable and desperate for money," and either out of work or "in low-paid graduate jobs or doing unpaid internships." People who are desperate for money often remain less likely to weigh the risks of enrolling in drug trials.

When informed about the dust-up, GSK promptly terminated its agreement with TouchPoint. Nonetheless, amid well publicized, ongoing bribery scandals the company is facing in China, Jordan, Lebanon and Poland, GSK hardly benefits from news that tie it to soliciting vulnerable students in its home country.

The fact is, even without trying to solicit susceptible populations such as impecunious students or homeless people on skid row, it is rarely necessary to hire brokers that promise to supply test subjects for clinical trials. If a sponsor and its clinical research organization (CRO) do a good job of selecting proper investigators to run a trial, these sites typically will have enough people in their patient populations to fill the quotas. The responsibility then falls on the sponsor to manage the study's vendors (e.g., supplies, data) and resolve problems at the clinics so personnel there can use their time to screen patients.

While this may sound self-evident, the process of clinical operations at many pharma companies is actually designed to prevent it from happening. 

That is a because the finance managers whose strategies control all functions at pharma these days have created a situation that dissuades both the sponsor's own employees, as well as the CRO, from managing alliance vendors and addressing problems at the clinics.

The salient fact emerging about this finance management of clinical trials is that it is penny wise and pound foolish.  In the short term, companies can obtain savings from jettisoning experienced clinical operations employees, preventing remaining project team members from rigorously managing operations, and relying on a CRO. But in the longer term sponsors end up paying more, even as studies take longer to complete.

Given this approach-avoidance method of running clinical trials, many sponsoring pharmas are prone to just throw money at problems that arise without first assessing whether the remedies they're buying really address the recruitment problems at hand. It remains far easier to just add more clinical sites to a study, increase the advertising budget and/or hire a recruitment agency, instead of diagnosing the underlying reasons for sluggish enrollment. In an era where job insecurity in pharma remains rampant, rationalizations for not asking the tough questions come all too easily.  

Hiring patient recruitment vendors represents another dodge, similar to running "slumdog" trials in underdeveloped countries. Both may appear as cheap solutions, but the downside risks are daunting. The checkered service entails greater expenses and much time gets wasted. 

The clinician’s ancient maxim—first diagnose, then treat—may not sound glamorous, but it remains true. The same applies to diligent operations management. Outsourcing shortcuts may appear cheap and easy, but in clinical trials as in other areas, the ultimate cost and time get well out of hand.  It remains sadly ironic that this is the exact opposite of what pharma hopes to achieve.


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Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
About this blog

Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Dual Board Certified Anesthesiologist and Surgical Intensivist
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