Jeremy Klein

2013 Late Phase Market Overview and Outlook

” report, which was developed based on data from 129 industry professionals with responsibility for Late Phase study conduct and outsourcing. The report includes market data and analysis on Phase IV, Phase IIIb, HEOR, registries, and comparative effectiveness studies.

Late Phase Study Conduct and Outsourced Opportunity


 Consistent with much of ISR’s research, study sponsors report a high degree of outsourcing of Late Phase studies (ranging from between 48-61% depending on study type); typically more than in earlier phases of development. Respondents anticipate they will be outsourcing at least one-half of their late phase study budgets over the next 12 months.

 - Respondents are clear in their expectations that Phase IV studies will be on the rise, both in terms of total studies conducted and those outsourced.

“Regardless of whether studies are conducted in-house or outsourced, for each of the following types of late phase studies, please indicate the growth or decline in the total number of studies your company will conduct in 2014.”  (Base = 129 respondents)
  
“Now, for the studies that your company outsources, for each of the following types of late phase studies, please indicate the growth or decline in the number of outsourced studies your company will conduct in 2014.”  (Base = 129 respondents)

All data points for the above chart are available in ISR’s full report. The following study types are excluded from the above chart: Clinical experience trials, Compliance / adherence, Disease registries, Expanded access programs (EAP), Head-to-head comparative effectiveness (CER), Health Economics Outcomes Research (HEOR), Medical / Product utilization, Patient reported outcomes (PRO), Pharmacoepidemiologic studies, Phase IIIb, pregnancy registries, Product registries, and Risk Management Programs (RMP).


One of the major topics covered in ISR’s report is service quality of clinical service providers; more specifically the characteristics of a service provider that drive “satisfaction” and “loyalty.”

As was the case the first time ISR visited Late Phase market dynamics in 2010, respondents in the 2013 report indicate that satisfaction, and to a degree loyalty, revolves around timelines’ management and (relatedly) site/patient recruitment effectiveness.

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ISR Reports Breaks Down: 2013 Late Phase Market Overview and Outlook

The following is data points are from ISR’s newly released “

Social Media: Best Practices and Strategic Use in Patient Recruitment

Resourcing for Patient Recruitment Activities

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Outsourcing of patient recruitment activities remains commonplace (73%). Where are those activities being sourced? Fifty-one percent are managed by multi-service CROs, followed by in-house resources (27%), and specialized patient recruitment firms (19%).

In 2015, the patient recruitment professionals we spoke to anticipate a modest change to come in the scaling down of in-house resources and uptick in the use of 3rd-party recruitment specialists.

Regulatory Ambiguity Major Barrier to Social Media Adoption

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Recruitment professionals are, perhaps understandably, being cautious in their approach to social media because they don’t want the rug pulled out from under them by regulatory bodies who later issue guidance for its use. Of respondents in ISR’s survey, 66% percent said their organization does not have policies in place regarding the use of social media for patient recruitment. 

Industry Adoption of Social Media for Patient Recruitment

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Data indicate 17% of respondent companies are either “avoiding” social media or have “abandoned” it after having tried it. Similarly, another 17% report their companies are quite aggressive, describing social media as “well entrenched” or that their company is “rolling the strategy out into many clinical trials.” Much more commonly, though, 67% of respondents report their companies are either “evaluating” the strategy or “testing” the strategy.

Effectiveness of social media platforms (i.e. Facebook, Twitter, etc.)

Profile of the "ideal clinical trial" for recruitment via social media provides characteristics of well- and poorly-suited studies for social media use

Use of and satisfaction with specific 3rd party service providers for social media patient recruitment

Anticipated growth of the use of social media for patient recruitment and barriers to adoption

ISR’s report is based on data compiled from a survey of 104 patient recruitment professionals. More information on their 

ISR's "Social Media: Best Practices and Strategic Use in Patient Recruitment"

Sensible approaches for reducing clinical trial costs

” it is worth a read. It gives one of the better economic assessments of clinical trial costs. In this study the authors quantify the average spending, per trial, on investigator payments and the figure is quite staggering as investigator payments account for 48% of the total trials cost. So it goes without saying that sponsors and CROs can’t afford to get the investigator payment level wrong. For sponsors and CROs, the downsides of not paying market-rate investigator fees impact both the financial health of the organization and the ability to recruit high-performing and experienced sites. Pay too much and your R&D budget evaporates too quickly, pay too little and it will be difficult to recruit experienced sites.
 
Industry Standard Research (ISR) recently launched a report that looked to quantify investigator payments/ grants across a number of therapeutic areas, study phases, and the types of compounds being investigated. In the “

” report we wanted to find what drives the costs of payments up and down so that sponsors and CROs can benchmark their payment levels and better plan for study costs. 

Averages can be deceiving. The average investigator payment/ grant per patient was $6,900, but that figure can vary wildly based on the therapeutic are (e.g. Oncology), Phase (e.g. Phase I), and compound type (e.g. Biosimilar). Trial length and complexity also play a large role in the payment levels. But it is not all about the money for some investigators. Many investigators indicated they would consider taking a lower payment if they were working on a novel compound.

Jeremy Klein

Articles

ISR Reports Breaks Down: 2013 Late Phase Market Overview and Outlook

ISR's "Social Media: Best Practices and Strategic Use in Patient Recruitment"

Benchmarking Investigator Payments