By Sherry Hubbard-Bednasz
You have a human condition to improve and a protocol to follow. All smooth sailing from here, right? Indeed, even the most well-planned clinical trial is dead in the water if the needed patients are not accessible or willing to participate. Yes, we’ve been saying it for some time, that the business of conducting clinical trials is becoming more complex. Believe me, in our market research world, respondent fatigue, nonresponse, and sampling snags are real issues that affect our research goals. These also apply to clinical development, granted in a far more intricate manner. Need humans? Welcome to the challenges of dealing with them.
Let’s add another layer: Outsourcing. Such a small word to depict sizable decision making. When it comes to clinical trials, it takes a village. And a lot of that village is outsourced. Whether you’re a veteran or new to this industry, we at ISR aim to take some of the mystery out of companies’ outsourcing decisions. Where do you start? What do you need? In this vast landscape of service providers, is there a match for you? Every year we survey hundreds of clinical development outsourcers to share their perspectives and experiences regarding two of the most challenging and time-consuming processes: CRO selection and performance evaluation.
It is not surprising that the task of CRO selection is often stress-inducing for many companies determining which provider is best-suited to conduct their trials. The desire to find the neon flashing sign pointing to all the answers is understandable. Unfortunately, that sign doesn’t exist. Many factors are at play when it comes to provider selection. One element we explore in depth per our annual CRO benchmarking survey is the influence of preferred provider agreements or the lack thereof. We ask clinical development outsourcers about the attributes they focus on under three selection environments: 1) using preferred provider agreements, 2) going outside of preferred provider agreements, and 3) no preferred provider agreements.
While these selection environments are different, all three decision-making scenarios tend to share some common pain points year over year. One commonality that stood out this year: Patients. For Phase 1 outsourcers, and for the third year in a row, access to patient populations was a universally shared attribute across the three scenarios. For Phase 2/3 outsourcers, patient recruitment strategy was a universally shared selection driver — and a newcomer on the shared scene. When asked to give a reason for their provider satisfaction ratings, several respondents called out a good or bad experience on the specific aspect of patient recruitment. This is proof of the importance and expectation that companies have when it comes to tracking down patients.
We take the patient-related selection driver a step further with a look at companies’ future plans. We asked more than 300 outsourcers their level of agreement with statements related to their clinical development programs. Two-thirds to three-quarters of respondents indicated future expectations for using more specialized patient recruitment and site identification companies and enrolling demographically diverse populations. Moreover, half of these respondents moderately to strongly agreed with these expectations. Important to note, these sentiments were collected in November and December of last year, prepandemic. No doubt in the COVID-19 environment, companies will be seeking even more assistance from providers to help guide them in the altered world of person-to-person contact.
When considering company size, respondents at large (R&D $1B+) pharma companies have a greater expectation regarding these future plans compared to respondents at non-large (R&D greater than $1B) pharma. In terms of increasing the use of specialized patient recruitment companies over the next two years, only 17 percent of respondents at large companies disagreed that this will be the case, compared to 31 percent of respondents — nearly double — at non-large pharma. Shedding light on this pain point, one dissatisfied respondent commented, “We are using [Provider] for a study in a difficult population in a difficult country and their local expertise has not resulted in timely study start or other activities.”
MY ORGANIZATION WILL INCREASE THE USE OF SPECIALIZED PATIENT RECRUITMENT COMPANIES OVER THE NEXT TWO YEARS.
Similarly, more than 85 percent of respondents at large pharma companies agreed that their clinical trial designs plan to enroll diverse populations, compared to 60 percent of respondents at non-large pharma. One satisfied respondent gave this comment with their provider rating, “[Provider] has strong regional regulatory intelligence, site networks, etc., that allow for rapid start-up in AsiaPac.”
CLINICAL TRIAL DESIGNS AT MY COMPANY ARE FOCUSING ON ENROLLING A DEMOGRAPHICALLY DIVERSE POPULATION
In terms of increasing the use of specialized site identification companies, the expectation is greater for respondents at large pharma companies compared to non-large pharma, 76 percent versus 60 percent, respectively. Several respondents said that specialized outside consultants assist their companies with this activity. One respondent shared that consultants provide “identification and qualification of potential sites, management of clinical sites, and clinical trial agreements.” Another respondent specifically commented, “Finding high-recruiting academic sites with special patient populations.”
MY ORGANIZATION WILL INCREASE THE USE OF SPECIALIZED SITE IDENTIFICATION COMPANIES OVER THE NEXT TWO YEARS
Indeed, if “show me the patients” wasn’t already being uttered (hollered?) across this industry, it is now for multiple reasons. Of course, patient access and patient recruitment are by no means new challenges for the sponsors facing them and the providers accommodating them. The new challenge ahead is navigating these pain points during present times. Companies prepandemic were already looking to providers for help. After all, improving the human condition doesn’t stop because the sky falls. But, it will require some heavy cloud lifting.
SHERRY HUBBARD-BEDNASZ is market research director at Industry Standard Research.
Survey Methodology: Industry Standard Research is a full-service market research provider to the pharma and pharma services industries. ISR’s CRO Quality Benchmarking research is conducted annually via an online survey. For the 2020 CRO Awards data, more than 60 service providers were evaluated on over 20 different performance metrics. Research participants were recruited from biopharmaceutical and medical device companies of all sizes and were screened for decision-making influence and authority when it comes to working with CROs. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that quality ratings come from actual involvement with a business and that companies identified as leaders are backed by experiential data.
For more information, please visit www.ISRreports.com.