Contract research organizations (CROs)

Transcription

1 Apri 2015 A Specia CenterWatch Feature Artice Reprint Voume 22, Issue 04 PSI, INC Research, Chitern best with sites Strategic outsourcing prioritizing, improving site reationships By Karyn Korieth and Annick Anderson Contract research organizations (CROs) have become more effective in managing working reationships with investigative sites during the past two years, according to a new CenterWatch survey, yet the average CRO continues to fa beow performance expectations in many of the areas investigators consider most critica for study success. In the 2015 CenterWatch Goba Investigative Site Survey, CROs overa received a combined exceent/good rating of 80%, a 2% increase from 2013, and the average CRO improved its performance in severa key areas, incuding working effectivey with sponsors and conducting cear study initiation visits and training. Yet more than haf of sites surveyed gave CROs ow marks for ensuring study monitors are we-trained and understand the protoco, the abiity to resove probems quicky, adequate patient recruitment support and timey grant payments, a areas that CROs increasingy are managing for sponsors. Five CROs came out on top: PSI CRO, INC Research, Chitern, PPD and Covance. INC Research, PPD and Covance aso ranked among the top five CROs in the 2013 survey; PSI and Chitern were not incuded in the Top performing CROs 2015 Average investigative site rating of CRO abiity to deiver on a given attribute CRO Sampe size Exceent Fair / Poor PSI % 5.3% INC Research % 4.9% Chitern % 4.0% PPD % 5.8% Covance % 4.3% Quinties 1, % 5.5% Medpace % 3.3% Icon % 5.7% PRA Heath Sciences/RPS % 5.5% Parexe % 7.3% inventiv % 10.0% rankings two years ago due to insufficient sampe sizes. Quinties, a strong performer in the 2013 survey, aso was highy rated in 2015 for the quaity of its site reationships, pacing sixth on the ist. Fiing out the ist from numbers seven to 11 were Medpace, Icon, PRA Heath Sciences, Parexe and inventiv. Importanty, CenterWatch anaysis suggests as sponsors increasingy adopt integrated and strategic outsourcing partnerships that give CROs greater responsibiity for seecting and managing sites, the average CRO has made great strides in improving its working reationships with sites. In fact, the proportion of sites giving the average CRO an exceent rating has neary doubed in the past decade, increasing Source: CenterWatch 2015; N= 1, 900 investigative sites rating CROs on 37 reationship attributes from about 25% in 2003 to 45% this year. We want to understand a site s needs and hep them be successfu, said INC Research CEO Jamie Macdonad. The CROs have reaized that it s about more than just coming on site, assessing the protoco and going through the mechanics. It s reay about understanding the sites needs, the chaenges they face and being an advisor and provider of soutions. And I think sponsors are empowering CROs to take the additiona time needed to support the site and not just do the mechanica side of cinica tria monitoring. Managing site reationships does take time and effort. CROs increasingy recognize that buiding strong reationships with experienced, A cose site reationship buit around trust, transparency and quaity performance can go great engths to eiminating the friction areas that have existed historicay. Susan Romberg, vice president of goba cinica deveopment at Chitern The CenterWatch Monthy (ISSN ). Voume 22, Issue CenterWatch centerwatch.com

2 CenterWatch Pubications and Services Cinica Trias Data Library A vauabe onine resource providing access to comprehensive charts and tabes on the ife sciences and cinica research industry. CWWeeky A newsetter that reports on breaking news in the cinica trias industry. Avaiabe every Monday in digita format. Annua subscriptions are $249. CenterWatch News Onine A free, virtua newsetter that covers news, deveopments and drug and professiona updates of the cinica research enterprise as it unfods. Research Practitioner A bi-monthy pubication providing educationa artices and practica insights and toos for study conduct professionas. Subscribers can earn up to 18 ANCC contact hours each year. Annua subscriptions start at $139. JobWatch A web-based service featuring cinica research jobs, career resources and a searchabe resume database. Drugs in Cinica Trias Database A searchabe database of 4,000+ detaied profies of new drugs in deveopment. CenterWatch aso prepares custom drug inteigence reports covering a variety of medica conditions. Cinica Trias Listing Service An internationa isting service of activey enroing cinica trias to support sponsors and CROs in their patient enroment initiatives. Market Anaytics Services Custom surveys for organizations to gain competitive insight into the market and their business. Training Guides/SOPs Goba Issues in Patient Recruitment and Retention Protecting Study Vounteers in Research, 4 th Ed. The CRA s Guide to Monitoring Cinica Research, 3 rd Ed. The CRC s Guide to Coordinating Cinica Research, 2 nd Ed. The PI s Guide to Conducting Cinica Research SOPs for Cinica Research SOPs for Sponsors SOPs for Medica Device Sponsors New Contact Saes, (617) , or saes@centerwatch.com. high-performing sites is not just critica to the success of the cinica deveopment processes they manage for sponsors, particuary as studies become more compex and incude more procedures. Reationships aso have become an important competitive advantage as investigator turnover rates continue to rise. We know for a fact that site performance is a function of the reationship that we buid or don t buid with a site. The cinica tria andscape has become very competitive, and in the future our abiity to estabish soid, trusting reationships with sites wi separate successfu CROs from the rest of the crowd, said Oga Afonsova, goba head of business deveopment at PSI. Survey methodoogy CenterWatch s 2015 Goba Investigative Site Survey, conducted onine from October 2014 through eary January 2015, asked Principa Investigators, Sub-Investigators and Study Coordinators to rate the CROs with which they worked during the past two years on 37 project attributes. In addition, sites provided feedback on the importance of these attributes in conducting successfu cinica trias. More than 72% of the 1,900 cinica research professionas who competed the survey were from North America and Europe. A tota of 11 CROs with sufficient sampe size were evauated in the 2015 survey, compared to eight CROs in the 2013 survey. CRO rankings were based on a combination of two measures: an overa reationship quaity rating based on the percentage of exceent scores from sites, and the frequency with which companies paced among the topthree rated sponsors across the 37 attributes measured. The CenterWatch survey not ony highights the importance of sites to the cinica deveopment process, but the investigator satisfaction ratings aso are vita to CROs, since their success in managing a cinica study depends on the quaity of their reationships with sites. Many companies use this biannua survey as a road map for evauating the effectiveness of their site reationships and identifying systems or processes for improvement. Overa exceent ratings increase CRO performance in this year s survey generay improved or stayed the same, compared to 2013, on each of the 37 individua attributes measured. The average exceent rating across a attributes increased three percentage points during the past two years, which is statisticay significant. CROs narrowed performance gaps five to eight percentage points across the five attributes sites rated as most important to study conduct success: knowedgeabe and we-trained monitors, organized and prepared study support, timey drug avaiabiity, easiy accessibe staff for issue resoution and professiona medica staff. The resuts underscore how CROs, under mounting pressure to achieve higher eves of performance and efficiency, have focused efforts in recent years on deveoping more effective reationships with sites to improve cinica tria operations. For us, it s about deveoping what we ca bue ribbon partnerships. It s about understanding at a fundamenta eve what each partner needs to bring about that reationship, said Ji Johnston, vice president of goba site activation, informatics & optimization at Covance. We need sites that provide high-quaity data, patients who are going to be eigibe for the study and migrate into the study in a short amount of time for us to reach our goas. But on the fip side, we aso have to be reay good partners for sites to make sure they understand that we aso are in it for them. We need to make sure we are contributing the right amount of information and making it easy for them to do the studies. Leading CROs have begun new programs and initiatives in recent years to improve communication with investigators, address site needs and better everage site reationships. These CROs have deveoped preferred 2 The CenterWatch Monthy Apri 2015 centerwatch.com

3 partnership programs, invested time and resources into training programs, given investigators insight into industry pipeines so they are ready for upcoming studies, offered greater support for patient recruitment efforts and asked sites for feedback on how to improve the quaity of their reationships. An effective reationship is buit on communication; specificay, two-way communication. When they contact us, they expect a repy. When we contact them, we expect a repy. With both phone cas and e-mais, neary every CRO has become effective at communication and that does hep make for a good reationship, said David Scott, president and CEO at Pam Beach Research, a Forida-based dedicated research center. CROs aso have participated in initiatives sponsored by TransCeerate BioPharma, which aims to streamine processes and reduce redundancies for sites, as we as projects begun by the Society for Cinica Research Sites (SCRS) to advance the roe of sites in cinica research. We have offered sponsorship and schoarships to the SCRS program to aow sites access to the SCRS offerings, which incude work on training best practices, advocacy for the roe of sites gobay, communication and a network through which sites can share ideas, thoughts, concerns and needs. We then internay take that feedback and use it to drive initiatives that are targeted at either our training, communication, grant payments or whatever Highest performing CROs 2015 CROs that received the highest average exceent ratings Attribute rated the most important Has professiona, knowedgeabe and we-trained monitors/cras Is organized and prepared Ensures timey drug avaiabiity Has easiy accessibe staff for escaation of issues and provides timey and appropriate resoution Has professiona medica staff in cinica operations Attributes for which CROs receive the highest average ratings rating exceent in 2015 rating exceent in 2013 Ensures timey drug avaiabiity 52% 49% Effectivey uses communication technoogies 51% (e.g., web portas, IVRS) Understands oca reguatory/ethics issues 50% 47% Has professiona medica staff in cinica 49% 46% operations Maintains open communication 49% 47% Source: CenterWatch; N= 1, 900 sites in 2015; N=2,032 sites in 2013 PSI, PPD, INC Research PSI, Medpace, PPD PSI, Chitern, INC Research PSI, Chitern, PPD, INC Research INC Research, Chitern, PSI, Medpace, PPD, Quinties Source: CenterWatch 2015; N= 1, 900 investigative sites rating CROs on 37 reationship attributes processes hep sites be more successfu, said INC s Macdonad. Leading CROs aso have adopted technoogy patforms that heped improve communication with sites and identify potentia data probems earier, which coud hep reduce the amount of time site staff spend on re-work. Pharma companies are counting on CROs to everage advanced technoogy and innovation to ease the burden on sites and to streamine processes, in addition to being the face of their company to those sites, said Pau Covin, executive vice president, goba cinica deveopment, PPD. As the environment continues to move toward more compexity and arger trias, and as sites get busier and busier, it is going to be very important that we everage our technoogy to make it easier for patients and sites to participate in trias. By using data anaytics to identify issues sooner and proactivey impementing corrective measures, we can streamine the process, reduce effort both for sites and for patients and reduce costs in the process. Susan Romberg, vice president of goba cinica deveopment at Chitern, said benefits of strong CRO-site reationships incude faster site startup through agreed standards for ethics and contract approvas, cear and efficient monitoring strategies, dedicated iaisons or project managers that incorporate we-defined communication and escaation pathways, and agreeabe and achievabe performance metrics. A cose site reationship buit around trust, transparency and quaity performance can go great engths to eiminating the friction areas that have existed historicay, said Romberg. CROs need to become more adept at identifying, supporting and rewarding the topperforming sites. We need to engage in diaog with them on what they need to be successfu and ook for ways to support that. The fact three of the top five CROs INC Research, PPD and Covance aso were among the top five CROs in the 2013 survey suggests CROs are getting better at creating continuity in management practices and strategies adopted in recent years to improve site reationships are beginning to pay off. We figured out quite a whie back the importance of site reationships, said INC Research s Macdonad. At the end of the day, 3 The CenterWatch Monthy Apri 2015 centerwatch.com

4 there are three main piars of a successfu cinica study: a scientificay vaid and operationay feasibe protoco; motivated investigators who are quaified and appropriate for a particuar study; and investigators that have eigibe, informed and consented patients to participate in the study. As in previous surveys, however, sponsors continue to receive generay higher exceent ratings than CROs for site reationship quaity. CROs scored two to four percentage points ower than sponsors in each of the six project categories measured. The widest variabiity between CROs and sponsors was for having professiona medica staff in cinica operations: 56% of site professionas gave sponsors an exceent rating, compared to ony 49% for CROs. Sponsors aso received higher ratings for having efficient administrative teams and easiy accessibe staff. Another notabe gap was for providing ongoing hep in running a study, an individua attribute within the study monitoring support category, for which the positive rating for sponsors was six percentage points higher than that given to CROs. It is understandabe there is a perception that, as a service provider, a CRO is not as invested or engaged as a sponsor in the outcome of a given tria, but that just isn t true. Our peope are invested, passionate and take great pride and emotion in the outcome of Average CRO rating across attributes their work, said Chitern s Romberg. In fact, referras from research sites are one of our top sources of new cients. Yet Jennifer Sek, co-owner of Foridabased Suncoast Cinica Research, said many sites prefer to work with sponsors directy because, in her experience, they are more knowedgeabe about the protoco, have better defined processes and are more wiing to partner with sites in terms of maintaining an open diaogue and compensating sites fairy. Sites now are more distanced from the sponsors. The CROs often misinterpret the protoco and are unwiing or untimey in escaating questions and concerns to the sponsor, said Sek. CROs have to adjust to differing sponsor expectations, so it eads to confusion and things having to be re-done or being done differenty from study to study. Attributes for which CROs receive the owest average ratings rating exceent in 2015 rating exceent in 2013 Provides protocos that require minima 38% 35% amendments Is fexibe: wiing to modify 39% 34% protocos/budgets Provides prompt payment of grants 39% 36% Offers reaistic grant payment schedues 39% 36% Has ow monitor turnover 40% 34% Provides adequate funding for patient 40% 38% recruitment Provides fair overa grant payment amounts 40% 36% 4% 35% 17% 13% 2% 4% Source: CenterWatch; N= 1, 900 sites in 2015; N=2,032 sites in % 36% 2% Exceent Good Neutra Fair Poor Source: CenterWatch; N= 1, 900 sites in 2015; N=2,032 sites in 2013 There is ess confusion and fewer ogistica issues when deaing directy with the sponsor. As the CRO roe has changed, however, and sponsors have rapidy transferred site management responsibiities to their CRO partners, the overa performance gap between sponsors and CROs has narrowed. The gap between top ratings received by sponsors and CROs has narrowed from 11 percentage points in 2001 to two percentage points this year. CROs and sponsors today operate at near parity in site management, an area that wi continue to grow in importance as the industry moves toward risk-based monitoring modes that require fewer study monitor visits to sites. The average CRO has made notabe improvements in conducting cear study initiation visits and training, for which exceent ratings increased four percentage points during the past two years, and in using technoogy to make processes more efficient, in which exceent ratings increased five percentage points. It s ony natura to see that gap narrow because of the increasing reiance on CROs and sites deepening reationships with CROs, said PPD s Covin. From a historic perspective, CROs have come a ong way in the past decade. As the industry has matured and focused on how to drive productivity and cost reduction, our sponsors have buit much more strategic reationships with CROs. This has ed to a much more integrated mode, increasing the importance of improved reationships with the cinica sites. 4 The CenterWatch Monthy Apri 2015 centerwatch.com

5 Wide gaps remain in most important areas Despite improvements, the widest performance gaps ranging from 14 to 23 percentage points remain in critica areas previous CenterWatch surveys have identified as the biggest chaenges to the quaity of CRO-site reationships. These areas incude providing knowedgeabe, we-trained monitors; organized and prepared study support; staff easiy accessibe to sove probems; fair grant payment amounts and prompt payment schedues. In the widest gap, 71% of sites beieve professiona, knowedgeabe CRAs are critica to study success, but ony of sites gave the average CRO an exceent rating for this attribute; this area aso had the widest performance gap in the 2013 survey. Investigators report CRAs don t aways understand the protoco or ack proper training and create probems for sites when they can t answer questions or give advice based on incorrect interpretation of study requirements. Monitor turnover aso remains a significant probem with ony 40% of sites giving the average CRO an exceent mark for this attribute, which was among the owest ratings in the survey. Sady, we can count on one hand how Attribute category performance many CRAs understood the protoco they were training our staff on at the site initiation visit over the ast year or 60-pus protocos, which is rather embarrassing and quite a sap in the face when compared to what we are tod to do and have training for, said Jon Ward, CEO of Utah-based Aspen Cinica Research. Yet the doube standard continues. Covance s Johnston beieves this area remains an industry-wide probem as the market remains highy competitive for CRAs, Average site rating of attributes in the category as 'very important' Average site rating of sponsor abiity to provide attributes in the category as 'exceent' Average site rating of CRO abiity to provide attributes in the category as 'exceent' Overa project support Study monitoring support Protoco/Study design and panning Site management Work stye Contracts and budgets Largest CRO performance gaps 2015 Percent of sites rating CRO abiity exceent Percent of sites rating attribute 'very important' Offers reaistic grant payment schedues Adequate funding of patient recruitment 57% 52% 55% 49% 46% 54% 45% 47% 45% 53% 50% 46% 52% 40% Uncompicated CRF design Reaistic project timeines Prompt grant payments Fair overa grant payment amounts Staff is easiy accessibe Is organized and prepared Knowedgeabe/we-trained CRAs Source: CenterWatch 2015; N= 1, 900 investigative site 39% 52% 40% 55% 44% 57% 39% 53% 40% 54% 47% 53% 62% 68% 71% Source: CenterWatch 2015; N= 1, 900 investigative sites which resuts in high turnover. The dynamics of how cinica tria work is outsourced or where trias are being run at any point in time aso eads CRAs to move from one company to another. In addition, cost pressures squeeze the time that some companies are abe to spend on individua CRA training. It aso depends on ocation and timing. We find in certain ocations of a country or region and at specific times it becomes utracompetitive in that market, said Johnston. When there is high demand the suppy is ow, and when the suppy is ow it becomes utra competitive. Peope at the CRA eve are ooking to expand their careers, their financia gain and their professiona deveopment. So they have a tendency to shift from one company to another. But we reay see it as a timing issue and it s generay infuenced by ocation. In addition, INC Research s Macdonad said much of the CRO industry remains functionay aigned and aocates CRAs based on avaiabiity and, in some instances, proximity to sites rather than therapeutic expertise. Our highest criteria in INC is to find CRAs that have the experience and passion to monitor in a particuar indication. Therefore, when they are on site, they are capabe of doing not just the traditiona CRA auditing and monitoring and source document verification work, but 5 The CenterWatch Monthy Apri 2015 centerwatch.com

6 are much more abe to coaborate on the issues sites see, said Macdonad. You have got to have an expert on site, not a generaist. In another area, CROs coud improve their reationships with sites, according to survey resuts, by having staff easiy accessibe to answer questions quicky and accuratey. CRAs traditionay have been the primary contact for sites, yet the growth of outsourcing has ed to a greater number of peope invoved in a study and investigators often don t know whom to ca with questions. Investigators report having one point of contact assigned to manage the reationship and answer questions about protoco requirements or payment issues a practice many eading CROs now empoy can hep ensure probems are addressed in a timey manner and buid trust. The probem ies in the fact that CROs are the middeman between the sponsor and the site/principa Investigator. Many times, days, weeks or sometimes months go by and an outstanding issue, question, concern or carification goes unanswered, said Aspen s Ward. We want CROs to be respectfu, courteous and timey in their communications. As in previous years, budget negotiation and the grant payment process, another responsibiity many sponsors have handed over to CROs, received some of the owest scores in the survey. In resuts and interviews, investigators expressed frustration that negotiation processes often are sower when a CRO is invoved and that their needs often are not communicated to the sponsor. Investigators report a ack of transparency in how budgets are determined and payment deays; according to SCRS, in 2014 about 65% of cinica research sites had ess than three months of operating cash, an increase from 57% in More than haf of sites rated this category as very important, but ony 40% of sites gave CROs an exceent rating for performance in the contract and budget category. My pet peeve is that payments are deayed, said Larry Seidman, D.O., president of Cinica Research of Phiadephia. When they te you they wi pay you every three months, it s often every four months. We reay have to negotiate to get paid monthy. We have to pay our empoyees every other week. We need to pay our vendors and are never ate. But we can t afford to carry a big pharmaceutica company or CRO. Johnston said deays in grant payments continue to be an industry-wide probem because the data needed to make payments which incude financia, operationa and miestone information often come from disparate systems or processes that must be aggregated manuay. The systems and the back offices that support grants are not aways up with the times. However, many niche grant payment providers have popped up in the ast coupe of years and they are highighting a pain point for the industry. It continues to be a time for the industry to focus on this and ensure that sites stay whoe, said Johnston. The investigative sites are going to need to have more timey payments on a more frequent basis. The smaer sites simpy can t absorb the fuctuation in when grants are paid. They are expecting to receive them in a timey manner to pay off their bis. That is sti a space where we have opportunity to make significant improvements. Looking ahead Deveoping strong working reationships with sites wi become increasingy important for CROs moving forward as the industry moves toward personaized medicine, for which patient popuations wi become more scarce and competition for experienced, top-performing investigators wi increase. Some investigators and site networks aready have begun imiting the number of CROs they work with to ony those who wi enter a strategic or preferred reationship or those that are easy to work with. There is a ot of competition right now for good sites and that is continuing to increase, said Covance s Johnston. Whie sites are considered a suppier of a service to us, we beieve they need to be treated ike a customer, more ike an account or an asset rather than just a transaction for the individua study. Survey resuts show top-rated CROs have become better at managing their working reationships with sites during the past two years. Yet, the resuts aso suggest severa opportunities for improvement. For CROs to buid stronger reationship with sites, they must ensure CRAs are propery trained and understand the protoco; communicate in a respectfu, timey manner; offer adequate funding for patient recruitment; offer organized study support and improve grant negotiation and payment processes. When we have a probem, we want the CRO to go to bat for us with the sponsor, try to hep us and have some aegiance to us, just ike they do to the sponsor, said Seidman. It s important to keep the Principa Investigator happy. When someone is supporting you, you go the extra mie. When we sign on to a study, we pedge that we are going to work tireessy to make it successfu. And we just want to fee appreciated, and we want to get the backing from the CRO and the sponsor. Karyn Korieth has been covering the cinica trias industry for CenterWatch since Her 30-year journaism career incudes work in oca news, the heathcare industry and nationa magazines. Karyn hods a Master s of Science degree from the Coumbia University Graduate Schoo of Journaism. Emai karyn.korieth@centerwatch.com. Annick Anderson has been conducting market research since 1998 in both the heath care and consumer packaged goods industries. Annick hods a Master s of Business Administration from the Boston University Graduate Schoo of Management. Emai annick.anderson@centerwatch.com. 6 The CenterWatch Monthy Apri 2015 centerwatch.com