Introduction
I have been a PI for 17 years having conducted pharmaceutical and device studies for both established and startup sponsors and CROs. As a practicing obstetrician/gynecologist, participating in clinical trials has given me the opportunity to offer cutting edge treatments to my patients and has kept me current with trends in my specialty. Most of all it is great fun.
It has been said that many clinicians try their hands in clinical research but few move on to a second study. Clinical research is not easy. It demands compassion and concern for patient welfare, attention to detail, resilience in the face of massive governmental red tape, and a certain amount of entrepreneurial acumen. Over the years I have developed a number of pet peeves extending throughout the study process which could easily be corrected and would be of mutual benefit for sponsors, CROs and sites.
Developing Business
Business development is critical for the survival of all sites. Not all sites have dedicated BD job lines. While experienced sites have developed relationships with sponsors over the years both new sponsors and sites need to broaden their networks. Study brokers fulfill this need. Excluding their obvious benefit of offering work they often provide entry into studies proposed by small or startup companies not on the usual radar or projects outside your traditional therapeutic areas I find it very worthwhile to use their services. Study brokers vary, there are individual agents, business development organizations, or study management organizations. Whatever form they take, they all seem to get information on the same studies simultaneously. As I’m affiliated with many brokers, my dilemma is whether or not to accept the invitation from one or all of them as you don’t know which one if any will actually succeed in obtaining the study. I don’t want to be left out. Furthermore the financial arrangements with each broker differs-some have annual membership fees, others a fixed per project cost (whether or not the study actually turns a profit,) and still others take a percentage off the top of study revenue. After trying to cover all bases to secure a study what’s a site to do when all the brokers tell you they have secured the project for you. Who deserves the credit?
Closing Thoughts
Using study brokers has definite advantages especially for new sites. It is important to understand the contract prior to engaging services. Many contracts call for continuing commissions to a broker even if the only project received from them was your first. If you perform well on your first study many sponsors will contact you directly for future projects and no further commissions need to be paid-unless your original contract calls for it.
About the Author
Scott Evan Eder, MD,MS, FACOG, CPI is a board certified obstetrician/gynecologist and owner of Women’s Health Research Center/The Center for Women’s Health & Wellness, LLC in Plainsboro, New Jersey. He has been conducting both pharmaceutical and device trials in women’s health,gynecology, and obstetrics for the last 17 years.
{ 6 comments… read them below or add one }
Good points across the board. The scenario described in the blog happens all the time. The most successful business development support for a site I believe is built around trust and relationships. There are several brokers who supply sites names without even stepping foot or kicking the tires of the site. With out a relationship built on trust and governed by a contract these arrangements rarely work for the sponsor, CRO, Site or broker. This trust should be built on data from the broker outlining the relationships he or she has built over the years This data is important as the data the site provides to the sponsor, CRO via the broker on enrollment metrics.
Dr. Eder,
You bring up a very interesting topic and some excellent points. After reading your description about motivators for and demands on PI’s it becomes clear that this is a very targeted subset of the medical community.
The “tourist” PI, one that dabbles on one study and never again is far too common for the tastes of this industry. More PIs and a greater breadth of research patients are constantly in dire need.
The business development side of the business for PIs and for sites becomes immediately important when the decision is made to be an active contributor in clinical trials.
If someone asked you right now to teach a class on rock climbing – how would that go? For most, you’d probably wonder where to start. Physicians and site coordinators (usually nurses or other health care professionals) are trained, spend all their time honing their skills and keeping up to date with medicine and patient care, NOT sales or business development. These are not people without a high degree of intelligence and ability – but sales and BD success are dependent on very specific strategies and tactics, not always obvious to people who have intent focus elsewhere in ANY given business.
Among the different strategies and tactics available to research sites, Dr. Eder has pointed out a common path. Without hiring an FTE or even a consultant sales person, there are numerous entities out there with about as many different business models, who’s sole purpose is to bring more studies to “their” sites.
Having entered the world of SMO’s in the early 2000’s, myself, I have a lot of perspective on this topic. This was a time period where “SMO” was a dirty word. And I literally spent the first 2 years with customers driving home the difference between our business model and an SMO. CROs and Sponsors had come to distrust SMOs and feel they were “risky”, at best. Like in any other situation, some bad apples spoiled it for the bunch – at least for a while. There had been some instances of SMOs contracting x # of sites on a study, collecting some initial payment, and disappearing. No doubt that left a bad impression on industry!
Since then, I am happy to say that the majority of site networks: SMOs, TMOs, ISNs, & brokers, existing today have the integrity so mandated by industry. And, consequently, I firmly believe that the majority of CRO and sponsor companies and staff utilize these networks and see value in doing so.
Perhaps someone else from a site network would care to go into all the benefits to a sponsor/CRO in using a network. Actually – it would be cool to hear comments from sponsors and CROs as well!
Dr. Eder brings up an excellent point about this resource: the site network/broker; how the hell do you keep track of them all? Without going into detailed descriptions of each type of network and the associated pros and cons, it is important to understand one major division amongst this group. Networks are either exclusive or not. If you are a member of a non-exclusive network, there really is no limit to the number of such companies you decide to engage.
Perhaps this niche is getting saturated if a site/PI is receiving the same study lead from multiple referring companies almost simultaneously. Most people’s instinct is to honor the “first come first serve” courtesy. Yet, this can be almost impossible to track.
To Charlie’s point, and thank you too for your contribution, Charlie; BD and sales, no matter what, comes down to relationships, rapport, and trust. This is also true between site/PI and network. If you are engaged with multiple networks and not truly engaged with any of them, the likely result is that you will continue to receive faxes and e-mails, some related, some unrelated to your interests, and sometimes a study will come to fruition but nothing with any regularity or predictability. The price is $$ + frustration.
Unless you have the bandwidth to manage well several different site relationships, perhaps an approach to consider would be to focus on one or two. Intimately work with them conveying your abilities and business goals. You are partnering in what should be a win-win scenario and it’s in their best interest to nurture this. If your chosen networks don’t “get this” – move on! If you are engaged and hungry, if the BD staff at the network is worth anything, they will gobble that up and bust their butts to find you studies. Work them and manage them!
My last comment pertains to the selection of network partner. Know their business model. Is there a fee? Do they take a percentage of the budget? What’s that percentage? What are the value props? What are the value adds? What else am I giving up in terms of control or what am I taking on in terms of additional responsibilities by working with your company? Is there a contract to sign?
Unless you are looking for an exclusive network – and in my opinion these are some of the most successful models, you should not have to sign any long-term contracts. If there is a contract it’s a red flag that there is perhaps a “level” of exclusivity required.
And finally, please keep in mind that networks are businesses and they are in business to make money off of you and your business. There’s nothing at all wrong with that (assuming you are receiving a valued service), obviously, but it is surprising to see how perceptions change & emotions flare when a site realizes it cost them $30k to get a study through a broker/network. If the site budget was $150k and the agreement allots for a 20% fee to the network and this was made clear to both parties – then there probably won’t be an issue. This is why I suggest knowing up front: all costs. There’s no need to have ill feelings over something that was agreed to and crystal clear. But, especially when it comes to money, most folks don’t like surprises unless it happens to be Publisher’s Clearinhouse that is delivering the surprise.
Thanks again to all that comment here! The more the merrier…
~Dan
Excellent points raised by you. I am doing clinical trials since last 5 years & have good relations with sponsors & CRO for whom I worked. I am being contacted by many SMOs & research brokers & am being sent feasibility for the same trial by 2 -3 such agencies & Sponsor also contacted me for the same project later on. I sent feasibility to one broker & sponsor also, now it is very difficult to decide with whom I should go. Sponsors are giving this task of identifying potential site s to many agencies at a time & later on they contact site’s they knows. My suggestion is sponsor must contact their previously identified sites first & if they do not find sufficient sites for the said project than they should ask the brokers so that potential sites seriously interested in clinical trials can get work continuously & they need not to contact brokers & can avoid conflicts.
Hi Dr. Mehta,
Thank you for sharing your thoughts and ideas on this subject. This topic perfectly exemplifies WHY goBalto is doing a “Site Side” series on clinical trial management.
What the sponsors need in the area of site identification and their approaches to satisfying those needs are not necessarily congruent with what is best for individual research sites and PIs.
What I do agree with is that sponsors should maintain accurate listings of PIs and sites with which they have done business in the past. So that for future trials, they may consider these sites, based on their own experiences with the sites and the sites’ previous performance. These sites should be contacted directly and immediately (first) by the sponsor when rolling out a new study.
Maintaining accurate and up-to-date records for a sponsor is a challenge. Using these metrics across different therapeutic and business groups within a sponsor is even a greater challenge, and many fail miserably in having this type of transparency. Take for example: sponsor A uses site X on a GI trial, and both parties are very satisfied with the results. Site X is a multi-therapeutic site and also does Derm studies. But when sponsor A comes out with a Derm study, they do not contact site X. Too bad for everyone!
At the end of the day, though, when a sponsor starts a new trial that needs 100 sites they know up front that they will have to speak to at least 200 sites before finding the right ones. It would seem that a common approach from sponsors and CROs in the site ID process is to take the feasibility questionnaire, drop it in an enormous fan that blasts the questionnaire across different regions of the world, then wait to see where it lands and who responds. In some cases it probably works just like that, but sponsors and CROs certainly do what they can to get through this process as quickly with as much quality as possible.
To get a more targeted approach to site ID a sponsor/CRO will outsource to multiple parties. IT IS NOT THE CONCERN OF THE SPONSOR OR THE CRO, WHICH PARTY IS RESPONSIBLE FOR FINDING THE SITES. As a site, or any type of network I would strongly caution anyone that directs their own frustration on this topic or the responsibility for managing this back on the sponsor/CRO. They are doing their job with the tools that they have.
This means that the responsibility for managing new study opportunities falls on the site. And just as a sponsor or CRO is in “the right” in utilizing all resources available to help with Site ID, so is the site within “their right” to work with multiple brokers and networks.
When it comes to your own company’s business development opportunities I would urge sites to recognize that THEY are the only ones that truly have their own site’s interests in mind and that it is the site’s responsibility to effectively manage all of these relationships. Set boundaries, create and follow SOPs, and most importantly – be proactive in your management of BD opportunities. If, as a site, you let the networks/brokers drive your BD you may find yourself sitting alone amongst different vehicles cruising to and fro while some of those vehicles will go directly to the opportunity and many others will get lost en route.
And thank you again for your thoughtful comments!
Best,
Dan
I am a clinical research professional, worked with a CRO for 4 years, with one year of experience in Site ID. As per my experience, Sponsors do maintain a list of their preferred sites, and pass it on to the CRO for a particular study. This ensures that those sites are surely contacted for a particular study. In Site ID, we maintain a database of sites such that all the indications the site is involved in is documented, thus, the site is not missed to be contacted for a particular indication. But then, here, it is important that during the initial interactions, the site upfrontly informs the sponsor / CRO / SMO of all the areas in which they conduct clinical trials. As a Site ID group, when we contacted SMOs for finding new sites, we always made sure that the SMO shares their list of sites which they plan to contact for particular study with us. We would filter it and tell the SMO to contact only those sites which are not already contacted by us. This would avoid duplication to a large extent.
Regards,
Shilpa
Good morning, dear Scott, I have read your article and comments and responses.
I am Dr Florindo de la Hoz, not board certified foreign physician, Epidemiologist, PhD, General Director and PI of Vicaria Comprehensive Health Research Network in Miami, Florida.
Our site is only 1 years old and despites we have contacted more than 15 sponsors, CROs and 1 broker and have received more than 60 studies opportunities, unfortunately we have only got 1 small Diabetes type 2 proposal, the main reason for getting the studies is our network and PIs “have not enough experience in research”.
But, I have more than 12 studies as a PI (9 out of this country, but most of these with American universities and CDC). As I have answered to the CROs and sponsors “all the ways start with the first step”, the research sites who has a good experience also were new, but these received opportunities for growing and acquiring experience, but if we have not the opportunity of receiving the site visit how we could show we are qualified for the research?, most of sponsors/CROs have based their adverse decisions in brief phone calls or the feasibility docs. In my opinion 2 issues are killing the new sites like us, one is not doing a site visits and the second is not let people like me with a broad experience act as a PI because we have not a board certification, even if we have a board certified MD as a co-investigator.
Could you please, send me your qualified opinion in how to advance in from my current situation? we will really appreciate it.
Thanks in advance.