Significant Science

Before we begin, Chris, I’d like to provide readers with some background about how I learned about you and why I think they will find this interview useful reading.

I envision several audiences for this interview. First, your comments may be helpful to members of the general public who may have heard the term “clinical trial” but who don’t really have a handle on this rather complex subject and who are the kinds of people likely to be interested by what you are doing at MyClinicalTrial.com.

A second potential audience may be members of the public recently diagnosed with a serious illness like amyotrophic lateral sclerosis–also known as Lou Gehrig’s Disease–or who have a condition like Parkinson Disease who are either hoping to find treatment for themselves or who simply want to advance the cause of science and prevent others from undergoing the ravages of illness that they have known.

A third potential audience is that of people who are healthy but who would like to enroll as healthy volunteers in a clinical trial so as to help others by contributing to medical research by providing researchers with important information for comparison with people who have specific illnesses.

A fourth potential audience is that of medical people who may not be full-time clinical researchers but who are intrigued by or passionate about a potential treatment and are running a clinical trial perhaps for the first time and are not in a well-known, well-funded medical center and so need your help and expertise to recruit trial participants.

This all leads to my first questions. Have I gauged the potential audience and users of MyClinicalTrial.com about right? Have I left out anyone?

Yes, you pretty much covered it. We want to provide resources to those people that are just looking for an answer to their healthcare challenges. Not all medicines work for everyone and new trials may provide a solution to those people that fall into the percentage that are not successfully treated. Also, for those people that don’t have insurance to cover their medical needs, some trials can help them by providing medical screening, supervision, and study medicine.

Could you tell us a little about your personal and professional background and why you think MyClinicalTrial.com is important?

I have been involved with clinical trials for over 20 years. It really started back in college when I volunteered for different trials. Later in life I began to use my marketing experiences to help identify patients for clinical trials to speed up the clinical trial process. I think most people have some friends or family members that are affected by cancer or other live threatening diseases. I personally have lost family to cancer and have family and friends that are in cancer trials. One friend was diagnosed with breast cancer. She had trouble finding trials for her cancer. MCT is a great tool for helping doctors spread the word about their trials and for patients finding studies that match their conditions locally.

Let’s backtrack a little here so as to address the matter of how information about clinical trials is being disseminated on the Internet and changing the patient recruitment process. For example, I first heard about MyClinicalTrial.com by seeing a tweet that linked to this press release.

Now that in itself is a rather interesting sign of the times vis-à-vis the mix of social media and orthodox marketing. Could you tell us how you envision the employment of social media on MyClinicalTrial.com? For instance, is MyClinicalTrial.com on Twitter so that every time a new study is added to its listing a user would get a tweet?

We are 30-45 days or so away from setting up a Twitter and Facebook account. It would notify people of new studies and information about their conditions.

That being so, will users of MyClinicalTrial.com be able to sign up for tweets on every new addition or just on new trials of their particular interest (e.g., multiple sclerosis, Type 2 diabetes)? Perhaps something along these lines?

Yes, very similar.

You offer email alerts notification sent to potential patients.

Yes, we will have an email notification function for those who sign up for it. It will target people based on their state, zip code radius, and/or medical condition.

Do you offer RSS feeds too or do you find that RSS is just not catching on in the world of clinical trials and in healthcare generally?

Not yet. We will pull in RSS feeds for providing additional content on our site.

It says in the press release, “Our goal is to educate people about the importance of clinical trials, provide the latest industry information, and identify the right studies for prospective volunteers.” Well, in the interest of the very laudable goal about public education on the subject of clinical trials, I’d like you to ask you to walk our audience and me through the statement below, which I found here.

“Patient Enrollment Services
MyClinicalTrial.com is an exclusive service provided by Clinical Site Services (CSS). CSS is not a patient recruitment company, but a Site Performance Company focused on developing and managing site’s ENROLLMENT PLANS to increase enrollment for clinical trials.”

Could you tell us a bit about why Clinical Site Services saw a need for MyClinicalTrial.com?

MCT is a method for the doctor to get information about their office and trial into the community; and for people to find trials that match their conditions on a local basis. We understand that most people don’t understand the verbiage that is listed on clinicaltrials.gov and other listing websites; we try to make it easy for most everyone to understand. We want people to be educated about clinical trials, the processes, the risks and benefits, and any other study information before they decide on whether to or not to participate. An educated study volunteer is much more likely to participate and stay in a trial.

How does MyClinicalTrial.com differ, for instance, from CenterWatch and
and TrialX and could you elaborate on the difference between a patient recruitment company and a site performance company? Don’t they both assist those running clinical trials with enrolling subjects (be they those with the illness under study or healthy volunteers)?

Clinical Site Services (CSS) works for Doctors (sites) and Sponsor Pharmaceutical companies with patient enrollment services. While patient recruitment is the number one reason for trial being delayed, we believe that sites (doctors doing the trials) need to be effective and efficient in the process of identifying patients for trials and, just as important, turning the interest of potential patients into enrollment. If someone is interested in participating in research, sites need to be able to find them, provide them information about the trial, and bring them in for screening. Most sites don’t do any of this well. CSS helps bridge the gap between the interested potential patient and the clinical trial. We help the sites perform better by providing services to increase their enrollment potential.

While you are at it, could you please tell us what a contract research organization is?

A Contract Research Organization or CRO is a company that manages the trial or parts of the trial for the pharmaceutical company. While the term is somewhat vague, companies that provide project management, protocol development, data collection and management, quality assurance, drug supply management and distribution, regulatory, patient recruitment, etc. are considered CROs.

The site for Clinical Site Services has some interesting wording, “convert initial interest into enrollment” and, “…we will formulate a retention strategy that creates a sense of community for the study and makes participants feel both supported and appreciated.” Could you tell us how you see MyClinicalTrial.com doing the first and do you envision MyClinicalTrial.com playing a role in the supported and appreciated part or is that later stage beyond the scope of MyClinicalTrial.com? To wit, will MyClinicalTrial.com basically concentrate on enabling potential enrollees to keep abreast of new clinical trials in their area of interest or do you hope that MyClinicalTrial.com will evolve into a full-blown online patient community (albeit with a focus on the clinical trial process rather than the full spectrum of chronic illness) a la PatientsLikeMe:

Clinical Site Services is a company that supports the enrollment process for pharmaceutical companies and sites that do the trials. MCT.com is a tool that CSS uses to promote clinical trials and the education of research. We will be adding features to MCT that are similar to patientslikeme.com in the future or partner with companies similar to them.

Where do your listings come from? Do you list studies that cannot be found on ClinicalTrials.gov?

Our listings come from sites that are doing trials, from Sponsors running trials, and from the ClinicalTrial.gov website.

What is the business model for MyClinicalTrial.com? It is a public awareness tool. But what else? You say here, “MyClinicalTrial is an informational website where study volunteers, doctors, and others can find out more about the development of medicines and devices. This website is promoted nationally through advertising and web branding.” Could you talk about where you are advertising MyClinicalTrial.com?

We currently advertise nationally through the Television, radio and print ads we run for our site clients. Each client has a unique study posting that is active during our advertising campaign. People can call the site directly or visit the study posting on MCT.com. We also are getting links on other websites that potential study participants may be visiting. Starting in 2010 we will be initiating internet advertising on the major search engines, social networks, and other sites that make sense.

You seem to have multiple audiences. The first is patients and the second are the groups you are trying to connect them to. That second group is your primary client base, which appears to be pharmaceutical companies and physicians conducting clinical trials. Are the physicians mostly those in private practice curious about a particular treatment and its safety and efficacy or researchers in academic and industrial laboratories or small biotech firms? Again, do you offer anything that patients can’t get from CenterWatch and TrialX–especially given that the two have recently partnered?

We will be adding a lot more functionality to the site. Email notification, log in to manage their profile and types of studies, we will be adding an organization section that connects groups with specific medical conditions –both nationally and locally. As we see the needs, we will be adding new functions and information.

Could you please tell us your reaction to the recent agreement between Pfizer and Private Access to establish an online community designed to increase clinical trial awareness and participation?

Pfizer has always been at the forefront of technology and new innovative ideas of improving the education of patients around clinical trials. I think it is great that they are doing this. It will help everyone in the industry.

Specifically, the Pfizer-Private Access platform will offer a way for patients to feel that their privacy will be protected. Do you see any problems at MyClinicalTrial.com in that regard? For instance, if I sign up as volunteer do I really want to simply enter into a form on a Web site that I am interested in clinical trials about cancer or sexual dysfunction?

The information people provide us is not used for anything else other than giving us an indication of the types of trials that they are interested in. We will only use this information for connecting them with information on clinical trials. None of the personal data will be sold.

Is there any particular reason that you have a cap of 250 miles on the search page here?

We have found that most people will not travel further than this and typically not more than 30 miles. If we provide a larger radius, other companies and competitors use the site for other reasons than finding trials to participate in. Most of our clients do not want people contacting them from a distance that a patient would not be willing to travel during the trial. If we find that people would like to increase this radius, we can do so later.

But if I have a rare disease and live in Wyoming, I may have to travel well over that distance to participate in a study, no?

People can still search for studies base on states if they want to increase the searchable area.

One thing I really liked about MyClinicalTrial.com is that I can search for clinical trials and obtain contact info on those conducting the study without having to register. That endows those wary of uploading info into a site with a way of contacting researchers without revealing too much too soon and contacting only those who seem to be studying one’s own specific condition. By contrast, I have to create an account in TrialX in order to contact a researcher via TrialX.

What do you see as the particular strengths of MyClinicalTrial.com? What makes it particularly innovative? What’s its wow factor? Or do you even see that as important or do you prefer a simple, unglamorous but useful tool for serious people, be they clinical researchers or patients afflicted with dire illnesses?

I hope our “wow” factor is the simplicity of the site and how easily it is to navigate to find the information that they are searching for. We hope to create a site that is evolving and growing from input from patients, sponsors, and organizations associated with clinical trials.

What improvements are you planning to implement at MyClinicalTrial.com in the next few months? It is not very social media heavy at this point, for instance.

We will be adding more social media aspects to the site soon. We will be setting up a Twitter and Facebook account. Also, there will be more information about medical conditions and organizations associated with these conditions.

On interesting development on the clinical trials landscape is the advent of a sort of do it yourself, primarily patient-led study that is connected to an online patient community, such as the recent study of lithium in ALS under the auspices of PatientsLikeMe. Do you have any comment on that and do you plan to list such studies on MyClinicalTrial.com?

The studies we have on our website will be posted by the researchers doing the study. There is a lot of information out on the web and many different websites that have different goals. Our goal is to provide information on clinical trials that come from those who are conducting the trials.

Do you see MyClinicalTrial.com as a part of the growing e-patient movement? That is, patients harnessing the tools of Web 2.0, Health 2.0 and Medicine 2.0 to become “prosumers” (a term I heard used at the recent Medicine 2.0 conference and which refers to patients who are very proactive in seeking out information outside traditional medical circles about their illnesses, particularly via the Internet).

I see MCT as a tool for people to identify options in their health care and potentially part of this e-patient movement.

How do you envision MyClinicalTrial.com in a year? In five?

Good question. There are so many directions we can take this website. In following our current goals, we do want to provide a website that people can come to and get answers quickly. We cannot be everything to everyone, but we hope to be a valuable resource to those people interested in clinical trials.

Finally, who are your personal heroes in medicine, technology and in any other field?

To be honest, my heroes are people that take the time to find better medicines to improve all of our lives. There are people like Darbey Steadman who is dealing with Stage 4 Metastasis breast cancer and is working hard as ever to help people with their financial needs who are participating in clinical trials. There are so many doctors that have devoted their lives to finding cures. These people are true heroes; these are those people that strive to make a difference in people’s lives.

Thank you for your time.