November 6, 2013

Collaboration Seeks To Simplify Investigator Engagement

Anyone involved in clinical work knows investigator engagement is not an easy task.

Gathering real-time feedback during a trial, selecting the right investigators, and effectively engaging with sites and investigators can be a monumental challenge.

Earlier this year Invesco Perpetual, an investment firm with holdings in Big Pharma companies including Pfizer, Merck, and GSK, announced a $50 million investment in DrugDev, a data sharing platform for clinical trial doctors with an online network of more than 80,000 clinical trial doctors in 93 countries. DrugDev stated at the time that the money would be used to enhance its clinical trial technology as well as acquire companies with complementary technologies. The first of those companies is CFS Clinical. DrugDev announced it has acquired the company, a provider of business and financial management activities for trials, as part of its plan to help companies control the spiraling cost of clinical trials.

The DrugDev network was started to provide doctors with greater access to available opportunities, and to make it easier for them to participate in clinical trials. DrugDev founder Melissa Easy notes this process is currently inefficient, and simplifying it has been one of her overriding goals.

“We have done a lot of feasibility identification work for sponsors, but our focus has always been on the investigators,” she notes. “Our goal is to make it easier for them to participate in clinical trials, while presenting them with additional trial opportunities. I believe our success has, in part, been driven by this focus on the investigators. As we build our relationships with them, it has not been difficult for us to differentiate ourselves because this is something the industry as a whole has not done very well.”

KOL’s Are Not Always The Answer

In any clinical trial, key opinion leaders (KOLs) need to be involved. However, Easy believes those leaders are unlikely to deliver the majority of the required patients, [if they deliver any at all]. Therefore, DrugDev will recruit doctors who see patients on a daily basis to help sponsors build the protocol and make sure it is deliverable. These physicians are not KOLs, but they will know, for any patient population, whether a stated protocol is workable. Once the protocol is finalized, DrugDev will determine the feasibility of a study by looking at different countries in which the trial could be conducted, and determine which investigators are interested in the protocol and whose sites can meet the predetermined criteria.

“One reason CFS is such a good fit for us is because one of its specialties is helping sites get through the complex study initiation logistics like contracting and regulatory documents,” says Easy. “Combining our relationship with investigators, with the technology and know-how of CFS Clinical, allows the two companies to become one in a very complementary way.”

Our goal has always been to make it easier for sites, sponsors, and CROs to work together,” says Kevin Williams, VP of corporate development & marketing for CFS Clinical. “We focus on the business and financial management aspect of trials, including study start-up and activation, site budgets, contracting, and essential regulatory documents. Then, once the site is ready to go, we manage all of the site payments globally. One of our core strengths has always been changing the paradigm for how sites get paid. The number one concern of sites, particularly in the US, continues to be how to get paid in a timely manner so there is sufficient cash flow to manage the business.”

Real-Time Feedback From Investigators

Easy believes an aspect of trials that has not been performed well is the garnering of real-time feedback from investigators during the feasibility stages of a trial. The sponsor company would clearly be the experts in their own protocol. Where DrugDev adds value is in ensuring the right questions are asked, so as to identify the key pieces of information that sponsors need to know about a site or investigator.

“We are trying to change the way certain tasks are performed,” says Easy. “For example, I have seen horrendous questionnaires that are long and will ask ridiculous questions, such as how many square feet are your offices. Questions like that are totally irrelevant and will not help a sponsor decide if a site is acceptable or if it will be a good match for a given protocol. In the end sponsors will often accept any site that is willing to perform their protocol because there are deadlines and targets that must be hit. Unfortunately they may also end up accepting sites that are not well matched to their protocol. A better approach is to find the right site by asking the critical questions first, so as to quickly disqualify certain sites that don’t meet needed criteria.”

DrugDev performs all activities online. Investigators who are registered with the company are contacted via email with a summary of what the protocol is about. If they are interested, they click on a link and are put through to an electronic survey tool where they are asked screening questions to determine whether or not they are appropriate. If not, they are told why. If they are appropriate, they advance to the latter stages where they get more information on the protocol and receive more detailed questions to answer.

“It took many years for sponsors to even try to engage investigators early on,” adds Williams. “Protocols were developed behind closed doors and feasibility was developed around that. Only then were investigators contacted and asked to work on the trial. DrugDev has created more of a community focus that allows larger interactions with more than just a few KOLs. This allows sites to feel they are a part of the development process instead of simply being called upon to enroll patients. It also allows physicians who are seeing those patients to provide input, in real time, on whether or not specified patients exist, how hard they are to locate, and any special nuances required to properly interact with them. We feel more involvement and engagement from the sites early on is essential to creating better protocols and finding the best site for the protocol.”

Reducing Costs And Eliminating Inefficiencies

With many in the industry complaining about the cost of trials, removing inefficiencies from the site selection process will certainly be a long-term goal. When looking at the inefficiencies which exist in the system, the amount of redundancy in processes, and the amount of rework often required, she estimates the potential savings could be as high as 20 to 50% of the cost of the study, if not more.

DrugDev is continuing to strive to bring additional services to the clinical trial space to further improve efficiency. Areas where Williams believes inefficiencies can still be eliminated include patient recruitment and training. “There is no reason why investigators should need to take the same GCP training over and over again across sponsors,” he notes. “Indeed, Transcelerate has already identified this as an issue that needs to be standardized. We will continue to look for things that will allow the industry to become more efficient, save money, at the same time, and make it easier for sites to engage with sponsors.”

With the acquisition now complete, the CFS Clinical name and brand will remain intact, and will simply fall under the umbrella of DrugDev.