Do you know what sponsors want from your site? Experts offer clues
Do you know what sponsors want from your site? Experts offer clues
Better education, transparency are key
With a rapid acceleration of changes in the clinical trial industry, including international outsourcing, even experienced clinical trial professionals might find it a little confusing trying to figure out what sponsors want from their sites.
And since sponsors are not uniform in their desires, with some seeming to value low cost above quality, the effort to position a particular clinical trial site as desirable becomes more challenging.
The problem is especially acute for new principal investigators (PIs) and clinical trial sites.
About one third of sites drop out of research trials because their inexperience led to their misunderstanding the difference between clinical research and clinical practice, says Robin Newman, RN, MSN, CPNP, RAC, CCRA, chief scientific officer of MedTrials Inc. of Dallas, TX. MedTrials is a clinical research consulting firm primarily working with the medical device and biotechnology industry.
For example, an orthopedic physician decides to conduct a clinical trial involving a marketed product for total knee replacement, Newman says.
"The first time around, the doctor will say this is just another total knee replacement, and he or she will not think about all of the end points necessary for the trial," Newman explains. "The doctor also doesn't think in terms of manpower expense."
The clinic's nurse is given the additional burden of managing the clinical trial, and unless the nurse is given training and the time needed to do the job correctly, the study will become a big headache for the office and possibly put subjects at risk, Newman says.
"Research is not just treating a patient in regular clinical practice; it's more complex," says Eduardo Tschen, MD, MBA, CPI, a clinical associate professor of dermatology at the University of New Mexico, who works with Academic Dermatology Associates in Albuquerque, NM.
"What happens is physicians think they can generate some revenue by just doing some clinical trials without putting in the effort up front, including training a coordinator," Tschen says. "And the physicians also need to be trained, but they need to understand that a clinical trial is different from their regular practice, and they need to understand the regulations."
Chiefly, physicians need to think of clinical trials as running a practice with much tighter controls, Tschen says.
Pharmaceutical companies and other sponsors have been reactionary to problems, such as trial delays and slow subject accruals, and the proactive measures of improved investigator and clinical trial staff education have not been a big priority, says Nadina C. Jose, MD, CPI, MBA, president and chief executive officer of Research Strategies Inc. of Pasadena, CA.
"There should be a mutual investment between the sponsor, clinical research organization [CRO], and site to provide early training and a good infrastructure for training for every study that is initiated," Jose says. "These should be paid by both the pharmaceutical companies and the sites themselves."
Clinical trial outcomes show that sites that are well-trained and experienced in research are far better able to produce quality data for clinical trials than untrained and inexperienced sites, Jose adds.
As the research industry evolves, smaller clinical trial sites, such as clinics within communities, are becoming more important, Tschen notes.
And sponsors are beginning to spend more time with training these new sites, Tschen says.
"Clinicians are enjoying this opportunity very much, but it's like anything else in that it takes time," Tschen says.
Here are some basic steps sites can take to improve their competitive advantage and improve study quality, according to Jose and other experts in the clinical trial industry:
- Invest in training and educating staff: Although it would be ideal if sponsors would assist in educating clinical trial staff, the reality is they leave that to sites, Tschen says.
Nonetheless, this is not an area for cutting corners, he says.
When a sponsor visits a facility and sees that the investigator is not available, a computer system is lacking, and staff are untrained, they'll think this not a setting conducive to conducting clinical trials, Tschen says.
One way to self-train is to observe an experienced clinical trial site, Tschen suggests.
"Quite a few coordinators have come to our facility to observe and see how we operate," Tschen says. "We give those coordinators hands-on experience for a few days or a few weeks, and we hold a series of lectures each week for coordinators."
There's no standard educational background required for clinical trials coordinators, but it's important to find the right kind of dedicated staff, who are interested in research and are well organized, Newman suggests.
"As long as you have a small number of trials running, and they're not too complex, that will get you down the road," Newman says. "As the trials become more complex, and you take on more trials, then you need certified staff, which not only know the rules, but know how to apply them across multiple scenarios."
Hands-on training or training by professionals who can bring the reality of daily research to life in the lesson plans would be the optimal method of educating new clinical trial staff and investigators, Jose says.
Investigators and clinical trial staff need to be trained with real life scenarios of what they might expect during an informed consent process, for instance, Jose says.
"If everyone understands what the expectations are at the beginning, this is what makes you a site that sponsors and CROs are trying to use," Jose says.
Research Strategies, which Jose founded 10 years ago, is a clinical trial support service company that provides comprehensive training for clinical trial professionals and investigators.
"The concept is not the traditional site management where you have a network of sites, but rather we're able to provide an a la carte menu of services to facilitate efficiency, provide administration services, conduct training and continuing education, and manage quality control," Jose explains.
The company provides basic training for all members of the research team at the outset, and then continuing education is provided through workshops, as needed, Jose says.
Before a site starts a study, the company will provide inservices about the protocol's specific information, she adds.
- Be transparent: Clinical trial sites that developed metrics or data showing their historical performance in certain therapeutic areas will go far in gaining the confidence of sponsors, Jose says.
These data may include the following:
- rates of enrollment;
- drop-out rates;
- completion rates;
- query response time;
- time frame to completion of study.
"Put these in a dossier and say, 'Here are our metrics, and here is our performance, and here's where we were deficient in the past,'" Jose says.
"A performance metrics is something I strongly advocate," she says. "So when a site submits it to the prospective sponsor, it will answer a lot of questions and will catch their eye."
Likewise, a site could develop a CD or even a video of what the site looks like, including the drug dispensary, lab, patient's room, where monitors will sit, etc., Jose suggests.
"It's like selling a house and showing your best features, making it a complete package," Jose says.
Another way to be transparent is to have a Web site and promote it potential sponsors, she says.
Also, sites could invite sponsors to visit their facilities, and when they do the staff should make them feel at home, Jose says.
- Have the PI fully involved in the study: The principal investigator is 100 percent responsible when a sponsor goes to the FDA to make a marketing submission, Newman says.
"Principal investigators have to be prepared to audit adequately, and they have to be engaged in the process because their lack of involvement jeopardizes the study," Newman says.
Sponsors and regulatory officials will think it's a problem if a PI has delegated too many of the tasks and now shows evidence of being involved in the data collection, Newman says.
"You can see in their charting that they're not doing the charting and following patients, and they have a lack of understanding about who is doing what on the trial, including for the informed consent process," Newman adds. "Investigators don't understand how vulnerable that makes them."
These types of investigators soon run into problems with warning letters or sanctions from federal agencies, and these are made public, causing damage to their reputations in the industry, Newman says.
"What I tell investigators is 'It may not be your fault, but it's your responsibility,'" Newman adds.
- Learn from mistakes: "You have to understand that your first clinical trial is a learning experience that won't make you wealthy or famous," Tschen says. "Investigators need to take it as a practice trial and learn what their shortcomings are and improve them."
For example, a first-time investigator typically will assign a staff nurse or another employee to take over the clinical trial work, and that usually fails, Tschen says.
Also, investigators quickly learn that there is less flexibility with patient visits during a clinical trial. So if a patient cannot come on a particular morning for a clinical trial site visit, then the investigator is left with the dilemma of either dropping the patient from the study or deviating from the protocol, Tschen says.
"Everyone needs to understand schedule conflicts and so forth, and that's what frustrates most physicians," Tschen says.
Also, the basic interactions and amount of time spent on interacting with patients changes within a clinical trial, he says.
"On average, a dermatologist will see 60 patients in one day, while in clinical trials we — two dermatologist/clinical researchers — probably see 25 patients in a day," Tschen says. "So we can spend much more time with our patients and take care of them much better."
Tschen's clinic has built up its research practice over 25 years, building up to a staff that includes six fulltime research coordinators and more than 1,200 clinical trials.
Clinical trials help physicians and their staffs learn how to improve the quality of the clinical practice, which in turn improves their clinical trial work, Tschen notes.
"More than anything else, you have a personal feeling of satisfaction from contributing to the development of new drugs or practices, and that's a benefit," Tschen says. "It also improves staff morale."
With a rapid acceleration of changes in the clinical trial industry, including international outsourcing, even experienced clinical trial professionals might find it a little confusing trying to figure out what sponsors want from their sites.Subscribe Now for Access
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