January 3, 2019 | As Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI, Norman Goldfarb is in a unique position to speak to sponsors, CROs, tool-providers, and regulatory oversight groups in the clinical-IT community and get their take on the pain points in clinical research and what changes are needed. Goldfarb has shared these candid conversations in an exclusive column for Clinical Informatics News, highlighting site payment methods, clinical trial oversight, and much more. As we look forward to the discussions in 2019, we would like to take a moment to highlight the insights captured in 2018.

--The Editors

Get Serious About Timely Payment To Clinical Research Sites

John P. Neal, Founder and Chairman of PCRS Network, called for study sponsors and CROs to get serious about paying sites in a timely manner. “When sites don’t seem to know what they are owed and keep doing business with slow paying sponsors and CROs, what message are they sending?” Neal said. “Sponsors and CROs won’t get serious about paying until sites get serious about collecting.” What can we do to speed up collections? Neal offered five steps. “First, sponsors and CROs should accept that sites need to be paid monthly, if not more frequently,” Neal said. “Second, sponsors and CROs should make their payment systems transparent to sites. Third, sponsors should make sure their CROs are adequately funded to make timely site payments. Fourth, sites should maintain their own comprehensive record of services performed on every study, and provide sponsors and CROs with timely information regarding what the site believes is owed to them, for what, and when those amounts are due. Fifth, sponsors, CROs and sites should expect and apply the same high ethical standards to their financial dealings that they demand in the conduct of clinical studies.”

Start Looking At Study Subjects As Individuals

“It’s about time clinical trials change their traditional focus from observing large groups of largely undifferentiated patients to the individual patient as the unit of observation,” Chris Beardmore, CEO & Co-founder of Anova Enterprises, said. These trials focused on the response of individual patients, called “N=1” clinical studies, attempt to determine what makes a specific patient’s disease unique, and then uses that information to design treatment, said Beardmore. “In cancer, for example, there can be multiple omic factors (e.g., gene, protein or metabolome),” Beardmore said. “Physicians and researchers would recommend a best treatment or combination of treatments for different combinations of these factors.”

Get Studies Organized Before FSFV

Not enough trial sponsors and CROs get everything in place for first-subject-first-visit (FSFV) before starting to schedule visits and see subjects, argued Janet Lewis, RN, CCRP, a consultant at J. Lewis Consultants. “I’ve heard so many times that the contract is holding things up, but it might be something else, or a lot of different things. The protocol might be changing, or training access might be delayed, or visit kits have not been received, or the EDC system might not be ready so source documents cannot be created, or the randomization system might not be accessible, or point people might have not been identified, or study IP might be delayed, or everyone’s contact information might not be available to everyone, or paper or eDiaries might not be ready. That’s just a recipe for chaos,” said Lewis. “Everyone needs to be communicating — finding the problems and deciding how to fix them. Unless you work all sides of the equation to figure out all the possible hold ups, you are not going to solve this problem. Everyone will just be playing catch up, spinning their wheels, and pointing fingers at each other. That’s a bad way for a ‘team’ to start off.”

Reward Investigators For Study Oversight

Anita Bowler, Finance Operations Manager at the University of Utah Huntsman Cancer Institute, believes the clinical research enterprise needs to recognize the time principal investigators (PIs) spend overseeing clinical studies. “Study budgets often ignore or understate the time PIs spend on a study,” Bowler said. “And they do not explicitly recognize the PI’s contributions. . . Academic institutions like Huntsman Cancer Institute track each physician’s earned hours of work ‘effort’ for government grants, performance assessment, work assignments, and compensation. PIs find it frustrating and demotivating when the effort they make on a clinical study is understated or misunderstood.”

Getting A Proper Handle On Adverse Events

SEC Clinical Consulting’s S. Eric Ceh didn’t hold anything back when discussing the need for clinical research sites to properly track and document adverse events (AEs). “You would not believe how much time I waste monitoring sites and resolving queries with study coordinators,” said Ceh. “. . . Sites should prepare for a study visit by reviewing the subject’s interim medical records to identify new AEs and identifying ongoing AEs from the previous visit notes or worksheet to discuss with the subject during the visit. The study coordinator should clearly document these assessments in the visit notes or worksheet so the site monitor has a complete picture of every AE.”

Face Up To The Need For Part 11 Compliance

Part 11 Compliance is the FDA’s criteria for considering electronic records, signatures, and handwritten signatures to electronic records to be trustworthy and reliable. According to Michelle Grienauer, a Senior Regulatory Attorney at Kinetiq (the consulting division of Quorum Review IRB), clinical research sites need to recognize that certain electronic systems used in clinical investigations are subject to FDA Part 11 and require validation to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. “Part 11 validation is a lot of work,” said Grienauer. “If you’re building your own system and your IT team does not have the expertise, you can bring in an experienced consultant, but he or she will still need a lot of information from your people.”

Time For Patients To Own Their Own Data

Given the new privacy laws in Europe and California, Darshan Kulkarni, Vice President of Regulatory Strategy and Policy at Synchrogenix, believes it’s about time patients own their own data. “The whole world seems to be restructuring itself around data, and that’s certainly true for patient data, especially including genetic data connected to physiological biomarkers and health conditions,” said Kulkarni. “How fair is it to use a patient’s data to create a new product and then sell that product back to the patient at whatever price the market might bear?”

Medicare Advantage: A Disadvantage For Clinical Research Participants

Kelly Willenberg, Manager of Kelly Willenberg & Associates, says it can get convoluted when a clinical trial site enrolls a Medicare Advantage patient. “If you enroll a study participant who is in a Medicare Advantage plan, routine study costs are supposed to be covered by his or her Advantage plan in an IDE device study, but, if it is an NDA drug study, the participant must be converted over to traditional Medicare,” said Willenberg. “If the conversion is not done correctly, the participant can be left holding the bag.”