Info & Opinion
April 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
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CRF has noticed a funny thing about patients filling out clinical trial diaries in India and eastern Europe. The data are immaculate. The patients are highly compliant, to the tune of doing 95-98 percent of what they’re supposed to.
Rachael King, the new CEO at CRF, isn’t sure what cultural factors explain that performance. “It’s very hard to work out why,” she says. “I do wonder if it’s a more obedient culture than the U.K. or America. We don’t wait for the light to turn green.”
King is a U.K.-based, former pharmacologist who previously ran CRF’s European and Asian operations. Before joining the company, she spent 12 years at Pfizer, on both basic research and as a cultural emissary between the biologists and the IT types. King also put in a few years at etrials and the companies from which it was formed. So she’s uniquely prepared to run a technology firm with a European headquarters in Helsinki, Finland and U.S. headquarters in Waltham, Mass.
King is energized about the new year. “We are very, very optimistic about 2009,” she says. The company has approximately 100 employees, and is adding more. “We added four new clients in December,” King says. “And that’s considered a short month.” On the down side, she notes, some biotech companies are facing financially-driven delays.
As King assesses the landscape for electronic patient reported outcomes (ePRO), she is especially heartened by the use of diaries in brand new therapeutic areas (cosmetics, say, or dermatology), and for purposes other than gathering primary and secondary efficacy data. Given the expense of configuring and deploying the diary devices, she acknowledges that the return on investment calculations for such studies can be difficult.
But some forward-looking sponsors are looking at the ePRO data as being crucial to support intellectual property interests and marketing objectives. “I see a focus on making sure [sponsors] are collecting the right information to maximize their patent opportunity and labeling claim opportunity,” says King. “In my previous experience, I hardly ever saw a diary that wasn’t [collecting] primary or secondary efficacy. I see an emphasis on good quality data as opposed to quantities of data. That’s a good thing.”
An example from a recent CRF project: an ediary for a pediatric vaccine. Antibody titers, obviously, were used to establish if the vaccine worked. But parents may also be interested in minor side effects associated with the injections. Pediatricians and sponsors are starting to want to differentiate products on those grounds, and electronic diaries can provide the scientific ballast for such market positioning.
Another client story, King says, illustrates the company’s ability to deliver rapid turnaround for projects that are anything but cut and dried. Late in November, 2008, a sponsor approached CRF. The study start was ... in December, 2008. The devices themselves would have to be deployed across several European countries and, by the way, 10 different regions in India, each with its own language. A few days later, CRF was standing in front of the investigators. The trial launched on time.
The linguistic aspects of the Indian diaries were especially tricky. “It’s not just a case of getting the translation. You have to have the right font,” King says. “They have a completely different alphabet in different areas.”
Which points to an ongoing issue: the ediary industry’s slowly diminishing dependence on Palm as a hardware supplier. On similar projects for the well-regarded but aging Palm platform, CRF had been forced to start from scratch and custom-design various fonts for a not-so-rare Erdu or Hindi dialect. On Windows, it’s a much simpler matter of simply licensing the appropriate font for a nominal cost.
There is uncertainty about Palm both as a business (facing unprecedented competition from Apple, RIM, Google, and Microsoft) and about the firm’s operating system. King says that CRF and its competitors have all already had occasional difficulties finding devices for ongoing trials. New trials are an added worry. “We can’t purchase Treos any more,” she says of a once market-leading Palm phone. “We have struggled to source them. We are told the E2 is also going to be withdrawn.”
CRF now has four trials live with Windows phones. “It’s out in the field and looking very stable,” she says of the Microsoft technology. The same software to create the diary screens on Palm is being used to generate the user experience on Windows. “Not just in the U.S. and Europe. The trials are really going well.”
The ediary market has always been helped and hindered by regulatory concerns. Of late, the FDA comments at conferences seem a bit more anti-diary than in the past, at least in this reporter’s unscientific sample. But King says the advantages of electronic diaries are becoming less and less challenged in the sponsor community. Despite prodigious quantities of paper diaries still being used, she says, the message about the diaries is gaining traction. This page on the CRF website notes that half of the company’s projects have more than 500 patients.
And while some clinical types may fret about the usability of the devices, especially for elderly patients, King says that CRF has been doing intensive analysis of compliance across all its trials. No matter what the demographic group using the device, she says, “we see practically no difference. As long as you keep it simple and easy to understand, there really isn’t a fear factor.”
Even in a study of terminally ill patients, she notes, using the devices was not a burden. Says King somberly: “We’ve seen good compliance from patients who must be in severe pain. A number of these people feel they’re giving something back. They can help the future for other people.”