By Ed Miseta, Chief Editor, Clinical Leader
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As an organization, clinical trial solution provider DrugDev has placed a focus on making the lives of site personnel easier. That mentality of servicing the site has primarily focused on interactions between sponsors and CROs and how those interactions can be improved. Contracts, payments, and management are key issues for all involved in these interactions. With its recent acquisition of SecureConsent, the company is now poised to facilitate better interactions between investigators and patients as well.
“For the last few years, we have been looking into how we can help sites with those patient interactions,” says Brett Kleger, chief commercial officer for DrugDev. “There are two reasons for this. The first is we have a large network of sites and we survey these sites quite often. Those sites have been asking for tools that will help them to better engage with patients. They don’t want more apps. They want tools that can truly make their lives easier. Second, our advisory board, which is primarily made up of individuals from large pharma companies, has told us eConsent is something that is very high on their list of interests.”
eConsent Leads To Better Comprehension
According to Kleger, patient comprehension is an important aspect of eConsent, as it is the first time many sites and sponsors will have any interaction with a patient. But more importantly, it is vital that patients understand what they are consenting to. Asking a patient to read a technical, 75-page document prior to taking part in a trial does not do much to educate the patient on the trial or make them aware of what they should expect. There will certainly be patients who flip to the last page and sign the document without ever reading a word of it.
“Patients need a consent process that really helps them to understand what the trial is really all about,” states Kleger. “With all of the interactions we have with sites, we felt it was important to improve that process in order to create better interactions with patients.”
eConsent solutions will also be a critical step in helping pharma to solve its patient recruitment and retention problem. Not only will many patients not bother to read a lengthy legal document, it is generally presented to them at a time when they may have just been informed they have a life-changing disease. If patients do not know what they are consenting to, odds are questionable they will continue to partake in the study.
“With eConsent we are not reducing the information presented to patients, we are simply presenting it to them in a way that makes it easier for them to understand,” says Kleger. “That presentation may include pictures, video, and, of course, text. They will also be able to click on links in order to get more detailed legal information. We have to do a better job of helping patients understand what they are getting into, which will also reduce the potential for patient dropout in trials. We have found dropout rates are considerably lower when patients know what they are signing up for. ”
While patient understanding is important, improper consent can also create data issues down the road. For example, data can be invalidated if a patient didn’t re-consent after a study protocol amendment occurred. With eConsent, companies can always make sure the right version of the consent form has been signed. Electronic solutions can also assist in reducing paper-based errors.
Bringing eConsent In-House
In an effort to better provide this service to clients, DrugDev announced this week it was acquiring eConsent provider SecureConsent. The DrugDev eConsent team will continue to operate out of its headquarters near Washington DC. Co-founder Eric Delente will assume leadership and growth responsibilities for DrugDev’s entire portfolio of patient solutions.
Prior to the acquisition, DrugDev had already been offering clients the SecureConsent solution. “We have been partnering with SecureConsent for about two years,” says Kleger. “As a result, we already had a lot of the plumbing and integration components in place. What we have done is simply made them a part of the team.”
For years DrugDev has been focused on investigators and interactions with sponsors and CROs. Kleger notes this acquisition marks the company’s official entry into a new arena, which is helping investigators work with patients. The patient solutions division headed up by Delente will also include patient reminders and apps designed to deliver documents to patients.