Legal Risks to Consider in Virtual Trials

It's been less than a year since Pfizer announced its plans to conduct the REMOTE trial, the first ever completely virtual clinical trial.

Since then, other virtual trials have surfaced such as the OARS trial conducted by Amp Orthopedics, that focuses on the safety of its nonthermal pulsed radio frequency technology to ameliorate pain from mild to moderate knee osteoarthritis. Trials on binge eating, diabetes, and sleep disorders are also being considered.

Benefits

The benefits to virtual trials seem endless: increased patient compliance; easier access for patients in remote areas or with limited transportation or time; lower withdrawal rate; increased responsiveness from both patients and investigators; increased cost effectiveness; and more reliable, better quality data.

And although most trials are not pure virtual trials now (trials completely done through mobile phones or web-based technology), according to Kai Peters, Partner at San Francisco based Gordon & Rees, all clinical trials may likely have some sort of virtual element in the near future.

"I think we will see elements of virtual clinical trials that really impact all clinical trials," said Peters. "For example, for patient reporting, the things that virtual clinical trials do in terms of patient reporting, keeping diaries, and real-time reporting, would just improve clinical trials and should be easier for patients as well. I also think that the element of sharing information will increase through virtual clinical trials, in both pure virtual clinical trials and all clinical trials, as the manner and method of doing this is better understood."

Thus, while many in the industry understand the basics of virtual clinical trials, the fundamentals surrounding areas such as legal risks may still be blurry.

Legal obstacles

Kai explained in an interview with Applied Clinical Trials, that although risks are always dependent on the specific company and trial, there are several general risks companies should consider when conducting a virtual trial. The first risk a company will face is with subject recruitment and informed consent. While it is imperative that the risks of a trial are explained adequately to a patient for all clinical trials, companies conducting a virtual trial need to take measures to ensure the patient understands both the pros and cons.

"Here, companies should consider disclosing non medical information like the fact that these are a novel form of conducting clinical trials," said Peters. "Because patients are not going in the traditional manner where they are sitting down with the doctor and talking about each point in detail, but instead are interacting online, companies have to be careful that all the risks and benefits are being communicated effectively."

For instance, Pfizer has aimed to ensure complete patient consent by asking potential subjects questions (online) after presenting risks or benefits about the trial to make sure they understood the information.

Particular risks involved in patient recruitment include off label promotion. If a clinical trial is being conducted for a new indication, the recruitment message and process needs to be carefully worded so that it does not accidentally fall under off-label promotion.

Another potential problem specific to virtual trials is confidentiality. Passing information and storing data online adds an increased risk of accidental disclosure of company or patient information. And, since patients are generally not seen face-to-face, companies need to have tighter identity verification.

Peters also noted that as subjects will be reporting adverse events in a more timely and faster manner in virtual trials, sponsors would need to make sure that they have an effective monitoring system to handle real-time reporting.

In addition, in agreements between sponsors and clinical trial sites, principal investigators, and vendors, it is important to closely scrutinize indemnification provisions, especially if different companies are involved. The agreements should address incidents specific to virtual trials such as technology breakdowns. Involvement of a physician is also important to maintain strong legal defenses.

Like any clinical trial, virtual trials need to be carefully planned, and comply with both state and federal laws. Despite the risks, Peters believes virtual trials will ultimately help speed up clinical development.

"I think virtual clinical trials will improve patient evaluation and will help bring new pharmaceutical and medical devices to market and that includes new indications for pharmaceuticals and medical devices. As you see more virtual clinical trials I think you will see a development in the regulatory and legal landscape and I think you will see better patient outcomes over the next five to 10 years," said Peters.