Will 21st Century Cures Modernize Drug Discovery? Part 2 – Issues & Solutions

By Ed Miseta, Chief Editor, Clinical Leader

I recently had the opportunity to attend a dinner discussion in Washington DC, attended by many industry executives and dignitaries, to discuss 21st Century Cures. In part 1 of this article, I discussed some of the challenges the industry faces. In this article, the focus is on issues with physician and patient involvement in trials, possible remedies, and hopes/concerns regarding the legislation.

Physician Involvement Is A Roadblock

Clinical trials are one of the pain points in the drug development process. Even in this age of the Internet, email, and social media, recruitment remains a challenge, and is a big part of the 21st Century Cures initiative. Why does recruitment and physician participation remain a challenge for many pharma companies?

Several attendees voiced their opinion on this subject, noting physicians in the U.S. may be part of the problem of low clinical trial participation rates. Part of the solution may involve going directly to patients and asking them to step up and be part of the solution. Unfortunately, patients tend to be loyal to their physicians, and only 5 percent of physicians in the U.S. are reportedly running clinical trials. Even if the industry reaches out to patients, many of them will resist leaving their physicians. This disconnect may prevent the awareness of clinical trials (and the benefits they serve) from getting out.

“In between every trial and every patient is a physician,” noted one attendee. “One of the problems I see is that there is no incentive for physicians to get involved in a trial. It’s difficult, it’s cumbersome, and they get no reward for doing it. The industry could greatly benefit from understanding what it will take to get doctors involved in promoting and carrying out trials.”

Many pharma companies and CROs are certainly getting more involved in developing networks of physicians who want to run trials and understanding their specific expertise. With precision/personalized medicine, we may actually see more physicians requesting additional trials for the same therapeutic area, so as to have more options to offer patients. “If your physician doesn’t do clinical trials, it may be time to change physicians,” said one attendee. “Other stakeholders (friends and family) can also impact participation, so we need to be talking to everyone about trials, not just patients.”

Fixing this problem will obviously take more than government involvement. Incentivizing physicians, or at the very least removing disincentives to trial participation, will help generate greater interest. For patients and other stakeholders, better education may be the key. In part 2 of this article, I will discuss recommendations on how to achieve this, as well as why participants in this discussion were both hopeful and discouraged by the legislation being proposed. 

Rewards And Education Are Key

Incentivizing physicians to take part in clinical trials will not be an easy task. Physicians, primary care doctors especially, often seem to be overwhelmed with their daily responsibilities. Their office systems, even with electronic medical records, are often just not up to the task. To get them to participate in clinical research, they will likely need better tools. Incentives may have to be a part of the solution as well. “Right now physicians only make money by seeing patients,” said one attendee. “Anything the industry does to take away from that will only cost them money.”

The question then becomes whether we are able to change this paradigm. If doctors are incentivized to care for patients, but not to do research, can they be convinced to get involved in trials, if they’re offered a monetary reward? Can a payment serve as an incentive to someone who is likely already highly compensated? Even if payments are the right reward, what should the amount of payment be, and how should they be administered?

On the patient side, payment for trial participation has also been discussed as a method of increasing recruitment rates. Indeed, there may not be enough incentives in place to keep patients in long-term studies. One participant noted studies where patients are expected to fill out on-line questionnaires that might take hours to complete. For this effort, they are paid nothing (or close to nothing). Some studies are required by the FDA, but the agency does not require any compensation to be paid to the patients.

Is Compensation The Solution?

But is compensation the gold standard for incentives for physicians or patients? Not everyone in the group seemed to think so. The belief is that while a financial incentive is nice, we would first have to get buy-in for the study itself. A patient would have to be aware of a study, believe in the benefits of it, and find it easy to participate. Only then would they consider the financial incentives of doing so.

However, several attendees felt better education may be the solution. There are patients who assume if they take part in a study, they may receive a placebo that will have no effect on their condition. In fact, in many studies the comparator is standard of care or optimal care. If patients understand they are not going to get an inactive agent, they have a greater interest in trial participation.

To garner greater physician participation, the best place to start might be in removing the disincentives that exist. This includes the administrative burden, the distraction, and the costly expenditure of time and effort that accrue from trial participation. Financial compensation would only help to offset the cost to the physician of being able to see fewer patients. Most doctors enter the profession because of their desire to help patients. If they can be convinced their clinical participation will have an impact on the future of medicine that may do more good than financial payments in recruiting greater numbers of them.

How this effort would look is also open to debate. One participant doubted the effectiveness of trying to reach out to individual physicians across the country. The solution may well require some type of pre-established network, such as a Patient-Powered Research Network (PPRN), accountable care organization, or some other integrated delivery system. These groups may be better positioned to undertake the effort since they have an infrastructure in place, including adequate personnel and electronic health records. Going to more than 900,000 individual doctors (in the U.S. alone) seems impractical.

Here again, education can make a difference. One participant noted that, while in school and in residence, medical students receive no (or minimal) experience in clinical trial conduct. Many simply learn from jumping in and doing it, which is not the optimal way for us to engage a large number of physicians to learn the process. There may also be some animosity to learning trials, since some physicians likely consider this to be a non-vital aspect of the profession. 

If one thing is clear, it’s that there will be no easy fix to the challenges the industry faces in speeding up the delivery of new drugs. While some solutions will require more discussion and interaction between industry stakeholders, the industry should be encouraged by government efforts to expedite the approval process and increase much needed funding.