Scientifically reviewed by Joshua D Grill, Ph.D.

A Physician's Guide to Clinical Trial Access

The world's aged population is growing at an unprecedented rate.  

By 2050, one in six people will be over 65 years old. Increasingly, the unique concerns of geriatrics are dominating the field of neurology. Many geriatric neurologists treat patients with comorbidities and neurological disorders — and the numbers are grim reading.

  • Dementia kills more seniors than breast and prostate cancers combined. 
  • 50% of dementia patients suffer from musculoskeletal, genitourinary, or ENT (ear, nose, & throat) comorbidities 
  • By 2030, forecasts indicate the YLD (estimated years of healthy life lost due to disability) will rise by 38% for seniors with Alzheimer's and other types of dementia. 
  • By 2050, the number of Americans living with Alzheimer's is expected to reach 14 million.
  • By 2050, dementias will cost America $1.1 trillion annually. 

The social and economic costs of cognitive disorders are tremendous. Because comorbidities can exacerbate neurological disorders, physicians face challenges on multiple fronts. For example, the COVID-19 pandemic complicated situations and endangered many geriatric patients. A 2020 study shows that those with comorbidities face a greater risk of immune dysfunction and death from COVID-19. Patients with cognitive disorders faced greater challenges receiving care due to safer at home and social distancing practices. 

So what can be done to help these patients with neurologic disease? Existing established treatments such as Aricept have been on the market for over 25 years, and with rising elderly numbers, new therapeutic options are sorely needed.

 

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Why You Should Participate in Clinical Trials 

While the barriers to participation are many, incentives exist to increase the rate of doctor participation in clinical trials. 

Advancing Medical Innovation

When you graduated from medical school, the world was your oyster. You are thrilled at the idea of advancing the cause of healing-oriented medicine. Today, you remain equally committed to evidence-based healthcare.

Without clinical trials, there can be no improvements in treatment options. And without doctors like you referring patients, clinical trials are delayed or may even fail.

If improving patient care options is important to you, contributing to clinical trials can be a viable option for you. Physician engagement is critical to healthcare innovation. By sharing your expertise, you'll influence medical research and practice trajectory for years to come.

 

The Ability to Offer New Care Options for Patients

Participating in clinical trials offers your patients the opportunity to contribute to discovering solutions for diseases and to potentially gain access to therapies before they are available to the general public. Through clinical trials, you also gain experience with the next generation of drugs so you can be prepared as the tide swells.  

From a practical standpoint, the benefits are apparent. By referring neurology patients to clinical trials or participating in one yourself, you offer new care options that can result in meaningful outcomes. 

These care options also allow you to reinforce your professional reputation and differentiate your practice from your competitors.  

Five years ago, the efficacy of immunotherapies in cancer was unknown. Today, it's a promising cancer treatment. Immunology continues to be a game-changer for rare cancers like Merkel cell carcinoma — one man is cancer-free because of it. Participating in clinical trials allowed him access to upcoming state-of-the-art therapies and care options before they were approved.  

Immunotherapy drugs have revolutionized lung cancer treatment. In fact, experts at the Yale  Cancer Center say they should be the first option given to lung cancer patients. For former President Carter, these drugs continue to keep him in complete remission for Stage 4  melanoma. As demonstrated, clinical trials can be a life-changing option for your patients.

 

Reliable Income To Offset Unpredictable Reimbursement From Insurance  Companies 

To physicians, the topic of reimbursement is a sensitive one. And, certainly, there are two sides to the coin. Both patients and doctors agree that healthcare costs are too high — much of it precipitated by administrative complexity, prescription pricing errors, and failed care delivery.

According to a 2019 JAMA study, the American medical industry wastes between $760 to $935 billion annually due to errors and inefficiency. That's roughly 25% of the $3.8 trillion the United States spends on healthcare each year.  

While healthcare costs increase for patients, physicians face their own challenges. Increasingly, patients who visit in-network hospitals get hit with surprise bills from out-of-network doctors at these facilities. According to a study, one in three patients says they have received a surprise bill in the past two years, with 30% indicating the amount was over $1000. 

Meanwhile, you have options. 

By participating in clinical trials, you'll be compensated in a way that complies with federal FMV (fair market value) guidelines, thus offsetting unpredictable reimbursement from insurance companies. 

 

 

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The Perceived Barriers to Physician Participation in Clinical Trials 

Scientific, staffing, and regulatory requirements

Conducting clinical trials carries numerous obligations. Trial protocols are created by sponsors or study investigators to explain the study purpose and define explicit plans that must be followed consistently to ensure rigor and reproducibility. Institutional review boards and regulatory bodies are particularly interested in ensuring that participation risks are minimized while benefits are maximized, and that participants' interests are protected in trials. Together, these requirements may make participating as an investigator a daunting proposition for clinicians.

 

Applicability and the Enthusiasm Gap 

Generating accurate results is vital for any trial. In Phase 3 trials, the goal is to assess efficacy, the last stage in a lengthy process to bring new drugs to market. If results are not verified, the loss of time and resources extends from previous trials to missed opportunities for pursuing more viable options. 

Certainly, physicians have little desire to participate in trials that study irrelevant or inapplicable research topics. Indeed, there's some data questioning the efforts of clinical research in addressing the burden of various diseases. 

That said, the greater challenge for physicians lies in the fact that many distrust the results of trials altogether. Although the Food and Drug Administration Amendments Act (FDAAA) requires trial sponsors to record all trial results, many do not.  

In 2018, a federal judge closed a loophole that allowed trial sponsors to avoid reporting all trial results on ClinicalTrials.gov. In cases of non-compliance, the FDA can institute fines of up to $10,000 a day and reclaim previously apportioned federal grants. 

However, the FDA has yet to impose fines or penalties on non-compliant trial sponsors. In fact, 30 recipients of NIH grants have missed all of their reporting deadlines since late 2019  and haven't transcribed any results for 67% of their trials to ClinicalTrials.gov. This lack of transparency can create a conflict for the physician and make it impossible to provide concrete answers about a drug's efficacy. 

The exclusion of under-represented populations also exacerbates distrust in the results.  If trial participants aren't representative of the general population affected by a disease, questions arise about whether enough high-risk patients were involved.

 

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The Level of Complexity in Addressing Patient Concerns  

Many patients face logistical and financial challenges and may be concerned about the risks of participating in trials:

  • In a study involving 678 respondents, 13.9% decided not to participate after reviewing the informed consent form. They based their decision on the possibility of adverse effects (28.7%) and too many study visits (24.5%).
    • Informed consent is a key part of the patient education process. Trials are not without risk, and it's important patients are educated about both the risks and potential benefits of a given trial.
  • There is substantial fear about the efficacy of investigational drugs and the likelihood of being given a placebo. 
    • Randomization and placebo controls remain the gold standard to remove bias and ensure rigor. Many trials include open-label extensions, offering access to active therapy to all participants at the conclusion of the blinded portions of studies.
  • Prohibitive travel costs can also exert downward pressure on patient participation. In a  University of Texas trial involving 105 patients, 50% lived more than 300 miles from the clinic. The median cost of travel and incidental needs was $985, which was a  considerable outlay. 
    • Time commitment, including travel, are important considerations for patients and caregivers. Though research sites may not be as conveniently located as visiting one’s doctor, many trials offer participants financial compensation and/or coverage for travel expenses.

 

The Lack of Financial and Non-Financial Incentives 

Compensation (or the lack thereof) is a key barrier to trial participation. Managing teams of research coordinators and ensuring that trials follow GCP principles is monumental. However, compensation often fails to keep pace because trial sponsors fear running afoul of FMV (fair market value) laws. 

Further, many physicians do not receive compensation for strictly academic responsibilities related to trial participation.

 

The Lack of Time and Resources 

As a physician, you likely feel that you already have too much desk-work. Keeping up with patient messaging, handling prescription refills, reviewing lab reports, updating EHRs, and following up on denied claims, consumes an inordinate amount of time (even with the aid of scribes). 

Add the time-spend with that of a clinical trial, and the prospect of participating declines. In the 2018 Medical Economics Physicians Report, almost 80% of doctors said that paperwork and administrative burdens were their top challenges. The 2019 Medical Economics Physicians Report shared a similar finding: the principal reason for stalled private practice growth was the increased time spent on uncompensated tasks. 

Many physicians find themselves spending 12% of their time with patients and 40% mired in administrative tasks. So, the fear that trial participation will inundate doctors with increased paperwork is real.

 

The Lack of Access to Trial Information 

According to the Tufts Center for the Study of Drug Development, 54% of doctors lack access to clinical trial info, 48% don't know where to refer patients, and 33% don't have time to learn about ongoing trials in their area.

Comfort with trials may also be lacking;40% of physicians never received clinical research training in medical school, and 39% have never attended clinical research–related lectures. Combining a lack of training and access to trial information is a significant barrier to physician trial participation. 

 

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How You Can Participate

Prior to talking about participation, it's important to note that while clinical trials are not perfect in their design or without risk, these emerging therapies do hold the promise of improved outcomes while charting a course towards finding life-changing cures. For these reasons, we can't stress enough the importance of active physician involvement in clinical research.

There are several options to facilitate your participation in clinical trials. Whichever option you choose, encourage your patients to become active participants by educating them on these care options and the important steps associated with the informed consent process.

Offer an empathetic ear and help educate them on the difference between clinical care and research. You'll also want to reassure them that participation in a clinical trial won't reduce their access to palliative treatments for symptom management. Clinicians can also communicate that participating in a trial will not affect the quality or consistency of care they receive from their physician. In fact, consistent communication with the provider through the course of the trial will be especially important for existing provider-patient relationships.

Finally, share some good news. Although COVID-19 has perpetrated suffering and death, it has also facilitated the rise of a more transparent, inclusive trial process. For the first time in research history, four manufacturers provided real-time sharing of their vaccine trial protocols during Phase 3 trials in late 2020. Experts are saying that this is a "historic opportunity for the democratization of science." 

Below, we offer four options for assisting your patients as they navigate their research journey. 

Ways to access clinical trials for your patients, and level of complexity
Breakdown
Become a Principal Investigator

Extremely High Clinical Interaction

Potential Monetary Investment

Jump to Details
  • Run trial yourself or through a sponsor
  • Require a research facility site
  • Significant start-up costs if self-running trial
  • Need to organize trial registration 
  • May need to organize site management
Become a Sub-investigator

High Clinical Interaction

Jump to Details
  • Participate in trial-related functions
  • Act as clinical research coordinator (CRC)
  • May require CRC certification
  • Daily involvement overseeing operations, iterating with patients, etc.
Refer Your Patients to Publicly Available Sources

Minimal Clinical Interaction

Jump to Details
  • Obtain a list of clinical trial sources
  • Encourage patients to apply 
  • More of hands-off referral option - patients tend not to be as eager to participate
Patient/Clinical Trial Matching Software
(SiteRx-Type Solution)

Minimal Clinical Interaction

Jump to Details
  • Enroll patients in clinical trials via HIPAA-compliant database
  • Active role in encouraging patients to participate in clinical trials - higher participation success rate as patients trust their doctor

Become a Principal Investigator (PI) 

What it entails:

You can either sponsor a trial yourself or work with a sponsor. The latter can be a drug manufacturer, community health institution, or (ARO) academic research organization. If you are the sponsor, you'll serve as the sponsor-investigator. You can choose your own site or work with an SMO (site management organization) for a research facility. 

A word of caution: while some SMOs provide full management services for clinical trials,  others do not. 

Finally, if you'd like to mitigate start-up and operational costs (which will be substantial), we advise working with a sponsor.  

How to get started:

  • Become familiarized with the rules and regulations of clinical trials.
  • Determine whether your existing practice site can accommodate a clinical trial. 
  • Provide your contact information to medical research institutions. For example, UBC (an organization that works with biotech institutions to ensure medical products' efficacy) recruits physicians to conduct clinical trials in key therapeutic areas.
  • Learn why and how to register your clinical trial, which is critical if you'd like to obtain IRB (institutional review board) approval for your site. 
  • Complete the needed forms to serve as a PI, such as Form FDA 1572, the investigational drug brochure (IDB), protocol (and amendments) page, curriculum vitae, confidential disclosure 
  • Have a representative from the research institute you are working with inspect your site.
  • If working with a sponsor, be prepared to make travel arrangements to the clinical trial site. Most trials for investigational drugs are 100% funded by pharmaceutical organizations or drug manufacturers. Note that you'll still have to sign the necessary forms and include your qualifications' curriculum vitae. 
  • Consider finding a mentor to help in the training process associated with clinical trials.

Become a Sub-investigator

What it entails: 

A sub-investigator is any clinical trial associate or team member who performs trial-related functions. Sub-investigators assist the principal investigator in conducting a trial according to GCP principles (Good Clinical Practice). 

A critical sub-investigator role is that of a clinical research coordinator (CRO). [Note, however, that not all sub-investigators are CROs].  

A CRO oversees daily operations, interacts with participants, sets up experiments,  administers drugs, documents procedures, and participates in all enrollment and clinical operations. Most of all, the sub-investigator is responsible for ensuring compliance with all federal and state regulations. 

If a principal investigator is a non-physician, the sub-investigator must be a qualified physician who can make all trial-related decisions. 

How to get started: 

  • At a minimum, a sub-investigator should possess a four-year bachelor's degree in chemistry, biology, or a science-related field. 
  • Some sponsors require CROs who serve as sub-investigators to have a master's degree in clinical trial research and CRC certification
  • Nurses can also become CROs if they earn CRC certification.
  • Consider finding a mentor to help in the training process associated with clinical trials.

 

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Refer Your Patients to Publicly Available Sources 

What it entails:

If you've never broached the subject of participating in clinical trials, having an empathetic dialogue with patients is critical.  

How to get started:

  • Use a private, quiet, and relaxing environment. 
  • Encourage attendance by family members or home care aides to support your patient.
  • Explain your patient's diagnosis and prognosis. 
  • Set aside time for questions, and listen to concerns without interrupting. 
  • Gently broach the topic of participating in a clinical trial. Talk about the benefits of joining, and carefully discuss the meaning of informed consent. Emphasize that trial participation is voluntary, and participants can opt-out at any time. 
  • Offer resources for participating in a trial (see below). 

Online sources of clinical trials for patients: 

  • Use the search feature at ClinicalTrials.gov to find public and privately funded trials in the United States and worldwide. 
  • Find clinical trial opportunities at the National Institutes of Health headquarters in Bethesda, Maryland. The NIH also sponsors COVID-19 trials. 
  • For geriatric patients with neurological conditions, try the NINDS search feature (National Institute of Neurological Disorders and Stroke). 
  • The National Cancer Institute also sponsors cancer trials. Patients can indicate cancer type, age, and zip code in text-input fields to identify suitable trials on the website. 
  • The Mayo Clinic site features active trials recruiting patients and also those that are accepting healthy participants. 
  • If patients find travel and lodging costs prohibitive, the Lazarex Cancer Foundation can help. 


Using HIPAA-Compliant Software to Refer Patients to Clinical Trials

Participating in clinical trials isn't your only option for delivering best-in-class care for your patients. You can also refer patients to clinical trials using HIPAA-compliant technology to enroll them. 

Your help can be profound. Studies show that patients look to their doctors for information on clinical trials. In a 2017 study involving 11,719 respondents, 94.3% believed that it was important for their physicians to be aware of trials underway in their communities. 

In another 2017 trial of 11,545 patients, 92.9% say they are comfortable collaborating with their doctors and having their health records evaluated for a suitable clinical trial. More than any other demographic, 70.6% of seniors overwhelmingly prefer learning about trial opportunities from their own physicians rather than from other sources.

Want Assistance?

HIPAA-compliant technology platforms like SiteRx represent the next frontier of transformative healthcare, allowing you to refer patients to leading-edge clinical trials in your region. SiteRx integrates seamlessly with your EHR and automatically matches your patients to clinical trials in your area. Learn more by requesting a demo today.

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