Triple-blind (i.e., triple-masking) studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention, and (c) the individual(s) who assess the outcomes.

A single-blind study masks the subjects from knowing which study treatment, if any, they are receiving. A double-blind study blinds both the subjects as well as the researchers to the treatment allocation.

During the course of an experiment, a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them. Unblinding that occurs before the conclusion of a study is a source of experimental error, as the bias that was eliminated by blinding is re-introduced.

A clinical trial is one of two main types of clinical studies. A clinical trial tests (or tries out) an intervention — a potential drug, medical device, activity, or procedure — in people. It also is referred to as an interventional clinical study.

Clinical research is an attractive industry for researchers in India because it foresees enormous growth and job opportunities not only for trained medical, pharmaceutical, and paramedical professionals but also for project management staff, regulatory authorities, government, and the society at large.

On average, you can expect to be paid anywhere from $50-$300 per day to participate in a study. The total amount you will be paid will depend on the length of the trial and the treatment or procedures performed.

Each clinical trial has its own benefits and risks. But for the most part, clinical trials (other than phase 0) have some of the same potential benefits: You might help others who have the same disease by helping to advance cancer research. You could get a treatment that’s not available outside of the trial.

Here’s Where to Find the Clinical-Trial Cash

1. Oral Medication Trial in Atlanta, Georgia.
2. Inpatient Trial in Dallas, Texas.
3. Injection Device Trial in Baltimore, Maryland.
4. Young, Postmenopausal Women Sought in Madison, Wisconsin.
5. Medical Device Trial in Evansville, Indiana.
6. Binge Eating Study in Boston, Massachusetts.

What are the Potential Risks of a Clinical Trial?

• The new treatment may cause serious side effects or be uncomfortable.
• The new treatment may not work, or it may not be better than the standard treatment.

With reports of at least 153 treatmentrelated deaths in clinical trials in the last four years, it’s critical that FDA revise its informed consent regulations to increase protection of these participants.

The sponsor of the study (such as the government, drug makers or technology companies) typically pays for all costs involved with a clinical research study. This includes supplying the new treatment, as well as any special testing, possible extra physician visits, and research costs involved in the clinical studies.

The average cost of phase 1, 2, and 3 clinical trials across therapeutic areas is around $4, 13, and 20 million respectively. Pivotal (phase 3) studies for new drugs approved by the Food and Drug Administration (FDA) of the United States cost a median of $41,117 per patient.

For the 225 individual trials reviewed, the study concluded the median cost of each was $19 million, with an interquartile range (IQR) of $12 million to $33 million. The estimated median cost for a pivotal clinical trial came out to $48 million, with an IQR of $20 million to $102 million.

Federal law requires most insurance companies to cover “routine patient care costs” incurred during an approved clinical trial. These costs include routine blood and radiology tests that you would have had as part of your cancer care even if you weren’t on the trial.

Types of Clinical Trials. There are several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials, and natural history studies.

Special rules apply for people enrolled in Medicare-managed care plans. These plans are also called Medicare Advantage plans. If you are in one of these plans, traditional Medicare covers routine costs of the clinical trial.

Yes. Medicare covers the costs of participating in many cancer treatment trials, whether you are in a Medicare + Choice Plan or in the Original Medicare Plan. You may take part in a trial outside of your Medicare + Choice Plan.

Trials that meet these qualifying criteria will receive Medicare coverage of their associated routine costs. Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial’s lead principal investigator certifies that the trial meets the criteria.

Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of …

Routine costs means items and services delivered to the member that are consistent with and typically covered by the Contract for a Member who is not enrolled in a clinical trial.

There are four parts of Medicare: Part A, Part B, Part C, and Part D.

• Part A provides inpatient/hospital coverage.
• Part B provides outpatient/medical coverage.
• Part C offers an alternate way to receive your Medicare benefits (see below for more information).
• Part D provides prescription drug coverage.

Just like with the FDA’s existing Expanded Access program, insurance companies and taxpayer-funded healthcare programs like Medicaid or Medicare are not required to cover the cost of investigational treatments, but they may choose to do so.

There are two options for treating patients with an unapproved test article outside of a clinical trial. One option is Expanded Access, which is categorized into single patient, intermediate group, and large group. The other option is Right to Try which is specifically for single patient.

According to the law, an investigational drug is eligible if it has completed a phase 1 trial and is in active development, has not been approved by the FDA for any use, and is the subject of an investigational new drug application filed with the FDA.

The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs. An eligible patient is a patient who has: Been diagnosed with a life-threatening disease or condition.

Some insurance companies have covered the costs of investigational treatments used by patients under state Right to Try laws, but others have not. Each patient’s cost situation will be different and determined by their individual insurance company or program and their own financial resources.

Jeff Stone

A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well experimental drugs work and whether they are safe to use.