Disruption in clinical trial procedures can be added to the list of changes that have occurred since the start of the pandemic in 2020. The clinical trial sites had always been the center of research, testing, and administering investigational drugs. But in accordance with rules surrounding physical distancing, eighty percent of all trial sites became off-limits.

Two years later, rather than revert to the centralized method of conducting clinical trials, Dr. Harsha Rajasimha, chairman of Jeeva Informatics Solutions, issued a press release stating that he had decided to continue along the path that had already been established. He was able to contribute enormously to this effort by relying on his experience in precision medicine, the genomics of cancer and rare diseases as well as digital therapeutics.

Dr. Harsha Rajasimha was mindful of the failure rate of clinical trials with patient dropout being a major cause. He outlined the advantages of conducting decentralized trials and described plans to expand their outreach. Dr. Rajasimha describes his goal as a ‘mission’ that will bring new perspectives and faster cures through the participation of patients in clinical research.

Clinical trials take many forms. One type of trial is called a double-blind trial. That means that neither the doctor nor the patient is told whether the patient is receiving the investigational drug or a placebo. Note that the opposite type of trial is called an “open-label” trial.

 A Personal Experience

Jeeva Informatics Solutions was founded by Dr. Rajasimha in 2013. There were two personal experiences in his life that influenced his decision to establish Jeeva. One was the loss of his child who was born with a rare disease. The second involved his brother’s chronic illness.

It has been Dr. Rajasimha’s goal to utilize his postdoctoral years at the National Institute of Health and the Food and Drug Administration to bring new drugs to patients with rare and common diseases who have no other options.

Jeeva hopes to reduce up to eighty percent of site visits through digital engagement and remote monitoring.

The Dropout Rate

The average dropout rate among clinical trial participants is thirty percent. Why do patients drop out of clinical trials? Or why is it difficult to meet planned patient enrollment?

 The reason given by the majority of patients is “inconvenience,” especially if frequent visits are required. Also, finances are often a problem. Although most sponsors reimburse patients for most out-of-pocket expenses, other costs may be applicable, such as unpaid time out of the office.

Jeeva is working towards improving unimpressive results.  Currently, eighty percent of clinical studies do not meet their completion date. Some trials have been delayed at least six months or longer. And approximately fifty percent of clinical study sites have little or no enrolled patients for their studies.

Racial and Ethnic Diversity

An article in Scientific America published a few years ago stated that almost forty percent of Americans at that time belonged to an ethnic or racial minority. However, patients who were enrolled in clinical trials were, at times, eighty or ninety percent white.

Problems exist because symptoms of heart disease, diabetes, and cancer vary among racial and ethnic minorities just as they do among the sexes. Therefore, since these diverse groups do not participate in most studies, clinicians do not know if the treatment that is being investigated will benefit all populations or what unknown side effects will emerge.

Other Options

Dr. Rajasimha described a project Jeeva has proposed to a major university here in the U.S. The study is a hybrid, decentralized study of the effect of food on academic performance. Eventually, 2,500 students will be enrolled over a five-year period.

The students will only visit the clinic once, as they are expected to generate the study’s data independently, including a record of their daily food intake. Jeeva will provide a mobile app to collect the data for three of the requisite reports.

Looking Forward

Judging the interest shown by investors (known collectively as ‘stakeholders’) and patients, Dr. Rajasimha believes that within a year, thirty to fifty percent of clinical trials will be fully decentralized or at a minimum, will be hybrids.

Jeeva is bringing medicine and vaccines to patients three times faster by digitizing repetitive tasks and reducing patients’ logistical burdens by over seventy percent. Its modular software platform expedites patient enrollment and engagement on browser-enabled mobile devices.

Conducting these trials while ensuring the safety of patients is of the utmost importance to stakeholders. Software that is developed for these projects is intended to establish patient recruitment and retention while still adhering to regulatory guidelines.

As the new process develops, Dr. Rajasimha believes that it will benefit patients and stakeholders and fulfill the goals set out for clinical trials as they were originally intended.

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