The human touch: Understanding HSP smooths way to clinical trials

Now that the average cost of bringing a new drug to market is $161 million to $2 billion, stakes are higher than ever for following regulations that might hasten clinical trial approval.

That’s partly why the ability to navigate human subject protection (HSP) rules has become so crucial in the pharma world. Not only are researchers challenged to recruit test subjects that fit study specifications, they must often jump through multiple hoops to meet FDA criteria ensuring human rights during participation.

It’s unclear what percentage of clinical trial applications are rejected each year, but the FDA reportedly found “objectionable conditions” at 2 percent of 644 clinical trials it investigated in 2013. Problems included falsification or submission of false information, lack of adverse events reporting, protocol violations, failure to protect the safety of patients and/or issues with oversight or informed consent.

Neither is Phase 1 approval a golden ticket. Only 70 percent of tested drugs make it through Phase 1 clinical studies, says the FDA, and only about one in 10 makes it through all three phases to gain FDA approval, according to another study.   

HSP issues have come to the forefront even more in recent years as U.S. pharma research increasingly takes place in developing countries; by 2012 the U.S. was already funding 40 percent (about $117 billion) of worldwide medical research.  

Many companies have addressed such increasingly complex ethical and administrative issues by forming their own independent review boards (IRBs) that register with the FDA and OHRP and serve to review and monitor biomedical research involving human subjects. Some use IRBs formed outside their companies. Others contract with a partner like Artcraft to help close the communication gap between site, sponsor and subject by handling recruitment, enrollment, compliance, adherence and retention. Artcraft can customize solutions from branding and training healthcare professionals and site staff to educating participants and caregivers about your study, using a comprehensive platform of print, tactile, and digital solutions at multiple touch points.

In general, the FDA wants proof of the following prior to approving clinical trials:

  • Procedures are consistent with sound research design and don’t unnecessarily expose participants to risk.
  • When possible, targeted procedures are already being performed on participants for diagnostic or treatment purposes.
  • Risks to participants are reasonable in relation to anticipated benefits and the importance of information gained.
  • Selection of participants is equitable given the purpose, setting, special problems and selection and recruitment criteria involved.
  • The data will be monitored following safety, privacy and confidentiality guidelines.
  • Additional safeguards are added per guidelines for potentially vulnerable participants such as children, prisoners, pregnant women, mentally disabled persons or economically or educationally disadvantaged persons. Almost always, one or two parents must give legal consent for their child to take part, and children 7 and older often must agree themselves.
  • Consent is documented for all participants or their legally authorized representatives, ensuring no one is coerced, language is understandable and no rights are waived.
  • The consent form doesn’t release the researcher, sponsor, institution or agents from liability for negligence.
  • A statement explains the purpose; time interval; description of procedures and whether they’re experimental; identification of risks and/or discomforts; identification of possible benefits to the participant or others; a disclosure of alternative procedures or treatments from which the participant may benefit; a description of confidentiality procedures; and contacts inside and outside the research team in the event of further questions.
  • Statements from participants that they understand they’re volunteering; they had time to read the form; the research isn’t FDA-regulated; and (if applicable) that the research regards a governmental public benefit or service. Participants must also know they have the right to withdraw from continued participation at any time without penalty or loss of benefits to which they’d otherwise be entitled.

While many believe the regulatory environment for testing new drugs is increasingly difficult, companies that know the challenges and strategize their approach accordingly will always have the advantage.

"It ain't getting any easier to develop new therapies," said Alan Eisenberg of the Biotechnology Industry Organization in Reuters. “(But) knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing.”

For more information about clinical study guidelines on human participants, access